510(k) · Cleared
ClearedREMEDY Acetabular Cup
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 23, 2019 as substantially equivalent to K173967 (Osteoremedies, LLC, 2018) and 1 other predicate after a 30-day review. Its family tree reaches back 7 generations to 1995. 4 later devices descend from it.
- Decided
- Aug 23, 2019
- Review
- 30 days
- Class
- Class II
- Product code
- KWL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K936159 (1995). 21 ancestors in all, the oldest P810020 (1984). 4 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK936159 Natural-Knee II SystemIntermedics Orthopedics · 1995 · Recalled
- 6 generations backK032522 Tecres Spacer-K Temporary Knee ProsthesisExactech, Inc. · 2004
- 5 generations backK050210 Disposable Cement Spacer Molds for Temporary Knee ProsthesesBiomet, Inc. · 2005 · Recalled
- 4 generations backK062274 Spacer-K Temporary Knee Spacer with Gentamicin, Models SPK0021…Tecres S.P.A. · 2008
- 3 generations backK101356 Spacer-G and Spacer-KTecres S.P.A. · 2011
- 2 generations backK112470 2GC Hip/Knee Modular SpacerMandell Horwitz Consultants, LLC · 2012
- 1 generation backK173967 Remedy Acetabular CupOsteoremedies, LLC · 2018
- This deviceK191981 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 · 2 generations on · 0 of its ownK262290 REMEDY POLY+PLUS SNAP FIT Acetabular CupOsteoremedies, LLC · 2026
- Descendant · cites it directly · 0 of its ownK223441 SpaceFlex Acetabular CupG21, S.R.L. · 2023
Most influential descendants
Showing 4 of 4 · See all- K192995OsteoRemedies Hip Spacer SystemOsteoremedies, LLC · 2020 · cites it directly2descendants
- K253675OsteoRemedies Hip Spacer SystemOsteoremedies, LLC · 2025 · cites it directly1descendant
- K262290REMEDY POLY+PLUS SNAP FIT Acetabular CupOsteoremedies, LLC · 2026 · 2 generations on0descendants
- K223441SpaceFlex Acetabular CupG21, S.R.L. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K936159 | Natural-Knee II System | Intermedics Orthopedics | 1995 | 6 |
| −6 | K032522 | Tecres Spacer-K Temporary Knee Prosthesis | Exactech, Inc. | 2004 | — |
| −5 | K050210 | Disposable Cement Spacer Molds for Temporary Knee Prostheses | Biomet, Inc. | 2005 | 8 |
| −4 | K062274 | Spacer-K Temporary Knee Spacer with Gentamicin, Models SPK0021, SPK0121… | Tecres S.P.A. | 2008 | — |
| −3 | K101356 | Spacer-G and Spacer-K | Tecres S.P.A. | 2011 | — |
| −2 | K112470 | 2GC Hip/Knee Modular Spacer | Mandell Horwitz Consultants, LLC | 2012 | — |
| −1 | K173967 | Remedy Acetabular Cup | Osteoremedies, LLC | 2018 | — |
| 0 (this device) | 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 | — |
| +2 | K262290 | REMEDY POLY+PLUS SNAP FIT Acetabular Cup | Osteoremedies, LLC | 2026 | — |
| +1 | K223441 | SpaceFlex Acetabular Cup | G21, S.R.L. | 2023 | — |
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 |
|---|---|---|
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 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 |
|---|---|---|---|
| * | K173967 | Remedy Acetabular CupSummary page 4…i-hip) metallic cemented or uncemented prosthesis Product Codes: KWL, KWY Predicate Devices: REMEDY Acetabular Cup (K173967) REMEDY SPECTRUM GV Hip Spacer (K172906) Device Description: The REMEDY Acetabular Cup is a tempora… | 2018 |
| * | K172906 | REMEDY PLUS Hip Spacer, UNITE PLUS Bone CementSummary page 4…rosthesis Product Codes: KWL, KWY Predicate Devices: REMEDY Acetabular Cup (K173967) REMEDY SPECTRUM GV Hip Spacer (K172906) Device Description: The REMEDY Acetabular Cup is a temporary spacer device available in a single size, intended to be combined… | 2018 |
What descends from it? (4)
3 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 24 years and passes through 6 companies; a new generation was cleared every 2.8 years on median.
- 4 of the 21 ancestors have a recall of any class.
- Of its descendants, K192995 (Osteoremedies, LLC, 2020) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K173967.
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. 2019, 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 Acetabular Cup 46mm ID/54mm OD consists of an acetabular cup that 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. The REMEDY Acetabular Cup 46mm ID/54mm OD is positioned into the acetabular cavity following removal of the existing acetabular and femoral components and radical debridement. The device must be…
Read the full statement (189 words)
The REMEDY Acetabular Cup 46mm ID/54mm OD consists of an acetabular cup that 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.
The REMEDY Acetabular Cup 46mm ID/54mm OD is positioned into the acetabular cavity following removal of the existing acetabular and femoral components and radical debridement. The device must be combined with the REMEDY Hip Spacer using the REMEDY 46mm Modular Head when gentamicin is the most appropriate antibiotic based on the susceptibility pattern of the infecting micro-organism(s), or the REMEDY SPECTRUM GV Hip Spacer using the REMEDY SPECTRUM GV 46mm Modular Head when gentamicin and vancomycin are the most appropriate antibiotic based on the susceptibility pattern of the infecting micro-organism(s). The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).
The REMEDY Acetabular Cup 46mm ID/54mm OD 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, etc.).
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/K191981 · printed Nov 3, 2026
Cite this page
510(k) Report. “K191981: REMEDY Acetabular Cup.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K191981
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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