510(k) · Cleared
Recalled · Class II · 2017JTS Extendible Distal Femoral 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 Jan 22, 2014 as substantially equivalent to K092138 (Stanmore Implants Worldwide, Ltd., 2011) and 3 other predicates after a 61-day review. Its family tree reaches back 3 generations to 1996. 2 later devices descend from it. It has been recalled once.
- Decided
- Jan 22, 2014
- Review
- 61 days
- Class
- Class II
- Product code
- KRO
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 3 generations to K945028 (1996). 11 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK945028 Finn Knee SystemBiomet, Inc. · 1996
- 2 generations backK051570 Avl Hinge Knee SystemBiomet, Inc. · 2005
- 1 generation backK120992 Mets Smiles Total Knee ReplacementStanmore Implants Worldwide, Ltd. · 2012 · Recalled
- This deviceK133152 JTS Extendible Distal Femoral ImplantStanmore Implants Worldwide, Ltd. · 2014
- Descendant · cites it directly · 0 of its ownK140900 Patient Specific Smiles Total Knee ReplacementStanmore Worldwide Implants, Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK140898 Patient Specific Distal FemoralStanmore Implants Worldwide, Ltd. · 2015 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K945028 | Finn Knee System | Biomet, Inc. | 1996 | — |
| −2 | K051570 | Avl Hinge Knee System | Biomet, Inc. | 2005 | — |
| −1 | K120992 | Mets Smiles Total Knee Replacement | Stanmore Implants Worldwide, Ltd. | 2012 | 6 |
| 0 (this device) | K133152 | JTS Extendible Distal Femoral Implant | Stanmore Implants Worldwide, Ltd. | 2014 | — |
| +1 | K140900 | Patient Specific Smiles Total Knee Replacement | Stanmore Worldwide Implants, Ltd. | 2015 | — |
| +1 | K140898 | Patient Specific Distal Femoral | Stanmore Implants Worldwide, Ltd. | 2015 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (4)
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 |
|---|---|---|---|
| * | K092138 | JTS Extendeable ImplantSummary page 1…mer constrained cemented prosthesis (21 CFR 888.3510) - KRO Predicate Devices * JTSe Extendible Implant, Stanmore Implants Worldwide Ltd (K092138) * METSO SMILES Total Knee Replacement, Stanmore Implants Worldwide Ltd (K120992)… | 2011 |
| * | K120992 | Mets Smiles Total Knee ReplacementSummary page 1…JTSe Extendible Implant, Stanmore Implants Worldwide Ltd (K092138) * METSO SMILES Total Knee Replacement, Stanmore Implants Worldwide Ltd (K120992) K133152 Page… | 2012 |
| * | K121055 | Mets Modular Total FemurSummary page 2…K133152 Page 2/3 * METS Modular Total Femoral Replacement, Stanmore Implants Worldwide Ltd (K1 21055) * METS® Modular Distal Femur, Stanmore Implants Worldwide Ltd (K121029) Purpose of the Special 510(k) noti… | 2012 |
| * | K121029 | Mets Modular Distal FemurSummary page 2…emoral Replacement, Stanmore Implants Worldwide Ltd (K1 21055) * METS® Modular Distal Femur, Stanmore Implants Worldwide Ltd (K121029) Purpose of the Special 510(k) notice. The JTS® Extendible Distal Femoral Implant is a modification to the JTS®0 Ex… | 2012 |
What descends from it? (2)
2 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)
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?
- The line of descent spans 18 years and passes through 2 companies; a new generation was cleared every 7.1 years on median.
- 5 of the 11 ancestors have a recall of any class.
- Of its descendants, K140900 (Stanmore Worldwide Implants, Ltd., 2015) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K092138.
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. 2014, 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 Distal Femoral Implant is indicated for cemented limb salvage procedures in paediatric (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 prosthesis and/or oncology indications; and
* malignant diseases (e.g., osteogenic sarcoma).
The JTS Extendible Distal Femoral Implant and its components are for single use only
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133152 · printed Nov 3, 2026
Cite this page
510(k) Report. “K133152: JTS Extendible Distal Femoral Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K133152
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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