HemiCAP Patello-Femoral Resurfacing Prosthesis
510(k) K060127
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK060127 | Date16 Mar 2006 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- KRR
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3540
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The HemiCAP Patello-Femoral Resurfacing Prosthesis is a semi-constrained, cemented knee prosthesis designed for patello-femoral joint resurfacing. It is classified as a metal/polymer prosthesis and is intended to address degenerative or traumatic conditions isolated to the patellofemoral articulation, including osteoarthritis, patellar dislocation, or post-traumatic instability. The device replaces the worn or damaged articular surfaces to restore joint function and alleviate pain.
This prosthesis is supplied as a single-use, sterile device intended for use in orthopedic surgical settings. It requires cement fixation and is compatible with standard operating room environments. The device is regulated under FDA 510(k) clearance (K060127) and falls under the Orthopedic specialty category. Multiple FEI numbers (e.g., 3005706667, 1000114185) correspond to its regulatory submission and classification as a Class II device.
Other devices from Arthrosurface, Inc.
Questions
AI-generated answers, 1 Oct 2026
What conditions is the HemiCAP Patello-Femoral Resurfacing Prosthesis designed to treat?
This prosthesis is specifically intended for degenerative or traumatic conditions isolated to the patellofemoral joint, including osteoarthritis, patellar dislocation, or post-traumatic instability. It replaces the worn or damaged articular surfaces to restore joint function and relieve pain.
How is the HemiCAP Patello-Femoral Resurfacing Prosthesis supplied and prepared for use?
The device is supplied as a single-use, sterile prosthesis. It requires cement fixation during surgery, meaning it is implanted using orthopedic bone cement to secure it in place. This ensures proper integration with the patient’s bone structure.
Is the HemiCAP Patello-Femoral Resurfacing Prosthesis reusable or intended for single-use?
The HemiCAP Patello-Femoral Resurfacing Prosthesis is explicitly designed for single-use only. This ensures sterility and safety for each patient, reducing the risk of cross-contamination or device degradation between procedures.
What materials are used in the construction of the HemiCAP Patello-Femoral Resurfacing Prosthesis?
The prosthesis is composed of metal and polymer materials, forming a semi-constrained design. This combination provides durability and stability while allowing for controlled movement within the patellofemoral joint.
How should the HemiCAP Patello-Femoral Resurfacing Prosthesis be stored before use?
As a sterile, single-use device, it should be stored in its original packaging in a clean, dry environment, protected from moisture, extreme temperatures, and direct sunlight. Follow manufacturer guidelines for shelf-life and expiration dates to ensure optimal performance.