510(k) · Cleared
ClearedSpacer-S
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 Dec 12, 2011 as substantially equivalent to K060535 (Tecres S.P.A., 2006) after a 67-day review. Its family tree reaches back 5 generations to 1991. 7 later devices descend from it.
- Decided
- Dec 12, 2011
- Review
- 67 days
- Class
- Class II
- Product code
- HSD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K911686 (1991). 29 ancestors in all, the oldest K790987 (1979). 7 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 4 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 3 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 2 generations backK042021 Exactech Equinoxe Shoulder SystemExactech, Inc. · 2004 · Recalled
- 1 generation backK060535 Spacer-S Temporary Shoulder SpacerTecres S.P.A. · 2006
- This deviceK112983 Spacer-STecres S.P.A. · 2011
- Descendant · cites it directly · 4 of its ownK131135 Biomet Stage One Disposable Cement Spacer Molds for Temporary…Biomet Manufacturing Corp · 2014 · Recalled
- Descendant · cites it directly · 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 · cites it directly · 1 of its ownK202338 SpaceFlex ShoulderG21, S.R.L. · 2021
- Descendant · 2 generations on · 0 of its ownK252443 SpaceFix Shoulder SpacerG21, S.R.L. · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K131135Biomet Stage One Disposable Cement Spacer Molds for Temporary Hemi-Shoulder ProsthesisBiomet Manufacturing Corp · 2014 · cites it directly4descendants
- K160071StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder ProsthesisBiomet, Inc. · 2016 · cites it directly3descendants
- K152267Remedy® Shoulder SpacerOsteoremedies, LLC · 2015 · cites it directly2descendants
- K202338SpaceFlex ShoulderG21, S.R.L. · 2021 · cites it directly1descendant
- K252443SpaceFix Shoulder SpacerG21, S.R.L. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −4 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −3 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −2 | K042021 | Exactech Equinoxe Shoulder System | Exactech, Inc. | 2004 | 10 |
| −1 | K060535 | Spacer-S Temporary Shoulder Spacer | Tecres S.P.A. | 2006 | — |
| 0 (this device) | K112983 | Spacer-S | Tecres S.P.A. | 2011 | — |
| +1 | K131135 | Biomet Stage One Disposable Cement Spacer Molds for Temporary Hemi-Shoulder… | Biomet Manufacturing Corp | 2014 | 5 |
| +1 | K160071 | StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis | Biomet, Inc. | 2016 | 5 |
| +1 | K152267 | Remedy® Shoulder Spacer | Osteoremedies, LLC | 2015 | — |
| +1 | K202338 | SpaceFlex Shoulder | G21, S.R.L. | 2021 | — |
| +2 | K252443 | SpaceFix Shoulder Spacer | G21, S.R.L. | 2025 | — |
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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K060535 | Spacer-S Temporary Shoulder SpacerSummary page 2…space Shoulder Spacer has the same intended use as the predicate device, the Interspace Shoulder Spacer cleared via K060535. Both devices are intended for use as a temporary shoulder implant for patients undergoing atwo-… | 2006 |
What descends from it? (7)
4 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 20 years and passes through 4 companies; a new generation was cleared every 5.3 years on median.
- 3 of the 29 ancestors have a recall of any class.
- Of its descendants, K131135 (Biomet Manufacturing Corp, 2014) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K060535.
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. 2011, this device’s year, is highlighted.
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?
Interspace Shoulder is indicated for temporary use (maximum of 180 days) as a shoulder replacement (SR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. The head and stem are inserted into the glenoideal cavity and the humeral medullary canal, respectively, following removal of the existing implant and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy…
Read the full statement (107 words)
Interspace Shoulder is indicated for temporary use (maximum of 180 days) as a shoulder replacement (SR) in skeletally mature patients undergoing a two-stage procedure due to a septic process.
The head and stem are inserted into the glenoideal cavity and the humeral medullary canal, respectively, following removal of the existing implant and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).
Interspace Shoulder 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 as stated in the FDA summary.
https://510kreport.com/device/K112983 · printed Nov 4, 2026
Cite this page
510(k) Report. “K112983: Spacer-S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K112983
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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