510(k) · Cleared
Cleared2GC Hip/Knee Modular Spacer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mandell Horwitz Consultants, LLC · KWL Prosthesis, Hip, Hemi-, Femoral, Metal
Cleared on Apr 5, 2012 as substantially equivalent to K101356 (Tecres S.P.A., 2011) after a 223-day review. Its family tree reaches back 5 generations to 1995. 16 later devices descend from it.
- Decided
- Apr 5, 2012
- Review
- 223 days
- Class
- Class II
- Product code
- KWL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K936159 (1995). 13 ancestors in all, the oldest P810020 (1984). 16 later devices descend from it, 8 citing it directly.
- Root · 5 generations backK936159 Natural-Knee II SystemIntermedics Orthopedics · 1995 · Recalled
- 4 generations backK032522 Tecres Spacer-K Temporary Knee ProsthesisExactech, Inc. · 2004
- 3 generations backK050210 Disposable Cement Spacer Molds for Temporary Knee ProsthesesBiomet, Inc. · 2005 · Recalled
- 2 generations backK062274 Spacer-K Temporary Knee Spacer with Gentamicin, Models SPK0021…Tecres S.P.A. · 2008
- 1 generation backK101356 Spacer-G and Spacer-KTecres S.P.A. · 2011
- This deviceK112470 2GC Hip/Knee Modular SpacerMandell Horwitz Consultants, LLC · 2012
- Descendant · cites it directly · 5 of its ownK183017 Remedy Femoral Component 84mm, Remedy Stemmed Knee SpacerOsteoremedies, LLC · 2019
- Descendant · cites it directly · 5 of its ownK173967 Remedy Acetabular CupOsteoremedies, LLC · 2018
- Descendant · 2 generations on · 4 of its ownK191981 REMEDY Acetabular CupOsteoremedies, LLC · 2019
- Descendant · 2 generations on · 2 of its ownK240683 Rx Knee SystemSignature Orthopaedics Pty, Ltd. · 2024
- Descendant · cites it directly · 2 of its ownK192995 OsteoRemedies Hip Spacer SystemOsteoremedies, LLC · 2020
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K183017Remedy Femoral Component 84mm, Remedy Stemmed Knee SpacerOsteoremedies, LLC · 2019 · cites it directly5descendants
- K173967Remedy Acetabular CupOsteoremedies, LLC · 2018 · cites it directly5descendants
- K191981REMEDY Acetabular CupOsteoremedies, LLC · 2019 · 2 generations on4descendants
- K240683Rx Knee SystemSignature Orthopaedics Pty, Ltd. · 2024 · 2 generations on2descendants
- K192995OsteoRemedies Hip Spacer SystemOsteoremedies, LLC · 2020 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K936159 | Natural-Knee II System | Intermedics Orthopedics | 1995 | 6 |
| −4 | K032522 | Tecres Spacer-K Temporary Knee Prosthesis | Exactech, Inc. | 2004 | — |
| −3 | K050210 | Disposable Cement Spacer Molds for Temporary Knee Prostheses | Biomet, Inc. | 2005 | 8 |
| −2 | K062274 | Spacer-K Temporary Knee Spacer with Gentamicin, Models SPK0021, SPK0121… | Tecres S.P.A. | 2008 | — |
| −1 | K101356 | Spacer-G and Spacer-K | Tecres S.P.A. | 2011 | — |
| 0 (this device) | K112470 | 2GC Hip/Knee Modular Spacer | Mandell Horwitz Consultants, LLC | 2012 | — |
| +1 | K183017 | Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer | Osteoremedies, LLC | 2019 | — |
| +1 | K173967 | Remedy Acetabular Cup | Osteoremedies, LLC | 2018 | — |
| +2 | K191981 | REMEDY Acetabular Cup | Osteoremedies, LLC | 2019 | — |
| +2 | K240683 | Rx Knee System | Signature Orthopaedics Pty, Ltd. | 2024 | — |
| +1 | K192995 | OsteoRemedies Hip Spacer System | Osteoremedies, LLC | 2020 | — |
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 |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 4 | 0 |
| 2020 | 2 | 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? (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 |
|---|---|---|---|
| * | K101356 | Spacer-G and Spacer-K Cleared while this submission was under review Summary page 2…Panel: Orthopedic 3 PREDICATE DEVICES The predicate devices are the Tecres Interspace Hip and Knee devices cleared in 5 10(k) submissions K101 356. The predicate devices are temporary spacers that have been classified under 21 CER § 888.3360 and 888.3560, and are Class 11 med… | 2011 |
What descends from it? (16)
See all 168 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K183017 | Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer | 2019 | 5 |
| K173967 | Remedy Acetabular Cup | 2018 | 5 |
| K192995 | OsteoRemedies Hip Spacer System | 2020 | 2 |
| K253675 | OsteoRemedies Hip Spacer System | 2025 | 1 |
| K190216 | SpaceFlex Knee | 2019 | 1 |
| K181732 | InterSpace Knee Extra-Large Size, InterSpace Knee ATS | 2019 | 1 |
| K260063 | GSPE Spacer | 2026 | 0 |
| 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 17 years and passes through 5 companies; a new generation was cleared every 2.8 years on median.
- 4 of the 13 ancestors have a recall of any class.
- Of its descendants, K183017 (Osteoremedies, LLC, 2019) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K101356.
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. 2012, 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?
The Hip Modular Spacer, which consists of a modular head and stem, is indicated for temporary use (maximum 180 days) as an adjunct to total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process and where gentamnicin is the most appropriate antibiotic based on the susceptibility pattern of the infecting micro-organisms. The head and stem components are inserted into the acetabular cavity and femoral…
Read the full statement (331 words)
The Hip Modular Spacer, which consists of a modular head and stem, is indicated for temporary use (maximum 180 days) as an adjunct to total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process and where gentamnicin is the most appropriate antibiotic based on the susceptibility pattern of the infecting micro-organisms.
The head and stem components are inserted into the acetabular cavity and femoral medullary canal, respectively, following removal of the existing acetabular and femoral components and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).
The Hip Modular Spacer 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.).
The Knee Modular Spacer, which consists of a modular femoral, tibial and tibial insert component, is indicated for temporary use (maximum 180 days) as an adjunct to total knee replacement (TKR) in patients undergoing a two-stage procedure due to a septic process and where gentamicin is the most appropriate antibiotic based on the susceptibility pattern of the infecting micro-organism(s).
The device is applied on the femoral condyles (femoral component) and on the tibial plate (tibial component) following removal of the existing implant and radical debridement. The use of the tibial insert component is optional, when a large tibial defect is present. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).
The Knee Modular Spacer 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 materials (gentamicin/polymethylmethacrylate), the device 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/K112470 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112470: 2GC Hip/Knee Modular Spacer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112470
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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