510(k) · Cleared

Recalled · 2006

Triathlon Press-Fit Total Knee System

K051380510(k) TraditionalCleared Aug 30, 200595-day reviewClass II21 CFR 888.3565Recalls 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. · MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

Cleared on Aug 30, 2005 as substantially equivalent to K042993 (Howmedica Osteonics Corp., 2005) and 3 other predicates after a 95-day review. Its family tree reaches back 2 generations to 2003. 54 later devices descend from it. It has been recalled once.

Decided: Aug 30, 2005
Review: 95 days
Class: Class II
Product code: MBH
Recalls: 1
Predicates: 4

Its longest line of descent runs back 2 generations to K031729 (2003). 5 ancestors in all. 54 later devices descend from it, 8 citing it directly.

By dateBy generation

Root · 2 generations backK031729 Triathlon Posteriorly Stabilized (PS) Total Knee SystemHowmedica Osteonics Corp. · 2003 · Recalled
1 generation backK042993 Triathlon Posteriorly Stabilized (PS) Femoral ComponentHowmedica Osteonics Corp. · 2005 · Recalled
This deviceK051380 Triathlon Press-Fit Total Knee SystemHowmedica Osteonics Corp. · 2005
Descendant · cites it directly · 51 of its ownK123486 Triathlon Tritanium Tibial BaseplateStryker · 2013 · Recalled
Descendant · 2 generations on · 38 of its ownK132624 Triathlon Tritanium Metal-Backed PatellaStryker Orthopaedics · 2013 · Recalled
Descendant · cites it directly · 29 of its ownK072575 Triathlon Screw-Fixation Tibial BaseplateStryker Orthopaedics · 2008
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

Showing 5 of 54 descendants. See all descendants

Descendants cleared per year

2008high 8 (2020) · low 0 (2009)2026

Most influential descendants

Showing 5 of 54 · See all

K123486Triathlon Tritanium Tibial BaseplateStryker · 2013 · cites it directly51descendants
K132624Triathlon Tritanium Metal-Backed PatellaStryker Orthopaedics · 2013 · 2 generations on38descendants
K072575Triathlon Screw-Fixation Tibial BaseplateStryker Orthopaedics · 2008 · cites it directly29descendants
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

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K031729	Triathlon Posteriorly Stabilized (PS) Total Knee System	Howmedica Osteonics Corp.	2003	3
−1	K042993	Triathlon Posteriorly Stabilized (PS) Femoral Component	Howmedica Osteonics Corp.	2005	1
0 (this device)	K051380	Triathlon Press-Fit Total Knee System	Howmedica Osteonics Corp.	2005	—
+1	K123486	Triathlon Tritanium Tibial Baseplate	Stryker	2013	7
+2	K132624	Triathlon Tritanium Metal-Backed Patella	Stryker Orthopaedics	2013	1
+1	K072575	Triathlon Screw-Fixation Tibial Baseplate	Stryker Orthopaedics	2008	—
+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

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2003	2	0
2004	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2013	2	0
2014	1	0
2016	1	0
2017	1	0
2018	4	0
2019	2	0
2020	8	0
2021	2	0
2022	5	0
2023	5	0
2024	7	0
2025	8	0
2026	7	0

FIG. 1 — Lineage of K051380, 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? (4)

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
*	K042993	Triathlon Posteriorly Stabilized (PS) Femoral Component Summary page 2 …lence of the Triathlon® Total Knee System is based on its similarities in intended use, design and sterilization to Howmedica Osteonics' Triathlon® PS Total Knee System (K042993, cleared January 12, 2005), Triathlon® CR Total Knee System (K040267, cleared May 05, 2004), Duracon® Total Knee System (K032163,…	Howmedica Osteonics Corp.	2005	1
*	K040267	Triathlon Cruciate Retaining (CR) Total Knee Summary page 2 …s in intended use, design and sterilization to Howmedica Osteonics' Triathlon® PS Total Knee System (K042993, cleared January 12, 2005), Triathlon® CR Total Knee System (K040267, cleared May 05, 2004), Duracon® Total Knee System (K032163, cleared September 12, 2003 and K032418 cleared, September 11, 2003).…	Howmedica Osteonics Corp.	2004	1
*	K032163	Duracon Total Knee System Summary page 2 …eonics' Triathlon® PS Total Knee System (K042993, cleared January 12, 2005), Triathlon® CR Total Knee System (K040267, cleared May 05, 2004), Duracon® Total Knee System (K032163, cleared September 12, 2003 and K032418 cleared, September 11, 2003). Predicate device information is located in Appendix D. ===…	Howmedica Osteonics Corp.	2003	3
*	K032418	Duracon Total Knee System with Peri-Apatite Coating Summary page 2 …(K042993, cleared January 12, 2005), Triathlon® CR Total Knee System (K040267, cleared May 05, 2004), Duracon® Total Knee System (K032163, cleared September 12, 2003 and K032418 cleared, September 11, 2003). Predicate device information is located in Appendix D.…	Howmedica Osteonics Corp.	2003	3

Also cleared against K042993: 6 other devices →

What descends from it? (54)

See all 54

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

Number	Device	Applicant	Decided	Descendants
K123486	Triathlon Tritanium Tibial Baseplate	Stryker	2013	51
K072575	Triathlon Screw-Fixation Tibial Baseplate	Stryker Orthopaedics	2008	29
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
K173849	Triathlon Total Knee System	Stryker Orthopaedics	2018	14
K191084	The Optimotion Blue Total Knee System	Optimotion Implants, LLC	2020	1
K252044	Triathlon® Total Knee System - Triathlon® Gold Femoral Components	Howmedica Osteonics Corp., Dba Stryker Orthopaedics	2025	0
K200782	Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon…	Howmedica Osteonics Corp.	2020	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Sep 21, 2006	Not classified	Z-0579-2009	Process change control	Stryker Orthopaedics became aware that one lot of the Triathlon Primary Beaded PA Baseplate Size 5 may not have the Peri-Apatite coating.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 2 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, K123486 (Stryker, 2013) has gone furthest, with 51 descendants of its own.
6 other devices also cite its predicate K042993.

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?

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…

Read the full statement (98 words)

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.

Additional Indications for Posterior Stabilized Components:

Ligamentous instability requiring implant bearing surface geometries with increased constraint.

Absent or non-functioning posterior cruciate ligament.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K051380 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051380: Triathlon Press-Fit Total 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/K051380

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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