# K052990: Stageone Disposable Cement Spacer Mold for Temporary Hip Prosthesis with Reinforcement Stem

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Dec 16, 2005 after 53 days
- Product code: KWY (Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3390
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K974807 (1998). 2 ancestors in all.
30 later devices descend from it; 3 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031841: Spacer G Temporary Hip Prosthesis, Exactech, Inc. (2004) Summary page 1.

## Most influential descendants
- K062273: Spacer-G Temporary Hip Prosthesis (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-1656-2020: Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
- Feb 26, 2020 · Class II · Z-1655-2020: Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
- Feb 26, 2020 · Class II · Z-1654-2020: Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
- Feb 26, 2020 · Class II · Z-1653-2020: Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
- Sep 21, 2018 · Class II · Z-0399-2019: There is a potential for comingling of the 43MM and 51 MM molds

## Indications for use
Disposable cement spacer molds with stainless steel reinforcements are intended to be used to mold a hemi-hip femoral prosthesis, indicated for temporary use (maximum 180 days) in skeletally mature patients undergoing a two-stage procedure due to septic process. The temporary prosthesis is inserted into the femoral medullary canal and acetabular cavity following removal of the existing femoral and acetabular implants and debridement. The temporary prosthesis is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). The hemi-hip femoral prosthesis is not intended for use more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g. resection, arthroplasty, fusion, etc.) Because of inherent mechanical limitations of the material (polymethylmethacrylate/gentamicin), the molded temporary prosthesis is only 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/K052990
Methodology: https://510kreport.com/methodology