# K002683: WMT Ultra-Fit Modular Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Nov 22, 2000 after 86 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
Longest line of descent: 1 generation back to K920362 (1993). 1 ancestor in all.
288 later devices descend from it; 2 cite it directly.
0 of 290 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K920362: 3M Modular Shoulder System, 3M Health Care, Ltd. (1993) Summary page 2.

## Most influential descendants
- K032679: Aequalis Shoulder Fracture System (2003), 287 descendants of its own
- K043077: Modification to Aequalis Shoulder Fracture System; Aequalis Shoulder System (2004), 258 descendants of its own
- K060209: Aequalis Shoulder Fracture System & Aequalis Shoulder System (2006), 257 descendants of its own
- K061439: Aequalis Reversed Prosthesis (2006), 199 descendants of its own
- K081059: Aequalis Reversed Shoulder Prosthesis (2008), 179 descendants of its own

## Indications for use
The WMT Modular Shoulder is indicated for use in shoulder arthroplasty for reduction or relief of pain and/or improved shoulder function in skeletally mature patients with sufficient and satisfactory bone stock to support the prosthesis with the following conditions: Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; Rheumatoid arthritis or post-traumatic 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/K002683
Methodology: https://510kreport.com/methodology