# K022079: Short and Long Soft Tissue Attachment

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Sep 24, 2002 after 90 days
- Product code: KWT (Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K925613 (1994). 3 ancestors in all.
16 later devices descend from it; 2 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913282: Lima RPS Shoulder, Turnkey Intergration USA, Inc. (1991) Summary page 1.
- K020045: 3-Piece Proximal Humeral Replacement System, Biomet Orthopedics, Inc. (2002) Summary page 1.

## Most influential descendants
- K033280: Discovery Elbow-Mosaic Distal Humeral Replacement System (2003), 15 descendants of its own
- K042321: Mosaic Non-Modular Proximal Body and Eas Offset Modular Humeral Head (2005), 9 descendants of its own
- K043505: Discovery-Mosaic Total Humerus System (2005), 8 descendants of its own
- K111746: Comprehensive Segmental Revision System (SRS) (2011), 7 descendants of its own
- K143659: Equinoxe Mega Prosthesis (2015), 5 descendants of its own

## Indications for use
The indications for the use of the Short and Long Soft Tissue Attachment Sleeves include: 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 The sleeves can be used for oncology applications. The sleeves are designed for use with the Biomet MosaicTM Humeral System (K020045), to provide the option for soft tissue stabilization and attachment. The Biomet MosaicTM Humeral System (K020045) is for use with bone cement.

Source page: https://510kreport.com/device/K022079
Methodology: https://510kreport.com/methodology