PM Cementless Screw-In Acetabular Cup
510(k) K850773
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK850773 | Date2 May 1985 | 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- Withdrawn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
- KWA
- Device Class
- Class III
- Regulation
- 21 CFR Part 888.3330
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The PM Cementless Screw-In Acetabular Cup is a semi-constrained metal acetabular component designed for hip replacement surgery. This device is intended to be implanted into the pelvis to form part of a total hip arthroplasty, providing a stable interface for the femoral head prosthesis without the use of bone cement.
This device is supplied sterile and intended for single-use. It is classified as a Class III medical device under FDA regulations and has received 510(k) clearance. The PM Cementless Screw-In Acetabular Cup is secured via screw fixation into the acetabulum, ensuring osseointegration with the surrounding bone. Multiple sizes and variants are available, as indicated by the associated registration numbers, and it is regulated under the FDA’s regulation number 888.3330.