510(k) Report

510(k) · Cleared

Recalled · Class II · 2013

Triathlon Total Knee System

K053514510(k) TraditionalCleared Jan 26, 200641-day reviewClass II21 CFR 888.3560Recalls 2

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

Stryker Orthopaedics · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Jan 26, 2006 after a 41-day review. The FDA summary names no predicate by number. 78 later devices descend from it. It has been recalled 2 times.

Decided
Jan 26, 2006
Review
41 days
Class
Class II
Product code
JWH
Recalls
2
Predicates
0

78 later devices descend from it, 7 citing it directly.

Descendants, by year cleared 2014: 2 descendants cleared2025: 6 descendants cleared2012: 2 descendants cleared2023: 12 descendants cleared2024: 7 descendants cleared2017: 2 descendants cleared2007: 2 descendants cleared2019: 7 descendants cleared2021: 7 descendants cleared2022: 6 descendants cleared2013: 2 descendants cleared2018: 7 descendants cleared2020: 9 descendants cleared2026: 5 descendants cleared2016: 1 descendant cleared2015: 1 descendant cleared20052010201520202025
  1. This deviceK053514 Triathlon Total Knee SystemStryker Orthopaedics · 2006
  2. Descendant · cites it directly · 64 of its ownK070095 Triathlon TS Knee SystemHowmedica Osteonics Corp. · 2007 · Recalled
  3. Descendant · 2 generations on · 35 of its ownK072221 Modification to Triathlon TS Knee SystemHowmedica Osteonics Corp. · 2007
  4. Descendant · 3 generations on · 33 of its ownK123166 Triathlon All-Polyethylene Condylar Stabilizing (CS) Tibial Implants…Howmedica Osteonics Corp. · 2013
  5. Descendant · cites it directly · 28 of its ownK141056 Triathlon Knee System Posterior Stabilized ComponentsStryker Orthopaedics · 2014 · Recalled
  6. Descendant · 2 generations on · 27 of its ownK140942 Klassic Knee Tibial Stem ExtensionTotal Joint Orthopedics, Inc. · 2014

Showing 5 of 78 descendants. See all descendants

Descendants cleared per year

2007: 22012: 22013: 22014: 22015: 12016: 12017: 22018: 72019: 72020: 92021: 72022: 62023: 122024: 72025: 62026: 5
2007high 12 (2023) · low 0 (2008)2026

Most influential descendants

Showing 5 of 78 · See all
  • K070095Triathlon TS Knee SystemHowmedica Osteonics Corp. · 2007 · cites it directly64descendants
  • K072221Modification to Triathlon TS Knee SystemHowmedica Osteonics Corp. · 2007 · 2 generations on35descendants
  • K123166Triathlon All-Polyethylene Condylar Stabilizing (CS) Tibial Implants Triathlon…Howmedica Osteonics Corp. · 2013 · 3 generations on33descendants
  • K141056Triathlon Knee System Posterior Stabilized ComponentsStryker Orthopaedics · 2014 · cites it directly28descendants
  • K140942Klassic Knee Tibial Stem ExtensionTotal Joint Orthopedics, Inc. · 2014 · 2 generations on27descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K053514Triathlon Total Knee SystemStryker Orthopaedics2006—
+1K070095Triathlon TS Knee SystemHowmedica Osteonics Corp.200713
+2K072221Modification to Triathlon TS Knee SystemHowmedica Osteonics Corp.2007—
+3K123166Triathlon All-Polyethylene Condylar Stabilizing (CS) Tibial Implants Triathlon…Howmedica Osteonics Corp.2013—
+1K141056Triathlon Knee System Posterior Stabilized ComponentsStryker Orthopaedics201411
+2K140942Klassic Knee Tibial Stem ExtensionTotal Joint Orthopedics, Inc.2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200720
201220
201320
201420
201510
201610
201720
201870
201970
202090
202170
202260
2023120
202470
202560
202650
FIG. 1 — Lineage of K053514, 2006–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K221479 Persona Personalized Knee Systemscore 22.4 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (78)

See all 78

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

NumberDeviceApplicantDecidedDescendants
K070095Triathlon TS Knee SystemHowmedica Osteonics Corp.200764
K141056Triathlon Knee System Posterior Stabilized ComponentsStryker Orthopaedics201428
K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics201724
K110404Eaum Total Knee SystemCorentec Co., Ltd.201214
K223528Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234
K251665Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252
K232175XN Knee Prosthesis SystemBeijing Chunlizhengda Medical Instruments Co., Ltd.20240

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

Recalls of this device

DateClassRecallRoot causeReason
Jan 24, 2013Class IIZ-0964-2013Process designThe standard Triathlon Femoral Stylus does not fit into the Specialty Sizers and the "R" and "L" markings on the Right Sizer are reversed.
Nov 13, 2008Not classifiedZ-0889-2009PackagingStryker Orthopaedics became aware of a visual defect in certain blister packages of certain devices.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K070095 (Howmedica Osteonics Corp., 2007) has gone furthest, with 64 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

2007: 182008: 172009: 112010: 192011: 252012: 332013: 312014: 332015: 272016: 182017: 252018: 252019: 282020: 222021: 242022: 172023: 202024: 192025: 202026 (partial year): 12
2007high 33 (2012) · low 11 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JWH

55in 2025

2007: 74 days median2008: 81 days median2009: 168 days median2010: 85 days median2011: 87 days median2012: 85 days median2013: 128 days median2014: 98 days median2015: 87 days median2016: 88 days median2017: 118 days median2018: 90 days median2019: 133 days median2020: 59 days median2021: 61 days median2022: 56 days median2023: 57 days median2024: 89 days median2025: 55 days median2026 (partial year): 63 days median
2007high 168 (2009) · low 55 (2025)2026

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

Recalls per year · JWH

2in 2025

2007: 142008: 102009: 1092010: 322011: 272012: 852013: 312014: 132015: 112016: 172017: 612018: 142019: 52020: 22021: 82022: 122023: 672024: 72025: 22026 (partial year): 4
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

2007: 1,3052008: 1,4832009: 1,8702010: 3,2862011: 5,1332012: 5,2032013: 6,1352014: 6,7222015: 6,8812016: 7,5862017: 12,2632018: 14,0712019: 14,9872020: 12,5922021: 9,4082022: 8,3642023: 8,9472024: 10,8282025: 9,306
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071874141,305
20081781101,483
2009111681091,870
20101985323,286
20112587275,133
20123385855,203
201331128316,135
20143398136,722
20152787116,881
20161888177,586
2017251186112,263
201825901414,071
201928133514,987
20202259212,592
2021246189,408
20221756128,364
20232057678,947
20241989710,828
2025205529,306
202612634—

What is it indicated for?

General Total Knee Arthroplasty (TKA) 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 uni-knee replacement or other…

Read the full statement (141 words)

General Total Knee Arthroplasty (TKA) 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 uni-knee replacement or other procedure.

Additional Indications for Universal Baseplates and Stem Components:

· Ligamentous instability requiring implant bearing surface geometries with increased constraint.

· Absent or non-functioning posterior cruciate ligament.

Indications for Bone Augments:

Painful, disabling joint disease of the knee secondary to: degenerative arthritis, rheumatoid arthritis, or post-traumatic arthritis, complicated by the presence of bone loss.

Salvage of previous unsuccessful uni-knee replacement or other surgical procedure, accompanied by bone loss.

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

Indications for use as stated in the FDA summary.

More from Stryker Orthopaedics

24 FDA decisions under this applicant name. See the company

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  • K191414EXETER Centralizer, EXETER 2.5mm PlugStryker Orthopaedics · 2019
  • K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 20182 recalls
  • K173849Triathlon Total Knee SystemStryker Orthopaedics · 20183 recalls
  • K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics · 20171 recall

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The JWH category page

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  • K262293EVOLUTION MPX™ Total Knee SystemSuzhou Microport Orthorecon Co., Ltd. · 2026
  • K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem…B-One Ortho, Corp. · 2026
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https://510kreport.com/device/K053514 · printed Nov 6, 2026

Cite this page

510(k) Report. “K053514: Triathlon 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/K053514

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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