# K992119: Bio-Modular Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Sep 13, 1999 after 82 days
- Product code: KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
419 later devices descend from it; 13 cite it directly.
1 of 420 devices in its family (counting itself) has 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) Integrated Shoulder System (Kirschner): named in the summary without a submission number
- (no number) Global Shoulder (DePuy): named in the summary without a submission number
- (no number) Foundation Shoulder System (Encore Orthopedics): named in the summary without a submission number

## Most influential descendants
- K021478: Delta Shoulder (2003), 338 descendants of its own
- K062116: Delta Cta Reverse Shoulder System Humeral Heads (2006), 295 descendants of its own
- K030941: Aequalis Reversed Shoulder Prosthesis (2004), 280 descendants of its own
- K041873: Aequalis Reversed Shoulder Prosthesis (2004), 277 descendants of its own
- K030710: Bio-Modular Shoulder System (2003), 253 descendants of its own

## Recalls of this device
- Feb 17, 2017 · Class II · Z-1859-2017: Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.

## Indications for use
1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis 2. Rheumatoid arthritis 3. Revision where other devices or treatments have failed 4. Correction of functional deformity 5. Treatment of acute fracture of the humeral head unmanageable using other treatment methods 6. Cuff tear arthroplasty

Source page: https://510kreport.com/device/K992119
Methodology: https://510kreport.com/methodology