# K183553: Compress and Mini Compress Anti-Rotation Spindles

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Jan 22, 2019 after 33 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: 7 generations back to K945028 (1996). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101475: Compress Anti-Rotation Spindles, Biomet Manufacturing Corp (2010) Summary page 6.
- K112905: Compress (R) Segmental Humeral Replacement System, Biomet Orthopedics, LLC (2012) Summary page 6.
- K123297: Compress Segmental Humeral Replacement System, Biomet Manufactuting Corp. (2012) Summary page 6.

## Indications for use
1. Correction of 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 Femoral Replacement System components are intended for uncemented use. 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 and Nexel® 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. When components of the Compress Segmental Humeral Replacement System are used with Biomet’s Discovery® Elbow System, the user should refer to the package insert contained with the Discovery® components for additional information (01-50-0901). Compatibility is limited to Biomet manufactured Discovery® Elbow components. When components of the Compress Segmental Humeral Replacement System are used with the Zimmer Nexel® Elbow System, the user should refer to the package insert contained with the Nexel® components for additional information (87-6204-077-88). When components of the Compress Segmental Humeral Replacement System are used with Biomet’s Comprehensive® Segmental Revision System, the user should refer to the package insert contained with the Comprehensive Segmental Revision System components for additional information (01-50-0911). 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/K183553
Methodology: https://510kreport.com/methodology