# K123297: Compress Segmental Humeral Replacement System

- Pathway: 510(k) (Special)
- Applicant: Biomet Manufactuting Corp.
- Decided: Nov 20, 2012 after 29 days
- Product code: MBF (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3670
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K945028 (1996). 19 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112905: Compress (R) Segmental Humeral Replacement System, Biomet Orthopedics, LLC (2012) Summary page 1.

## Most influential descendants
- K183553: Compress and Mini Compress Anti-Rotation Spindles (2019), 0 descendants of its own

## Indications for use
The Compress® Segmental Humeral Replacement System is indicated for: 1. Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. 2. Tumor resections. 3. Revision of previously failed total joint arthroplasty. 4. Trauma. The Compress® Segmental Humeral Replacement System components are intended for uncemented use.

Source page: https://510kreport.com/device/K123297
Methodology: https://510kreport.com/methodology