510(k) · Cleared
Recalled · Class II · 2017JTS Extendeable Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stanmore Implants Worldwide, Ltd. · KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Cleared on Mar 22, 2011 as substantially equivalent to K021489 (Wrightmedicaltechnologyinc, 2002) and 1 other predicate after a 615-day review. Its family tree reaches back 1 generation to 2002. 7 later devices descend from it. It has been recalled once.
- Decided
- Mar 22, 2011
- Review
- 615 days
- Class
- Class II
- Product code
- KRO
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K021489 (2002). 2 ancestors in all. 7 later devices descend from it, 7 citing it directly.
- Root · 1 generation backK021489 Repiphysis Limb Salvage SystemWrightmedicaltechnologyinc · 2002
- This deviceK092138 JTS Extendeable ImplantStanmore Implants Worldwide, Ltd. · 2011
- Descendant · cites it directly · 3 of its ownK121029 Mets Modular Distal FemurStanmore Implants Worldwide, Ltd. · 2012
- Descendant · cites it directly · 3 of its ownK121055 Mets Modular Total FemurStanmore Implants Worldwide, Ltd. · 2012
- Descendant · cites it directly · 3 of its ownK120992 Mets Smiles Total Knee ReplacementStanmore Implants Worldwide, Ltd. · 2012 · Recalled
- Descendant · cites it directly · 2 of its ownK133152 JTS Extendible Distal Femoral ImplantStanmore Implants Worldwide, Ltd. · 2014 · Recalled
- Descendant · cites it directly · 0 of its ownK140900 Patient Specific Smiles Total Knee ReplacementStanmore Worldwide Implants, Ltd. · 2015
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K121029Mets Modular Distal FemurStanmore Implants Worldwide, Ltd. · 2012 · cites it directly3descendants
- K121055Mets Modular Total FemurStanmore Implants Worldwide, Ltd. · 2012 · cites it directly3descendants
- K120992Mets Smiles Total Knee ReplacementStanmore Implants Worldwide, Ltd. · 2012 · cites it directly3descendants
- K133152JTS Extendible Distal Femoral ImplantStanmore Implants Worldwide, Ltd. · 2014 · cites it directly2descendants
- K140900Patient Specific Smiles Total Knee ReplacementStanmore Worldwide Implants, Ltd. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K021489 | Repiphysis Limb Salvage System | Wrightmedicaltechnologyinc | 2002 | — |
| 0 (this device) | K092138 | JTS Extendeable Implant | Stanmore Implants Worldwide, Ltd. | 2011 | — |
| +1 | K121029 | Mets Modular Distal Femur | Stanmore Implants Worldwide, Ltd. | 2012 | — |
| +1 | K121055 | Mets Modular Total Femur | Stanmore Implants Worldwide, Ltd. | 2012 | — |
| +1 | K120992 | Mets Smiles Total Knee Replacement | Stanmore Implants Worldwide, Ltd. | 2012 | 6 |
| +1 | K133152 | JTS Extendible Distal Femoral Implant | Stanmore Implants Worldwide, Ltd. | 2014 | 1 |
| +1 | K140900 | Patient Specific Smiles Total Knee Replacement | Stanmore Worldwide Implants, Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 4 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 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 KRO? 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 KRO device
- #1 K251665 Triathlon® Hinge Knee Systemscore 19.0 · 12 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 |
|---|---|---|---|
| * | K021489 | Repiphysis Limb Salvage SystemSummary page 1…d cemented prosthesis (21 C.F.R. § 888.3510) Predicate Devices * Wright Medical Technology Inc., Repiphysis Limb Salvage System (K021489) * Howmedica (Stryker) Global Modular Replacement System (K023087) Intended Use / Indications for Use The JTS® Extendible… | 2002 |
| * | K023087 | Global Modular Replacement System (GMRS)Summary page 1…510) Predicate Devices * Wright Medical Technology Inc., Repiphysis Limb Salvage System (K021489) * Howmedica (Stryker) Global Modular Replacement System (K023087) Intended Use / Indications for Use The JTS® Extendible Implant is intended to be used for cemented limb sparing procedures in p… | 2002 |
What descends from it? (7)
7 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121029 | Mets Modular Distal Femur | 2012 | 3 |
| K121055 | Mets Modular Total Femur | 2012 | 3 |
| K120992 | Mets Smiles Total Knee Replacement | 2012 | 3 |
| K133152 | JTS Extendible Distal Femoral Implant | 2014 | 2 |
| K140900 | Patient Specific Smiles Total Knee Replacement | 2015 | 0 |
| K140898 | Patient Specific Distal Femoral | 2015 | 0 |
| K121056 | Mets Modular Proximal Femur | 2012 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 4, 2017 | Class II | Z-3104-2017 | Labeling design | Three (3) complaints were identified in which the potential for utilization of the JTS Grower Drive in the incorrect orientation in relation to the limb entry point of the device, together with the potential to select incorrect settings… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All KRO devicesKRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · KRO
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KRO
56in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KRO
14so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KRO
915in 2025
MAUDE reports naming product code KRO, 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 | 1 | — | 1 | 37 |
| 2008 | 3 | 126 | 3 | 44 |
| 2009 | 3 | 86 | 8 | 66 |
| 2010 | 1 | — | 0 | 110 |
| 2011 | 2 | — | 1 | 119 |
| 2012 | 2 | — | 1 | 173 |
| 2013 | 3 | 189 | 2 | 194 |
| 2014 | 2 | — | 0 | 406 |
| 2015 | 6 | 113 | 1 | 333 |
| 2016 | 3 | 148 | 5 | 369 |
| 2017 | 1 | — | 4 | 543 |
| 2018 | 0 | — | 1 | 614 |
| 2019 | 3 | 244 | 0 | 759 |
| 2020 | 1 | — | 0 | 749 |
| 2021 | 3 | 57 | 1 | 770 |
| 2022 | 1 | — | 0 | 892 |
| 2023 | 4 | 148 | 0 | 746 |
| 2024 | 3 | 87 | 0 | 855 |
| 2025 | 3 | 56 | 1 | 915 |
| 2026 | 1 | — | 14 | — |
What is it indicated for?
The JTS® Extendible Implant is indicated for cemented limb sparing procedures in paedliatric (between the ages of 2 and 21) cases where radical resection and replacement of the distal femur is required with the following conditions:
patients suffering from severe arthropathy of the knee that does not respond to any conservative therapy or better alternative surgical treatment;
surgical intervention for severe trauma, revision knee arthroplasties, failed previous prostheses and/or oncology indications; and malignant diseases (e.g osteogenic sarcoma).
The JTS® Extendible Implant and its components are for single use only
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092138 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092138: JTS Extendeable Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092138
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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