MicroPort CoCr Femoral Heads
510(k) K190123
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK190123 | Date15 Jul 2019 | 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- Withdrawn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
- LPH
- FDA applicant
- Microport Orthopedics, Inc.
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3358
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The MicroPort CoCr Femoral Heads are spherical orthopedic implants classified as a femoral head prosthesis for total hip arthroplasty. Manufactured from low-carbon cobalt chromium molybdenum alloy, these components articulate with a polyethylene acetabular liner to restore hip function and mobility.
Intended for use in surgical settings, these femoral heads are supplied sterile and designed for single-use. They comply with FDA 510(k) clearance (K190123) under the Traditional review pathway and are categorized under the Orthopedic advisory committee. No MRI safety or reusable specifications are noted in the regulatory data.
From the manufacturer
With over 50 years of clinical history, MicroPort Orthopedics has extensive experience in all aspects of Total Hip Arthroplasty (THA). We offer a full range of acetabular systems and femoral stems in various styles and philosophies to complement our range of surgical approaches.