Cormet 2000 Hemi Hip Metallic Resurfacing Prosthesis

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K994153 ↗

FDA Product Code

KXA

Device Class

Class II

Regulation

21 CFR Part 888.3400

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K973425 Active Cleared 27 Feb 1998

• Corin Metafix Hip Stem

  Class II

  FDA 510(k) K131952 Active Cleared 16 Dec 2013

• The Ligament Anchor Soft Screw

  Class II

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• Optimized Positioning System (OPS) ReView

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• The C-Fit Femoral Hip System

  Class II

  FDA 510(k) K965019 Active Cleared 25 Mar 1997

• Trinity Polyaxial Screw, Mehdian Spinal Rod (6mm), Model 159.XXX Series Catalogue Numbers

  Class II

  FDA 510(k) K010776 Active Cleared 6 Apr 2001

See all devices from Corin USA →

• What clinical situation is the Cormet 2000 Hemi Hip Prosthesis intended for?

  It is designed for hemiarthroplasty of the hip, providing a metallic resurfacing option that preserves more of the patient’s native bone compared with a total hip replacement. By resurfacing only the femoral side, surgeons can maintain natural anatomy while still restoring joint function.

• How is the prosthesis supplied for use in surgery?

  The device is supplied as a femoral head prosthesis intended for trial reductions during hip arthroplasty. Surgeons use it intra‑operatively to judge the correct size and to achieve the desired offset, leg‑length, and range of motion before final implantation.

• Is the Cormet 2000 prosthesis a single‑use or reusable product?

  The data describe it as a prosthetic component used during the surgical procedure; such components are typically implanted permanently and are not reused. Therefore, each unit is intended for a single patient and is not re‑sterilized for subsequent use.

• What sizes or models are available for this prosthesis?

  Specific size ranges are not listed in the provided information. The device is used for trial reductions, meaning a set of sizes is offered so the surgeon can select the appropriate femoral head that matches the patient’s anatomy and desired biomechanics.

• What regulatory clearance does the Cormet 2000 have?

  The prosthesis received traditional 510(k) clearance from the FDA (K994153) under product code KXA and regulation number 888.3400, indicating it was found substantially equivalent to a legally marketed predicate device.