# K161273: StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Jan 25, 2017 after 265 days
- Product code: MBB (Bone Cement, Antibiotic)
- Device class: 2
- Regulation: 21 CFR 888.3027
- 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: 3 generations back to K936159 (1995). 3 ancestors in all.
3 later devices descend from it; 3 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)
- K050210: Disposable Cement Spacer Molds for Temporary Knee Prostheses, Biomet, Inc. (2005) Summary page 4.

## Most influential descendants
- K190216: SpaceFlex Knee (2019), 1 descendant of its own
- K213287: StageOne Knee Cement Spacer Molds (2022), 0 descendants of its own
- K201960: SpaceFlex Knee - 80mm Size (2020), 0 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 (PALACOS® R+G Bone Cement and Refobacin® Bone Cement R), 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/K161273
Methodology: https://510kreport.com/methodology