510(k) · Cleared

Cleared

Modification to Triathlon TS Knee System

K072221510(k) TraditionalCleared Oct 15, 200766-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 Oct 15, 2007 as substantially equivalent to K070095 (Howmedica Osteonics Corp., 2007) after a 66-day review. Its family tree reaches back 3 generations to 2003. 35 later devices descend from it.

Decided: Oct 15, 2007
Review: 66 days
Class: Class II
Product code: JWH
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K031729 (2003). 5 ancestors in all, the oldest K973164 (1997). 35 later devices descend from it, 6 citing it directly.

By dateBy generation

Root · 3 generations backK031729 Triathlon Posteriorly Stabilized (PS) Total Knee SystemHowmedica Osteonics Corp. · 2003 · Recalled
2 generations backK042993 Triathlon Posteriorly Stabilized (PS) Femoral ComponentHowmedica Osteonics Corp. · 2005 · Recalled
1 generation backK070095 Triathlon TS Knee SystemHowmedica Osteonics Corp. · 2007 · Recalled
This deviceK072221 Modification to Triathlon TS Knee SystemHowmedica Osteonics Corp. · 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 · 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
Descendant · 2 generations on · 14 of its ownK173849 Triathlon Total Knee SystemStryker Orthopaedics · 2018 · Recalled

Showing 5 of 35 descendants. See all descendants

Descendants cleared per year

2013high 6 (2020) · low 0 (2016)2026

Most influential descendants

Showing 5 of 35 · 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
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
K173849Triathlon Total Knee SystemStryker Orthopaedics · 2018 · 2 generations on14descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K031729	Triathlon Posteriorly Stabilized (PS) Total Knee System	Howmedica Osteonics Corp.	2003	3
−2	K042993	Triathlon Posteriorly Stabilized (PS) Femoral Component	Howmedica Osteonics Corp.	2005	1
−1	K070095	Triathlon TS Knee System	Howmedica Osteonics Corp.	2007	13
0 (this device)	K072221	Modification to Triathlon TS Knee System	Howmedica Osteonics Corp.	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	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
+2	K173849	Triathlon Total Knee System	Stryker Orthopaedics	2018	3

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
2006	1	0

Descendants by year cleared

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

FIG. 1 — Lineage of K072221, 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
*	K070095	Triathlon TS Knee System Summary page 2 …System tibial inserts is based on its similarities in indications for use, intended use, design and sterilization to Howmedica Osteonics' Triathlon TS Total Knee System (K070095, cleared June 01, 2007).…	Howmedica Osteonics Corp.	2007	13

Also cleared against K070095: 7 other devices →

What descends from it? (35)

See all 35

6 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
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
K223528	Triathlon® Hinge Knee System	Howmedica Osteonics Corp., Dba Stryker Orthopaedics	2023	4
K230416	Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®	Stryker	2023	3

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 4 years and passes through 1 company; a new generation was cleared every 1.4 years on median.
5 of the 5 ancestors have a recall of any class.
Of its descendants, K123166 (Howmedica Osteonics Corp., 2013) has gone furthest, with 33 descendants of its own.
7 other devices also cite its predicate K070095.

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?

General Total Knee Arthroplasty (TKR) Indications: 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. Revision of previous unsuccessful knee replacement or other procedure.…

Read the full statement (142 words)

General Total Knee Arthroplasty (TKR) Indications:

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.

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 (PS) and Total Stabilizer (TS) Components:

Ligamentous instability requiring implant bearing surface geometries with increased constraint.

Absent or non-functioning posterior cruciate ligament.

Severe anteroposterior instability of the knee joint.

Additional Indications for Total Stabilizer (TS) Components:

Severe instability of the knee secondary to compromised collateral ligament integrity or function.

The Triathlon TS Total Knee System components are intended for cemented use only.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K072221 · printed Nov 6, 2026

Cite this page

510(k) Report. “K072221: Modification to Triathlon TS Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072221

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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