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 Mar 13, 2000 as substantially equivalent to K811630 (Howmedica Corp., 1981) and 2 other predicates after a 90-day review. Its family tree reaches back 1 generation to 1981. 6 later devices descend from it.
- Decided
- Mar 13, 2000
- Review
- 90 days
- Class
- Class II
- Product code
- KRO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K811630 (1981). 3 ancestors in all. 6 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK811630 Kinematic Rotating Hinge Total Knee PR.Howmedica Corp. · 1981
- This deviceK994207 Howmedica Osteonics Modular Rotating Hinge KneeHowmedica Osteonics Corp. · 2000
- Descendant · cites it directly · 4 of its ownK223069 Modular Rotating Hinge Knee Systems and Compatible ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023
- Descendant · cites it directly · 4 of its ownK223528 Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023 · 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 · 0 of its ownK261898 Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total…Howmedica Osteonics Corp. dba Stryker Orthopaedics · 2026
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K223069Modular Rotating Hinge Knee Systems and Compatible ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023 · cites it directly4descendants
- K223528Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023 · 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
- K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K811630 | Kinematic Rotating Hinge Total Knee PR. | Howmedica Corp. | 1981 | — |
| 0 (this device) | K994207 | Howmedica Osteonics Modular Rotating Hinge Knee | Howmedica Osteonics Corp. | 2000 | — |
| +1 | K223069 | Modular Rotating Hinge Knee Systems and Compatible Components | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2023 | — |
| +1 | K223528 | Triathlon® Hinge Knee System | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2023 | 1 |
| +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 | K261898 | Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System | Howmedica Osteonics Corp. dba Stryker Orthopaedics | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K811630 | Kinematic Rotating Hinge Total Knee PR.Summary page 1…Hinge Knee are substantially equivalent to features of the following Howmedica Osteonics predicate devices, which have been cleared for marketing via the 510(k) process (K811630, K932070, and K910500 respectively): ® Howmedica Kinematic Rotating Hinge Total Knee PR. ® Howmedica Duracon Total Stabilizer Kn… | 1981 |
| * | K932070 | Duracon Stabilizer Femoral Component and InsertSummary page 1…e are substantially equivalent to features of the following Howmedica Osteonics predicate devices, which have been cleared for marketing via the 510(k) process (K811630, K932070, and K910500 respectively): ® Howmedica Kinematic Rotating Hinge Total Knee PR. ® Howmedica Duracon Total Stabilizer Knee ® How… | 1995 |
| * | K910500 | Howmedica Kinemax Plus Total Knee SystemSummary page 1…tially equivalent to features of the following Howmedica Osteonics predicate devices, which have been cleared for marketing via the 510(k) process (K811630, K932070, and K910500 respectively): ® Howmedica Kinematic Rotating Hinge Total Knee PR. ® Howmedica Duracon Total Stabilizer Knee ® Howmedica Kinema… | 1991 |
What descends from it? (6)
4 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?
- None of the 3 ancestors has a recall.
- Of its descendants, K223069 (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 | — |
What is it indicated for?
The Modular Rotating Hinge Knee is intended to be implanted with bone cement for the following conditions:
® There is destruction of the joint surfaces, with or without significant bone deformity.
® The cruciate and/or collateral ligaments do not stabilize the knee joint.
® The ligaments are inadequate and/or the musculature is weak.
® Revision is required of a failed prosthesis where there has been gross instability, with or without bone loss or inadequate soft tissue.
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/K994207 · printed Nov 4, 2026
Cite this page
510(k) Report. “K994207: Howmedica Osteonics Modular Rotating Hinge Knee.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K994207
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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