510(k) · Cleared
ClearedHowmedica Osteonics Modular Rotating Hinge Knee
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Cleared on Nov 13, 2000 after an 88-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it.
- Decided
- Nov 13, 2000
- Review
- 88 days
- Class
- Class II
- Product code
- KRO
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 5 citing it directly.
- This deviceK002552 Howmedica Osteonics Modular Rotating Hinge KneeHowmedica Osteonics Corp. · 2000
- Descendant · cites it directly · 4 of its ownK223528 Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023 · Recalled
- Descendant · cites it directly · 4 of its ownK130299 GMK HingeMedacta International · 2013 · Recalled
- Descendant · cites it directly · 3 of its ownK230416 Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®Stryker · 2023
- Descendant · cites it directly · 2 of its ownK251665 Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025
- Descendant · 2 generations on · 2 of its ownK172347 GMK Hinge, GMK RevisionMedacta International S.A. · 2017
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K223528Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023 · cites it directly4descendants
- K130299GMK HingeMedacta International · 2013 · cites it directly4descendants
- K230416Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®Stryker · 2023 · cites it directly3descendants
- K251665Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025 · cites it directly2descendants
- K172347GMK Hinge, GMK RevisionMedacta International S.A. · 2017 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002552 | Howmedica Osteonics Modular Rotating Hinge Knee | Howmedica Osteonics Corp. | 2000 | — |
| +1 | K223528 | Triathlon® Hinge Knee System | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2023 | 1 |
| +1 | K130299 | GMK Hinge | Medacta International | 2013 | 2 |
| +1 | K230416 | Triathlon® Hinge Knee System; Triathlon® Revision Insert X3® | Stryker | 2023 | — |
| +1 | K251665 | Triathlon® Hinge Knee System | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2025 | — |
| +2 | K172347 | GMK Hinge, GMK Revision | Medacta International S.A. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (11)
See all 115 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223528 | Triathlon® Hinge Knee System | 2023 | 4 |
| K130299 | GMK Hinge | 2013 | 4 |
| K230416 | Triathlon® Hinge Knee System; Triathlon® Revision Insert X3® | 2023 | 3 |
| K251665 | Triathlon® Hinge Knee System | 2025 | 2 |
| K241716 | Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge… | 2024 | 0 |
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, K223528 (Howmedica Osteonics Corp., Dba Stryker Orthopaedics, 2023) has gone furthest, with 4 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 | — |
https://510kreport.com/device/K002552 · printed Nov 5, 2026
Cite this page
510(k) Report. “K002552: Howmedica Osteonics Modular Rotating Hinge Knee.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K002552
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026