# K101475: Compress Anti-Rotation Spindles

- Pathway: 510(k) (Special)
- Applicant: Biomet Manufacturing Corp
- Decided: Jun 18, 2010 after 21 days
- Product code: KWA (Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component))
- Device class: 3
- Regulation: 21 CFR 888.3330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K945028 (1996). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062998: Compress Segmental Femoral Replacement System (Short Spindle and Anchor Plug), Biomet Manufacturing Corp (2007) Summary page 2.
- K043547: Compress Segmental Femoral Replacement System, Biomet, Inc. (2005) Summary page 2.

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

## Indications for use
The Compress® Segmental Femoral Replacement System is indicated for: 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.

Source page: https://510kreport.com/device/K101475
Methodology: https://510kreport.com/methodology