FIVE STAR MANUFACTURING, INC.

Five Star Manufacturing, Inc. is an ISO 13485-certified, FDA-registered precision medical device manufacturer and surgical instrument repair specialist based in New Bedford, Massachusetts. The company operates two primary service lines: Five Star Manufacturing handles design and production of general hand-held surgical instruments, orthopedic instruments, implantable devices, and custom medical components from prototype through full-scale production. Five Star Surgical provides complete instrument lifecycle management, including factory-trained repair and restoration of surgical instruments to original manufacturer specifications. The company serves a dual customer base of original equipment manufacturers (including Zimmer Biomet, Arthrex, Smith + Nephew, DePuy Synthes, BD, and Integra) and healthcare systems (Northern Light Health, UMass Memorial, Boston Medical Center, Cambridge Health Alliance, Southcoast Hospitals Group). Manufacturing capabilities include precision machining, assembly, and quality control for instruments used in general surgery, orthopedic, and specialty procedures. Repair services encompass ultrasonic cleaning, instrument resharpening, functional testing, and restoration to meet or exceed industry standards. Five Star holds ISO 13485 medical device quality management certification, FDA device registration, and ITAR compliance (effective 2026). The organization emphasizes meticulous craftsmanship, attention to detail, and commitment to quality throughout manufacturing and repair processes. No specific product models or regulatory 510(k) clearances are detailed on the public website.