101-32 Femoral Component
510(k) K813599
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK813599 | Date22 Jan 1982 | 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- Withdrawn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
- JDL
- Device Class
- Class III
- Regulation
- 21 CFR Part 888.3320
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
This device is a Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) as classified under FDA nomenclature. It is designed as a femoral component for hip replacement surgery, providing structural support and articulation within a semi-constrained hip prosthesis system. The component is intended for cemented fixation to the femur, ensuring stability and longevity in orthopedic reconstructions.
The 101-32 Femoral Component is supplied sterile and intended for single-use in orthopedic surgical settings. It is classified as a Class III medical device under FDA regulations and has received FDA 510K clearance as substantially equivalent to a predicate device. Storage and handling must comply with sterile surgical instrument protocols, and compatibility with MRI environments should be verified per manufacturer guidelines. Sizes and variants are referenced in associated FEI numbers for regulatory tracking.