510(k) · Cleared
ClearedSpaceFix Shoulder Spacer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
G21, S.R.L. · MBB Bone Cement, Antibiotic
Cleared on Sep 15, 2025 as substantially equivalent to K202338 (G21, S.R.L., 2021) and 1 other predicate after a 42-day review. Its family tree reaches back 9 generations to 1991.
- Decided
- Sep 15, 2025
- Review
- 42 days
- Class
- Class II
- Product code
- MBB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K911686 (1991). 54 ancestors in all, the oldest K790987 (1979). No later device cites it as a predicate yet.
- Root · 9 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 5 generations between
- 3 generations backK131135 Biomet Stage One Disposable Cement Spacer Molds for Temporary…Biomet Manufacturing Corp · 2014 · Recalled
- 2 generations backK160071 StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder…Biomet, Inc. · 2016 · Recalled
- 1 generation backK202338 SpaceFlex ShoulderG21, S.R.L. · 2021
- This deviceK252443 SpaceFix Shoulder SpacerG21, S.R.L. · 2025
Show all 9 generations
- Root · 9 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 8 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 7 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 6 generations backK042021 Exactech Equinoxe Shoulder SystemExactech, Inc. · 2004 · Recalled
- 5 generations backK060535 Spacer-S Temporary Shoulder SpacerTecres S.P.A. · 2006
- 4 generations backK112983 Spacer-STecres S.P.A. · 2011
- 3 generations backK131135 Biomet Stage One Disposable Cement Spacer Molds for Temporary…Biomet Manufacturing Corp · 2014 · Recalled
- 2 generations backK160071 StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder…Biomet, Inc. · 2016 · Recalled
- 1 generation backK202338 SpaceFlex ShoulderG21, S.R.L. · 2021
- This deviceK252443 SpaceFix Shoulder SpacerG21, S.R.L. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −8 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −7 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −6 | K042021 | Exactech Equinoxe Shoulder System | Exactech, Inc. | 2004 | 10 |
| −5 | K060535 | Spacer-S Temporary Shoulder Spacer | Tecres S.P.A. | 2006 | — |
| −4 | K112983 | Spacer-S | Tecres S.P.A. | 2011 | — |
| −3 | K131135 | Biomet Stage One Disposable Cement Spacer Molds for Temporary Hemi-Shoulder… | Biomet Manufacturing Corp | 2014 | 5 |
| −2 | K160071 | StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis | Biomet, Inc. | 2016 | 5 |
| −1 | K202338 | SpaceFlex Shoulder | G21, S.R.L. | 2021 | — |
| 0 (this device) | K252443 | SpaceFix Shoulder Spacer | G21, S.R.L. | 2025 | — |
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 |
| 2015 | 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 K240856 Hip Spacer Molds; Knee Spacer Molds; Shoulder…score 10.2 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K202338 | SpaceFlex ShoulderSummary page 6…Class II Product Code: KWS, MBB C. PREDICATE DEVICES Primary Predicate: • Name: SpaceFlex Shoulder • 510(k): K202338 • Product code: KWS, MBB • Regulation: 21 CFR 888.3027 • Classification: Class II Additional Predicate: • Name… | 2021 |
| * | K152267 | Remedy® Shoulder SpacerSummary page 6…8 • Product code: KWS, MBB • Regulation: 21 CFR 888.3027 • Classification: Class II Additional Predicate: • Name: Remedy Shoulder Spacer • 510(k): K152267 • Product code: KWS, MBB • Regulation: 21 CFR 888.3660 • Classification: Class II D. DEVICE DESCRIPTION The SpaceFix… | 2015 |
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 34 years and passes through 7 companies; a new generation was cleared every 4.6 years on median.
- 11 of the 54 ancestors have a recall of any class.
How does its category compare?
All MBB devicesMBB Bone Cement, Antibiotic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
The SpaceFix Shoulder Spacer is intended for temporary (maximum 180 days) use as part of a two-stage procedure in skeletally mature patients undergoing a total or hemi shoulder arthroplasty revision due to prosthetic joint infection. The device is indicated for use when the infecting organism is sensitive to gentamicin, as the PMMA bone cement includes gentamicin for local antibiotic delivery. Following prosthesis explantation and thorough debridement…
Read the full statement (111 words)
The SpaceFix Shoulder Spacer is intended for temporary (maximum 180 days) use as part of a two-stage procedure in skeletally mature patients undergoing a total or hemi shoulder arthroplasty revision due to prosthetic joint infection.
The device is indicated for use when the infecting organism is sensitive to gentamicin, as the PMMA bone cement includes gentamicin for local antibiotic delivery.
Following prosthesis explantation and thorough debridement, the device is implanted in the glenoid cavity and humeral canal.
At the conclusion of the temporary implantation period (not to exceed 180 days), the device must be removed and either replaced with a definitive shoulder prosthesis or alternative surgical intervention (e.g., resection arthroplasty, fusion).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K252443 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252443: SpaceFix Shoulder Spacer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252443
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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