510(k) · Cleared

Cleared

Triathlon Low Profile Tibial Tray

K062037510(k) SpecialCleared Aug 3, 200615-day reviewClass II21 CFR 888.3560

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Howmedica Osteonics Corp. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Aug 3, 2006 after a 15-day review. The FDA summary names its predicate without a number. 29 later devices descend from it.

Decided: Aug 3, 2006
Review: 15 days
Class: Class II
Product code: JWH
Recalls: None
Predicates: 0

29 later devices descend from it, 2 citing it directly.

This deviceK062037 Triathlon Low Profile Tibial TrayHowmedica Osteonics Corp. · 2006
Descendant · cites it directly · 28 of its ownK141056 Triathlon Knee System Posterior Stabilized ComponentsStryker Orthopaedics · 2014 · Recalled
Descendant · cites it directly · 24 of its ownK172326 Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee…Stryker Orthopaedics · 2017 · Recalled
Descendant · 2 generations on · 14 of its ownK173849 Triathlon Total Knee SystemStryker Orthopaedics · 2018 · Recalled
Descendant · 2 generations on · 11 of its ownK190402 Triathlon Total Knee System-Additional ComponentsStryker Orthopaedics (Aka Howmedica Osteonics Corp.) · 2019
Descendant · 2 generations on · 4 of its ownK230952 Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023

Showing 5 of 29 descendants. See all descendants

Descendants cleared per year

2014high 6 (2020) · low 0 (2015)2026

Most influential descendants

Showing 5 of 29 · See all

K141056Triathlon Knee System Posterior Stabilized ComponentsStryker Orthopaedics · 2014 · cites it directly28descendants
K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics · 2017 · cites it directly24descendants
K173849Triathlon Total Knee SystemStryker Orthopaedics · 2018 · 2 generations on14descendants
K190402Triathlon Total Knee System-Additional ComponentsStryker Orthopaedics (Aka Howmedica Osteonics Corp.) · 2019 · 2 generations on11descendants
K230952Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral ComponentHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023 · 2 generations on4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K062037	Triathlon Low Profile Tibial Tray	Howmedica Osteonics Corp.	2006	—
+1	K141056	Triathlon Knee System Posterior Stabilized Components	Stryker Orthopaedics	2014	11
+1	K172326	Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System	Stryker Orthopaedics	2017	1
+2	K173849	Triathlon Total Knee System	Stryker Orthopaedics	2018	3
+2	K190402	Triathlon Total Knee System-Additional Components	Stryker Orthopaedics (Aka Howmedica Osteonics Corp.)	2019	—
+2	K230952	Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS)…	Howmedica Osteonics Corp., Dba Stryker Orthopaedics	2023	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	1	0
2017	1	0
2018	3	0
2019	2	0
2020	6	0
2021	1	0
2022	2	0
2023	3	0
2024	4	0
2025	2	0
2026	4	0

FIG. 1 — Lineage of K062037, 2006–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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	Recalls
*	—	Triathlon® Posterior Stabilizing (PS) Total Knee System Named without a submission number	—
*	—	Triathlon® Cruciate Retaining (CR) Total Knee System Named without a submission number	—
*	—	Scorpio® Low Profile Tibial Tray Named without a submission number	—

What descends from it? (29)

See all 29

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K141056	Triathlon Knee System Posterior Stabilized Components	Stryker Orthopaedics	2014	28
K172326	Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System	Stryker Orthopaedics	2017	24

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, K141056 (Stryker Orthopaedics, 2014) has gone furthest, with 28 descendants of its own.

How does its category compare?

All JWH devices

JWH 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

2007high 33 (2012) · low 11 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JWH

55in 2025

2007high 168 (2009) · low 55 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JWH

2in 2025

2007high 109 (2009) · low 2 (2020)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JWH

9,306in 2025

2007high 14,987 (2019) · low 1,305 (2007)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?

Painful, disabling joint disease of the knee resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis.

Post-traumatic loss of knee joint configuration and function.

Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K062037 · printed Nov 4, 2026

Cite this page

510(k) Report. “K062037: Triathlon Low Profile Tibial Tray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062037

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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