510(k) Report

FDA applicant

Genesis Orthopedics, Inc.

Cambridge, MA2 decisions1995–19950 recalls

FDA records 2 decisions for Genesis Orthopedics, Inc. (Cambridge, MA) in 1995: 2 510(k) clearances. Most are in product codes HTY (Pin, Fixation, Smooth) and HWC (Screw, Fixation, Bone). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Genesis Orthopedics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Genesis Orthopedics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Genesis Orthopedics, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HTYPin, Fixation, Smooth1decision
  • HWCScrew, Fixation, Bone1decision

What has FDA decided for it lately?

  • K954511GO Intramedullary Nail Locking ScrewGenesis Orthopedics, Inc. · 1995
  • K954543GO Universalk-Wire Fluted DrillGenesis Orthopedics, Inc. · 1995

All 2 as Genesis Orthopedics, Inc. →

Other applicant names beginning “Genesis”

FDA records each applicant name separately; these may or may not be the same firm.

Genesis Industries, Inc. 17Genesis Fracture Care, Inc. 5Genesis Biosystems, Inc. 4Genesis Labs, Inc. 3Genesis Digital Imaging, Inc. 2Genesis Software Innovations 2Genesis Medical, Inc. 2Genesis Medical Interventional, Inc. 2Genesis Medical Technology, Inc. 1Genesis Health Technologies 1Genesis Air, Inc. 1Genesis Health Light Corporation 1