510(k) · Cleared
ClearedRepiphysis Limb Salvage System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wrightmedicaltechnologyinc · KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Cleared on Dec 4, 2002 after a 210-day review. The FDA summary names no predicate by number. 9 later devices descend from it.
- Decided
- Dec 4, 2002
- Review
- 210 days
- Class
- Class II
- Product code
- KRO
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 5 citing it directly.
- This deviceK021489 Repiphysis Limb Salvage SystemWrightmedicaltechnologyinc · 2002
- Descendant · cites it directly · 7 of its ownK092138 JTS Extendeable ImplantStanmore Implants Worldwide, Ltd. · 2011 · Recalled
- 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 · 2 generations on · 2 of its ownK133152 JTS Extendible Distal Femoral ImplantStanmore Implants Worldwide, Ltd. · 2014 · Recalled
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K092138JTS Extendeable ImplantStanmore Implants Worldwide, Ltd. · 2011 · cites it directly7descendants
- 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 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K021489 | Repiphysis Limb Salvage System | Wrightmedicaltechnologyinc | 2002 | — |
| +1 | K092138 | JTS Extendeable Implant | Stanmore Implants Worldwide, Ltd. | 2011 | 1 |
| +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 |
| +2 | K133152 | JTS Extendible Distal Femoral Implant | Stanmore Implants Worldwide, Ltd. | 2014 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 4 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 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 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?
The FDA summary names no predicate by number.
What descends from it? (9)
5 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?
- Of its descendants, K092138 (Stanmore Implants Worldwide, Ltd., 2011) has gone furthest, with 7 descendants of its own.
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.
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?
Limb salvage surgery is indicated for cemented procedures where radical resection and replacement of the distal femur and/or proximal tibia is required with the following conditions:
1. patients suffering from severe arthropathy of the knee that does not respond to any cqnservative therapy or better alternative surgical treatment;
2. surgical intervention for severe trauma. revision knee arthroplasties, and/or oncology indications.
3. metastatic diseases (e.g., osteosarcomas, chondrosarcomas, gaint cell tumors, bone tumors)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021489 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021489: Repiphysis Limb Salvage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021489
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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