510(k) · Cleared
ClearedSpacer-S Temporary Shoulder Spacer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tecres S.P.A. · HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Cleared on May 24, 2006 as substantially equivalent to K042021 (Exactech, Inc., 2004) after an 85-day review. Its family tree reaches back 4 generations to 1991. 8 later devices descend from it.
- Decided
- May 24, 2006
- Review
- 85 days
- Class
- Class II
- Product code
- HSD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K911686 (1991). 28 ancestors in all, the oldest K790987 (1979). 8 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 3 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 2 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 1 generation backK042021 Exactech Equinoxe Shoulder SystemExactech, Inc. · 2004 · Recalled
- This deviceK060535 Spacer-S Temporary Shoulder SpacerTecres S.P.A. · 2006
- Descendant · cites it directly · 7 of its ownK112983 Spacer-STecres S.P.A. · 2011
- Descendant · 2 generations on · 4 of its ownK131135 Biomet Stage One Disposable Cement Spacer Molds for Temporary…Biomet Manufacturing Corp · 2014 · Recalled
- Descendant · 2 generations on · 3 of its ownK160071 StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder…Biomet, Inc. · 2016 · Recalled
- Descendant · cites it directly · 2 of its ownK152267 Remedy® Shoulder SpacerOsteoremedies, LLC · 2015
- Descendant · 2 generations on · 1 of its ownK202338 SpaceFlex ShoulderG21, S.R.L. · 2021
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K112983Spacer-STecres S.P.A. · 2011 · cites it directly7descendants
- K131135Biomet Stage One Disposable Cement Spacer Molds for Temporary Hemi-Shoulder ProsthesisBiomet Manufacturing Corp · 2014 · 2 generations on4descendants
- K160071StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder ProsthesisBiomet, Inc. · 2016 · 2 generations on3descendants
- K152267Remedy® Shoulder SpacerOsteoremedies, LLC · 2015 · cites it directly2descendants
- K202338SpaceFlex ShoulderG21, S.R.L. · 2021 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −3 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −2 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −1 | K042021 | Exactech Equinoxe Shoulder System | Exactech, Inc. | 2004 | 10 |
| 0 (this device) | K060535 | Spacer-S Temporary Shoulder Spacer | Tecres S.P.A. | 2006 | — |
| +1 | K112983 | Spacer-S | Tecres S.P.A. | 2011 | — |
| +2 | K131135 | Biomet Stage One Disposable Cement Spacer Molds for Temporary Hemi-Shoulder… | Biomet Manufacturing Corp | 2014 | 5 |
| +2 | K160071 | StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis | Biomet, Inc. | 2016 | 5 |
| +1 | K152267 | Remedy® Shoulder Spacer | Osteoremedies, LLC | 2015 | — |
| +2 | K202338 | SpaceFlex Shoulder | G21, S.R.L. | 2021 | — |
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 |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 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 HSD? 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 HSD device
- #1 K191433 AGILON® XO Shoulder Replacement Systemscore 13.8 · 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? (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 |
|---|---|---|---|
| * | K042021 | Exactech Equinoxe Shoulder SystemSummary page 2…the results of performance testing, it is concluded that the Spacer-S device is substantially equivalent functionally to the predicate Equinoxe Shoulder System device (#K04202 1). Whereas the Spacer-S device differs technologically from the predicate, the differences do not raise new questions of safety an… | 2004 |
What descends from it? (8)
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 15 years and passes through 4 companies; a new generation was cleared every 5.3 years on median.
- 3 of the 28 ancestors have a recall of any class.
- Of its descendants, K112983 (Tecres S.P.A., 2011) has gone furthest, with 7 descendants of its own.
- 13 other devices also cite its predicate K042021.
How does its category compare?
All HSD devicesHSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HSD
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HSD
145in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HSD
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSD
757in 2025
MAUDE reports naming product code HSD, 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 | 4 | 72 | 0 | 128 |
| 2008 | 3 | 92 | 2 | 259 |
| 2009 | 0 | — | 2 | 156 |
| 2010 | 0 | — | 0 | 225 |
| 2011 | 2 | — | 0 | 241 |
| 2012 | 2 | — | 0 | 254 |
| 2013 | 4 | 218 | 0 | 288 |
| 2014 | 1 | — | 0 | 434 |
| 2015 | 0 | — | 0 | 574 |
| 2016 | 3 | 145 | 0 | 784 |
| 2017 | 0 | — | 3 | 985 |
| 2018 | 1 | — | 1 | 649 |
| 2019 | 0 | — | 0 | 830 |
| 2020 | 2 | — | 1 | 658 |
| 2021 | 0 | — | 0 | 573 |
| 2022 | 1 | — | 0 | 508 |
| 2023 | 0 | — | 0 | 586 |
| 2024 | 1 | — | 0 | 693 |
| 2025 | 0 | — | 0 | 757 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Spacer-S is indicated for temporary use (maximum 180 days) as an adjunct to total shoulder replacement and hemi shoulder replacement procedures in skeletally mature patients undergoing a two-stage revision procedure due to a septic process. Spacer-S is only indicated for an implantation period of 180 days or less.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060535 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060535: Spacer-S Temporary Shoulder Spacer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060535
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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