510(k) · Cleared
Recalled · Class II · 2015Howmedica Total Stabilizer Knee Components
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Corp. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Nov 20, 1997 after an 87-day review. The FDA summary names no predicate by number. 66 later devices descend from it. It has been recalled once.
- Decided
- Nov 20, 1997
- Review
- 87 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 1
- Predicates
- 0
66 later devices descend from it, 2 citing it directly.
- This deviceK973164 Howmedica Total Stabilizer Knee ComponentsHowmedica Corp. · 1997
- Descendant · cites it directly · 64 of its ownK070095 Triathlon TS Knee SystemHowmedica Osteonics Corp. · 2007 · Recalled
- Descendant · 2 generations on · 35 of its ownK072221 Modification to Triathlon TS Knee SystemHowmedica Osteonics Corp. · 2007
- Descendant · 3 generations on · 33 of its ownK123166 Triathlon All-Polyethylene Condylar Stabilizing (CS) Tibial Implants…Howmedica Osteonics Corp. · 2013
- Descendant · 2 generations on · 28 of its ownK141056 Triathlon Knee System Posterior Stabilized ComponentsStryker Orthopaedics · 2014 · Recalled
- Descendant · 2 generations on · 27 of its ownK140942 Klassic Knee Tibial Stem ExtensionTotal Joint Orthopedics, Inc. · 2014
Showing 5 of 66 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 66 · See all- K070095Triathlon TS Knee SystemHowmedica Osteonics Corp. · 2007 · cites it directly64descendants
- K072221Modification to Triathlon TS Knee SystemHowmedica Osteonics Corp. · 2007 · 2 generations on35descendants
- K123166Triathlon All-Polyethylene Condylar Stabilizing (CS) Tibial Implants Triathlon…Howmedica Osteonics Corp. · 2013 · 3 generations on33descendants
- K141056Triathlon Knee System Posterior Stabilized ComponentsStryker Orthopaedics · 2014 · 2 generations on28descendants
- K140942Klassic Knee Tibial Stem ExtensionTotal Joint Orthopedics, Inc. · 2014 · 2 generations on27descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973164 | Howmedica Total Stabilizer Knee Components | Howmedica Corp. | 1997 | — |
| +1 | K070095 | Triathlon TS Knee System | Howmedica Osteonics Corp. | 2007 | 13 |
| +2 | K072221 | Modification to Triathlon TS Knee System | Howmedica Osteonics Corp. | 2007 | — |
| +3 | K123166 | Triathlon All-Polyethylene Condylar Stabilizing (CS) Tibial Implants Triathlon… | Howmedica Osteonics Corp. | 2013 | — |
| +2 | K141056 | Triathlon Knee System Posterior Stabilized Components | Stryker Orthopaedics | 2014 | 11 |
| +2 | 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 |
| 2007 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 4 | 0 |
| 2019 | 6 | 0 |
| 2020 | 9 | 0 |
| 2021 | 7 | 0 |
| 2022 | 5 | 0 |
| 2023 | 11 | 0 |
| 2024 | 4 | 0 |
| 2025 | 5 | 0 |
| 2026 | 5 | 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 JWH? 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 JWH device
- #1 K221479 Persona Personalized Knee Systemscore 22.4 · 11 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? (66)
See all 662 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 21, 2015 | Class II | Z-0362-2016 | Under Investigation by firm | Stryker Orthopaedics has received two customer complaints regarding Duracon Tibial Wedge implants puncturing the packaging's Tyvek lid(s). |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K070095 (Howmedica Osteonics Corp., 2007) has gone furthest, with 64 descendants of its own.
How does its category compare?
All JWH devicesJWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JWH
20in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JWH
55in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JWH
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JWH
9,306in 2025
MAUDE reports naming product code JWH, 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 | 18 | 74 | 14 | 1,305 |
| 2008 | 17 | 81 | 10 | 1,483 |
| 2009 | 11 | 168 | 109 | 1,870 |
| 2010 | 19 | 85 | 32 | 3,286 |
| 2011 | 25 | 87 | 27 | 5,133 |
| 2012 | 33 | 85 | 85 | 5,203 |
| 2013 | 31 | 128 | 31 | 6,135 |
| 2014 | 33 | 98 | 13 | 6,722 |
| 2015 | 27 | 87 | 11 | 6,881 |
| 2016 | 18 | 88 | 17 | 7,586 |
| 2017 | 25 | 118 | 61 | 12,263 |
| 2018 | 25 | 90 | 14 | 14,071 |
| 2019 | 28 | 133 | 5 | 14,987 |
| 2020 | 22 | 59 | 2 | 12,592 |
| 2021 | 24 | 61 | 8 | 9,408 |
| 2022 | 17 | 56 | 12 | 8,364 |
| 2023 | 20 | 57 | 67 | 8,947 |
| 2024 | 19 | 89 | 7 | 10,828 |
| 2025 | 20 | 55 | 2 | 9,306 |
| 2026 | 12 | 63 | 4 | — |
What is it indicated for?
The Howmedica Total Stabilizer Knee Components (Stabilizer femoral component, stabilizer tibial insert, modular offset adaptor, femoral/tibial stem extenders and tibial wedges) are intended to be used along with previously released Duracon tibial and patellar components as a total knee system in primary or revision cemented total knee arthroplasty. This total knee system IS intended to be used to relieve pain and instability of the knee joint as a result…
Read the full statement (267 words)
The Howmedica Total Stabilizer Knee Components (Stabilizer femoral component, stabilizer tibial insert, modular offset adaptor, femoral/tibial stem extenders and tibial wedges) are intended to be used along with previously released Duracon tibial and patellar components as a total knee system in primary or revision cemented total knee arthroplasty. This total knee system IS intended to be used to relieve pain and instability of the knee joint as a result of non-inflammatory joint disease, inflammatory joint disease, trauma, or failed previous prosthesis.
The Howmedica Total Stabilizer femoral component and tibial insert components are specifically intended to be used when the cruciate ligaments are absent, inadequate, or cannot be preserved during the operative procedure, especially when anterior-posterior stability is impaired due to the absence of the patella. The collateral ligaments may or may not be intact. In addition, these components may be used in revision of a failed previous prosthesis where the cruciate ligaments are absent.
The Howmedica tibial wedges are intended to be used with the Howmedica Universal tibial baseplate to augment bone loss on the surface of the tibia. Tibial bone loss may be observed in primary or revision total knee arthroplasty.
The Howmedica Modular Offset Adaptor is intended to be used in situations where a stem extender is being used, and the tibial baseplate or femoral component requires offsetting to allow optimal coverage of the prepared bone surfaces.
The Howmedica Stem Extenders are intended to be used with Duracon/ Kinemax femoral/tibial components in primary/revision total knee arthroplasty where additional stability is required.
The Howmedica Total Stabilizer Knee Components are intended to be implanted using 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/K973164 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973164: Howmedica Total Stabilizer Knee Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973164
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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