510(k) · Cleared

Cleared

Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®

K230416510(k) TraditionalCleared May 19, 202392-day reviewClass II21 CFR 888.3510

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

Stryker · KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer

Cleared on May 19, 2023 as substantially equivalent to K002552 (Howmedica Osteonics Corp., 2000) and 8 other predicates after a 92-day review. Its family tree reaches back 11 generations to 1994. 3 later devices descend from it.

Decided: May 19, 2023
Review: 92 days
Class: Class II
Product code: KRO
Recalls: None
Predicates: 9

Its longest line of descent runs back 11 generations to K943462 (1994). 94 ancestors in all, the oldest K811630 (1981). 3 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 11 generations backK943462 Darwin Knee SystemJohnson & Johnson Professionals, Inc. · 1994 · Recalled
7 generations between
3 generations backK150307 RESTORIS Multicompartmental Knee SystemMako Surgical Corp. · 2015
2 generations backK172326 Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee…Stryker Orthopaedics · 2017 · Recalled
1 generation backK223528 Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023 · Recalled
This deviceK230416 Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®Stryker · 2023
Descendant · cites it directly · 2 of its ownK251665 Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025
Descendant · cites it directly · 0 of its ownK261898 Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total…Howmedica Osteonics Corp. dba Stryker Orthopaedics · 2026
Descendant · cites it directly · 0 of its ownK252898 Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium®…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025 · Recalled

Show all 11 generations

Root · 11 generations backK943462 Darwin Knee SystemJohnson & Johnson Professionals, Inc. · 1994 · Recalled
10 generations backK033272 Depuy Sigma Tibial InsertsDePuy Orthopaedics, Inc. · 2004 · Recalled
9 generations backK040166 Depuy Sigma XLK Tibial InsertsDePuy Orthopaedics, Inc. · 2004
8 generations backK061648 Depuy Graduated Compartmental Knee (GCK)DePuy Orthopaedics, Inc. · 2006 · Recalled
7 generations backK070849 Depuy GCK Femoral and Tibial ComponentsDePuy Orthopaedics, Inc. · 2007
6 generations backK082172 Mako Modular Knee Compartmental Implant SystemMako Surgical Corporation · 2008 · Recalled
5 generations backK090763 Restoris Multicompartmental Knee (MCK) SystemMako Surgical Corporation · 2009 · Recalled
4 generations backK133039 Restoris Multicompartmental Knee SystemMako Surgical Corporation · 2013
3 generations backK150307 RESTORIS Multicompartmental Knee SystemMako Surgical Corp. · 2015
2 generations backK172326 Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee…Stryker Orthopaedics · 2017 · Recalled
1 generation backK223528 Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023 · Recalled
This deviceK230416 Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®Stryker · 2023

Most influential descendants

Showing 3 of 3 · See all

K251665Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025 · cites it directly2descendants
K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics · 2026 · cites it directly0descendants
K252898Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−11	K943462	Darwin Knee System	Johnson & Johnson Professionals, Inc.	1994	8
−10	K033272	Depuy Sigma Tibial Inserts	DePuy Orthopaedics, Inc.	2004	51
−9	K040166	Depuy Sigma XLK Tibial Inserts	DePuy Orthopaedics, Inc.	2004	—
−8	K061648	Depuy Graduated Compartmental Knee (GCK)	DePuy Orthopaedics, Inc.	2006	1
−7	K070849	Depuy GCK Femoral and Tibial Components	DePuy Orthopaedics, Inc.	2007	—
−6	K082172	Mako Modular Knee Compartmental Implant System	Mako Surgical Corporation	2008	2
−5	K090763	Restoris Multicompartmental Knee (MCK) System	Mako Surgical Corporation	2009	5
−4	K133039	Restoris Multicompartmental Knee System	Mako Surgical Corporation	2013	—
−3	K150307	RESTORIS Multicompartmental Knee System	Mako Surgical Corp.	2015	—
−2	K172326	Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System	Stryker Orthopaedics	2017	1
−1	K223528	Triathlon® Hinge Knee System	Howmedica Osteonics Corp., Dba Stryker Orthopaedics	2023	1
0 (this device)	K230416	Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®	Stryker	2023	—
+1	K251665	Triathlon® Hinge Knee System	Howmedica Osteonics Corp., Dba Stryker Orthopaedics	2025	—
+1	K261898	Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System	Howmedica Osteonics Corp. dba Stryker Orthopaedics	2026	—
+1	K252898	Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric…	Howmedica Osteonics Corp., Dba Stryker Orthopaedics	2025	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1981	1	0
1988	1	0
1990	1	0
1991	3	0
1993	1	0
1995	3	0
1996	3	0
1997	3	0
1998	3	0
1999	2	0
2000	5	0
2001	4	0
2002	5	0
2003	8	0
2004	9	0
2005	8	0
2006	6	0
2007	6	0
2008	3	0
2010	1	0
2013	3	0
2014	1	0
2015	1	0
2017	1	0
2023	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2025	2	0
2026	1	0

FIG. 1 — Lineage of K230416, 1994–2026Source: 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 KRO? 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 KRO device

#1 K251665 Triathlon® Hinge Knee Systemscore 19.0 · 12 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? (9)

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
*	K002552	Howmedica Osteonics Modular Rotating Hinge Knee Summary page 5 ….3560) Product Codes: KRO, JWH Primary Legally Marketed Predicate Device to Which Substantial Equivalence is Claimed: x Modular Rotating Hinge Knee (MRH) – K002552, K994207, K223069 Additional Legally Marketed Predicate Devices to Which Substantial Equivalence is Claimed: x Triathlon® Tot…	Howmedica Osteonics Corp.	2000	—
*	K994207	Howmedica Osteonics Modular Rotating Hinge Knee Summary page 5 …roduct Codes: KRO, JWH Primary Legally Marketed Predicate Device to Which Substantial Equivalence is Claimed: x Modular Rotating Hinge Knee (MRH) – K002552, K994207, K223069 Additional Legally Marketed Predicate Devices to Which Substantial Equivalence is Claimed: x Triathlon® Total Stabil…	Howmedica Osteonics Corp.	2000	—
*	K223069	Modular Rotating Hinge Knee Systems and Compatible Components Cleared while this submission was under review Summary page 5 …des: KRO, JWH Primary Legally Marketed Predicate Device to Which Substantial Equivalence is Claimed: x Modular Rotating Hinge Knee (MRH) – K002552, K994207, K223069 Additional Legally Marketed Predicate Devices to Which Substantial Equivalence is Claimed: x Triathlon® Total Stabilized (TS)…	Howmedica Osteonics Corp., Dba Stryker Orthopaedics	2023	—
*	K172326	Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System Summary page 5 …552, K994207, K223069 Additional Legally Marketed Predicate Devices to Which Substantial Equivalence is Claimed: x Triathlon® Total Stabilized (TS) Plus Insert X3® – K172326, K141056, K072221, K070095, K172634 x Triathlon® Hinge Knee System – K223528…	Stryker Orthopaedics	2017	1
*	K141056	Triathlon Knee System Posterior Stabilized Components Summary page 5 …207, K223069 Additional Legally Marketed Predicate Devices to Which Substantial Equivalence is Claimed: x Triathlon® Total Stabilized (TS) Plus Insert X3® – K172326, K141056, K072221, K070095, K172634 x Triathlon® Hinge Knee System – K223528…	Stryker Orthopaedics	2014	11
*	K072221	Modification to Triathlon TS Knee System Summary page 5 …069 Additional Legally Marketed Predicate Devices to Which Substantial Equivalence is Claimed: x Triathlon® Total Stabilized (TS) Plus Insert X3® – K172326, K141056, K072221, K070095, K172634 x Triathlon® Hinge Knee System – K223528 K…	Howmedica Osteonics Corp.	2007	—
*	K070095	Triathlon TS Knee System Summary page 5 …Legally Marketed Predicate Devices to Which Substantial Equivalence is Claimed: x Triathlon® Total Stabilized (TS) Plus Insert X3® – K172326, K141056, K072221, K070095, K172634 x Triathlon® Hinge Knee System – K223528 K230416 Page 2 of…	Howmedica Osteonics Corp.	2007	13
*	K172634	Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components Summary page 5 …arketed Predicate Devices to Which Substantial Equivalence is Claimed: x Triathlon® Total Stabilized (TS) Plus Insert X3® – K172326, K141056, K072221, K070095, K172634 x Triathlon® Hinge Knee System – K223528 K230416 Page 2 of 5 Leg…	Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics	2017	7
*	K223528	Triathlon® Hinge Knee System Summary page 5 …al Equivalence is Claimed: x Triathlon® Total Stabilized (TS) Plus Insert X3® – K172326, K141056, K072221, K070095, K172634 x Triathlon® Hinge Knee System – K223528 K230416 Page 2 of 5 Legally Marketed Reference Devices Used to Supp…	Howmedica Osteonics Corp., Dba Stryker Orthopaedics	2023	1
†	K222056	Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee	Howmedica Osteonics Corp., Dba Stryker Orthopaedics	2023	1
†	K132624	Triathlon Tritanium Metal-Backed Patella	Stryker Orthopaedics	2013	1
†	K031729	Triathlon Posteriorly Stabilized (PS) Total Knee System	Howmedica Osteonics Corp.	2003	3
†	K983226	Osteonics X Cemented Hip Stem Series	Osteonics Corp.	1998	2
†	K153345	Stryker Orthopaedics Hip Systems Labeling Update	Stryker Orthopaedics	2016	1
†	K973164	Howmedica Total Stabilizer Knee Components	Howmedica Corp.	1997	1
†	K915512	Duracon Total Knee System Tibial Components	Pfizer Hospital Products Group, Inc.	1992	4

Also cleared against K002552: 4 other devices →

What descends from it? (3)

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

Number	Device	Applicant	Decided	Descendants
K251665	Triathlon® Hinge Knee System	Howmedica Osteonics Corp., Dba Stryker Orthopaedics	2025	2
K261898	Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System	Howmedica Osteonics Corp. dba Stryker Orthopaedics	2026	0
K252898	Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella…	Howmedica Osteonics Corp., Dba Stryker Orthopaedics	2025	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 29 years and passes through 7 companies; a new generation was cleared every 1.4 years on median.
48 of the 94 ancestors have a recall of any class.
Of its descendants, K251665 (Howmedica Osteonics Corp., Dba Stryker Orthopaedics, 2025) has gone furthest, with 2 descendants of its own.
4 other devices also cite its predicate K002552.

How does its category compare?

All KRO devices

KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.

FDA decisions per year · KRO

3in 2025

2007high 6 (2015) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KRO

56in 2025

2007high 244 (2019) · low 56 (2025)2026

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

Recalls per year · KRO

14so far in 2026, the most since 2007

2007high 14 (2026) · low 0 (2010)2026

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

Adverse event reports per year · KRO

915in 2025

2007high 915 (2025) · low 37 (2007)2025

MAUDE reports naming product code KRO, 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	1	—	1	37
2008	3	126	3	44
2009	3	86	8	66
2010	1	—	0	110
2011	2	—	1	119
2012	2	—	1	173
2013	3	189	2	194
2014	2	—	0	406
2015	6	113	1	333
2016	3	148	5	369
2017	1	—	4	543
2018	0	—	1	614
2019	3	244	0	759
2020	1	—	0	749
2021	3	57	1	770
2022	1	—	0	892
2023	4	148	0	746
2024	3	87	0	855
2025	3	56	1	915
2026	1	—	14	—

What is it indicated for?

Triathlon® Hinge Knee System: Rotating Hinge Knee System is intended to be implanted with bone cement for the following condition(s): * There is destruction of the joint surfaces, with or without significant bone deformity. * The cruciate and/or collateral ligaments do not stabilize the knee joint. * The ligaments are inadequate and/or the musculature is weak. And/or * Revision is required of a failed prosthesis where there has been gross instability…

Read the full statement (232 words)

Triathlon® Hinge Knee System:

Rotating Hinge Knee System is intended to be implanted with bone cement for the following condition(s):

* There is destruction of the joint surfaces, with or without significant bone deformity.

* The cruciate and/or collateral ligaments do not stabilize the knee joint.

* The ligaments are inadequate and/or the musculature is weak. And/or

* Revision is required of a failed prosthesis where there has been gross instability, with or without bone loss or inadequate soft tissue.

» And/or where segmental resection and replacement of the distal femur is required.

Triathlon® Revision Insert X3®:

General Total Knee Arthroplasty (TKR) Indications:

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

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

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K230416 · printed Nov 4, 2026

Cite this page

510(k) Report. “K230416: Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K230416

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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