# K112905: Compress (R) Segmental Humeral Replacement System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Orthopedics, LLC
- Decided: May 24, 2012 after 234 days
- Product code: MBF (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3670
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K945028 (1996). 18 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100147: S4 Cervical Occipital Plate Spinal System, Aesculap Implant System, Inc. (2010)
- K062998: Compress Segmental Femoral Replacement System (Short Spindle and Anchor Plug), Biomet Manufacturing Corp (2007) Summary page 2.
- K033280: Discovery Elbow-Mosaic Distal Humeral Replacement System, Biomet, Inc. (2003) Summary page 2.
- K020045: 3-Piece Proximal Humeral Replacement System, Biomet Orthopedics, Inc. (2002) Summary page 2.

## Most influential descendants
- K173411: Comprehensive Segmental Revision System (SRS) (2018), 2 descendants of its own
- K223631: Comprehensive Segmental Revision System (SRS) (2023), 1 descendant of its own
- K123297: Compress Segmental Humeral Replacement System (2012), 1 descendant of its own
- K251686: Tornier Humeral Reconstruction System Max (Tornier HRS Max) (2025), 0 descendants of its own
- K183553: Compress and Mini Compress Anti-Rotation Spindles (2019), 0 descendants of its own

## Recalls of this device
- Aug 21, 2019 · Class II · Z-0519-2020: Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
- Oct 12, 2018 · Class II · Z-0642-2019: Correction to update the surgical technique for the Compress System. To make users aware of the changes that were made only to the selection criteria section on page 42 regarding which array to use in

## 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. The Discovery Elbow components when used in conjunction with the Compress® Segmental Humeral Replacement System are restricted to the Compress® Segmental Humeral Replacement System indications and are intended to be inserted with bone cement. The Modular Hybrid Glenoid when used in conjunction with the Compress® Segmental Humeral Replacement System is restricted to the Compress® Segmental Humeral Replacement System indications and is intended to be used with bone cement. The optional porous titanium peg may be inserted without bone cement. The optional polyethylene peg should be inserted with bone cement.

Source page: https://510kreport.com/device/K112905
Methodology: https://510kreport.com/methodology