510(k) · Cleared
ClearedREMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement
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 Aug 29, 2018 as substantially equivalent to K143100 (Cossington, Ltd., 2015) after a 341-day review. Its family tree reaches back 5 generations to 2001. 9 later devices descend from it.
- Decided
- Aug 29, 2018
- Review
- 341 days
- Class
- Class II
- Product code
- KWL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K000943 (2001). 9 later devices descend from it, 6 citing it directly.
- Root · 5 generations backK000943 Cemex System Gun Application VersionExactech, Inc. · 2001
- 4 generations backK033596 Cemex Genta Bone Cement; Cemex Genta System Bone CementExactech, Inc. · 2004
- 3 generations backK043403 Cemex System Genta Fast Bone CementExactech, Inc. · 2004
- 2 generations backK092773 Cemex Genta, Genta System and Genta System FastTecres S.P.A. · 2009
- 1 generation backK143100 NP Cement HV Genta;NP Cement LV Genta;NP Cement HV System Genta;NP…Cossington, Ltd. · 2015
- This deviceK172906 REMEDY PLUS Hip Spacer, UNITE PLUS Bone CementOsteoremedies, LLC · 2018
- Descendant · cites it directly · 4 of its ownK191981 REMEDY Acetabular CupOsteoremedies, LLC · 2019
- Descendant · cites it directly · 2 of its ownK192995 OsteoRemedies Hip Spacer SystemOsteoremedies, LLC · 2020
- Descendant · cites it directly · 1 of its ownK253675 OsteoRemedies Hip Spacer SystemOsteoremedies, LLC · 2025
- Descendant · cites it directly · 1 of its ownK231556 SPECTRUM® GV Bone CementOsteoremedies, LLC · 2023
- Descendant · 2 generations on · 0 of its ownK262290 REMEDY POLY+PLUS SNAP FIT Acetabular CupOsteoremedies, LLC · 2026
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K191981REMEDY Acetabular CupOsteoremedies, LLC · 2019 · cites it directly4descendants
- K192995OsteoRemedies Hip Spacer SystemOsteoremedies, LLC · 2020 · cites it directly2descendants
- K253675OsteoRemedies Hip Spacer SystemOsteoremedies, LLC · 2025 · cites it directly1descendant
- K231556SPECTRUM® GV Bone CementOsteoremedies, LLC · 2023 · cites it directly1descendant
- K262290REMEDY POLY+PLUS SNAP FIT Acetabular CupOsteoremedies, LLC · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K000943 | Cemex System Gun Application Version | Exactech, Inc. | 2001 | — |
| −4 | K033596 | Cemex Genta Bone Cement; Cemex Genta System Bone Cement | Exactech, Inc. | 2004 | — |
| −3 | K043403 | Cemex System Genta Fast Bone Cement | Exactech, Inc. | 2004 | — |
| −2 | K092773 | Cemex Genta, Genta System and Genta System Fast | Tecres S.P.A. | 2009 | — |
| −1 | K143100 | NP Cement HV Genta;NP Cement LV Genta;NP Cement HV System Genta;NP Cement LV… | Cossington, Ltd. | 2015 | — |
| 0 (this device) | K172906 | REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement | Osteoremedies, LLC | 2018 | — |
| +1 | K191981 | REMEDY Acetabular Cup | Osteoremedies, LLC | 2019 | — |
| +1 | K192995 | OsteoRemedies Hip Spacer System | Osteoremedies, LLC | 2020 | — |
| +1 | K253675 | OsteoRemedies Hip Spacer System | Osteoremedies, LLC | 2025 | — |
| +1 | K231556 | SPECTRUM® GV Bone Cement | Osteoremedies, LLC | 2023 | — |
| +2 | K262290 | REMEDY POLY+PLUS SNAP FIT Acetabular Cup | Osteoremedies, LLC | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 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 K253675 OsteoRemedies Hip Spacer Systemscore 16.0 · 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 |
|---|---|---|---|
| * | K143100 | NP Cement HV Genta;NP Cement LV Genta;NP Cement HV System Genta;NP Cement LV System GentaSummary page 5…for the UNITE PLUS Bone Cement Predicate Devices: DePuy Prostalac Hip Temporary Prosthesis System NP Cements Genta HV Bone Cements (K143100) Reference Device: REMEDY Hip Spacer cleared as the 2GC Hip Modular Spacer (K112470) ===… | 2015 |
| * | — | DePuy Prostalac Hip Temporary Prosthesis System Named without a submission number | |
| † | K112470 | 2GC Hip/Knee Modular Spacer | 2012 |
What descends from it? (9)
6 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)
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 17 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K191981 (Osteoremedies, LLC, 2019) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K143100.
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. 2018, 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 REMEDY PLUS Hip Spacer, which consists of a modular head and stem, 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 and vancomycin are the most appropriate antibiotics based on the susceptibility pattern of the infecting micro-organism(s). The head and stem components are inserted into the…
Read the full statement (165 words)
The REMEDY PLUS Hip Spacer, which consists of a modular head and stem, 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 and vancomycin are the most appropriate antibiotics based on the susceptibility pattern of the infecting micro-organism(s).
The head and stem components are inserted into the acetabular cavity and femoral medullary canal, respectively, following removal of the existing acetabular and femoral components and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).
The REMEDY PLUS Hip Spacer is not intended for use for 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.).
The UNITE PLUS Bone Cement is intended for the fixation of a REMEDY PLUS spacer devices to the host bone.
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/K172906 · printed Nov 5, 2026
Cite this page
510(k) Report. “K172906: REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K172906
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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