510(k) · Cleared

Cleared

Triathlon Metal Backed Patella

K061521510(k) SpecialCleared Aug 11, 200670-day reviewClass II21 CFR 888.3565

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

Howmedica Osteonics Corp. · MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

Cleared on Aug 11, 2006 as substantially equivalent to K032418 (Howmedica Osteonics Corp., 2003) after a 70-day review. Its family tree reaches back 1 generation to 2003. 43 later devices descend from it.

Decided: Aug 11, 2006
Review: 70 days
Class: Class II
Product code: MBH
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K032418 (2003). 43 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK032418 Duracon Total Knee System with Peri-Apatite CoatingHowmedica Osteonics Corp. · 2003 · Recalled
This deviceK061521 Triathlon Metal Backed PatellaHowmedica Osteonics Corp. · 2006
Descendant · cites it directly · 38 of its ownK132624 Triathlon Tritanium Metal-Backed PatellaStryker Orthopaedics · 2013 · Recalled
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 · 2 generations on · 14 of its ownK173849 Triathlon Total Knee SystemStryker Orthopaedics · 2018 · Recalled
Descendant · 2 generations on · 11 of its ownK190402 Triathlon Total Knee System-Additional ComponentsStryker Orthopaedics (Aka Howmedica Osteonics Corp.) · 2019

Showing 5 of 43 descendants. See all descendants

Descendants cleared per year

2013high 7 (2020) · low 0 (2015)2026

Most influential descendants

Showing 5 of 43 · See all

K132624Triathlon Tritanium Metal-Backed PatellaStryker Orthopaedics · 2013 · cites it directly38descendants
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
K173849Triathlon Total Knee SystemStryker Orthopaedics · 2018 · 2 generations on14descendants
K190402Triathlon Total Knee System-Additional ComponentsStryker Orthopaedics (Aka Howmedica Osteonics Corp.) · 2019 · 2 generations on11descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K032418	Duracon Total Knee System with Peri-Apatite Coating	Howmedica Osteonics Corp.	2003	3
0 (this device)	K061521	Triathlon Metal Backed Patella	Howmedica Osteonics Corp.	2006	—
+1	K132624	Triathlon Tritanium Metal-Backed Patella	Stryker Orthopaedics	2013	1
+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
+2	K173849	Triathlon Total Knee System	Stryker Orthopaedics	2018	3
+2	K190402	Triathlon Total Knee System-Additional Components	Stryker Orthopaedics (Aka Howmedica Osteonics Corp.)	2019	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0
2014	1	0
2017	1	0
2018	3	0
2019	2	0
2020	7	0
2021	2	0
2022	5	0
2023	5	0
2024	6	0
2025	3	0
2026	7	0

FIG. 1 — Lineage of K061521, 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 MBH? 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 MBH device

#1 K241597 Freedom® Total Knee System - Porous Tibial…score 19.9 · 8 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
*	K032418	Duracon Total Knee System with Peri-Apatite Coating Summary page 2 …the use of bone cement. Substantial Equivalence: The metal-backed patella is substantially equivalent to Howmedica Osteonics' Duracon metal- backed patella cleared in K032418. Each device is similar in design, and has the same indications, intended use, and sterilization.…	Howmedica Osteonics Corp.	2003	3

Also cleared against K032418: 2 other devices →

What descends from it? (43)

See all 43

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

Number	Device	Applicant	Decided	Descendants
K132624	Triathlon Tritanium Metal-Backed Patella	Stryker Orthopaedics	2013	38
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

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, K132624 (Stryker Orthopaedics, 2013) has gone furthest, with 38 descendants of its own.
2 other devices also cite its predicate K032418.

How does its category compare?

All MBH devices

MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MBH

8in 2025

2007high 10 (2007) · low 1 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MBH

98in 2025

2007high 209 (2009) · low 48 (2021)2026

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

Recalls per year · MBH

1in 2024

2007high 15 (2011) · low 0 (2007)2026

Class I (5 since 2007) Class II/III not classified

Adverse event reports per year · MBH

1,561in 2025

2007high 1,561 (2025) · low 21 (2008)2025

MAUDE reports naming product code MBH, 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	10	59	0	27
2008	3	70	0	21
2009	3	209	2	89
2010	4	84	0	121
2011	5	84	15	247
2012	5	90	1 (1)	370
2013	6	138	4 (4)	308
2014	9	114	0	385
2015	8	100	0	955
2016	4	74	1	1,034
2017	4	115	9	1,007
2018	6	89	1	1,191
2019	1	—	1	1,394
2020	7	112	2	1,089
2021	6	48	0	1,539
2022	7	57	0	1,261
2023	6	94	2	1,263
2024	10	84	1	1,497
2025	8	98	0	1,561
2026	7	153	4	—

What is it indicated for?

The Triathlon® Total Knee System components included in this submission are intended for use in total knee arthroplasty to relieve pain and restore knee functions for indications such as:

* Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis or avascular necrosis;

* Rheumatoid arthritis;

* Correction of functional deformity;

* Revision procedures where other treatments or devices have failed;

* Post traumatic loss of joint anatomy, particularly when there is patello-femoral erosion, dysfunction or prior patellectomy; and,

* Irreparable fracture of the knee.

These products are intended to achieve fixation without the use of bone cement.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K061521 · printed Nov 6, 2026

Cite this page

510(k) Report. “K061521: Triathlon Metal Backed Patella.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061521

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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