510(k) · Cleared
ClearedHowmedica Modular Replacement System - Distal Femoral/Proximal Tibial Segments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Corp. · KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Cleared on Jul 13, 1998 after a 382-day review. The FDA summary names no predicate by number. 2 of the 79 devices in its family, counting itself, have a Class I recall. 78 later devices descend from it.
- Decided
- Jul 13, 1998
- Review
- 382 days
- Class
- Class II
- Product code
- KRO
- Recalls
- None
- Predicates
- 0
78 later devices descend from it, 4 citing it directly. 2 of the 79 devices in this family, counting this one, have a Class I recall.
- This deviceK972401 Howmedica Modular Replacement System - Distal Femoral/Proximal…Howmedica Corp. · 1998
- Descendant · cites it directly · 63 of its ownK003182 Orthogenesis LPS SystemDepuy, Inc. · 2001
- Descendant · 2 generations on · 54 of its ownK040281 LPS Metaphyseal Sleeve (Limb Preservation System)DePuy Orthopaedics, Inc. · 2004
- Descendant · 3 generations on · 36 of its ownK060515 Depuy PFC Sigma Knee ProsthesisDePuy Orthopaedics, Inc. · 2006
- Descendant · 3 generations on · 31 of its ownK063633 Depuy Knee Prosthesis System Universal Stem Extensions and Femoral…DePuy Orthopaedics, Inc. · 2007 · Recalled
- Descendant · 4 generations on · 27 of its ownK140942 Klassic Knee Tibial Stem ExtensionTotal Joint Orthopedics, Inc. · 2014
Showing 5 of 78 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 78 · See all- K003182Orthogenesis LPS SystemDepuy, Inc. · 2001 · cites it directly63descendants
- K040281LPS Metaphyseal Sleeve (Limb Preservation System)DePuy Orthopaedics, Inc. · 2004 · 2 generations on54descendants
- K060515Depuy PFC Sigma Knee ProsthesisDePuy Orthopaedics, Inc. · 2006 · 3 generations on36descendants
- K063633Depuy Knee Prosthesis System Universal Stem Extensions and Femoral Metaphyseal SleevesDePuy Orthopaedics, Inc. · 2007 · 3 generations on31descendants
- K140942Klassic Knee Tibial Stem ExtensionTotal Joint Orthopedics, Inc. · 2014 · 4 generations on27descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972401 | Howmedica Modular Replacement System - Distal Femoral/Proximal Tibial Segments | Howmedica Corp. | 1998 | — |
| +1 | K003182 | Orthogenesis LPS System | Depuy, Inc. | 2001 | — |
| +2 | K040281 | LPS Metaphyseal Sleeve (Limb Preservation System) | DePuy Orthopaedics, Inc. | 2004 | — |
| +3 | K060515 | Depuy PFC Sigma Knee Prosthesis | DePuy Orthopaedics, Inc. | 2006 | — |
| +3 | K063633 | Depuy Knee Prosthesis System Universal Stem Extensions and Femoral Metaphyseal… | DePuy Orthopaedics, Inc. | 2007 | 1 |
| +4 | K140942 | Klassic Knee Tibial Stem Extension | Total Joint Orthopedics, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 4 | 1 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 4 | 1 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 5 | 0 |
| 2019 | 7 | 0 |
| 2020 | 7 | 0 |
| 2021 | 8 | 0 |
| 2022 | 4 | 0 |
| 2023 | 10 | 0 |
| 2024 | 4 | 0 |
| 2025 | 6 | 0 |
| 2026 | 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.
2 devices in this family have a Class I recall. 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? (78)
See all 784 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K041085LPS (Limb Preservation System) Lower Extremity Dovetail IntercalaryDepuy, Inc. · 2004 · 2 generations on · ◆ in the 2004 descendants bar of FIG. 11 Class I recall
- K071417Depuy LPS Diaphyseal and Metaphyseal SleevesDePuy Orthopaedics, Inc. · 2007 · 2 generations on · ◆ in the 2007 descendants bar of FIG. 14 Class I recalls
What does this lineage say?
- Of its descendants, K003182 (Depuy, Inc., 2001) has gone furthest, with 63 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?
The Howmedica® Modular Replacement System - Distal Femoral/Proximal Tibial Segments are presently cleared for use with bone cement in Oncology patients where radical resection and replacement of the distal femur is required (reference premarket notification K952970). Howmedica seeks clearance to expand this indication to include use with bone cement in limb salvage procedures where radical resection and replacement of the distal femur/proximal tibia is…
Read the full statement (117 words)
The Howmedica® Modular Replacement System - Distal Femoral/Proximal Tibial Segments are presently cleared for use with bone cement in Oncology patients where radical resection and replacement of the distal femur is required (reference premarket notification K952970). Howmedica seeks clearance to expand this indication to include use with bone cement in limb salvage procedures where radical resection and replacement of the distal femur/proximal tibia is required. Limb salvage procedures would include surgical intervention for severe trauma, failed previous knee arthroplasties, and/or Oncology indications. All of these surgical interventions have in common the need for radical resection of the distal femur/proximal tibia, and the need for a prosthetic replacement. This device achieves fixation by the use of bone cement.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972401 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972401: Howmedica Modular Replacement System - Distal Femoral/Proximal Tibial Segments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972401
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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