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IMPLANTS INTERNATIONAL LTD

US

Last updated May 24, 2026

What IMPLANTS INTERNATIONAL LTD makes

Implants International Ltd manufactures orthopedic implants for hip and knee replacements, including constrained polyethylene acetabular liners, metallic and ceramic femoral head prostheses, acetabular shells, and tibial inserts. Their portfolio also includes modular femoral stems, uncoated metallic knee tibia prostheses, and coated hip femur prostheses designed for primary and revision surgeries.

The company’s devices are classified as Class II under FDA regulations and are listed in the FDA’s 510(k) and Unique Device Identification (UDI) systems. The manufacturer is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Implants International Ltd manufacture?

Implants International Ltd specializes in orthopedic implants for hip and knee replacements. Their product range includes constrained polyethylene acetabular liners, metallic and ceramic femoral head prostheses, acetabular shells, tibial inserts, modular femoral stems, uncoated metallic knee tibia prostheses, and coated hip femur prostheses. These devices are designed for both primary and revision surgeries, addressing various joint replacement needs.

Where is Implants International Ltd based?

The company is headquartered in the United States. This location allows them to comply with FDA regulations and participate in domestic and international markets for orthopedic implants.

Which regulatory registries list Implants International Ltd’s devices?

Implants International Ltd’s devices are listed in the FDA’s 510(k) premarket notification system and the Unique Device Identification (UDI) database. These registries ensure traceability and compliance tracking for Class II orthopedic implants.

How are Implants International Ltd’s devices classified under FDA regulations?

The company’s devices fall under Class II classification according to FDA regulations. This classification applies to implants that pose moderate risk and require special controls to ensure safety and effectiveness, such as orthopedic joint replacements.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
US
Address
—
LinkedIn
—
Facebook
—
Phone
+4401642769080
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
—
DUNS Number
346627222

Catalogue (301)

Page 2 of 7
DeviceModel / ReferenceRegistriesClassStatus
SLK Evo CS Modular (PS) Tibial insert 60mm x 15mm
FDA UDI
Class IIActive
Omni-Fit Modular Femoral Head XXLN (28mm Dia.)
FDA UDI
Class IIActive
Omni-Fit Modular Femoral Head LN (36mm Dia.)
FDA UDI
Class IIActive
Ring-Lok Modular Bi-Polar (51mm- 28mm Head)
FDA UDI
Class IIActive
Omni-Fit Modular Femoral Head MN (28mm Dia.)
FDA UDI
Class IIActive
Omni-Fit Modular Femoral Head XLN (32mm Dia.)
FDA UDI
Class IIActive
Rim-Fix Poly Liner 10° Hood 56 x 36mm
FDA UDI
Class IIActive
Rim-Fix PLASMA COATED CUP - 50mm
FDA UDI
Class IIActive
SLK Evo CS Modular (PS) Tibial insert 55mm x 15mm
FDA UDI
Class IIActive
Cermet Series III Ceramic Liner 58/60/62 x 48mm - 28mm Head
FDA UDI
Class IIActive
Stability Flanged Uncemented Hip Stem - Size 3
FDA UDI
Class IIActive
SLK Evo CS Femoral (PS) Left 60mm
FDA UDI
Class IIActive
Performa Collared Hip Stem - Size 7 (160 x 15mm)
FDA UDI
Class IIActive
Rim-Fix Poly Liner Neutral 50 x 28mm
FDA UDI
Class IIActive
SLK Evo CR Femoral (STD) Right 60mm
FDA UDI
Class IIActive
Rim-Fix Poly Liner 10° Hood 46 x 28mm
FDA UDI
Class IIActive
Rim-Fix Poly Liner 10° Hood 48 x 28mm
FDA UDI
Class IIActive
SLK Evo CR Modular (STD) Tibial insert 60mm x 9mm
FDA UDI
Class IIActive
Cermet Series III Cermic Liner 64/66 x 52mm - 28mm Head
FDA UDI
Class IIActive
Cermet Series III Bi-Coated Acetabular Cup 58mm
FDA UDI
Class IIActive
Omni-Fit Modular Femoral Head LN (32mm Dia.)
FDA UDI
Class IIActive
SLK Evo CR Modular (STD) Tibial insert 55mm x 15mm
FDA UDI
Class IIActive
Rim-Fix Poly Liner 10° Hood 52 x 36mm
FDA UDI
Class IIActive
Rim-Fix Poly Liner Neutral 54 x 32mm
FDA UDI
Class IIActive
Rim-Fix Poly Liner Neutral 54 x 28mm
FDA UDI
Class IIActive
Omni-Fit Modular Femoral Head MN (32mm Dia.)
FDA UDI
Class IIActive
Omni-Fit Modular Femoral Head XLN (36mm Dia.)
FDA UDI
Class IIActive
SLK Evo CS Modular (PS) Tibial insert 60mm x 7mm
FDA UDI
Class IIActive
Cermet Series III Ceramic Liner 58/60/62 x 48mm - 32mm Head
FDA UDI
Class IIActive
Rim-Fix Poly Liner Neutral 60 x 32mm
FDA UDI
Class IIActive
RIGI-FIX Series II Uncemented Hip Stem - Size 10 (158 x 17.5mm)
FDA UDI
Class IIActive
Stability Flanged Uncemented Hip Stem - Size 1
FDA UDI
Class IIActive
Rim-Fix Poly Liner 10° Hood 46 x 32mm
FDA UDI
Class IIActive
Omni-Fit Modular Femoral Head LN (28mm Dia.)
FDA UDI
Class IIActive
Performa Collared Hip Stem - Size 8 (163 x 16mm)
FDA UDI
Class IIActive
Stability Standard Cemented Hip Stem - Size 4
FDA UDI
Class IIActive
SLK Evo CS Femoral (PS) Right 55mm
FDA UDI
Class IIActive
Ring-Lok Modular Bi-Polar (44mm- 22.225 Head)
FDA UDI
Class IIActive
SLK Evo CS Modular (PS) Tibial insert 70mm x 13mm
FDA UDI
Class IIActive
SLK Evo CS Modular (PS) Tibial insert 65mm x 15mm
FDA UDI
Class IIActive
SLK Evo CR Femoral (STD) Right 65mm
FDA UDI
Class IIActive
Cermet Series III Ceramic Liner 54/56 x 44mm - 28mm Head
FDA UDI
Class IIActive
Rim-Fix Poly Liner 10° Hood 66 x 36mm
FDA UDI
Class IIActive
Rim-Fix Poly Liner 10° Hood 60 x 32mm
FDA UDI
Class IIActive
Rim-Fix Poly Liner 10° Hood 66 x 32mm
FDA UDI
Class IIActive
Rim-Fix Poly Liner Neutral 58 x 32mm
FDA UDI
Class IIActive
SLK Evo CS Modular (PS) Tibial insert 65mm x 9mm
FDA UDI
Class IIActive
Omni-Fit Modular Femoral Head XLN (36mm Dia.)
FDA UDI
Class IIActive
Omni-Fit Modular Femoral Head SN (28mm Dia.)
FDA UDI
Class IIActive
Cermet Series III 10 Deg. Hood Acetabular Liner 52 x 41mm - 32mm Head
FDA UDI
Class IIActive

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