510(k) · Cleared
Recalled · Class II · 2020Stageone Disposable Cement Spacer Mold for Temporary Hip Prosthesis with Reinforcement Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Cleared on Dec 16, 2005 as substantially equivalent to K031841 (Exactech, Inc., 2004) after a 53-day review. Its family tree reaches back 2 generations to 1998. 30 later devices descend from it. It has been recalled 5 times.
- Decided
- Dec 16, 2005
- Review
- 53 days
- Class
- Class II
- Product code
- KWY
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 2 generations to K974807 (1998). 30 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK974807 Osteo Austin Moore Endoprosthesis SystemOsteonics Corp. · 1998
- 1 generation backK031841 Spacer G Temporary Hip ProsthesisExactech, Inc. · 2004
- This deviceK052990 Stageone Disposable Cement Spacer Mold for Temporary Hip Prosthesis…Biomet, Inc. · 2005
- Descendant · cites it directly · 20 of its ownK062273 Spacer-G Temporary Hip ProsthesisTecres S.P.A. · 2008
- Descendant · 2 generations on · 19 of its ownK101356 Spacer-G and Spacer-KTecres S.P.A. · 2011
- Descendant · 3 generations on · 16 of its ownK112470 2GC Hip/Knee Modular SpacerMandell Horwitz Consultants, LLC · 2012
- Descendant · 4 generations on · 5 of its ownK183017 Remedy Femoral Component 84mm, Remedy Stemmed Knee SpacerOsteoremedies, LLC · 2019
- Descendant · 4 generations on · 5 of its ownK173967 Remedy Acetabular CupOsteoremedies, LLC · 2018
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K062273Spacer-G Temporary Hip ProsthesisTecres S.P.A. · 2008 · cites it directly20descendants
- K101356Spacer-G and Spacer-KTecres S.P.A. · 2011 · 2 generations on19descendants
- K1124702GC Hip/Knee Modular SpacerMandell Horwitz Consultants, LLC · 2012 · 3 generations on16descendants
- K183017Remedy Femoral Component 84mm, Remedy Stemmed Knee SpacerOsteoremedies, LLC · 2019 · 4 generations on5descendants
- K173967Remedy Acetabular CupOsteoremedies, LLC · 2018 · 4 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K974807 | Osteo Austin Moore Endoprosthesis System | Osteonics Corp. | 1998 | — |
| −1 | K031841 | Spacer G Temporary Hip Prosthesis | Exactech, Inc. | 2004 | — |
| 0 (this device) | K052990 | Stageone Disposable Cement Spacer Mold for Temporary Hip Prosthesis with… | Biomet, Inc. | 2005 | — |
| +1 | K062273 | Spacer-G Temporary Hip Prosthesis | Tecres S.P.A. | 2008 | — |
| +2 | K101356 | Spacer-G and Spacer-K | Tecres S.P.A. | 2011 | — |
| +3 | K112470 | 2GC Hip/Knee Modular Spacer | Mandell Horwitz Consultants, LLC | 2012 | — |
| +4 | K183017 | Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer | Osteoremedies, LLC | 2019 | — |
| +4 | K173967 | Remedy Acetabular Cup | Osteoremedies, LLC | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 6 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 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? (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 |
|---|---|---|---|
| * | K031841 | Spacer G Temporary Hip ProsthesisSummary page 1…or uncemented prosthesis (21 CFR 888.3390) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Spacer-G Temporary Hip Prosthesis cleared by the FDA in K031841 and marketed in the US under the InterSpace TM Hip by Exactech, Inc., Gainesville, FL. Device Description: The device consists of… | 2004 |
What descends from it? (30)
See all 303 later devices cite it directly; ranked here by how many devices descend from each in turn.
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-1656-2020 | Process control | Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. |
| Feb 26, 2020 | Class II | Z-1655-2020 | Process control | Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. |
| Feb 26, 2020 | Class II | Z-1654-2020 | Process control | Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. |
| Feb 26, 2020 | Class II | Z-1653-2020 | Process control | Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. |
| Sep 21, 2018 | Class II | Z-0399-2019 | Error in labeling | There is a potential for comingling of the 43MM and 51 MM molds |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 5.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K062273 (Tecres S.P.A., 2008) has gone furthest, with 20 descendants of its own.
- 4 other devices also cite its predicate K031841.
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.
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 reinforcements are intended to be used to mold a hemi-hip femoral prosthesis, indicated for temporary use (maximum 180 days) in skeletally mature patients undergoing a two-stage procedure due to septic process. The temporary prosthesis is inserted into the femoral medullary canal and acetabular cavity following removal of the existing femoral and acetabular implants and debridement. The temporary…
Read the full statement (150 words)
Disposable cement spacer molds with stainless steel reinforcements are intended to be used to mold a hemi-hip femoral prosthesis, indicated for temporary use (maximum 180 days) in skeletally mature patients undergoing a two-stage procedure due to septic process.
The temporary prosthesis is inserted into the femoral medullary canal and acetabular cavity following removal of the existing femoral and acetabular implants and debridement. The temporary prosthesis is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).
The hemi-hip femoral prosthesis is not intended for use more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g. resection, arthroplasty, fusion, etc.)
Because of inherent mechanical limitations of the material (polymethylmethacrylate/gentamicin), the molded temporary 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/K052990 · printed Nov 5, 2026
Cite this page
510(k) Report. “K052990: Stageone Disposable Cement Spacer Mold for Temporary Hip Prosthesis with Reinforcement Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052990
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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