Comprehensive Shoulder System 31-406908
Comprehensive Shoulder System 31-406908 is a Class II device made by Biomet Orthopedics, Inc., cleared under FDA 510(k) K193038 on 28 Oct 2020 and listed in FDA GUDID since 28 Jul 2017 (UDI-DI 00880304430884), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK193038 | Date28 Oct 2020 | StatusActive |
| United States | GUDID listing | Number00880304430884 | Date28 Jul 2017 | StatusListed |
Official records
- AccessGUDID record 00880304430884
- FDA 510(k) database K193038
Across registries
- FDA 510(k) K193038 decided 28 Oct 2020 Active
- FDA GUDID UDI-DI 00880304430884 listed 28 Jul 2017 Listed
Recalls
-
- Ongoing Z-1403-2025
Five complaints received where surgeon was unable to remove and/or connect the inserter with the stem during surgery due to excess material remaining within the taper. Issue may lead to clinically significant extension of surgery to find a replacement.
Timeline
- Listed FDA GUDID 00880304430884
- Cleared FDA 510(k) K193038
- Recall initiated FDA recalls Z-1403-2025
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Comprehensive Shoulder System
- Generic name
- Humeral stem prosthesis trial, reusable
- Model / Ref / Catalog
- 31-406908
- Primary DI / UDI-DI
- 00880304430884
- 510(k) Number
- FDA product code
- KWS, HSD, MBF, KWT
- GMDN term
- Humeral stem prosthesis trial, reusable
- Device class
- Class II
- Regulation number
- 888.3660, 888.3690, 888.3670, 888.3650
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization