# K062274: Spacer-K Temporary Knee Spacer with Gentamicin, Models SPK0021, SPK0121, SPK0221, SPK0321

- Pathway: 510(k) (Traditional)
- Applicant: Tecres S.P.A.
- Decided: May 22, 2008 after 654 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K936159 (1995). 3 ancestors in all.
20 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)
- K032522: Tecres Spacer-K Temporary Knee Prosthesis, Exactech, Inc. (2004) Summary page 2.
- K050210: Disposable Cement Spacer Molds for Temporary Knee Prostheses, Biomet, Inc. (2005) Summary page 2.

## Most influential descendants
- 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
- K191981: REMEDY Acetabular Cup (2019), 4 descendants of its own

## Indications for use
Spacer-K is indicated for temporary use (maximum 180 days) as an adjunct in total knee replacement (TKR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. Spacer-K is only indicated for an implantation period of 180 days or less. Because of the inherent mechanical limitations of the device material (gentamicin/polymethilmethacrylate), Spacer-K is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers, canes) throughout the implantation period.

Source page: https://510kreport.com/device/K062274
Methodology: https://510kreport.com/methodology