Absorbable Acetabular Screw
by Zimmer, Inc.
510(k) K946347
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK946347 | Date11 Jul 1995 | 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- Withdrawn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
- HWC
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3040
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 24 Sep 2026
The Absorbable Acetabular Screw is a bio‑absorbable orthopedic implant designed for fixation within the acetabulum. It provides temporary bone stabilization and is intended to be resorbed by the body after the healing period, eliminating the need for hardware removal.
The device is classified as a Class II orthopedic device (product code HWC) and received traditional FDA 510(k) clearance (K946347) on 11 July 1995. It is supplied by Zimmer, Inc. and is identified as a single‑use, sterile implant, with the clearance indicating compliance with U.S. regulatory requirements for such devices.
Other devices from Zimmer, Inc.
Questions
AI-generated answers, 24 Sep 2026
What is the intended clinical use of the absorbable acetabular screw?
It is designed to secure bone fragments within the acetabulum during the healing phase of orthopedic surgery, offering temporary stabilization that the body gradually absorbs, so a second operation to remove hardware is not required.
Is the screw supplied sterile and for single‑use only?
Yes, the device is provided as a sterile, single‑use implant. This ensures that each screw is free from microbial contamination and eliminates the risk of cross‑contamination that could arise from re‑processing.
How does the bio‑absorbable material affect postoperative care?
Because the screw gradually resorbs, postoperative protocols focus on standard bone healing monitoring rather than planning a hardware removal procedure. Clinicians can expect the implant to disappear as the bone remodels, reducing long‑term foreign‑body concerns.
What regulatory pathway was used for this device?
The absorbable acetabular screw received traditional FDA 510(k) clearance (K946347) in July 1995, indicating it was found substantially equivalent to a legally marketed predicate device and meets the Class II orthopedic device requirements.