510(k) · Cleared

Cleared

Size 1 Triathlon Posterior Stabilized (PS) Tibial Insert

K050539510(k) SpecialCleared Mar 29, 200527-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 Mar 29, 2005 as substantially equivalent to K031729 (Howmedica Osteonics Corp., 2003) after a 27-day review. Its family tree reaches back 1 generation to 2003. 48 later devices descend from it.

Decided: Mar 29, 2005
Review: 27 days
Class: Class II
Product code: JWH
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K031729 (2003). 48 later devices descend from it, 6 citing it directly.

By dateBy generation

Root · 1 generation backK031729 Triathlon Posteriorly Stabilized (PS) Total Knee SystemHowmedica Osteonics Corp. · 2003 · Recalled
This deviceK050539 Size 1 Triathlon Posterior Stabilized (PS) Tibial InsertHowmedica Osteonics Corp. · 2005
Descendant · cites it directly · 40 of its ownK063423 Triathlon CS (Condylar Stabilizing) Lipped InsertHowmedica Osteonics · 2007
Descendant · cites it directly · 33 of its ownK123166 Triathlon All-Polyethylene Condylar Stabilizing (CS) Tibial Implants…Howmedica Osteonics Corp. · 2013
Descendant · cites it directly · 28 of its ownK141056 Triathlon Knee System Posterior Stabilized ComponentsStryker Orthopaedics · 2014 · Recalled
Descendant · 2 generations on · 25 of its ownK071881 Triathlon PKR SystemHowmedica Osteonics Corp. · 2007 · Recalled
Descendant · cites it directly · 24 of its ownK172326 Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee…Stryker Orthopaedics · 2017 · Recalled

Showing 5 of 48 descendants. See all descendants

Descendants cleared per year

2007high 7 (2024) · low 0 (2008)2026

Most influential descendants

Showing 5 of 48 · See all

K063423Triathlon CS (Condylar Stabilizing) Lipped InsertHowmedica Osteonics · 2007 · cites it directly40descendants
K123166Triathlon All-Polyethylene Condylar Stabilizing (CS) Tibial Implants Triathlon…Howmedica Osteonics Corp. · 2013 · cites it directly33descendants
K141056Triathlon Knee System Posterior Stabilized ComponentsStryker Orthopaedics · 2014 · cites it directly28descendants
K071881Triathlon PKR SystemHowmedica Osteonics Corp. · 2007 · 2 generations on25descendants
K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics · 2017 · cites it directly24descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K031729	Triathlon Posteriorly Stabilized (PS) Total Knee System	Howmedica Osteonics Corp.	2003	3
0 (this device)	K050539	Size 1 Triathlon Posterior Stabilized (PS) Tibial Insert	Howmedica Osteonics Corp.	2005	—
+1	K063423	Triathlon CS (Condylar Stabilizing) Lipped Insert	Howmedica Osteonics	2007	—
+1	K123166	Triathlon All-Polyethylene Condylar Stabilizing (CS) Tibial Implants Triathlon…	Howmedica Osteonics Corp.	2013	—
+1	K141056	Triathlon Knee System Posterior Stabilized Components	Stryker Orthopaedics	2014	11
+2	K071881	Triathlon PKR System	Howmedica Osteonics Corp.	2007	1
+1	K172326	Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System	Stryker Orthopaedics	2017	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	2	0
2012	1	0
2013	2	0
2014	2	0
2015	1	0
2017	3	0
2018	4	0
2019	4	0
2020	6	0
2021	2	0
2022	2	0
2023	3	0
2024	7	0
2025	3	0
2026	6	0

FIG. 1 — Lineage of K050539, 2003–2026Source: 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

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What was it cleared against? (1)

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	Applicant	Decided	Recalls
*	K031729	Triathlon Posteriorly Stabilized (PS) Total Knee System Summary page 1 …The intended use of the size one Triathlon TM Posterior Stabilized Tibial Insert is the same as that of the predicate device described in premarket notification K03 1729 - it is T~~~~~~~~~~~~~~~~~~~~~I T m intended for use…	Howmedica Osteonics Corp.	2003	3

Also cleared against K031729: 14 other devices →

What descends from it? (48)

See all 48

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

Number	Device	Applicant	Decided	Descendants
K063423	Triathlon CS (Condylar Stabilizing) Lipped Insert	Howmedica Osteonics	2007	40
K123166	Triathlon All-Polyethylene Condylar Stabilizing (CS) Tibial Implants Triathlon…	Howmedica Osteonics Corp.	2013	33
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
K113060	Unity Toatal Knee System	Corin USA	2012	8
K261898	Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System	Howmedica Osteonics Corp. dba Stryker Orthopaedics	2026	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?

Its one ancestor has a recall.
Of its descendants, K063423 (Howmedica Osteonics, 2007) has gone furthest, with 40 descendants of its own.
14 other devices also cite its predicate K031729.

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?

The intended use of the size one Triathlon Posterior Stabilized Tibial Insert is the same as that of the predicate device described in premarket notification K031729 - it is intended for use with Triathlon PS femoral components, Triathlon Primary Cemented Tibial Tray, and Triathlon and/or Duracon® patellar components in primary or revision cemented total knee arthroplasty. Specific indications/contraindications are listed below (these are identical to…

Read the full statement (295 words)

Indications:

* Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or, rheumatoid 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.

* Revision of previous unsuccessful knee replacement or other procedure.

* Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture management techniques

Additional Indications for Posterior Stabilized Components:

* Ligamentous instability requiring implant bearing surface geometries with increased constraint.

* Absent or non-functioning posterior cruciate ligament.

Contraindications

• Any active or suspected latent infection in or about the knee joint.

* Distant foci of infection which may cause hematogenous spread to the implant site

* Any mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care.

* Bone stock compromised by disease, infection or prior implantation that cannot provide adequate support and/or fixation to the prosthesis.

* Skeletal immaturity.

* Severe instability of the knee joint secondary to the absence of collateral ligament integrity and function.

* Obesity. An overweight or obese patient can produce loads on the prosthesis that can lead to failure of the fixation of the device or to failure of the device itself.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K050539 · printed Nov 4, 2026

Cite this page

510(k) Report. “K050539: Size 1 Triathlon Posterior Stabilized (PS) Tibial Insert.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K050539

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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