510(k) · Cleared
Recalled · Class II · 2020Biomet Stage One Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Manufacturing Corp · MBB Bone Cement, Antibiotic
Cleared on Jan 22, 2014 as substantially equivalent to K060692 (Biomet Manufacturing Corp, 2006) and 2 other predicates after a 275-day review. Its family tree reaches back 6 generations to 1991. 4 later devices descend from it. It has been recalled 5 times.
- Decided
- Jan 22, 2014
- Review
- 275 days
- Class
- Class II
- Product code
- MBB
- Recalls
- 5
- Predicates
- 3
Its longest line of descent runs back 6 generations to K911686 (1991). 50 ancestors in all, the oldest K790987 (1979). 4 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 5 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 4 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 3 generations backK042021 Exactech Equinoxe Shoulder SystemExactech, Inc. · 2004 · Recalled
- 2 generations backK060535 Spacer-S Temporary Shoulder SpacerTecres S.P.A. · 2006
- 1 generation backK112983 Spacer-STecres S.P.A. · 2011
- This deviceK131135 Biomet Stage One Disposable Cement Spacer Molds for Temporary…Biomet Manufacturing Corp · 2014
- Descendant · cites it directly · 3 of its ownK160071 StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder…Biomet, Inc. · 2016 · Recalled
- Descendant · 2 generations on · 1 of its ownK202338 SpaceFlex ShoulderG21, S.R.L. · 2021
- Descendant · 3 generations on · 0 of its ownK252443 SpaceFix Shoulder SpacerG21, S.R.L. · 2025
- Descendant · 2 generations on · 0 of its ownK221968 StageOne™ Shoulder Cement Spacer MoldsBiomet, Inc. · 2022
Most influential descendants
Showing 4 of 4 · See all- K160071StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder ProsthesisBiomet, Inc. · 2016 · cites it directly3descendants
- K202338SpaceFlex ShoulderG21, S.R.L. · 2021 · 2 generations on1descendant
- K252443SpaceFix Shoulder SpacerG21, S.R.L. · 2025 · 3 generations on0descendants
- K221968StageOne™ Shoulder Cement Spacer MoldsBiomet, Inc. · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −5 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −4 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −3 | K042021 | Exactech Equinoxe Shoulder System | Exactech, Inc. | 2004 | 10 |
| −2 | K060535 | Spacer-S Temporary Shoulder Spacer | Tecres S.P.A. | 2006 | — |
| −1 | K112983 | Spacer-S | Tecres S.P.A. | 2011 | — |
| 0 (this device) | K131135 | Biomet Stage One Disposable Cement Spacer Molds for Temporary Hemi-Shoulder… | Biomet Manufacturing Corp | 2014 | — |
| +1 | K160071 | StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis | Biomet, Inc. | 2016 | 5 |
| +2 | K202338 | SpaceFlex Shoulder | G21, S.R.L. | 2021 | — |
| +3 | K252443 | SpaceFix Shoulder Spacer | G21, S.R.L. | 2025 | — |
| +2 | K221968 | StageOne™ Shoulder Cement Spacer Molds | Biomet, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 2 | 0 |
| 1987 | 3 | 0 |
| 1988 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 6 | 0 |
| 2000 | 6 | 0 |
| 2001 | 6 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MBB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MBB device
- #1 K252443 SpaceFix Shoulder Spacerscore 12.4 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K060692 | Comprehensive Primary Shoulder StemsSummary page 1…ly marketed device(s) to which Comprehensive Total Shoulder Standard Stem equivalence is claimed (K060692) StageOne- Disposable Cement Spacer Mold For… | 2006 |
| * | K052990 | Stageone Disposable Cement Spacer Mold for Temporary Hip Prosthesis with Reinforcement…Summary page 1…Temporary Hip Prosthesis with Reinforcement Stem (K052990) Tecres InterSpaceo Shoulder (K1 12983) Reason for 510(k) subm… | 2005 |
| * | K112983 | Spacer-SSummary page 1…(K052990) Tecres InterSpaceo Shoulder (K1 12983) Reason for 510(k) submission New device Device description… | 2011 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160071 | StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis | 2016 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 26, 2020 | Class II | Z-1658-2020 | Process control | Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. |
| Feb 26, 2020 | Class II | Z-1661-2020 | Process control | Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. |
| Feb 26, 2020 | Class II | Z-1659-2020 | Process control | Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. |
| Feb 26, 2020 | Class II | Z-1660-2020 | Process control | Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. |
| Feb 26, 2020 | Class II | Z-1657-2020 | Process control | Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 5 companies; a new generation was cleared every 5.3 years on median.
- 9 of the 50 ancestors have a recall of any class.
- Of its descendants, K160071 (Biomet, Inc., 2016) has gone furthest, with 3 descendants of its own.
- 14 other devices also cite its predicate K060692.
How does its category compare?
All MBB devicesMBB Bone Cement, Antibiotic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · MBB
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBB
106in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBB
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBB
172in 2025
MAUDE reports naming product code MBB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 1 |
| 2008 | 1 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 9 |
| 2010 | 0 | — | 0 | 18 |
| 2011 | 0 | — | 0 | 31 |
| 2012 | 0 | — | 0 | 34 |
| 2013 | 0 | — | 2 | 32 |
| 2014 | 1 | — | 0 | 41 |
| 2015 | 1 | — | 0 | 20 |
| 2016 | 2 | — | 0 | 327 |
| 2017 | 1 | — | 0 | 288 |
| 2018 | 0 | — | 0 | 332 |
| 2019 | 2 | — | 0 | 497 |
| 2020 | 1 | — | 0 | 375 |
| 2021 | 1 | — | 0 | 649 |
| 2022 | 3 | 106 | 1 | 275 |
| 2023 | 0 | — | 0 | 262 |
| 2024 | 2 | — | 0 | 212 |
| 2025 | 1 | — | 0 | 172 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
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…
Read the full statement (156 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131135 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131135: Biomet Stage One Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131135
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026