# K992899: Bio-Modular Shoulder Offset Humeral Heads

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Oct 21, 1999 after 52 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 K872454 (1987). 3 ancestors in all.
254 later devices descend from it; 3 cite it directly.
1 of 258 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K872454: Biomet Modular Shoulder Prosthesis, Biomet, Inc. (1987) Summary page 2.
- K952928: Aequalis Shoulder System for Total & Hemishoulder Applications, Tornier (1995) Summary page 2.
- K974044: Global Total Shoulder Eccentric Humeral Head, DePuy Orthopaedics, Inc. (1998) Summary page 2.

## Most influential descendants
- K030710: Bio-Modular Shoulder System (2003), 253 descendants of its own
- K043100: Bio-Modular Shoulder System with Hydroxyapatite (HA) Coated Glenoid Components (2005), 176 descendants of its own
- K072804: Comprehensive RS Shoulder System (2007), 175 descendants of its own
- K080642: Comprehensive Reverse Shoulder (2008), 172 descendants of its own
- K060692: Comprehensive Primary Shoulder Stems (2006), 138 descendants of its own

## 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 arthropathy

Source page: https://510kreport.com/device/K992899
Methodology: https://510kreport.com/methodology