# K001706: WMT Modular Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Aug 16, 2000 after 72 days
- Product code: KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) 3M Modular Shoulder System: named in the summary without a submission number

## Indications for use
The WMT Modular Shoulder System, humeral head and stem, is intended to be used for total or hemi-arthroplasty. When used for total shoulder arthroplasty, the subject components are to be used with existing 3M shoulder glenoid components cleared in K920362 or with 3M Neer III Shoulder (K895226, SE 11/3/89) compatible glenoid components. Indications for Use: Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; Rheumatoid arthritis; Revision where other devices or treatments have failed; Correction of functional deformity; Treatment of acute fracture of the humeral head unmanageable using other treatment methods; and Cuff tear arthroplasty. Hemi-shoulder replacement is also indicated for: Ununited humeral head fractures; and Avascular necrosis of the humeral head. The humeral stem may be implanted by press-fit or cement fixation.

Source page: https://510kreport.com/device/K001706
Methodology: https://510kreport.com/methodology