510(k) · Cleared

Recalled · 2009

Triathlon Cruciate Retaining (CR) Total Knee

K040267510(k) TraditionalCleared May 5, 200490-day reviewClass II21 CFR 888.3560Recalls 1

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 May 5, 2004 after a 90-day review. The FDA summary names its predicate without a number. 163 later devices descend from it. It has been recalled once.

Decided: May 5, 2004
Review: 90 days
Class: Class II
Product code: JWH
Recalls: 1
Predicates: 0

163 later devices descend from it, 17 citing it directly.

This deviceK040267 Triathlon Cruciate Retaining (CR) Total KneeHowmedica Osteonics Corp. · 2004
Descendant · cites it directly · 54 of its ownK051380 Triathlon Press-Fit Total Knee SystemHowmedica Osteonics Corp. · 2005 · Recalled
Descendant · 2 generations on · 51 of its ownK123486 Triathlon Tritanium Tibial BaseplateStryker · 2013 · Recalled
Descendant · cites it directly · 48 of its ownK042883 Size 1 Triathlon Cruciate Retaining (CR) Tibial InsertHowmedica Osteonics Corp. · 2004
Descendant · cites it directly · 45 of its ownK101499 Journey CR Knee SystemSmith & Nephew, Inc. · 2010
Descendant · cites it directly · 41 of its ownK094050 Itotal CR Knee Replacement SystemConformis, Inc. · 2010

Showing 5 of 163 descendants. See all descendants

Descendants cleared per year

2004high 15 (2020) · low 0 (2006)2026

Most influential descendants

Showing 5 of 163 · See all

K051380Triathlon Press-Fit Total Knee SystemHowmedica Osteonics Corp. · 2005 · cites it directly54descendants
K123486Triathlon Tritanium Tibial BaseplateStryker · 2013 · 2 generations on51descendants
K042883Size 1 Triathlon Cruciate Retaining (CR) Tibial InsertHowmedica Osteonics Corp. · 2004 · cites it directly48descendants
K101499Journey CR Knee SystemSmith & Nephew, Inc. · 2010 · cites it directly45descendants
K094050Itotal CR Knee Replacement SystemConformis, Inc. · 2010 · cites it directly41descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K040267	Triathlon Cruciate Retaining (CR) Total Knee	Howmedica Osteonics Corp.	2004	—
+1	K051380	Triathlon Press-Fit Total Knee System	Howmedica Osteonics Corp.	2005	1
+2	K123486	Triathlon Tritanium Tibial Baseplate	Stryker	2013	7
+1	K042883	Size 1 Triathlon Cruciate Retaining (CR) Tibial Insert	Howmedica Osteonics Corp.	2004	—
+1	K101499	Journey CR Knee System	Smith & Nephew, Inc.	2010	—
+1	K094050	Itotal CR Knee Replacement System	Conformis, Inc.	2010	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2005	1	0
2007	2	0
2008	1	0
2010	2	0
2011	3	0
2012	10	0
2013	11	0
2014	10	0
2015	8	0
2016	6	0
2017	6	0
2018	6	0
2019	9	0
2020	15	0
2021	12	0
2022	11	0
2023	13	0
2024	13	0
2025	13	0
2026	10	0

FIG. 1 — Lineage of K040267, 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

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What was it cleared against? (7)

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 PS Total Knee System Named without a submission number	—
*	—	Duracon CR Femoral Component Named without a submission number	—
*	—	Scorpio CR Femoral Component Named without a submission number	—
*	—	Duracon A/P Lipped Tibial Insert Named without a submission number	—
*	—	Duracon Symmetric Patellar Component Named without a submission number	—
*	—	Duracon Asymmetric Patellar Component Named without a submission number	—
*	—	Kinemax All Polyethylene Patella Named without a submission number	—

What descends from it? (163)

See all 163

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

Number	Device	Applicant	Decided	Descendants
K051380	Triathlon Press-Fit Total Knee System	Howmedica Osteonics Corp.	2005	54
K042883	Size 1 Triathlon Cruciate Retaining (CR) Tibial Insert	Howmedica Osteonics Corp.	2004	48
K101499	Journey CR Knee System	Smith & Nephew, Inc.	2010	45
K094050	Itotal CR Knee Replacement System	Conformis, Inc.	2010	41
K063423	Triathlon CS (Condylar Stabilizing) Lipped Insert	Howmedica Osteonics	2007	40
K132624	Triathlon Tritanium Metal-Backed Patella	Stryker Orthopaedics	2013	38
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
K173849	Triathlon Total Knee System	Stryker Orthopaedics	2018	14
K190402	Triathlon Total Knee System-Additional Components	Stryker Orthopaedics (Aka Howmedica Osteonics Corp.)	2019	11

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Sep 1, 2009	Not classified	Z-2334-2010	Mixed-up of materials/components	A lot for lot mix up occurred between the Triathlon Total Knee System Primary Tibial Baseplate # 4 Cemented, Catalog # 5520-B-400, Lot SH8NT and the #2 Cemented, Catalog # 5520-B-200, Lot SH7RP.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K051380 (Howmedica Osteonics Corp., 2005) has gone furthest, with 54 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?

Read the full statement (315 words)

The Triathlon CR Total Knee System consists of a femoral component, tibial insert, and all-polyethylene patellar components that are intended to be used with the previously cleared Triathlon Primary Cemented Tibial Tray in primary or revision total knee arthroplasty. The Triathlon All Polyethylene Patellar components are intended to be used with the femoral components of the previously released Duracon Total Knee System, as well as the previously released Triathlon PS Femoral component in situations where replacement of the articular surface of the patella is required. The Triathlon CR Total Knee System is intended to accommodate the posterior cruciate ligament (PCL) if it is present. Specific indications and contraindications are listed below:

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.

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/K040267 · printed Nov 6, 2026

Cite this page

510(k) Report. “K040267: Triathlon Cruciate Retaining (CR) Total Knee.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040267

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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