# K050210: Disposable Cement Spacer Molds for Temporary Knee Prostheses

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Jul 19, 2005 after 172 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K936159 (1995). 2 ancestors in all.
24 later devices descend from it; 3 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032522: Tecres Spacer-K Temporary Knee Prosthesis, Exactech, Inc. (2004) Summary page 1.

## Most influential descendants
- K062274: Spacer-K Temporary Knee Spacer with Gentamicin, Models SPK0021, SPK0121, SPK0221, SPK0321 (2008), 20 descendants of its own
- K101356: Spacer-G and Spacer-K (2011), 19 descendants of its own
- K112470: 2GC Hip/Knee Modular Spacer (2012), 16 descendants of its own
- K183017: Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer (2019), 5 descendants of its own
- K173967: Remedy Acetabular Cup (2018), 5 descendants of its own

## Recalls of this device
- Feb 26, 2020 · Class II · Z-1664-2020: Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
- Feb 26, 2020 · Class II · Z-1669-2020: Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
- Feb 26, 2020 · Class II · Z-1663-2020: Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
- Feb 26, 2020 · Class II · Z-1665-2020: Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
- Feb 26, 2020 · Class II · Z-1667-2020: Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
- Feb 26, 2020 · Class II · Z-1662-2020: Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
- Feb 26, 2020 · Class II · Z-1668-2020: Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
- Feb 26, 2020 · Class II · Z-1666-2020: Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

## Indications for use
Disposable cement spacer molds are indicated for use to mold a temporary total knee replacement (TKR) for skeletally mature patients undergoing a two-stage procedure due to a septic process. The molded temporary knee prosthesis is indicated for an implantation period of 180 days or less. Because of inherent mechanical limitations of the device material (gentamicin/polymethylmethacrylate), the molded temporary prosthesis is indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers) throughout the implant period.

Source page: https://510kreport.com/device/K050210
Methodology: https://510kreport.com/methodology