510(k) · Cleared
ClearedG21 SpaceFlex Hip
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 Oct 29, 2019 as substantially equivalent to K161166 (Biomet, Inc., 2016) and 1 other predicate after a 90-day review. Its family tree reaches back 5 generations to 1998.
- Decided
- Oct 29, 2019
- Review
- 90 days
- Class
- Class II
- Product code
- MBB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K974807 (1998). No later device cites it as a predicate yet.
- Root · 5 generations backK974807 Osteo Austin Moore Endoprosthesis SystemOsteonics Corp. · 1998
- 4 generations backK031841 Spacer G Temporary Hip ProsthesisExactech, Inc. · 2004
- 3 generations backK052990 Stageone Disposable Cement Spacer Mold for Temporary Hip Prosthesis…Biomet, Inc. · 2005 · Recalled
- 2 generations backK080979 Stageone Select Cement Spacer Molds for Temporary Hip ReplacementBiomet Manufacturing Corp · 2008 · Recalled
- 1 generation backK161166 StageOne Select Cement Spacer Molds for Temporary Hip ReplacementBiomet, Inc. · 2016 · Recalled
- This deviceK192041 G21 SpaceFlex HipG21, S.R.L. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K974807 | Osteo Austin Moore Endoprosthesis System | Osteonics Corp. | 1998 | — |
| −4 | K031841 | Spacer G Temporary Hip Prosthesis | Exactech, Inc. | 2004 | — |
| −3 | K052990 | Stageone Disposable Cement Spacer Mold for Temporary Hip Prosthesis with… | Biomet, Inc. | 2005 | 5 |
| −2 | K080979 | Stageone Select Cement Spacer Molds for Temporary Hip Replacement | Biomet Manufacturing Corp | 2008 | 15 |
| −1 | K161166 | StageOne Select Cement Spacer Molds for Temporary Hip Replacement | Biomet, Inc. | 2016 | 15 |
| 0 (this device) | K192041 | G21 SpaceFlex Hip | G21, S.R.L. | 2019 | — |
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? (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 |
|---|---|---|---|
| * | K161166 | StageOne Select Cement Spacer Molds for Temporary Hip ReplacementSummary page 4…Class II Product codes MBB, KWL, KWY III. PREDICATE DEVICES Primary Predicate: StageOne Select Hip Cement Spacer Molds, Biomet, Inc. (K161166) Additional Predicate: SPACER-G Temporary Hip Prosthesis, Tecres S.p.A. (K031841)… | 2016 |
| * | K031841 | Spacer G Temporary Hip ProsthesisSummary page 4…CATE DEVICES Primary Predicate: StageOne Select Hip Cement Spacer Molds, Biomet, Inc. (K161166) Additional Predicate: SPACER-G Temporary Hip Prosthesis, Tecres S.p.A. (K031841) 1 of 3… | 2004 |
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 21 years and passes through 5 companies; a new generation was cleared every 3.1 years on median.
- 3 of the 5 ancestors have a recall of any class.
- 1 other device also cites its predicate K161166.
How does its category compare?
All MBB devicesMBB Bone Cement, Antibiotic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 with titanjium reinforcement stem and prolongation are indicated for use to mold a temporary hemi-hip replacement for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. The temporary prosthesis is molded using low viscosity polymethylmethacrylate bone cement and inserted into the femoral medullary canal and acetabular cavity following removal of the existing femoral and acetabular…
Read the full statement (164 words)
Disposable cement spacer molds with titanjium reinforcement stem and prolongation are indicated for use to mold a temporary hemi-hip replacement for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. The temporary prosthesis is molded using low viscosity polymethylmethacrylate bone cement and inserted into the femoral medullary canal and acetabular cavity following removal of the existing femoral and acetabular implants and debridement.
The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). The hemi-hip prosthesis made from the SpaceFlex Hip 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-hip prosthesis material (low viscosity polymethylmethacrylate), the temporary hemi-hip prosthesis is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers) throughout the implant period.
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/K192041 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192041: G21 SpaceFlex Hip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192041
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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