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.
DeviceDevice · Authorizations Verified Status Regime Registry Class
Osteonics Omnifit Ad Hip Stem Series Ref K940715
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Osteonics Scorpio Posteriorly Stabilized Total Knee System Ref K962152 Open recall
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIOsteonics Screw Hole Plugs Ref K965056
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIOsteonics Shoulder Humeral Components Ref K955731
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIOmnifit Epf Dual Geometry Acetabular Cup Ref K912654
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIOsteo Small And Mini Bone Screws Ref K971778
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIOmnifit Bone Screw Ref K873251
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIOsteonics N2/Vac Packaging Process Ref K955421
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIOsteonics Restoration Acetabular Ring Ref K970957
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIOsteonics(R) Series 7000 Total Knee Ref K940813
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIOsteonics Microsutered Femoral Componentes Ref K926201
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIPt Distal Tip Cement Spacer Ref K894708
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIOmnifit Total Knee Series Ii Tibial Inserts Ref K884398 Open recall
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIOsteonics Polyethylene Acetabular Components Ref K974685
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIOsteonics Omnifit Ad-Ha Hip Stem Series Ref K941366
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIOsteonics Unix Unicompartmental Ref K923011
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIOsteo Ic Retrograde/Antegrade Femoral Nail Ref K982601
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIOmnifit(R) Total Knee System (Modification) Ref K871769
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIColbalt Alloy Orthopaedic Wire Ref K811500
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIOsteonics Ion Implanted Total Knee Femoral Comp Ref K910989
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIOsteonics Gap-Ii Restoration Acetabular Shells Ref K980774
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Osteonics Ecsi Hip Stem Series Ref K900836
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Omniflex-C Uhmwpe Mid-Shaft Restrictor Ref K923616
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Osteonics N2/Vac Packaging Process Ref K955944
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Osteonics(R) Arc Depositioned Femoral Components Ref K930187
Active Regimes: 510(k) Registry: 510(k) ClassClass:IINormalized HS3N Proportional Series Hip Stems Ref K844818
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIPt Ii Distal Cement Spacer Ref K914406
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIOsteo 9mm Ic Tibial Nail Ref K984353
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIMicro-Structured Surface Hip Prosthesis Ref K831708
Active Regimes: 510(k) Registry: 510(k) ClassClass:—- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Restoration Ha Acetabular Cup Series Ref K943957
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIOsteonics Ps Hemi-Hip Stem Series Ref K933882
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIMicro-Struc. Acetabular Compon- MC2P Ref K850352 Open recall
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIIPs Omnifit Normalized Hip Stem Series Ref K910662
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIOsteo Compression Condyle Screw System Ref K971321
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIOsteo Bos System Product Line Extension Ref K973438
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIOsteo Anatomical Bone Plates Ref K972196
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIOsteonics Flanged Polyethylene Acetabular Cup Ref K963671
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIHip Stem System Titanium Alloy Ref K812801
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIOmnifit Ii Epf Hip Stem Series Ref K911585
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Osteo I-C Humeral Nail System Ref K981309
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIOsteonics Drm Acetabular Component Ref K903636
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Osteonics Secur-Fit Ad Generation Ii Acetabular Component System Ref K983502 Open recall
Active Regimes: 510(k) Registry: 510(k) ClassClass:II
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