510(k) · Cleared
ClearedStageOne™ Shoulder Cement Spacer Molds
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · MBB Bone Cement, Antibiotic
Cleared on Sep 15, 2022 as substantially equivalent to K160071 (Biomet, Inc., 2016) after a 72-day review. Its family tree reaches back 8 generations to 1991.
- Decided
- Sep 15, 2022
- Review
- 72 days
- Class
- Class II
- Product code
- MBB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K911686 (1991). 52 ancestors in all, the oldest K790987 (1979). No later device cites it as a predicate yet.
- Root · 8 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 7 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 6 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 5 generations backK042021 Exactech Equinoxe Shoulder SystemExactech, Inc. · 2004 · Recalled
- 4 generations backK060535 Spacer-S Temporary Shoulder SpacerTecres S.P.A. · 2006
- 3 generations backK112983 Spacer-STecres S.P.A. · 2011
- 2 generations backK131135 Biomet Stage One Disposable Cement Spacer Molds for Temporary…Biomet Manufacturing Corp · 2014 · Recalled
- 1 generation backK160071 StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder…Biomet, Inc. · 2016 · Recalled
- This deviceK221968 StageOne™ Shoulder Cement Spacer MoldsBiomet, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −7 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −6 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −5 | K042021 | Exactech Equinoxe Shoulder System | Exactech, Inc. | 2004 | 10 |
| −4 | K060535 | Spacer-S Temporary Shoulder Spacer | Tecres S.P.A. | 2006 | — |
| −3 | K112983 | Spacer-S | Tecres S.P.A. | 2011 | — |
| −2 | K131135 | Biomet Stage One Disposable Cement Spacer Molds for Temporary Hemi-Shoulder… | Biomet Manufacturing Corp | 2014 | 5 |
| −1 | K160071 | StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis | Biomet, Inc. | 2016 | 5 |
| 0 (this device) | 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 |
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? (1)
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 |
|---|---|---|---|
| * | K160071 | StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder ProsthesisSummary page 4…prosthesis (21 CFR 888.3660) Predicate Device: StageOne™ Disposable Cement K160071 Spacer Molds for Temporary Hemi- Biomet, Inc. Shoulder Prosthesis… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 31 years and passes through 6 companies; a new generation was cleared every 5.3 years on median.
- 11 of the 52 ancestors have a recall of any class.
- 1 other device also cites its predicate K160071.
How does its category compare?
All MBB devicesMBB Bone Cement, Antibiotic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
StageOne™ Shoulder 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 Refobacin® Bone Cement R 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…
Read the full statement (153 words)
StageOne™ Shoulder 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 Refobacin® Bone Cement R 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 StageOne™ Shoulder Cement Spacer 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 (Refobacin® Bone Cement R), 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/K221968 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221968: StageOne™ Shoulder Cement Spacer Molds.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221968
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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