510(k) · Cleared
ClearedRemedy® Shoulder Spacer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteoremedies, LLC · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Cleared on Dec 15, 2015 as substantially equivalent to K060535 (Tecres S.P.A., 2006) and 1 other predicate after a 126-day review. Its family tree reaches back 6 generations to 1991. 2 later devices descend from it.
- Decided
- Dec 15, 2015
- Review
- 126 days
- Class
- Class II
- Product code
- KWS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K911686 (1991). 30 ancestors in all, the oldest K790987 (1979). 2 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 5 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 4 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 3 generations backK042021 Exactech Equinoxe Shoulder SystemExactech, Inc. · 2004 · Recalled
- 2 generations backK060535 Spacer-S Temporary Shoulder SpacerTecres S.P.A. · 2006
- 1 generation backK112983 Spacer-STecres S.P.A. · 2011
- This deviceK152267 Remedy® Shoulder SpacerOsteoremedies, LLC · 2015
- Descendant · cites it directly · 0 of its ownK252443 SpaceFix Shoulder SpacerG21, S.R.L. · 2025
- Descendant · cites it directly · 0 of its ownK240856 Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer MoldsOsartis GmbH · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −5 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −4 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −3 | K042021 | Exactech Equinoxe Shoulder System | Exactech, Inc. | 2004 | 10 |
| −2 | K060535 | Spacer-S Temporary Shoulder Spacer | Tecres S.P.A. | 2006 | — |
| −1 | K112983 | Spacer-S | Tecres S.P.A. | 2011 | — |
| 0 (this device) | K152267 | Remedy® Shoulder Spacer | Osteoremedies, LLC | 2015 | — |
| +1 | K252443 | SpaceFix Shoulder Spacer | G21, S.R.L. | 2025 | — |
| +1 | K240856 | Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds | Osartis GmbH | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1987 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 5 | 0 |
| 2001 | 5 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 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 KWS? 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 KWS device
- #1 K220847 AETOS Shoulder Systemscore 21.1 · 16 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 |
|---|---|---|---|
| * | K060535 | Spacer-S Temporary Shoulder SpacerSummary page 5…Orthopedic 3 PREDICATE DEVICE The predicate device is as follows: • Tecres’ InterSpace Shoulder, which was cleared through 510(k) application K060535 and K112983. The following reference devices were considered in analysis of the technological characteristics of the Remedy® Shou… | 2006 |
| * | K112983 | Spacer-SSummary page 5…Orthopedic 3 PREDICATE DEVICE The predicate device is as follows: • Tecres’ InterSpace Shoulder, which was cleared through 510(k) application K060535 and K112983. The following reference devices were considered in analysis of the technological characteristics of the Remedy® Shoulder Spacer.… | 2011 |
| † | K131135 | Biomet Stage One Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis | 2014 |
| † | K042021 | Exactech Equinoxe Shoulder System | 2004 |
| † | K061454 | Exactech Equinoxe Shoulder Stems | 2006 |
| † | K140063 | Equinoxe Extra Short Humeral Head | 2014 |
| † | K040432 | Solar 2 Anatomic Shoulder | 2005 |
| † | K071032 | Arthrex Univers II Shoulder Prosthesis | 2007 |
| † | K103466 | Arthrex Univers II Shoulder Prosthesis | 2010 |
| † | K062273 | Spacer-G Temporary Hip Prosthesis | 2008 |
| † | K062274 | Spacer-K Temporary Knee Spacer with Gentamicin, Models SPK0021, SPK0121, SPK0221, SPK0321 | 2008 |
| † | K112470 | 2GC Hip/Knee Modular Spacer | 2012 |
What descends from it? (2)
2 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 5 companies; a new generation was cleared every 5.3 years on median.
- 3 of the 30 ancestors have a recall of any class.
- Of its descendants, K252443 (G21, S.R.L., 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K060535.
How does its category compare?
All KWS devicesKWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · KWS
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWS
97in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWS
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWS
2,281in 2025
MAUDE reports naming product code KWS, 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 | — | 21 | 158 |
| 2008 | 4 | 37 | 29 | 238 |
| 2009 | 4 | 108 | 0 | 294 |
| 2010 | 7 | 33 | 10 | 393 |
| 2011 | 11 | 90 | 11 | 486 |
| 2012 | 7 | 86 | 10 | 542 |
| 2013 | 12 | 120 | 0 | 818 |
| 2014 | 7 | 89 | 1 | 1,066 |
| 2015 | 8 | 129 | 0 | 1,170 |
| 2016 | 10 | 114 | 1 | 970 |
| 2017 | 7 | 120 | 4 | 1,681 |
| 2018 | 4 | 152 | 1 | 1,545 |
| 2019 | 9 | 106 | 2 | 1,728 |
| 2020 | 3 | 98 | 5 | 1,567 |
| 2021 | 5 | 151 | 0 | 1,358 |
| 2022 | 5 | 158 | 0 | 1,268 |
| 2023 | 4 | 250 | 2 | 1,750 |
| 2024 | 2 | — | 0 | 2,122 |
| 2025 | 3 | 97 | 0 | 2,281 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Remedy® Shoulder Spacer, which consists of a modular head and stem, is indicated for temporary use (maximum 180 days) as an adjunct to total or hemi-shoulder replacement in skeletally mature patients undergoing a two-stage procedure due to a septic process and where gentamicin is the most appropriate antibiotic based on the susceptibility pattern of the infecting micro-organisms. The head and stem components are inserted into the glenoidal cavity and…
Read the full statement (139 words)
The Remedy® Shoulder Spacer, which consists of a modular head and stem, is indicated for temporary use (maximum 180 days) as an adjunct to total or hemi-shoulder replacement in skeletally mature patients undergoing a two-stage procedure due to a septic process and where gentamicin is the most appropriate antibiotic based on the susceptibility pattern of the infecting micro-organisms.
The head and stem components are inserted into the glenoidal cavity and humeral medullary canal, respectively, following removal of the existing prosthetic 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® Shoulder 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.).
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/K152267 · printed Nov 5, 2026
Cite this page
510(k) Report. “K152267: Remedy® Shoulder Spacer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K152267
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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