# K161166: StageOne Select Cement Spacer Molds for Temporary Hip Replacement

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Sep 8, 2016 after 135 days
- Product code: MBB (Bone Cement, Antibiotic)
- Device class: 2
- Regulation: 21 CFR 888.3027
- Recalls of this device: 15 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K974807 (1998). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080979: Stageone Select Cement Spacer Molds for Temporary Hip Replacement, Biomet Manufacturing Corp (2008) Summary page 4.

## Most influential descendants
- K222760: StageOne™ Select Hip Cement Spacer Molds (2022), 0 descendants of its own
- K192041: G21 SpaceFlex Hip (2019), 0 descendants of its own

## Recalls of this device
- Feb 26, 2020 · Class II · Z-1640-2020: Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
- Feb 26, 2020 · Class II · Z-1638-2020: Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
- Feb 26, 2020 · Class II · Z-1650-2020: Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
- Feb 26, 2020 · Class II · Z-1646-2020: Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
- Feb 26, 2020 · Class II · Z-1642-2020: Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
- Feb 26, 2020 · Class II · Z-1648-2020: Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
- Feb 26, 2020 · Class II · Z-1651-2020: Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
- Feb 26, 2020 · Class II · Z-1641-2020: Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
- Feb 26, 2020 · Class II · Z-1649-2020: Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
- Feb 26, 2020 · Class II · Z-1643-2020: Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
- Feb 26, 2020 · Class II · Z-1645-2020: Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
- Feb 26, 2020 · Class II · Z-1644-2020: Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
- Feb 26, 2020 · Class II · Z-1647-2020: Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
- Feb 26, 2020 · Class II · Z-1652-2020: Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
- Feb 26, 2020 · Class II · Z-1639-2020: Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

## Indications for use
Disposable cement spacer molds with stainless steel reinforcement stems, adapters and inserts are indicated for use to mold a temporary hemi-hip replacement for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. The temporary prosthesis is molded using PALACOS® R+G Bone Cement or Refobacin® Bone Cement R, assembled and inserted into the femoral medullary canal and acetabular cavity following removal of the existing femoral and acetabular implants and debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). The hemi-hip prosthesis made from the StageOne™ Select disposable cement molds is not intended for use more than 180 days, at which time it must be explanted and permanent devices implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion, etc.) Due to the inherent mechanical limitations of the hemi-hip prosthesis material (PALACOS® R+G Bone Cement and Refobacin® Bone Cement R), the temporary hemi-hip 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/K161166
Methodology: https://510kreport.com/methodology