510(k) · Cleared

Cleared

Triathlon CS (Condylar Stabilizing) Lipped Insert

K063423510(k) TraditionalCleared Jan 22, 200770-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 · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Jan 22, 2007 as substantially equivalent to K021451 (Howmedica Osteonics Corp., 2002) and 7 other predicates after a 70-day review. Its family tree reaches back 2 generations to 2004. 40 later devices descend from it.

Decided: Jan 22, 2007
Review: 70 days
Class: Class II
Product code: JWH
Recalls: None
Predicates: 8

Its longest line of descent runs back 2 generations to K040267 (2004). 8 ancestors in all, the oldest K021451 (2002). 40 later devices descend from it, 10 citing it directly.

By dateBy generation

Root · 2 generations backK040267 Triathlon Cruciate Retaining (CR) Total KneeHowmedica Osteonics Corp. · 2004 · Recalled
1 generation backK042883 Size 1 Triathlon Cruciate Retaining (CR) Tibial InsertHowmedica Osteonics Corp. · 2004
This deviceK063423 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 · cites it directly · 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
Descendant · cites it directly · 18 of its ownK172634 Triathlon® X3® UHMWPE Tibial Inserts and Patellar ComponentsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2017 · Recalled

Showing 5 of 40 descendants. See all descendants

Descendants cleared per year

2007high 6 (2020) · low 0 (2008)2026

Most influential descendants

Showing 5 of 40 · See all

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 · cites it directly25descendants
K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics · 2017 · cites it directly24descendants
K172634Triathlon® X3® UHMWPE Tibial Inserts and Patellar ComponentsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2017 · cites it directly18descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K040267	Triathlon Cruciate Retaining (CR) Total Knee	Howmedica Osteonics Corp.	2004	1
−1	K042883	Size 1 Triathlon Cruciate Retaining (CR) Tibial Insert	Howmedica Osteonics Corp.	2004	—
0 (this device)	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
+1	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
+1	K172634	Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components	Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics	2017	7

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	3	0
2005	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2013	2	0
2014	2	0
2015	1	0
2017	2	0
2018	3	0
2019	4	0
2020	6	0
2021	2	0
2022	2	0
2023	3	0
2024	5	0
2025	3	0
2026	4	0

FIG. 1 — Lineage of K063423, 2004–2026Source: 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? (8)

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
*	K021451	Duracon CS Tibial Insert Summary page 2 …uivalent to other modular tibial inserts regarding intended use, design, materials, and operational principles such as the Duracon® CS Lipped Tibial Insert cleared under K021451, K023724 and K032163, the Triathlon® CR Tibial insert cleared under K040267, K042883 and K051146, and the Triathlont PS insert cl…	Howmedica Osteonics Corp.	2002	—
*	K023724	Duracon CS Lipped Extra Small Tibial Insert Summary page 2 …to other modular tibial inserts regarding intended use, design, materials, and operational principles such as the Duracon® CS Lipped Tibial Insert cleared under K021451, K023724 and K032163, the Triathlon® CR Tibial insert cleared under K040267, K042883 and K051146, and the Triathlont PS insert cleared und…	Howmedica Osteonics Corp.	2003	—
*	K032163	Duracon Total Knee System Summary page 2 …ular tibial inserts regarding intended use, design, materials, and operational principles such as the Duracon® CS Lipped Tibial Insert cleared under K021451, K023724 and K032163, the Triathlon® CR Tibial insert cleared under K040267, K042883 and K051146, and the Triathlont PS insert cleared under K031729,…	Howmedica Osteonics Corp.	2003	3
*	K040267	Triathlon Cruciate Retaining (CR) Total Knee Summary page 2 …erials, and operational principles such as the Duracon® CS Lipped Tibial Insert cleared under K021451, K023724 and K032163, the Triathlon® CR Tibial insert cleared under K040267, K042883 and K051146, and the Triathlont PS insert cleared under K031729, K050539 and K051146. Range of Constraint and Contact Ar…	Howmedica Osteonics Corp.	2004	1
*	K042883	Size 1 Triathlon Cruciate Retaining (CR) Tibial Insert Summary page 2 …nd operational principles such as the Duracon® CS Lipped Tibial Insert cleared under K021451, K023724 and K032163, the Triathlon® CR Tibial insert cleared under K040267, K042883 and K051146, and the Triathlont PS insert cleared under K031729, K050539 and K051146. Range of Constraint and Contact Area/Peak S…	Howmedica Osteonics Corp.	2004	—
*	K051146	Triathlon Knee System Summary page 2 …al principles such as the Duracon® CS Lipped Tibial Insert cleared under K021451, K023724 and K032163, the Triathlon® CR Tibial insert cleared under K040267, K042883 and K051146, and the Triathlont PS insert cleared under K031729, K050539 and K051146. Range of Constraint and Contact Area/Peak Stress was pr…	Howmedica Osteonics Corp.	2005	3
*	K031729	Triathlon Posteriorly Stabilized (PS) Total Knee System Summary page 2 …Insert cleared under K021451, K023724 and K032163, the Triathlon® CR Tibial insert cleared under K040267, K042883 and K051146, and the Triathlont PS insert cleared under K031729, K050539 and K051146. Range of Constraint and Contact Area/Peak Stress was presented to compare to other tibial inserts on the ma…	Howmedica Osteonics Corp.	2003	3
*	K050539	Size 1 Triathlon Posterior Stabilized (PS) Tibial Insert Summary page 2 …eared under K021451, K023724 and K032163, the Triathlon® CR Tibial insert cleared under K040267, K042883 and K051146, and the Triathlont PS insert cleared under K031729, K050539 and K051146. Range of Constraint and Contact Area/Peak Stress was presented to compare to other tibial inserts on the market. The…	Howmedica Osteonics Corp.	2005	—

What descends from it? (40)

See all 40

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

Number	Device	Applicant	Decided	Descendants
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
K071881	Triathlon PKR System	Howmedica Osteonics Corp.	2007	25
K172326	Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System	Stryker Orthopaedics	2017	24
K172634	Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components	Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics	2017	18
K173849	Triathlon Total Knee System	Stryker Orthopaedics	2018	14
K190402	Triathlon Total Knee System-Additional Components	Stryker Orthopaedics (Aka Howmedica Osteonics Corp.)	2019	11
K183533	Unity Total Knee System	Corin U.S.A. Limited	2019	1
K131368	Neo Knee System	Pipeline Orthopedics	2013	1
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?

The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 2.2 years on median.
4 of the 8 ancestors have a recall of any class.
Of its descendants, K123166 (Howmedica Osteonics Corp., 2013) has gone furthest, with 33 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. 2007, this device’s year, is highlighted.

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: 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

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K063423 · printed Nov 4, 2026

Cite this page

510(k) Report. “K063423: Triathlon CS (Condylar Stabilizing) Lipped Insert.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063423

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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