Osteonics Corp.

United StatesFDA applicant, unverified

Devices: 178

What Osteonics Corp. makes

Osteonics Corp. manufactures orthopedic implants for joint replacement, including modular hip stems (cemented and uncemented), acetabular components, elbow prostheses, and knee tibial components. Their portfolio includes specialized femoral heads, shoulder humeral prostheses, and acetabular cups designed for primary and revision surgeries. The company also produces fixation devices such as interlaminar clamps for spinal applications.

The company’s devices are classified under FDA regulations as Class I, Class II, and Class III, with many authorised via the 510(k) pathway. Products are listed in the FDA’s 510(k) database, reflecting their regulatory clearance status. The manufacturer operates from the United States.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

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Osteonics Corp.

What Osteonics Corp. makes

Catalogue178

Osteonics Series 7000 Total Knee Femoral Components Ref K944285

Osteonics 7000 Posterior Stab. Total Knee Fem. Com Ref K914565 Open recall

Osteonics 22mm, +10 Neck Bearing Heads Ref K933359

Osteo Compression Condyle Screw System Ref K983508

Osteonics Spinal System - Variable Offset Connector Assembly Ref K964544

Osteonics All Polyethylene Glenoid Shoulder Component Ref K962082 Open recall

Osteo 4.0mm Cannulated Screw System Ref K983165

Osteonics Omnifit Ha Hip Stem Series, Osteonics Secur-Fit Ha Hip Stem Series, Osteonics Primary Secur-Fit Plus Hip Stems Ref K982032

Osteonics Anteverted Neck Ha Hip Stems Ref K980766

Omnifit Total Knee Series Iii, Iv & Post. Stab. Fem Ref K884410

Osteonics Series 7000 Basic Femoral Components Ref K941128

Osteonics Secur-Fit Ha Plus Hip Stem Series Ref K951517

(Modified) Omnifit Threaded Acetabular Component Ref K861723

Osteonics Spinal System Ref K951725

Osteonics Ha Generation Ii Acetabular Component System Ref K983382

Osteonics Spinal System - Sacral Offset Connector Assembly Ref K984375

Osteo 4.0mm Cannulated Screw System Ref K981259

Hansson Pin System Ref K964893

Osteonics Restoration Ha Hip Stems Ref K983870

Osteonics Fx-Cablelok Grip Components Ref K980594

Omnifit (Tm) Total Knee Prosthesis System Ref K863668 Open recall

Osteonics Offset Hip Stems Ref K954598

Omnifit/Omniflex/Odc/Omnifit-Ha Hip Stem Series Ref K913812

7000 Series Modular Tibial Components Ref K915192

Omnifit Threaded Acetabular Comp. W/Micro Coating Ref K883921

Omnifit Self Tapping Cancellous Bone Screws Ref K894124

M.C.R. Knee Prosthesis (Series 3000) Ref K860654

Mod-Ml Unicompartmental Knee Prosthesis Ref K896856