# K062998: Compress Segmental Femoral Replacement System (Short Spindle and Anchor Plug)

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing Corp
- Decided: Jan 19, 2007 after 109 days
- Product code: KWA (Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component))
- Device class: 3
- Regulation: 21 CFR 888.3330
- Recalls of this device: 21 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K945028 (1996). 7 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043547: Compress Segmental Femoral Replacement System, Biomet, Inc. (2005) Summary page 2.

## Most influential descendants
- K112905: Compress (R) Segmental Humeral Replacement System (2012), 5 descendants of its own
- K173411: Comprehensive Segmental Revision System (SRS) (2018), 2 descendants of its own
- K080330: Segmental Distal Femoral Components and Proximal Femoral Bodies with a Compress Female Taper (2008), 2 descendants of its own
- K223631: Comprehensive Segmental Revision System (SRS) (2023), 1 descendant of its own
- K142814: Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid Tibial (2015), 1 descendant of its own

## Recalls of this device
- Oct 9, 2023 · Class II · Z-0371-2024: Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
- Oct 9, 2023 · Class II · Z-0372-2024: Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
- Oct 9, 2023 · Class II · Z-0374-2024: Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
- Oct 9, 2023 · Class II · Z-0378-2024: Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
- Oct 9, 2023 · Class II · Z-0380-2024: Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
- Oct 9, 2023 · Class II · Z-0381-2024: Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
- Oct 9, 2023 · Class II · Z-0382-2024: Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
- Oct 9, 2023 · Class II · Z-0383-2024: Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
- Oct 9, 2023 · Class II · Z-0384-2024: Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
- Oct 9, 2023 · Class II · Z-0386-2024: Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
- Oct 9, 2023 · Class II · Z-0388-2024: Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
- Oct 9, 2023 · Class II · Z-0370-2024: Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
- Oct 9, 2023 · Class II · Z-0373-2024: Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
- Oct 9, 2023 · Class II · Z-0375-2024: Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
- Oct 9, 2023 · Class II · Z-0376-2024: Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
- Oct 9, 2023 · Class II · Z-0377-2024: Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
- Oct 9, 2023 · Class II · Z-0379-2024: Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
- Oct 9, 2023 · Class II · Z-0385-2024: Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
- Oct 9, 2023 · Class II · Z-0387-2024: Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
- 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 24, 2018 · Class II · Z-0553-2019: Potential metal burrs in the holes of the device preventing the appropriate drill and transverse pins from being inserted

## 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 (Short Spindle and Anchor Plug) components are intended for uncemented use only.

Source page: https://510kreport.com/device/K062998
Methodology: https://510kreport.com/methodology