510(k) · Cleared
ClearedOsteoRemedies Hip Spacer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteoremedies, LLC · KWL Prosthesis, Hip, Hemi-, Femoral, Metal
Cleared on Dec 23, 2025 as substantially equivalent to K192995 (Osteoremedies, LLC, 2020) and 4 other predicates after a 32-day review. Its family tree reaches back 9 generations to 1995. 1 later device descends from it.
- Decided
- Dec 23, 2025
- Review
- 32 days
- Class
- Class II
- Product code
- KWL
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 9 generations to K936159 (1995). 23 ancestors in all, the oldest P810020 (1984). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK936159 Natural-Knee II SystemIntermedics Orthopedics · 1995 · Recalled
- 5 generations between
- 3 generations backK173967 Remedy Acetabular CupOsteoremedies, LLC · 2018
- 2 generations backK191981 REMEDY Acetabular CupOsteoremedies, LLC · 2019
- 1 generation backK192995 OsteoRemedies Hip Spacer SystemOsteoremedies, LLC · 2020
- This deviceK253675 OsteoRemedies Hip Spacer SystemOsteoremedies, LLC · 2025
- Descendant · cites it directly · 0 of its ownK262290 REMEDY POLY+PLUS SNAP FIT Acetabular CupOsteoremedies, LLC · 2026
Show all 9 generations
- Root · 9 generations backK936159 Natural-Knee II SystemIntermedics Orthopedics · 1995 · Recalled
- 8 generations backK032522 Tecres Spacer-K Temporary Knee ProsthesisExactech, Inc. · 2004
- 7 generations backK050210 Disposable Cement Spacer Molds for Temporary Knee ProsthesesBiomet, Inc. · 2005 · Recalled
- 6 generations backK062274 Spacer-K Temporary Knee Spacer with Gentamicin, Models SPK0021…Tecres S.P.A. · 2008
- 5 generations backK101356 Spacer-G and Spacer-KTecres S.P.A. · 2011
- 4 generations backK112470 2GC Hip/Knee Modular SpacerMandell Horwitz Consultants, LLC · 2012
- 3 generations backK173967 Remedy Acetabular CupOsteoremedies, LLC · 2018
- 2 generations backK191981 REMEDY Acetabular CupOsteoremedies, LLC · 2019
- 1 generation backK192995 OsteoRemedies Hip Spacer SystemOsteoremedies, LLC · 2020
- This deviceK253675 OsteoRemedies Hip Spacer SystemOsteoremedies, LLC · 2025
Most influential descendants
Showing 1 of 1 · See all- K262290REMEDY POLY+PLUS SNAP FIT Acetabular CupOsteoremedies, LLC · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K936159 | Natural-Knee II System | Intermedics Orthopedics | 1995 | 6 |
| −8 | K032522 | Tecres Spacer-K Temporary Knee Prosthesis | Exactech, Inc. | 2004 | — |
| −7 | K050210 | Disposable Cement Spacer Molds for Temporary Knee Prostheses | Biomet, Inc. | 2005 | 8 |
| −6 | K062274 | Spacer-K Temporary Knee Spacer with Gentamicin, Models SPK0021, SPK0121… | Tecres S.P.A. | 2008 | — |
| −5 | K101356 | Spacer-G and Spacer-K | Tecres S.P.A. | 2011 | — |
| −4 | K112470 | 2GC Hip/Knee Modular Spacer | Mandell Horwitz Consultants, LLC | 2012 | — |
| −3 | K173967 | Remedy Acetabular Cup | Osteoremedies, LLC | 2018 | — |
| −2 | K191981 | REMEDY Acetabular Cup | Osteoremedies, LLC | 2019 | — |
| −1 | K192995 | OsteoRemedies Hip Spacer System | Osteoremedies, LLC | 2020 | — |
| 0 (this device) | K253675 | OsteoRemedies Hip Spacer System | Osteoremedies, LLC | 2025 | — |
| +1 | K262290 | REMEDY POLY+PLUS SNAP FIT Acetabular Cup | Osteoremedies, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 KWL? 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 KWL device
- #1 K262290 REMEDY POLY+PLUS SNAP FIT Acetabular Cupscore 14.4 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (7)
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 |
|---|---|---|---|
| * | K192995 | OsteoRemedies Hip Spacer SystemSummary page 5…II Product Codes: KWL, KWY Subject & Predicate Devices: Subject Devices Predicate Devices REMEDY POLY+PLUS REMEDY Acetabular Cup (K192995, K191981 and K173967) Acetabular Cup REMEDY CoCr Modular REMEDY Hip Spacer (K112470) – Originally cleared under the trad… | 2020 |
| * | K191981 | REMEDY Acetabular CupSummary page 5…uct Codes: KWL, KWY Subject & Predicate Devices: Subject Devices Predicate Devices REMEDY POLY+PLUS REMEDY Acetabular Cup (K192995, K191981 and K173967) Acetabular Cup REMEDY CoCr Modular REMEDY Hip Spacer (K112470) – Originally cleared under the trade Femora… | 2019 |
| * | K173967 | Remedy Acetabular CupSummary page 5…KWL, KWY Subject & Predicate Devices: Subject Devices Predicate Devices REMEDY POLY+PLUS REMEDY Acetabular Cup (K192995, K191981 and K173967) Acetabular Cup REMEDY CoCr Modular REMEDY Hip Spacer (K112470) – Originally cleared under the trade Femoral Head… | 2018 |
| * | K112470 | 2GC Hip/Knee Modular SpacerSummary page 5…Predicate Devices REMEDY POLY+PLUS REMEDY Acetabular Cup (K192995, K191981 and K173967) Acetabular Cup REMEDY CoCr Modular REMEDY Hip Spacer (K112470) – Originally cleared under the trade Femoral Head name, 2GC Hip/Knee Modular Spacer REM… | 2012 |
| * | K172906 | REMEDY PLUS Hip Spacer, UNITE PLUS Bone CementSummary page 5…cer (K112470) – Originally cleared under the trade Femoral Head name, 2GC Hip/Knee Modular Spacer REMEDY SPECTRUM GV Hip Spacer (K172906) – Originally cleared under the trade name, REMEDY PLUS Hip Spacer XS REMED… | 2018 |
| * | — | XS REMEDY Modular Heads Named without a submission number | |
| * | — | REMEDY SPECTRUM GV Modular Heads Named without a submission number | |
| † | K000004 | Alliance Left Heart Delivery System Introducer, Model #407509 | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K262290 | REMEDY POLY+PLUS SNAP FIT Acetabular Cup | 2026 | 0 |
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 30 years and passes through 6 companies; a new generation was cleared every 2.8 years on median.
- 4 of the 23 ancestors have a recall of any class.
- Of its descendants, K262290 (Osteoremedies, LLC, 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All KWL devicesKWL Prosthesis, Hip, Hemi-, Femoral, Metal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · KWL
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWL
32in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWL
2in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWL
29in 2025
MAUDE reports naming product code KWL, 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 | 2 | — | 36 | 11 |
| 2008 | 1 | — | 0 | 13 |
| 2009 | 0 | — | 2 | 21 |
| 2010 | 0 | — | 0 | 55 |
| 2011 | 2 | — | 0 | 51 |
| 2012 | 1 | — | 0 | 62 |
| 2013 | 0 | — | 0 | 89 |
| 2014 | 0 | — | 0 | 107 |
| 2015 | 1 | — | 1 | 223 |
| 2016 | 0 | — | 0 | 210 |
| 2017 | 0 | — | 2 | 347 |
| 2018 | 2 | — | 0 | 294 |
| 2019 | 1 | — | 0 | 415 |
| 2020 | 1 | — | 0 | 270 |
| 2021 | 0 | — | 0 | 107 |
| 2022 | 1 | — | 0 | 99 |
| 2023 | 0 | — | 0 | 48 |
| 2024 | 1 | — | 0 | 143 |
| 2025 | 3 | 32 | 0 | 29 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The OsteoRemedies Hip Spacer System consists of modular heads and stems, and optional acetabular cups. The REMEDY® components of the OsteoRemedies Hip Spacer System include gentamicin and the REMEDY SPECTRUM® GV components include gentamicin and vancomycin. The OsteoRemedies Hip Spacer System is indicated for temporary use (maximum 180 days) as an adjunct to total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to…
Read the full statement (189 words)
The OsteoRemedies Hip Spacer System consists of modular heads and stems, and optional acetabular cups. The REMEDY® components of the OsteoRemedies Hip Spacer System include gentamicin and the REMEDY SPECTRUM® GV components include gentamicin and vancomycin.
The OsteoRemedies Hip Spacer System is indicated for temporary use (maximum 180 days) as an adjunct to total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process and where gentamicin or gentamicin/vancomycin are the most appropriate antibiotics based on the susceptibility pattern of the infecting micro-organism(s).
Following removal of the existing femoral and acetabular components and radical debridement, the head and stem components are inserted into the femoral medullary canal and can mate directly with the native acetabulum or an acetabular component which is placed in the acetabular cavity. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).
The OsteoRemedies Hip Spacer System is not intended for use for more than 180 days, at which time all components must be explanted, and a permanent device implanted or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253675 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253675: OsteoRemedies Hip Spacer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253675
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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