510(k) · Cleared
ClearedInterSpace Knee Extra-Large Size, InterSpace Knee ATS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tecres S.P.A. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Apr 27, 2019 as substantially equivalent to K062274 (Tecres S.P.A., 2008) and 2 other predicates after a 299-day review. Its family tree reaches back 6 generations to 1995. 1 later device descends from it.
- Decided
- Apr 27, 2019
- Review
- 299 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K936159 (1995). 14 ancestors in all, the oldest P810020 (1984). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK936159 Natural-Knee II SystemIntermedics Orthopedics · 1995 · Recalled
- 5 generations backK032522 Tecres Spacer-K Temporary Knee ProsthesisExactech, Inc. · 2004
- 4 generations backK050210 Disposable Cement Spacer Molds for Temporary Knee ProsthesesBiomet, Inc. · 2005 · Recalled
- 3 generations backK062274 Spacer-K Temporary Knee Spacer with Gentamicin, Models SPK0021…Tecres S.P.A. · 2008
- 2 generations backK101356 Spacer-G and Spacer-KTecres S.P.A. · 2011
- 1 generation backK112470 2GC Hip/Knee Modular SpacerMandell Horwitz Consultants, LLC · 2012
- This deviceK181732 InterSpace Knee Extra-Large Size, InterSpace Knee ATSTecres S.P.A. · 2019
- Descendant · cites it directly · 0 of its ownK240856 Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer MoldsOsartis GmbH · 2024
Most influential descendants
Showing 1 of 1 · See all- K240856Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer MoldsOsartis GmbH · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K936159 | Natural-Knee II System | Intermedics Orthopedics | 1995 | 6 |
| −5 | K032522 | Tecres Spacer-K Temporary Knee Prosthesis | Exactech, Inc. | 2004 | — |
| −4 | K050210 | Disposable Cement Spacer Molds for Temporary Knee Prostheses | Biomet, Inc. | 2005 | 8 |
| −3 | 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 | — |
| −1 | K112470 | 2GC Hip/Knee Modular Spacer | Mandell Horwitz Consultants, LLC | 2012 | — |
| 0 (this device) | K181732 | InterSpace Knee Extra-Large Size, InterSpace Knee ATS | Tecres S.P.A. | 2019 | — |
| +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 |
|---|---|---|
| 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 |
|---|---|---|
| 2024 | 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 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? (3)
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 5…Page 2 of 8 Device Description The InterSpace Knee, cleared by FDA via K101356 and K062274, is a temporary spacer device available in three sizes (S-M-L). With this 510(k) submission, Tecres is adding the additional XL s… | 2008 |
| * | K101356 | Spacer-G and Spacer-KSummary page 5…1732 Page 2 of 8 Device Description The InterSpace Knee, cleared by FDA via K101356 and K062274, is a temporary spacer device available in three sizes (S-M-L). With this 510(k) submission, Tecres is adding the add… | 2011 |
| * | K112470 | 2GC Hip/Knee Modular SpacerSummary page 8…comparisons, the following predicate device was selected: • Knee Modular Spacer which was submitted by Garventis, LLC and cleared through 510(k) application K112470. The InterSpace Knee ATS when combined with the InterSpace Knee provides a total temporary knee spacer for patients with a large… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240856 | Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds | 2024 | 0 |
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 3.3 years on median.
- 4 of the 14 ancestors have a recall of any class.
- Of its descendants, K240856 (Osartis GmbH, 2024) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K062274.
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. 2019, this device’s year, is highlighted.
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?
InterSpace Knee is indicated for temporary use (maximum 180 days) as a total knee replacement (TKR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. InterSpace Knee 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 (299 words)
InterSpace Knee is indicated for temporary use (maximum 180 days) as a total knee replacement (TKR) in skeletally mature patients undergoing a two-stage procedure due to a septic process.
InterSpace Knee 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).
InterSpace Knee 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), the Interspace Knee is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers, canes) throughout the implantation period
InterSpace Knee ATS is indicated for temporary use (maximum 180 days) as an adjunct to total knee replacement (TKR) in skeletally mature patients undergoing a two-stage procedure due to a septic process, and where a large tibial defect is present.
InterSpace Knee ATS is applied on the tibial plate following removal of the existing implant and radical debridement. The device must be combined with the tibial component of InterSpace Knee. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).
InterSpace Knee ATS 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), the Interspace Knee ATS 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 as stated in the FDA summary.
https://510kreport.com/device/K181732 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181732: InterSpace Knee Extra-Large Size, InterSpace Knee ATS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181732
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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