510(k) · Cleared
Recalled · Class II · 2022Patient Specific Distal Femoral
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 20, 2015 as substantially equivalent to K121029 (Stanmore Implants Worldwide, Ltd., 2012) and 2 other predicates after a 287-day review. Its family tree reaches back 4 generations to 1996. It has been recalled 2 times.
- Decided
- Jan 20, 2015
- Review
- 287 days
- Class
- Class II
- Product code
- KRO
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 4 generations to K945028 (1996). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK945028 Finn Knee SystemBiomet, Inc. · 1996
- 3 generations backK051570 Avl Hinge Knee SystemBiomet, Inc. · 2005
- 2 generations backK120992 Mets Smiles Total Knee ReplacementStanmore Implants Worldwide, Ltd. · 2012 · Recalled
- 1 generation backK133152 JTS Extendible Distal Femoral ImplantStanmore Implants Worldwide, Ltd. · 2014 · Recalled
- This deviceK140898 Patient Specific Distal FemoralStanmore Implants Worldwide, Ltd. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K945028 | Finn Knee System | Biomet, Inc. | 1996 | — |
| −3 | K051570 | Avl Hinge Knee System | Biomet, Inc. | 2005 | — |
| −2 | 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 |
| 0 (this device) | K140898 | Patient Specific Distal Femoral | Stanmore Implants Worldwide, Ltd. | 2015 | — |
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 |
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? (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 |
|---|---|---|---|
| * | K121029 | Mets Modular Distal FemurSummary page 5…Distal Femur and its components are for cemented use only. Predicate Device(s) The predicate devices are the METS® Modular Distal Femur, cleared on September 19, 2012 (K121029), the JTS® Extendible Distal Femoral Implant cleared on March 22, 2011(K092138) and the JTS® Extendible Distal Femoral Implant cl… | 2012 |
| * | K092138 | JTS Extendeable ImplantSummary page 5…) The predicate devices are the METS® Modular Distal Femur, cleared on September 19, 2012 (K121029), the JTS® Extendible Distal Femoral Implant cleared on March 22, 2011(K092138) and the JTS® Extendible Distal Femoral Implant cleared on January 22, 2014 (K133152). Technological Characteristics The Patient… | 2011 |
| * | K133152 | JTS Extendible Distal Femoral ImplantSummary page 5…2012 (K121029), the JTS® Extendible Distal Femoral Implant cleared on March 22, 2011(K092138) and the JTS® Extendible Distal Femoral Implant cleared on January 22, 2014 (K133152). Technological Characteristics The Patient Specific Distal Femur is a patient-specific implant system that is used to replace d… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 24, 2022 | Class II | Z-1778-2022 | Under Investigation by firm | A MK4 Tibial Bearing was supplied with the intention to mate with the Tibial Metal Casing in-situ. However, the device in-situ was a MK3 Tibial Metal Casing. The supplied MK4 tibial bearing was not exchangeable for the MK3 tibial bearing.… |
| 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 19 years and passes through 2 companies; a new generation was cleared every 7.1 years on median.
- 6 of the 12 ancestors have a recall of any class.
- 1 other device also cites its predicate K121029.
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. 2015, 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 Patient Specific Distal Femur is intended for the replacement of diseased or deficient bone in the distal femur. It is indicated for: • Limb salvage procedures where radical resection and replacement of the bone is required • Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis or traumatic arthritis • Correction of varus, valgus or post traumatic deformity • Correction of revision of unsuccessful…
Read the full statement (115 words)
The Patient Specific Distal Femur is intended for the replacement of diseased or deficient bone in the distal femur. It is indicated for:
• Limb salvage procedures where radical resection and replacement of the bone is required
• Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis or traumatic arthritis
• Correction of varus, valgus or post traumatic deformity
• Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement
• Ligament deficiencies
• Tumor resection
• Revision of previously failed total joint arthroplasty
• Trauma
The Patient Specific Distal Femur and its components are for single use only.
The Patient Specific Distal Femur and is components are for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140898 · printed Nov 5, 2026
Cite this page
510(k) Report. “K140898: Patient Specific Distal Femoral.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K140898
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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