# K131135: Biomet Stage One Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing Corp
- Decided: Jan 22, 2014 after 275 days
- Product code: MBB (Bone Cement, Antibiotic)
- Device class: 2
- Regulation: 21 CFR 888.3027
- 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: 6 generations back to K911686 (1991). 50 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060692: Comprehensive Primary Shoulder Stems, Biomet Manufacturing Corp (2006) Summary page 1.
- K052990: Stageone Disposable Cement Spacer Mold for Temporary Hip Prosthesis with Reinforcement Stem, Biomet, Inc. (2005) Summary page 1.
- K112983: Spacer-S, Tecres S.P.A. (2011) Summary page 1.

## Most influential descendants
- K160071: StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis (2016), 3 descendants of its own
- K202338: SpaceFlex Shoulder (2021), 1 descendant of its own
- K252443: SpaceFix Shoulder Spacer (2025), 0 descendants of its own
- K221968: StageOne™ Shoulder Cement Spacer Molds (2022), 0 descendants of its own

## Recalls of this device
- Feb 26, 2020 · Class II · Z-1658-2020: Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
- Feb 26, 2020 · Class II · Z-1661-2020: Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
- Feb 26, 2020 · Class II · Z-1659-2020: Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
- Feb 26, 2020 · Class II · Z-1660-2020: Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
- Feb 26, 2020 · Class II · Z-1657-2020: 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 hemi-shoulder replacement for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. The temporary prosthesis is molded using Cobalt MV with Gentamiciri Bone Cement and inserted into the humeral medullary canal and glenoidal cavity following removal of the existing total shoulder replacement implants and debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). The hemi-shoulder prosthesis made from the StageOne 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-shoulder prosthesis material (Cobalt IV with Gentamicin Bone Cement), the temporary hemi-shoulder prosthesis is only indicated for patients who will consistently follow activity limitations throughout the implant period.

Source page: https://510kreport.com/device/K131135
Methodology: https://510kreport.com/methodology