Aequalis Shoulder System
510(k) K041339
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK041339 | Date17 Jun 2004 | StatusActive |
Official records
- FDA 510(k) database K041339
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KWS
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3660
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 27 Sep 2026
The AEQUALIS SHOULDER SYSTEM is a shoulder arthroplasty device designed for use in total shoulder replacement procedures. It provides anatomic and reversed configuration options within a single system, allowing for precise intra-operative implant-to-patient fit and easy conversion to reversed if necessary during surgery.
The device is supplied by Tornier and was cleared through the FDA 510(k) process under K-number K041339 with product code KWS. It is intended for use in orthopedic surgical settings and is not described as sterile, single-use, reusable, MRI safe, or having specific size variations in the provided data. Storage conditions and additional authorisations beyond the FDA 510(k) clearance are not specified in the available information.