510(k) · Cleared
ClearedKinematic II Rotating Hinge Knee
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · LGE Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing
Cleared on Aug 12, 1999 after a 30-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.
- Decided
- Aug 12, 1999
- Review
- 30 days
- Class
- Class II
- Product code
- LGE
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK992346 Kinematic II Rotating Hinge KneeHowmedica Osteonics Corp. · 1999
- Descendant · cites it directly · 1 of its ownK142814 Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral &…Biomet Manufacturing, LLC · 2015 · Recalled
- Descendant · 2 generations on · 0 of its ownK253515 Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and…Biomet Orthopedics, Inc. · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K992346 | Kinematic II Rotating Hinge Knee | Howmedica Osteonics Corp. | 1999 | — |
| +1 | K142814 | Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid Tibial | Biomet Manufacturing, LLC | 2015 | 6 |
| +2 | K253515 | Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and Augments | Biomet Orthopedics, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 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 LGE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | — | Kinematic II Rotating Hinge Knee Metal Tibial Bearing Component Named without a submission number | |
| * | — | Kinematic II Rotating Hinge Knee Tibial Plugs Named without a submission number | |
| † | K952970 | Howmedica Femoral & Proximal Tibial Modular Replacement Sytesm | 1996 |
| † | K972401 | Howmedica Modular Replacement System - Distal Femoral/Proximal Tibial Segments | 1998 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142814 | Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid Tibial | 2015 | 1 |
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, K142814 (Biomet Manufacturing, LLC, 2015) has gone furthest, with 1 descendant of its own.
How does its category compare?
All LGE devicesLGE Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LGE
FDA has decided no LGE device since 2007.
Median 510(k) review, days · LGE
Too few LGE 510(k)s in any year since 2007 to give a median.
Recalls per year · LGE
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LGE
1in 2023
MAUDE reports naming product code LGE, 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 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 7 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The intended use of the subject MRS Pediatric Tibial Bearing Components and the MRS Pediatric All Poly Tibial Components is identical to that of the Modular Replacement System. The Modular Replacement System was cleared via 510(k) #K952970. A second submission, reference 510(k) #K972401, was found substantially equivalent which expanded the indications for use for the system. The original indications for use were for oncology patients where radical…
Read the full statement (201 words)
The intended use of the subject MRS Pediatric Tibial Bearing Components and the MRS Pediatric All Poly Tibial Components is identical to that of the Modular Replacement System. The Modular Replacement System was cleared via 510(k) #K952970. A second submission, reference 510(k) #K972401, was found substantially equivalent which expanded the indications for use for the system. The original indications for use were for oncology patients where radical resection of the distal femur/proximal tibia is required. The expanded indications for use are limb salvage procedures where radical resection and replacement of the distal femur/proximal tibia is required. Limb salvage procedure would include surgical intervention for severe trauma, failed previous knee arthroplasties, and/or oncology indications.
As with the predicate Kinematic II Rotating Hinge Knee Metal Tibial Bearing Component and the Kinematic II Rotating Hinge Knee Tibial Plugs, the subject MRS Pediatric Tibial Bearing Components and the MRS Pediatric All Poly Tibial Components are single use devices. They are intended for cemented fixation only. The subject MRS Pediatric Tibial Bearing Components and the MRS Pediatric All Poly Tibial Components are intended to be used in conjunction with the commercially available components of the Modular Replacement System and the Kinematic II Rotating Hinge Knee System.
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/K992346 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992346: Kinematic II Rotating Hinge Knee.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992346
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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