510(k) · Cleared
ClearedTecres Spacer-K Temporary Knee Prosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Exactech, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on May 28, 2004 as substantially equivalent to K936159 (Intermedics Orthopedics, 1995) after a 287-day review. Its family tree reaches back 1 generation to 1995. 27 later devices descend from it.
- Decided
- May 28, 2004
- Review
- 287 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K936159 (1995). 27 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK936159 Natural-Knee II SystemIntermedics Orthopedics · 1995 · Recalled
- This deviceK032522 Tecres Spacer-K Temporary Knee ProsthesisExactech, Inc. · 2004
- Descendant · cites it directly · 24 of its ownK050210 Disposable Cement Spacer Molds for Temporary Knee ProsthesesBiomet, Inc. · 2005 · Recalled
- Descendant · cites it directly · 20 of its ownK062274 Spacer-K Temporary Knee Spacer with Gentamicin, Models SPK0021…Tecres S.P.A. · 2008
- Descendant · 2 generations on · 19 of its ownK101356 Spacer-G and Spacer-KTecres S.P.A. · 2011
- Descendant · 3 generations on · 16 of its ownK112470 2GC Hip/Knee Modular SpacerMandell Horwitz Consultants, LLC · 2012
- Descendant · 4 generations on · 5 of its ownK183017 Remedy Femoral Component 84mm, Remedy Stemmed Knee SpacerOsteoremedies, LLC · 2019
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K050210Disposable Cement Spacer Molds for Temporary Knee ProsthesesBiomet, Inc. · 2005 · cites it directly24descendants
- K062274Spacer-K Temporary Knee Spacer with Gentamicin, Models SPK0021, SPK0121, SPK0221, SPK0321Tecres S.P.A. · 2008 · cites it directly20descendants
- K101356Spacer-G and Spacer-KTecres S.P.A. · 2011 · 2 generations on19descendants
- K1124702GC Hip/Knee Modular SpacerMandell Horwitz Consultants, LLC · 2012 · 3 generations on16descendants
- K183017Remedy Femoral Component 84mm, Remedy Stemmed Knee SpacerOsteoremedies, LLC · 2019 · 4 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K936159 | Natural-Knee II System | Intermedics Orthopedics | 1995 | 6 |
| 0 (this device) | K032522 | Tecres Spacer-K Temporary Knee Prosthesis | Exactech, Inc. | 2004 | — |
| +1 | K050210 | Disposable Cement Spacer Molds for Temporary Knee Prostheses | Biomet, Inc. | 2005 | 8 |
| +1 | K062274 | Spacer-K Temporary Knee Spacer with Gentamicin, Models SPK0021, SPK0121… | Tecres S.P.A. | 2008 | — |
| +2 | K101356 | Spacer-G and Spacer-K | Tecres S.P.A. | 2011 | — |
| +3 | K112470 | 2GC Hip/Knee Modular Spacer | Mandell Horwitz Consultants, LLC | 2012 | — |
| +4 | K183017 | Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer | Osteoremedies, LLC | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 5 | 0 |
| 2020 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 4 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 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 JWH? 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 JWH device
- #1 K221479 Persona Personalized Knee Systemscore 22.4 · 11 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 |
|---|---|---|---|
| * | K936159 | Natural-Knee II SystemSummary page 2…The Spacer-K device is substantially equivalent to the "Natural Knee". The device was cleared for marketing through premarket submission #K936159. Model Manufacturer 510(k) Number… | 1995 |
What descends from it? (27)
See all 273 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?
How does its category compare?
All JWH devicesJWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JWH
20in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JWH
55in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JWH
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JWH
9,306in 2025
MAUDE reports naming product code JWH, 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 | 18 | 74 | 14 | 1,305 |
| 2008 | 17 | 81 | 10 | 1,483 |
| 2009 | 11 | 168 | 109 | 1,870 |
| 2010 | 19 | 85 | 32 | 3,286 |
| 2011 | 25 | 87 | 27 | 5,133 |
| 2012 | 33 | 85 | 85 | 5,203 |
| 2013 | 31 | 128 | 31 | 6,135 |
| 2014 | 33 | 98 | 13 | 6,722 |
| 2015 | 27 | 87 | 11 | 6,881 |
| 2016 | 18 | 88 | 17 | 7,586 |
| 2017 | 25 | 118 | 61 | 12,263 |
| 2018 | 25 | 90 | 14 | 14,071 |
| 2019 | 28 | 133 | 5 | 14,987 |
| 2020 | 22 | 59 | 2 | 12,592 |
| 2021 | 24 | 61 | 8 | 9,408 |
| 2022 | 17 | 56 | 12 | 8,364 |
| 2023 | 20 | 57 | 67 | 8,947 |
| 2024 | 19 | 89 | 7 | 10,828 |
| 2025 | 20 | 55 | 2 | 9,306 |
| 2026 | 12 | 63 | 4 | — |
What is it indicated for?
Spacer-K is indicated for use as a temporary total knee replacement (TKR) for skeletally mature patients undergoing a two-stage procedure due to a septic process. Spacer-K is only indicated for an implantation period of 180 days or less. Because of the inherent mechanical limitations of the device material (gentamicin/polymethylmethacrylate), Spacer-K is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers, canes) throughout the implantation period.
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/K032522 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032522: Tecres Spacer-K Temporary Knee Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032522
Report an extraction error
Are you the manufacturer?
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