Cormet Hip Resurfacing System

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

Generic Name

Prosthesis, hip, semi-constrained, metal/metal, resurfacing

PMA Number

P050016 ↗

FDA Product Code

NXT

Device Class

Class III

Advisory Committee

Orthopedic

FDA Decision

APPR Approved

• The Mehdian Lumbo-Sacral Pedicle Screw System

  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

  FDA 510(k) K994152 Active Cleared 6 Mar 2000

• Optimized Positioning System (OPS) ReView

  Class II

  FDA 510(k) K193042 Active Cleared 26 Jun 2020

• 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 types of patients is the Cormet Hip Resurfacing System designed to help, and why might it be preferred over traditional total hip arthroplasty?

  The Cormet Hip Resurfacing System is designed for skeletally mature patients suffering from non-inflammatory degenerative arthritis (such as osteoarthritis or avascular necrosis) or inflammatory arthritis (like rheumatoid arthritis). It is particularly suited for patients who are younger or more active, as these individuals may not be ideal candidates for traditional total hip arthroplasty due to a higher likelihood of requiring future revisions on the same hip. The system aims to reduce pain and improve hip function while preserving more bone structure than a full replacement.

• How is the Cormet Hip Resurfacing System fixed in place, and what does this mean for its durability and reusability?

  The Cormet Hip Resurfacing System uses hybrid fixation, combining a cemented femoral head component with a cementless acetabular component. This design allows for secure placement while potentially extending the lifespan of the implant. Since it is explicitly labeled as a **single-use device**, it is not intended for reuse, ensuring patient safety and compliance with regulatory standards.

• What regulatory pathway was followed for the approval of the Cormet Hip Resurfacing System, and what does this indicate about its intended use?

  The Cormet Hip Resurfacing System was approved through the FDA’s **Premarket Approval (PMA) process**, specifically under PMA number **P050016**. This pathway is reserved for high-risk devices like orthopedic implants, confirming that its intended use—resurfacing hip arthroplasty for pain relief and improved function in specific patient populations—was thoroughly evaluated for safety and effectiveness. The approval also aligns with its classification as a **Class III device**, reflecting its critical role in patient care.

• Does the Cormet Hip Resurfacing System come in multiple sizes or models, and how might this affect surgical planning?

  Yes, the Cormet Hip Resurfacing System includes **multiple model references** (listed in the OpenFDA database), which suggests a range of sizes to accommodate different patient anatomies. This variability allows surgeons to select the most appropriate implant dimensions for optimal fit, stability, and function during resurfacing hip arthroplasty. The exact sizing details would be referenced in the product documentation provided by Corin USA.