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 Ion Implanted Femoral Bearing Series Ref K910988
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
- Active Regimes: 510(k) Registry: 510(k) ClassClass:III
- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Omnifit Acetabular Shell Cement Spacer System Ref K882812
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIOmnifit Zirconia C-Taper Femoral Bearing Head Ref K925695
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:—
- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Osteonics(R) Mid-Shaft Cement Spacer Ref K910461
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIOsteonics Extended Femoral Bearing Head Ref K982936
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIUhr UNIVERSAL6HIP Replacement Ref K800207
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIOsteonics Cdh Hip Stem Ref K910922
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIThe Omnifit Epf Hip Joint Femoral Stem Ref K896047
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIOsteonics(R) 6011 Hip Stem Series Ref K905158
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIHcl Acetabular Components Ref K803192
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Osteonics Restoration Monolithic Hip Stem Ref K943774
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIOmnifit Total Knee Bone Augmentation Wedges Ref K874635
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIOmnifit Total Knee Prosthesis System Ref K862837
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIRestoration Acetabular Cup Ref K943549
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIOsteo Compression Hip Screw System Ref K971654
Active Regimes: 510(k) Registry: 510(k) ClassClass:IISilkon Stainless Steel Cable System Ref K962132
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIOsteo Bos System In Stainless Steel Ref K973204
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIOsteo Dynatroc Proximal Femoral Nail Ref K983339
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIOsteonics Tibial Tray Screw Hole Plugs Ref K970779
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIOsteo Kirschner Wires Ref K971962
Active Regimes: 510(k) Registry: 510(k) ClassClass:II7000 Series Total Knee Patellar Components Ref K915186
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIMicro-Structured HS2P Hip Stems Ref K833970
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIKdr Acetabular Component Ref K895702
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIOmnifit Ceramic Morse Taper Head (1002 Series) Ref K885102
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIOstroncs Hemi-Hip Stem Series Ref K922146
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIOsteonics Alumina C-Taper Head Ref K971409
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIOsteonics Primary Secur-Fit Plus Hip Stems Ref K990203
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIOsteonics Acetabular Wedge System Ref K971422
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Omnifit Constrained Acetabular Bearing Insert Ref K890197
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIOmnifit Ceramic Morse Taper Head Ref K894694
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIOsteo Bos System Ref K972323
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIOsteonics(R) Prt Hip Stem Series Ref K911890
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIOsteonics Ps Head And Neck Hip Stem Series Ref K902712
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Osteonics Anteverted Neck Hip Stem Ref K971497
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIOsteonics Series 7000 Ad Tibial Tray Ref K983657
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIOsteonics Spinal System Cylindrical Bone Screws Ref K984302
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIOsteonics +10 Unipolar Adaptor Sleeve Ref K984585
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAcetabular Dome Hole Plugs Ref K942809
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIIOsteonics(R) Ccr Hip Stem Series Ref K945574
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIOsteonics Restoration Cemented Hip Stem Series Ref K943778
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIOsteonics Cement Restrictor Ref K900462
Active Regimes: 510(k) Registry: 510(k) ClassClass:II
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