510(k) · Cleared
ClearedSpacer-G and Spacer-K
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tecres S.P.A. · KWL Prosthesis, Hip, Hemi-, Femoral, Metal
Cleared on Sep 20, 2011 as substantially equivalent to K062274 (Tecres S.P.A., 2008) and 1 other predicate after a 494-day review. Its family tree reaches back 4 generations to 1995. 19 later devices descend from it.
- Decided
- Sep 20, 2011
- Review
- 494 days
- Class
- Class II
- Product code
- KWL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K936159 (1995). 12 ancestors in all, the oldest P810020 (1984). 19 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK936159 Natural-Knee II SystemIntermedics Orthopedics · 1995 · Recalled
- 3 generations backK032522 Tecres Spacer-K Temporary Knee ProsthesisExactech, Inc. · 2004
- 2 generations backK050210 Disposable Cement Spacer Molds for Temporary Knee ProsthesesBiomet, Inc. · 2005 · Recalled
- 1 generation backK062274 Spacer-K Temporary Knee Spacer with Gentamicin, Models SPK0021…Tecres S.P.A. · 2008
- This deviceK101356 Spacer-G and Spacer-KTecres S.P.A. · 2011
- Descendant · cites it directly · 16 of its ownK112470 2GC Hip/Knee Modular SpacerMandell Horwitz Consultants, LLC · 2012
- Descendant · 2 generations on · 5 of its ownK183017 Remedy Femoral Component 84mm, Remedy Stemmed Knee SpacerOsteoremedies, LLC · 2019
- Descendant · 2 generations on · 5 of its ownK173967 Remedy Acetabular CupOsteoremedies, LLC · 2018
- Descendant · 3 generations on · 4 of its ownK191981 REMEDY Acetabular CupOsteoremedies, LLC · 2019
- Descendant · 3 generations on · 2 of its ownK240683 Rx Knee SystemSignature Orthopaedics Pty, Ltd. · 2024
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K1124702GC Hip/Knee Modular SpacerMandell Horwitz Consultants, LLC · 2012 · cites it directly16descendants
- K183017Remedy Femoral Component 84mm, Remedy Stemmed Knee SpacerOsteoremedies, LLC · 2019 · 2 generations on5descendants
- K173967Remedy Acetabular CupOsteoremedies, LLC · 2018 · 2 generations on5descendants
- K191981REMEDY Acetabular CupOsteoremedies, LLC · 2019 · 3 generations on4descendants
- K240683Rx Knee SystemSignature Orthopaedics Pty, Ltd. · 2024 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K936159 | Natural-Knee II System | Intermedics Orthopedics | 1995 | 6 |
| −3 | K032522 | Tecres Spacer-K Temporary Knee Prosthesis | Exactech, Inc. | 2004 | — |
| −2 | 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 | — |
| 0 (this device) | K101356 | Spacer-G and Spacer-K | Tecres S.P.A. | 2011 | — |
| +1 | K112470 | 2GC Hip/Knee Modular Spacer | Mandell Horwitz Consultants, LLC | 2012 | — |
| +2 | K183017 | Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer | Osteoremedies, LLC | 2019 | — |
| +2 | K173967 | Remedy Acetabular Cup | Osteoremedies, LLC | 2018 | — |
| +3 | K191981 | REMEDY Acetabular Cup | Osteoremedies, LLC | 2019 | — |
| +3 | K240683 | Rx Knee System | Signature Orthopaedics Pty, Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 5 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 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 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 |
|---|---|---|---|
| * | K062274 | Spacer-K Temporary Knee Spacer with Gentamicin, Models SPK0021, SPK0121, SPK0221, SPK0321Summary page 8…023 SUBSTANTIAL EQUIVALENCE: The Spacer devices are substantially equivalent to themselves. Each Spacer device has previously been cleared: Spacer-K in K062274 and, Spacer-G in K062273. The intended use and conditions of use remain the same. This 510(k) application was submitted for a mi… | 2008 |
| * | K062273 | Spacer-G Temporary Hip ProsthesisSummary page 8…ANTIAL EQUIVALENCE: The Spacer devices are substantially equivalent to themselves. Each Spacer device has previously been cleared: Spacer-K in K062274 and, Spacer-G in K062273. The intended use and conditions of use remain the same. This 510(k) application was submitted for a minor change in the materia… | 2008 |
What descends from it? (19)
See all 193 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 16 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
- 4 of the 12 ancestors have a recall of any class.
- Of its descendants, K112470 (Mandell Horwitz Consultants, LLC, 2012) has gone furthest, with 16 descendants of its own.
- 2 other devices also cite its predicate K062274.
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. 2011, 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?
Spacer-K is indicated for temporary use (maximum of 180 days) as a total knee replacement (TKR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. Interspace is applied on the femoral condyles and on the tibial plate 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…
Read the full statement (238 words)
Spacer-K is indicated for temporary use (maximum of 180 days) as a total knee replacement (TKR) in skeletally mature patients undergoing a two-stage procedure due to a septic process.
Interspace is applied on the femoral condyles and on the tibial plate 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).
Spacer-K 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.). 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.
Spacer-G is indicated for temporary use (maximum of 180 days) as a total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process.
The device is inserted into the femoral medullary canal and acetabular cavity 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).
Spacer-G 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/K101356 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101356: Spacer-G and Spacer-K.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101356
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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