Orthopedics in California

Echolight S.p.A. is an Italian medical device manufacturer specializing in bone density assessment and osteoporosis diagnosis. The company originated as a spin-off from Italy's Consiglio Nazionale delle Ricerche (CNR) and markets the EchoS system—a non-ionizing radiation bone densitometer that uses proprietary Radiofrequency Echographic Multi Spectrometry (R.E.M.S.) technology. The EchoS device performs ultrasound-based scanning of the lumbar spine and proximal femur to evaluate bone mineral density (BMD), T-score, Z-score, and bone microarchitecture quality without exposing patients to ionizing radiation. Scan time is rapid: 80 seconds for spine assessment, 40 seconds for femur. The system produces immediate medical reports with fracture risk indices and body composition data. Key clinical advantages over dual-energy X-ray absorptiometry (DXA) and quantitative ultrasound (QUS) include radiation-free operation, portability, lack of need for certified operators or shielded rooms, and applicability to pediatric, pregnant, diabetic, oncology, and secondary osteoporosis patients. EchoS is available in both stationary and portable configurations. The company holds FDA clearance, CE marking, ISO 13485:2016 quality management certification, ISO 9001:2015 compliance, and multiple international regulatory approvals. Echolight's R.E.M.S. technology is recognized in Italian Ministry of Health clinical guidelines (ISS guidelines on fragility fracture diagnosis and risk stratification). The company engages in ongoing clinical validation at major international osteoporosis centers and participates in scientific symposia including WCO-IOF-ESCEO conferences.

Adler MicroMed is a sales, marketing, and distribution company specializing in high-quality medical devices for gastroenterologists, colorectal surgeons, and general surgeons. The company represents small to mid-sized hi-tech medical device manufacturers, both domestic and international, providing world-class design with superior performance, functionality, and affordability. Primary product lines focus on gastroenterology and colorectal surgery applications, including advanced endoscopic visualization and intervention systems. The company also distributes devices for endovascular treatment of varicose veins, general surgery, neurosurgery, ENT, and orthopedic specialties. Key offerings include the NeoLaser system for laser-based therapeutic applications and the SapiMed product line for coloproctological procedures, including dilation and intervention devices. Products emphasize modular design, flexibility, and clinical efficacy. Adler MicroMed operates as a B2B distributor and authorized reseller, maintaining an online shop for direct procurement of colorectal devices. The company serves hospital systems, surgical centers, and private practices across multiple surgical specialties. Distribution and customer support are based in San Diego, California, with direct sales and consultation services available.

West Coast Surgical is a contract manufacturer and design-to-production partner specializing in surgical devices and instrumentation. With over 20 years of experience, the company focuses on cardiovascular, neuro, and spine instruments, offering end-to-end services from concept development through finished device manufacturing. Core capabilities include device design and development, contract manufacturing, prototyping, and design for manufacturing (DFM). The company operates FDA-registered facilities in Half Moon Bay, California and Houston, Texas, equipped with advanced machining capabilities including CNC milling (5-axis), Swiss lathes, wire EDM, heat treating, and inspection/quality control systems. West Coast Surgical serves both established medical device companies and emerging ventures, with expertise in regulatory compliance and quality system implementation.

CorTechs Labs is a SaaS-based medical imaging software company specializing in AI-powered quantitative analysis of brain and oncological imaging. The company develops advanced algorithms for automated brain segmentation, volumetric analysis, and lesion quantification across MRI, CT, and PET modalities. Their solutions enable clinicians to detect and monitor neurodegenerative diseases (dementia, Alzheimer's, multiple sclerosis), brain tumors, and prostate cancer with improved diagnostic confidence and efficiency. CorTechs' flagship NeuroQuant® platform has processed over 2 million brain scans across 1,500+ medical institutions in 44 countries, providing radiologists with rapid, objective measurements for disease progression tracking and comparative analysis against normative databases. The company also offers OnQ™ Prostate for prostate MRI analysis and specialized tools for lesion surveillance and post-operative assessment. Solutions integrate with major OEM imaging platforms (GE, Siemens, Philips, Canon) and are supported by Category III CPT codes for reimbursement.

SURGLASSES Inc. (Taiwan Main Orthopaedic Biotechnology Co., Ltd.) is a medical technology manufacturer specializing in augmented reality (AR) surgical guidance systems for orthopedic and neurosurgery applications. The company develops computer-assisted surgical navigation platforms designed to reduce X-ray radiation exposure, improve surgical precision, and enable minimally invasive procedures. Core product lines include the Caduceus S AR Navigation System (FDA 510(k) cleared in December 2022), a spine 3D computer surgery navigation system, and surgical planning software. The company also manufactures medical education platforms, including the Asclepius Virtual Dissection Table (available in multiple sizes for institutional use) and the Asclepius AI Table, described as the world's first AI-powered anatomy table featuring integrated modules for anatomy, radiology, histopathology atlas, and CT rendering. The Asclepius platform supports online examination and anatomy app functionality for medical schools and training institutions. SURGLASSES holds FDA 510(k) clearance and serves hospitals, physicians, and patients across North America and Asia-Pacific markets. The company reports completion of the first AR surgery procedure in the United States (April 2023). Operations include manufacturing and distribution facilities in Taiwan and the United States, with focus on reducing surgical time, improving outcomes, and lowering procedural costs through advanced visualization and navigation technologies.

Ekso Bionics is a publicly traded leader in wearable exoskeleton technology, founded in 2005 by UC Berkeley experts and headquartered in San Rafael, California. The company develops FDA-cleared robotic exoskeletons for clinical and home rehabilitation, targeting patients with spinal cord injury, stroke, brain injury, and multiple sclerosis. Its healthcare portfolio includes the EksoNR (inpatient rehabilitation), Ekso Indego Therapy (outpatient therapy), and Ekso Indego Personal (home/community use). All products feature Variable Assist technology that adapts power delivery to enhance mobility and functional independence. With 500+ rehabilitation centers worldwide and Medicare coverage eligibility, Ekso Bionics serves hospitals, outpatient facilities, and individuals seeking mobility restoration and neurological recovery support.

Accurate Surgical & Scientific Instruments Corp. (ASSI) is a leading manufacturer of precision surgical instruments for specialized surgical disciplines. With nearly four decades of industry experience, ASSI supplies a comprehensive range of expertly crafted instruments including bipolar and monopolar forceps, scissors, needle holders, retractors, microvascular clamps, and specialty tools for microsurgery, hand surgery, neurosurgery, plastic and reconstructive surgery, ophthalmology, ENT, urology, and vascular surgery. The company emphasizes precision engineering, quality materials (stainless steel, titanium, insulated variants), and customer service. Products span electrosurgical instruments, bone and soft tissue surgery tools, and specialized microsurgical equipment. ASSI operates manufacturing and distribution facilities on both US coasts with B2B direct sales to hospitals, surgical centers, and medical professionals.

Bone Health Technologies develops and manufactures Osteoboost, an FDA-cleared, wearable vibration therapy device designed to treat osteopenia in postmenopausal women. The device uses targeted mechanical stimulation technology inspired by NASA research on bone loss mitigation in astronauts. Osteoboost is a drug-free, prescription-strength treatment worn as a belt that delivers localized vibrations to stimulate bone-building cells. In a 12-month clinical trial, the device demonstrated 85% reduction in vertebral bone density loss and 83% reduction in vertebral bone strength loss in women using it at least 3 times weekly, compared to placebo. The company received FDA clearance through the De Novo pathway as the first-of-its-kind treatment for osteopenia. The device showed no device-related serious adverse events in clinical trials and is HSA/FSA eligible. Osteoboost addresses a significant clinical gap in early-stage bone health intervention, filling the void between osteopenia diagnosis and pharmaceutical treatment. The company has secured $8M in recent funding to expand production and market access. The device is currently available for direct consumer purchase and requires a prescription from a healthcare provider. Manufacturing and clinical validation meet FDA standards for Class II medical devices.

Fziomed, Inc. is a global leader in surgical adhesion prevention, founded in 1996 and headquartered in San Luis Obispo, California. The company specializes in developing, manufacturing, and commercializing surgical biomaterials designed to prevent postsurgical adhesions—a common complication following surgical procedures. Fziomed's products utilize proprietary dual-polymer gel technology to create clear, absorbable formulations that provide temporary tissue separation during the healing process, significantly reducing adhesion formation. The company's flagship product, Oxiplex® gel, received FDA De Novo classification and marketing authorization in July 2025 for reducing postoperative leg pain and neurological symptoms in adult patients undergoing lumbar spine procedures. Fziomed's adhesion barrier products are marketed in over 70 countries and have been utilized in nearly 1 million procedures worldwide since 2002. The product portfolio addresses multiple surgical disciplines including spine surgery, tendon and peripheral nerve procedures, intrauterine surgery, and abdominal/pelvic procedures. With approximately 59 employees, Fziomed maintains full control over both manufacturing and commercialization of its innovative surgical solutions.

Mainstay Medical Limited manufactures the ReActiv8 Restorative Neurostimulation system, a minimally invasive medical device designed to treat mechanical chronic low back pain (CLBP). ReActiv8 is the first and only restorative neurostimulation therapy that directly stimulates the nerves of the multifidus muscle, which is responsible for stabilizing the lumbar spine. The device addresses the underlying anatomical cause of mechanical low back pain rather than merely managing symptoms through pain medication or conservative approaches. The system is minimally invasive and employs the body's natural mechanisms to interrupt the cycle of pain, degeneration, and loss of function. Clinical trial data (ReActiv8-B) demonstrates significant outcomes including ≥50% VAS pain reduction, ≥20-point ODI improvement, and voluntary opioid reduction or elimination in eligible patients. The ReActiv8 system is full-body MRI conditional, permitting patients to undergo diagnostic MRI scans post-implantation. The company markets the device to both patients experiencing chronic low back pain unresponsive to conventional therapies and physicians seeking a restorative alternative to pharmacological, physical therapy, and surgical interventions. Mainstay Medical serves the orthopedic and spine specialty markets and provides patient information, clinical data, and physician resources to support adoption and treatment planning.

Mizuho OSI is a surgical equipment manufacturer specializing in operating room tables and positioning systems for orthopedic, spinal, and trauma surgery. Founded over 40 years ago, the company pioneered the specialty surgery table market and continues to develop innovative intraoperative positioning solutions. Their product portfolio includes motorized surgical tables (ProAxis® for spinal surgery, Hana® for orthopedic procedures, and Trios® modular system), head positioning systems (Levó®), protective equipment (ProneView®), positioning accessories, pressure injury abatement products, and surgical consumables. Mizuho OSI serves hospitals, ambulatory surgery centers (ASCs), and specialty surgical facilities across the United States and internationally through distributors. The company emphasizes surgeon collaboration in product design, intraoperative positioning precision, and patient safety outcomes. Products are designed to provide superior patient positioning, improved surgical access, and the ability to make real-time adjustments during procedures. The organization offers comprehensive support including biomed and clinical training programs, in-service education, procedure setup resources, mobile applications, service contracts, technical support, and parts availability. California-based with US manufacturing and distribution capabilities.

MaxMoreSpine designs and distributes minimally invasive endoscopic spine surgery systems for the treatment of degenerative spinal disorders, lumbar disc herniation, and facet joint pathology. The company manufactures a portfolio of transforaminal, interlaminar, intradiscal, and cervical endoscopic systems that enable surgeons to perform spinal procedures using local anesthesia with reduced instrumentation, lower disposable costs, and improved patient safety compared to traditional open surgery. Primary product lines include the PTED Endoscopic System (percutaneous transforaminal endoscopic decompression), PSLD Endoscopic System (posterior interlaminar lumbar decompression), MaxFusion by Dr. Morgenstern (endoscopic transforaminal lumbar interbody fusion), Biportal Endoscopic System, J@blation System (facet joint ablation), and cervical mini systems. MaxMoreSpine serves orthopedic and neurosurgeons, pain management physicians, and hospitals globally. The company actively supports continued medical education through hands-on workshops, cadaveric training programs, and participation in international conferences. Products feature 4K visualization capabilities and neurological safety monitoring. Based in San Diego, California, MaxMoreSpine maintains European operations and distributes systems internationally.

Bioseal is a California-based manufacturer and supplier of sterile, single-use surgical supplies and procedural trays serving healthcare providers for over 35 years. The company specializes in surgical put-ups, single-use instruments, infection control solutions, and custom medical device packaging for Central Sterile Processing Departments and Operating Room Managers. Bioseal offers ISO-certified quality management, OEM custom manufacturing solutions, and products tailored to multiple hospital departments including Emergency, ICU, OR, Cardiology, Labor/Delivery, Orthopedics, and specialty clinics. Key product lines include the Duraholder Instrument Protection System (IPS), BioView Scopes, disposable and custom procedural trays, cast padding, endoscopy kits, and specialized tubing systems. The company maintains group purchasing agreements and serves hospitals nationwide with a focus on reducing patient risk and lowering procurement costs through standardized sterile products and regulatory-compliant sterilization solutions.

O.N. Diagnostics develops non-invasive diagnostic applications for bone health and fracture risk assessment. The company's FDA-cleared VirtuOst® technology performs Biomechanical Computed Tomography (BCT) analysis, providing comprehensive measurements of bone mineral density and bone strength using existing CT scans of the hip or spine without requiring additional radiation, special imaging protocols, or calibration phantoms. VirtuOst identifies patients with osteoporosis and high-risk osteopenia, supporting clinical decision-making in patient care while enabling research applications in clinical trials, drug development, and medical device design. Since 2005, the company has maintained leadership in clinical bone assessment research and collaborates with academic and industry partners internationally.

New Deantronics is a medical device developer and manufacturer founded in San Francisco in 1985, with engineering and manufacturing operations in Taiwan and a state-of-the-art 200,000 sq. ft. facility in Spanish Springs, Nevada. The company specializes in designing, developing, and manufacturing innovative surgical and medical devices for use in general surgery, neurosurgery, cardiology, orthopedics, and aesthetic medicine. New Deantronics is particularly known for miniaturized medical devices, including nano cameras used in minimally invasive surgical procedures. The company offers comprehensive services including design, development, manufacturing, packaging, sterilization, regulatory compliance, and post-market support. The company emphasizes quality, precision, and innovation, with a strong focus on FDA and ISO 13485 regulatory compliance. New Deantronics also operates medical device incubation centers to support startup innovation in the medical device sector.

Unik Orthopedics develops personalized medical devices and cloud-based surgical planning software for total knee and hip replacement procedures. The company provides an open-platform solution combining advanced imaging analysis, customized 3D surgical planning, personalized single-use surgical instruments, and robotic-assisted technologies that work with any implant brand. Using MRI or CT imaging, the company creates precise 3D anatomical models of each patient, enabling surgeons to develop individualized surgical plans optimized for implant size, alignment, and placement. Custom instruments are manufactured in their California facility and delivered within two weeks of imaging. The technology reduces surgical steps, requires fewer instruments, and improves procedural efficiency and consistency compared to conventional instrumentation. Unik Orthopedics partners with healthcare facilities, orthopedic surgeons, and implant manufacturers to enhance patient outcomes and surgical precision. The company positions its personalized approach as reducing error margins and improving patient satisfaction in joint replacement surgery.

Active Life Scientific is the industry leader in tactile assessment of tissue, specializing in bone quality measurement. The company pioneered Reference Point Indentation (RPI) technology, enabling quantified-touch for surgeons and physicians. BoneScore® is the first FDA-cleared (De Novo) device for non-invasive, radiation-free tactile assessment of bone biomechanical properties, measuring bone strength and fracture toughness at critical fracture sites (hip, wrist, spine). The OsteoProbe® delivers real-time tactile feedback and in vivo/in situ material measurement, complementing traditional bone density tests like DXA. Applications span orthopedic surgery, osteoporosis assessment, fracture risk evaluation, arthroplasty planning, and bone health monitoring. Technology applicable to preclinical research, biomaterials characterization, and tissue engineering.

Siren is a digital health and remote patient monitoring company specializing in smart textile technology for chronic disease management. The company manufactures FDA-registered Siren Socks, wearable temperature-monitoring devices embedded with microsensors that detect early signs of foot inflammation in patients with diabetes and neuropathy. The socks wirelessly transmit data to a monitoring platform where licensed nurses review metrics and alert healthcare providers to potential injuries, enabling early intervention to prevent diabetic foot ulcers. Siren's integrated care management service includes device delivery, continuous nurse-led monitoring, provider alerts, and clinical decision support. The platform operates without requiring smartphone connectivity and features machine-washable, auto-replacing sock technology. The company serves high-risk diabetic populations through partnerships with the US Department of Veterans Affairs and healthcare networks nationwide, focusing on reducing preventable amputations and hospitalizations through proactive foot health surveillance.

ECA Medical Instruments is a manufacturer of single-use, Surgery-Ready™ procedure kits and surgical instruments. The company specializes in pre-assembled, sterile surgical kits that serve as a single-source solution for hospitals and surgical centers, eliminating the need for on-site sterilization and calibration. ECA is recognized as an international authority on torque-limiting instrumentation, a critical capability in orthopedic and spine surgery where precise torque application prevents over-tightening of fasteners and implants. Product lines include orthopedic procedure kits, spine surgery kits (including cervical fusion kits), cardiovascular procedure kits, and neuromodulation instrumentation. All kits are supplied sterile and calibrated on-site before shipment, ensuring compliance with surgical standards and reducing preparation time in the operating room. The company serves market leaders in surgical hospitals, orthopedic centers, and specialty surgical facilities. ECA's manufacturing process integrates instrument sourcing, kit assembly, sterilization, and quality assurance, positioning the firm as a comprehensive vendor for surgical procedure kit solutions.

ATEC Spine (Alphatec Holdings, Inc.) is a spinal surgery device manufacturer specializing in innovative interbody fusion systems and surgical technologies. The company develops porous titanium interbody spacers, including the IdentiTi II LIF platform, designed for anterior and posterior spinal fusion procedures. ATEC's product portfolio encompasses procedural technologies across multiple spine surgery approaches: anterior cervical discectomy and fusion (ACDF), transforaminal lumbar interbody fusion (TLIF), anterior lumbar interbody fusion (ALIF), posterior cervical fusion (PCF), lateral transpsoas (LTP), prone transpsoas (PTP), posterior lumbar interbody fusion (PLIF), posterior fixation, and corpectomy. The company positions itself as a revolutionizer of spine surgery approaches with intentional, integrated, and individualized design principles. ATEC Spine serves spine surgeons and hospitals performing complex spinal procedures, competing in the orthopedic implant and minimally invasive spine surgery segment. The company reported full-year 2025 total revenue of $764 million with 25% growth, demonstrating significant market presence. ATEC maintains an active presence at major spine surgery societies and regional symposia, engaging surgeons on procedural innovation and clinical outcomes. The company emphasizes surgeon-driven education, data-informed decision-making, and procedural discipline in spinal fusion techniques.

Breg, Inc. is a leading orthopedic support and rehabilitation device manufacturer based in Carlsbad, California. The company designs and manufactures over 320 prefabricated and custom orthopedic braces, supports, and related products serving patients, healthcare providers, and durable medical equipment (DME) suppliers across the United States and internationally. Product lines include knee bracing (post-operative, custom rigid frames, soft sleeves), ankle and foot bracing (walker boots, stirrups, soft sleeves), spine bracing (lumbar supports, cervical collars), hip bracing, upper extremity supports (shoulder, elbow, wrist), and cold therapy systems. Breg operates dual distribution centers (West and East) enabling rapid fulfillment of both prefabricated and custom-fabricated orders with lead times ranging from same-day to three days. The company offers DME program administration support and custom fabrication services. Products carry limited manufacturer warranties ranging from three months to five years depending on component type. Breg maintains ACHC accreditation and adheres to AdvaMedDx Code of Ethics, signaling commitment to regulatory compliance and ethical business practices. The company markets to orthopedic surgeons, physical therapists, athletic trainers, and healthcare facilities for acute and chronic joint mobility support.

Composite Manufacturing, Inc. (CMI) is an FDA-registered manufacturer and biomedical engineering company specializing in advanced carbon fiber and composite medical device design and production. For over 40 years, CMI has engineered custom composite solutions for neurological surgery, interventional neuroradiology, orthopedic procedures, urological interventions, and general surgical practices. The company manufactures radiolucent patient positioning systems, surgical tables, and imaging-compatible equipment featuring carbon fiber composites that are up to 5x stronger than aluminum at a fraction of the weight. CMI provides end-to-end capabilities including in-house design, tooling, prototyping, and manufacturing with vertical integration ensuring superior quality control, cost efficiency, and rapid market response. Their proprietary technologies enable complex geometries and high-performance solutions for demanding medical, surgical, and imaging applications.

Bentec Medical OpCo, LLC is a medical-grade silicone fabrication and contract manufacturing specialist founded in 1994 and currently headquartered in Woodland, California. The company operates in two primary segments: (1) OEM contract manufacturing services providing silicone component fabrication, assembly, sterilization, packaging, design consultation, and regulatory support for medical device partners; and (2) proprietary FDA and CE-approved silicone medical devices distributed under the Bentec Medical brand. The company specializes in advanced silicone fabrication capabilities including micro-molding, multi-lumen extrusions, hybrid calendered sheeting, dip coating, and knife coating. Manufacturing expertise encompasses tight-tolerance components, complex multi-process assemblies, and material compounding. Bentec serves OEM customers and direct end-users across oncology, cardiology, urology, pediatrics, bariatric, general and cosmetic surgery, ENT, and interventional radiology specialties. Quality and regulatory credentials include FDA registration, ISO 13485:2016 certification, and ISO 14644 Class 7 cleanroom certification. The company maintains a track record of 100% monthly supplier scorecards from Fortune 500 OEM customers. Manufacturing capabilities combine proprietary techniques with fully validated processes and stringent environmental controls. Bentec was acquired by Hermitage/Greyrock in 2016, which implemented institutional ownership standards, enhanced engineering and quality management systems, and expanded production capacity and fabrication technology.

Avatar Medical USA Inc develops FDA-cleared and CE-marked 3D medical imaging visualization software that transforms DICOM medical images into interactive 3D patient avatars for clinical consultation, surgical planning, and medical education. The platform is hardware-agnostic and integrates with existing PACS systems without preprocessing requirements. It enables real-time 3D visualization suitable for multiple surgical specialties including neurosurgery, oncology, ENT, oral maxillofacial surgery, cardiovascular and vascular surgery, and urology. The software supports intraoperative guidance, multidisciplinary team collaboration, and patient engagement during pre- and post-operative consultations. Avatar Medical also offers Eonis Vision, a consultation-focused product, and Avatar Medical Academy for medical education. The platform supports extended reality (XR) interaction for immersive visualization. Clinical applications span from patient communication and informed consent to detailed surgical planning and training environments. The company serves major teaching hospitals and medical centers across North America and Europe, including Assistance Publique-Hôpitaux de Paris, Sorbonne University, and University of Miami.

Radlink, Inc. is a medical device software company specializing in intraoperative imaging navigation and surgical guidance systems for orthopedic surgery, with primary focus on hip arthroplasty (total hip replacement). The company develops AI-powered software platforms that integrate with standard fluoroscopy (C-arm and mobile X-ray) systems to provide real-time, patient-specific surgical guidance without requiring specialized hardware or invasive tracking. Core products include Radlink One Touch (redesigned surgeon's checklist interface), Radlink Hip (anterior and posterior approach THA software), Radlink3D (3D intraoperative assessment of acetabular cup and femur positioning with spinopelvic mobility analysis), Panoramic Fluoro (panoramic fluoroscopic imaging), and OrthoPlan 2.0 (preoperative planning). The platform operates as an open system compatible with any implant brand and any C-arm or mobile X-ray device on the market. Software enhancements include spinopelvic assessment for functional component positioning and leg length discrepancy prediction. Radlink also offers DR Pro (digital radiology software) and PACS/EMR/Citrix integration capabilities. The company markets to surgeons, hospitals, and health systems seeking to improve OR efficiency, reduce costs, and enhance clinical accuracy. Headquarters: El Segundo, California. The technology is clinically validated with peer-reviewed publications in orthopedic journals and is actively promoted through industry conferences including AAHKS (American Association of Hip and Knee Surgeons).