510(k) · Cleared
Recalled · Class II · 2020Stageone Select Cement Spacer Molds for Temporary Hip Replacement
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Manufacturing Corp · KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Cleared on Oct 31, 2008 as substantially equivalent to K052990 (Biomet, Inc., 2005) and 1 other predicate after a 207-day review. Its family tree reaches back 3 generations to 1998. 3 later devices descend from it. It has been recalled 15 times.
- Decided
- Oct 31, 2008
- Review
- 207 days
- Class
- Class II
- Product code
- KWY
- Recalls
- 15
- Predicates
- 2
Its longest line of descent runs back 3 generations to K974807 (1998). 3 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK974807 Osteo Austin Moore Endoprosthesis SystemOsteonics Corp. · 1998
- 2 generations backK031841 Spacer G Temporary Hip ProsthesisExactech, Inc. · 2004
- 1 generation backK052990 Stageone Disposable Cement Spacer Mold for Temporary Hip Prosthesis…Biomet, Inc. · 2005 · Recalled
- This deviceK080979 Stageone Select Cement Spacer Molds for Temporary Hip ReplacementBiomet Manufacturing Corp · 2008
- Descendant · cites it directly · 2 of its ownK161166 StageOne Select Cement Spacer Molds for Temporary Hip ReplacementBiomet, Inc. · 2016 · Recalled
- Descendant · 2 generations on · 0 of its ownK222760 StageOne™ Select Hip Cement Spacer MoldsBiomet, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK192041 G21 SpaceFlex HipG21, S.R.L. · 2019
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K974807 | Osteo Austin Moore Endoprosthesis System | Osteonics Corp. | 1998 | — |
| −2 | K031841 | Spacer G Temporary Hip Prosthesis | Exactech, Inc. | 2004 | — |
| −1 | K052990 | Stageone Disposable Cement Spacer Mold for Temporary Hip Prosthesis with… | Biomet, Inc. | 2005 | 5 |
| 0 (this device) | K080979 | Stageone Select Cement Spacer Molds for Temporary Hip Replacement | Biomet Manufacturing Corp | 2008 | — |
| +1 | K161166 | StageOne Select Cement Spacer Molds for Temporary Hip Replacement | Biomet, Inc. | 2016 | 15 |
| +2 | K222760 | StageOne™ Select Hip Cement Spacer Molds | Biomet, Inc. | 2022 | — |
| +2 | K192041 | G21 SpaceFlex Hip | G21, S.R.L. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 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 KWY? 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 KWY device
- #1 K253357 b-ONE® Bipolar Headscore 11.2 · 1 generation · 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 |
|---|---|---|---|
| * | K052990 | Stageone Disposable Cement Spacer Mold for Temporary Hip Prosthesis with Reinforcement…Summary page 1…sthesis (21 CFR § 888.3390 & 21 CFR § 888.3360). Legally Marketed Devices To Which Substantial Equivalence Is Claimed: StageOne T" Disposable Cement Spacer Mold (K052990) - Biomet Inc. Tecres Spacer-G Temporary Hip Prosthesis (K031841) - Exactech Inc. Device Description: Cement Space… | 2005 |
| * | K031841 | Spacer G Temporary Hip ProsthesisSummary page 1…es To Which Substantial Equivalence Is Claimed: StageOne T" Disposable Cement Spacer Mold (K052990) - Biomet Inc. Tecres Spacer-G Temporary Hip Prosthesis (K031841) - Exactech Inc. Device Description: Cement Spacer Molds are designed to mold a temporary "spacer" hip implant made of… | 2004 |
| † | K051532 | Cobalt G HV Bone Cement | 2005 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161166 | StageOne Select Cement Spacer Molds for Temporary Hip Replacement | 2016 | 2 |
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-1640-2020 | Process control | Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. |
| Feb 26, 2020 | Class II | Z-1638-2020 | Process control | Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. |
| Feb 26, 2020 | Class II | Z-1650-2020 | Process control | Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. |
| Feb 26, 2020 | Class II | Z-1646-2020 | Process control | Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. |
| Feb 26, 2020 | Class II | Z-1642-2020 | Process control | Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. |
| Feb 26, 2020 | Class II | Z-1648-2020 | Process control | Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. |
| Feb 26, 2020 | Class II | Z-1651-2020 | Process control | Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. |
| Feb 26, 2020 | Class II | Z-1641-2020 | Process control | Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. |
| Feb 26, 2020 | Class II | Z-1649-2020 | Process control | Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. |
| Feb 26, 2020 | Class II | Z-1643-2020 | Process control | Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. |
| Feb 26, 2020 | Class II | Z-1645-2020 | Process control | Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. |
| Feb 26, 2020 | Class II | Z-1644-2020 | Process control | Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. |
| Feb 26, 2020 | Class II | Z-1647-2020 | Process control | Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. |
| Feb 26, 2020 | Class II | Z-1652-2020 | Process control | Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. |
| Feb 26, 2020 | Class II | Z-1639-2020 | Process control | Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. |
The 5 latest of 15 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 4 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K161166 (Biomet, Inc., 2016) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K052990.
How does its category compare?
All KWY devicesKWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · KWY
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWY
126in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWY
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWY
180in 2025
MAUDE reports naming product code KWY, 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 | 0 | — | 25 | 370 |
| 2008 | 3 | 123 | 0 | 900 |
| 2009 | 1 | — | 24 | 961 |
| 2010 | 4 | 187 | 1 | 688 |
| 2011 | 1 | — | 0 | 758 |
| 2012 | 1 | — | 1 | 978 |
| 2013 | 2 | — | 2 | 1,148 |
| 2014 | 1 | — | 0 | 1,055 |
| 2015 | 1 | — | 0 | 1,213 |
| 2016 | 1 | — | 3 | 877 |
| 2017 | 1 | — | 2 | 826 |
| 2018 | 3 | 219 | 1 | 1,380 |
| 2019 | 5 | 126 | 1 | 1,530 |
| 2020 | 1 | — | 0 | 1,259 |
| 2021 | 0 | — | 0 | 276 |
| 2022 | 2 | — | 0 | 208 |
| 2023 | 2 | — | 0 | 178 |
| 2024 | 0 | — | 1 | 209 |
| 2025 | 1 | — | 2 | 180 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Disposable cement spacer molds with stainless steel reinforcement stems, adaptors and inserts 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 assembled and inserted into the femoral medullary canal and acetabular cavity following removal of the existing femoral and acetabular implants and debridement. The device is…
Read the full statement (152 words)
Disposable cement spacer molds with stainless steel reinforcement stems, adaptors and inserts 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 assembled 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 StageOne Select hemi-hip prosthesis 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 (polymethylhnethacrylate/gentamicin), 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 as stated in the FDA summary.
https://510kreport.com/device/K080979 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080979: Stageone Select Cement Spacer Molds for Temporary Hip Replacement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080979
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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