510(k) Report

510(k) · Cleared

Recalled · Class II · 2021

Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System

K172326510(k) TraditionalCleared Oct 30, 201790-day reviewClass II21 CFR 888.3560Recalls 1

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 Oct 30, 2017 as substantially equivalent to K031729 (Howmedica Osteonics Corp., 2003) and 21 other predicates after a 90-day review. Its family tree reaches back 9 generations to 1994. 24 later devices descend from it. It has been recalled once.

Decided
Oct 30, 2017
Review
90 days
Class
Class II
Product code
JWH
Recalls
1
Predicates
22

Its longest line of descent runs back 9 generations to K943462 (1994). 83 ancestors in all, the oldest K880155 (1988). 24 later devices descend from it, 14 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2015: 1 other ancestor2014: 1 other ancestor2013: 3 other ancestors2008: 3 other ancestors2007: 6 other ancestors2006: 6 other ancestors2005: 8 other ancestors2004: 9 other ancestors2003: 8 other ancestors2010: 1 other ancestor2002: 5 other ancestors1999: 2 other ancestors1998: 3 other ancestors1997: 3 other ancestors1996: 3 other ancestors1993: 1 other ancestor1991: 2 other ancestors1990: 1 other ancestor2001: 4 other ancestors2000: 1 other ancestor1995: 2 other ancestors1988: 1 other ancestor2024: 3 descendants cleared2020: 5 descendants cleared2019: 2 descendants cleared2025: 2 descendants cleared2023: 3 descendants cleared2018: 2 descendants cleared2026: 4 descendants cleared2022: 2 descendants cleared2021: 1 descendant clearedK943462 · Darwin Knee System · Johnson & Johnson Professionals, Inc. · 1994 · recalled×2: 2 generations cleared close together, K033272 (2004), K040166 (2004) K061648 · Depuy Graduated Compartmental Knee (GCK) · DePuy Orthopaedics, Inc. · 2006 · recalledK070849 · Depuy GCK Femoral and Tibial Components · DePuy Orthopaedics, Inc. · 2007K082172 · Mako Modular Knee Compartmental Implant System · Mako Surgical Corporation · 2008 · recalledK090763 · Restoris Multicompartmental Knee (MCK) System · Mako Surgical Corporation · 2009 · recalledK133039 · Restoris Multicompartmental Knee System · Mako Surgical Corporation · 2013K150307 · RESTORIS Multicompartmental Knee System · Mako Surgical Corp. · 20151990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 20 other ancestors2 generations back: 16 other ancestors3 generations back: 12 other ancestors4 generations back: 17 other ancestors5 generations back: 9 other ancestors 1 generation forward: 14 descendants2 generations forward: 8 descendants3 generations forward: 2 descendants K150307 · RESTORIS Multicompartmental Knee System · Mako Surgical Corp. · 2015K133039 · Restoris Multicompartmental Knee System · Mako Surgical Corporation · 2013K090763 · Restoris Multicompartmental Knee (MCK) System · Mako Surgical Corporation · 2009 · recalledK082172 · Mako Modular Knee Compartmental Implant System · Mako Surgical Corporation · 2008 · recalledK070849 · Depuy GCK Femoral and Tibial Components · DePuy Orthopaedics, Inc. · 2007K061648 · Depuy Graduated Compartmental Knee (GCK) · DePuy Orthopaedics, Inc. · 2006 · recalledK040166 · Depuy Sigma XLK Tibial Inserts · DePuy Orthopaedics, Inc. · 2004K033272 · Depuy Sigma Tibial Inserts · DePuy Orthopaedics, Inc. · 2004 · recalledK943462 · Darwin Knee System · Johnson & Johnson Professionals, Inc. · 1994 · recalled−50
  1. Root · 9 generations backK943462 Darwin Knee SystemJohnson & Johnson Professionals, Inc. · 1994 · Recalled
  2. 5 generations between
  3. 3 generations backK090763 Restoris Multicompartmental Knee (MCK) SystemMako Surgical Corporation · 2009 · Recalled
  4. 2 generations backK133039 Restoris Multicompartmental Knee SystemMako Surgical Corporation · 2013
  5. 1 generation backK150307 RESTORIS Multicompartmental Knee SystemMako Surgical Corp. · 2015
  6. This deviceK172326 Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee…Stryker Orthopaedics · 2017
  7. Descendant · cites it directly · 14 of its ownK173849 Triathlon Total Knee SystemStryker Orthopaedics · 2018 · Recalled
  8. Descendant · cites it directly · 11 of its ownK190402 Triathlon Total Knee System-Additional ComponentsStryker Orthopaedics (Aka Howmedica Osteonics Corp.) · 2019
  9. Descendant · cites it directly · 4 of its ownK230952 Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023
  10. Descendant · cites it directly · 4 of its ownK223528 Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023 · Recalled
  11. Descendant · cites it directly · 3 of its ownK242831 Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2024
Show all 9 generations
  1. Root · 9 generations backK943462 Darwin Knee SystemJohnson & Johnson Professionals, Inc. · 1994 · Recalled
  2. 8 generations backK033272 Depuy Sigma Tibial InsertsDePuy Orthopaedics, Inc. · 2004 · Recalled
  3. 7 generations backK040166 Depuy Sigma XLK Tibial InsertsDePuy Orthopaedics, Inc. · 2004
  4. 6 generations backK061648 Depuy Graduated Compartmental Knee (GCK)DePuy Orthopaedics, Inc. · 2006 · Recalled
  5. 5 generations backK070849 Depuy GCK Femoral and Tibial ComponentsDePuy Orthopaedics, Inc. · 2007
  6. 4 generations backK082172 Mako Modular Knee Compartmental Implant SystemMako Surgical Corporation · 2008 · Recalled
  7. 3 generations backK090763 Restoris Multicompartmental Knee (MCK) SystemMako Surgical Corporation · 2009 · Recalled
  8. 2 generations backK133039 Restoris Multicompartmental Knee SystemMako Surgical Corporation · 2013
  9. 1 generation backK150307 RESTORIS Multicompartmental Knee SystemMako Surgical Corp. · 2015
  10. This deviceK172326 Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee…Stryker Orthopaedics · 2017

Showing 5 of 24 descendants. See all descendants

Descendants cleared per year

2018: 22019: 22020: 52021: 12022: 22023: 32024: 32025: 22026: 4
2018high 5 (2020) · low 1 (2021)2026

Most influential descendants

Showing 5 of 24 · See all
  • K173849Triathlon Total Knee SystemStryker Orthopaedics · 2018 · cites it directly14descendants
  • K190402Triathlon Total Knee System-Additional ComponentsStryker Orthopaedics (Aka Howmedica Osteonics Corp.) · 2019 · cites it directly11descendants
  • K230952Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral ComponentHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023 · cites it directly4descendants
  • K223528Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023 · cites it directly4descendants
  • K242831Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2024 · cites it directly3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K943462Darwin Knee SystemJohnson & Johnson Professionals, Inc.19948
−8K033272Depuy Sigma Tibial InsertsDePuy Orthopaedics, Inc.200451
−7K040166Depuy Sigma XLK Tibial InsertsDePuy Orthopaedics, Inc.2004—
−6K061648Depuy Graduated Compartmental Knee (GCK)DePuy Orthopaedics, Inc.20061
−5K070849Depuy GCK Femoral and Tibial ComponentsDePuy Orthopaedics, Inc.2007—
−4K082172Mako Modular Knee Compartmental Implant SystemMako Surgical Corporation20082
−3K090763Restoris Multicompartmental Knee (MCK) SystemMako Surgical Corporation20095
−2K133039Restoris Multicompartmental Knee SystemMako Surgical Corporation2013—
−1K150307RESTORIS Multicompartmental Knee SystemMako Surgical Corp.2015—
0 (this device)K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics2017—
+1K173849Triathlon Total Knee SystemStryker Orthopaedics20183
+1K190402Triathlon Total Knee System-Additional ComponentsStryker Orthopaedics (Aka Howmedica Osteonics Corp.)2019—
+1K230952Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS)…Howmedica Osteonics Corp., Dba Stryker Orthopaedics2023—
+1K223528Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20231
+1K242831Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components…Howmedica Osteonics Corp., Dba Stryker Orthopaedics2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198810
199010
199120
199310
199520
199630
199730
199830
199920
200010
200140
200250
200380
200490
200580
200660
200760
200830
201010
201330
201410
201510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201820
201920
202050
202110
202220
202330
202430
202520
202640
FIG. 1 — Lineage of K172326, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (22)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K031729Triathlon Posteriorly Stabilized (PS) Total Knee System
Summary page 10
…KRR, HSX, NPJ Legally Marketed Device to Which Substantial Equivalence is Claimed: Triathlon Total Knee System components cleared via the following 510(k) submissions: K031729, K040267, K042883, K042993, K050539, K051146, K051380, K053514, K061521, K062037, K063423, K070095, K072221, K072575, K123166, K1…
Howmedica Osteonics Corp.20033
*K040267Triathlon Cruciate Retaining (CR) Total Knee
Summary page 10
…, NPJ Legally Marketed Device to Which Substantial Equivalence is Claimed: Triathlon Total Knee System components cleared via the following 510(k) submissions: K031729, K040267, K042883, K042993, K050539, K051146, K051380, K053514, K061521, K062037, K063423, K070095, K072221, K072575, K123166, K123486, K1…
Howmedica Osteonics Corp.20041
*K042883Size 1 Triathlon Cruciate Retaining (CR) Tibial Insert
Summary page 10
…gally Marketed Device to Which Substantial Equivalence is Claimed: Triathlon Total Knee System components cleared via the following 510(k) submissions: K031729, K040267, K042883, K042993, K050539, K051146, K051380, K053514, K061521, K062037, K063423, K070095, K072221, K072575, K123166, K123486, K132624, K1…
Howmedica Osteonics Corp.2004—
*K042993Triathlon Posteriorly Stabilized (PS) Femoral Component
Summary page 10
…keted Device to Which Substantial Equivalence is Claimed: Triathlon Total Knee System components cleared via the following 510(k) submissions: K031729, K040267, K042883, K042993, K050539, K051146, K051380, K053514, K061521, K062037, K063423, K070095, K072221, K072575, K123166, K123486, K132624, K141056 and…
Howmedica Osteonics Corp.20051
*K050539Size 1 Triathlon Posterior Stabilized (PS) Tibial Insert
Summary page 10
…ice to Which Substantial Equivalence is Claimed: Triathlon Total Knee System components cleared via the following 510(k) submissions: K031729, K040267, K042883, K042993, K050539, K051146, K051380, K053514, K061521, K062037, K063423, K070095, K072221, K072575, K123166, K123486, K132624, K141056 and K143393;…
Howmedica Osteonics Corp.2005—
*K051146Triathlon Knee System
Summary page 10
…ich Substantial Equivalence is Claimed: Triathlon Total Knee System components cleared via the following 510(k) submissions: K031729, K040267, K042883, K042993, K050539, K051146, K051380, K053514, K061521, K062037, K063423, K070095, K072221, K072575, K123166, K123486, K132624, K141056 and K143393; Triathlo…
Howmedica Osteonics Corp.20053
*K051380Triathlon Press-Fit Total Knee System
Summary page 10
…antial Equivalence is Claimed: Triathlon Total Knee System components cleared via the following 510(k) submissions: K031729, K040267, K042883, K042993, K050539, K051146, K051380, K053514, K061521, K062037, K063423, K070095, K072221, K072575, K123166, K123486, K132624, K141056 and K143393; Triathlon PKR Sys…
Howmedica Osteonics Corp.20051
*K053514Triathlon Total Knee System
Summary page 10
…uivalence is Claimed: Triathlon Total Knee System components cleared via the following 510(k) submissions: K031729, K040267, K042883, K042993, K050539, K051146, K051380, K053514, K061521, K062037, K063423, K070095, K072221, K072575, K123166, K123486, K132624, K141056 and K143393; Triathlon PKR System clear…
Stryker Orthopaedics20062
*K061521Triathlon Metal Backed Patella
Summary page 10
…is Claimed: Triathlon Total Knee System components cleared via the following 510(k) submissions: K031729, K040267, K042883, K042993, K050539, K051146, K051380, K053514, K061521, K062037, K063423, K070095, K072221, K072575, K123166, K123486, K132624, K141056 and K143393; Triathlon PKR System cleared via K0…
Howmedica Osteonics Corp.2006—
*K062037Triathlon Low Profile Tibial Tray
Summary page 10
…ed: Triathlon Total Knee System components cleared via the following 510(k) submissions: K031729, K040267, K042883, K042993, K050539, K051146, K051380, K053514, K061521, K062037, K063423, K070095, K072221, K072575, K123166, K123486, K132624, K141056 and K143393; Triathlon PKR System cleared via K071881; Re…
Howmedica Osteonics Corp.2006—
*K063423Triathlon CS (Condylar Stabilizing) Lipped Insert
Summary page 10
…hlon Total Knee System components cleared via the following 510(k) submissions: K031729, K040267, K042883, K042993, K050539, K051146, K051380, K053514, K061521, K062037, K063423, K070095, K072221, K072575, K123166, K123486, K132624, K141056 and K143393; Triathlon PKR System cleared via K071881; Restoris MC…
Howmedica Osteonics2007—
*K070095Triathlon TS Knee System
Summary page 10
…l Knee System components cleared via the following 510(k) submissions: K031729, K040267, K042883, K042993, K050539, K051146, K051380, K053514, K061521, K062037, K063423, K070095, K072221, K072575, K123166, K123486, K132624, K141056 and K143393; Triathlon PKR System cleared via K071881; Restoris MCK System…
Howmedica Osteonics Corp.200713
*K072221Modification to Triathlon TS Knee System
Summary page 10
…stem components cleared via the following 510(k) submissions: K031729, K040267, K042883, K042993, K050539, K051146, K051380, K053514, K061521, K062037, K063423, K070095, K072221, K072575, K123166, K123486, K132624, K141056 and K143393; Triathlon PKR System cleared via K071881; Restoris MCK System cleared v…
Howmedica Osteonics Corp.2007—
*K072575Triathlon Screw-Fixation Tibial Baseplate
Summary page 10
…onents cleared via the following 510(k) submissions: K031729, K040267, K042883, K042993, K050539, K051146, K051380, K053514, K061521, K062037, K063423, K070095, K072221, K072575, K123166, K123486, K132624, K141056 and K143393; Triathlon PKR System cleared via K071881; Restoris MCK System cleared via K09076…
Stryker Orthopaedics2008—
*K123166Triathlon All-Polyethylene Condylar Stabilizing (CS) Tibial Implants Triathlon…
Summary page 10
…eared via the following 510(k) submissions: K031729, K040267, K042883, K042993, K050539, K051146, K051380, K053514, K061521, K062037, K063423, K070095, K072221, K072575, K123166, K123486, K132624, K141056 and K143393; Triathlon PKR System cleared via K071881; Restoris MCK System cleared via K090763 and K15…
Howmedica Osteonics Corp.2013—
*K123486Triathlon Tritanium Tibial Baseplate
Summary page 10
…the following 510(k) submissions: K031729, K040267, K042883, K042993, K050539, K051146, K051380, K053514, K061521, K062037, K063423, K070095, K072221, K072575, K123166, K123486, K132624, K141056 and K143393; Triathlon PKR System cleared via K071881; Restoris MCK System cleared via K090763 and K150307. De…
Stryker20137
*K132624Triathlon Tritanium Metal-Backed Patella
Summary page 10
…owing 510(k) submissions: K031729, K040267, K042883, K042993, K050539, K051146, K051380, K053514, K061521, K062037, K063423, K070095, K072221, K072575, K123166, K123486, K132624, K141056 and K143393; Triathlon PKR System cleared via K071881; Restoris MCK System cleared via K090763 and K150307. Device Desc…
Stryker Orthopaedics20131
*K141056Triathlon Knee System Posterior Stabilized Components
Summary page 10
…(k) submissions: K031729, K040267, K042883, K042993, K050539, K051146, K051380, K053514, K061521, K062037, K063423, K070095, K072221, K072575, K123166, K123486, K132624, K141056 and K143393; Triathlon PKR System cleared via K071881; Restoris MCK System cleared via K090763 and K150307. Device Description:…
Stryker Orthopaedics201411
*K143393Triathlon Tritanium Cone Augments
Summary page 10
…ons: K031729, K040267, K042883, K042993, K050539, K051146, K051380, K053514, K061521, K062037, K063423, K070095, K072221, K072575, K123166, K123486, K132624, K141056 and K143393; Triathlon PKR System cleared via K071881; Restoris MCK System cleared via K090763 and K150307. Device Description: === Page 11…
Stryker Orthopaedics20151
*K071881Triathlon PKR System
Summary page 10
…050539, K051146, K051380, K053514, K061521, K062037, K063423, K070095, K072221, K072575, K123166, K123486, K132624, K141056 and K143393; Triathlon PKR System cleared via K071881; Restoris MCK System cleared via K090763 and K150307. Device Description:…
Howmedica Osteonics Corp.20071
*K090763Restoris Multicompartmental Knee (MCK) System
Summary page 10
…1, K062037, K063423, K070095, K072221, K072575, K123166, K123486, K132624, K141056 and K143393; Triathlon PKR System cleared via K071881; Restoris MCK System cleared via K090763 and K150307. Device Description: K172326 - Page 2 of 5 The devices…
Mako Surgical Corporation20095
*K150307RESTORIS Multicompartmental Knee System
Summary page 10
…K063423, K070095, K072221, K072575, K123166, K123486, K132624, K141056 and K143393; Triathlon PKR System cleared via K071881; Restoris MCK System cleared via K090763 and K150307. Device Description: K172326 - Page 2 of 5 The devices covered by t…
Mako Surgical Corp.2015—

Also cleared against K031729: 14 other devices →

What descends from it? (24)

See all 24

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

NumberDeviceApplicantDecidedDescendants
K173849Triathlon Total Knee SystemStryker Orthopaedics201814
K190402Triathlon Total Knee System-Additional ComponentsStryker Orthopaedics (Aka Howmedica Osteonics Corp.)201911
K230952Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral ComponentHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234
K223528Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234
K242831Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon…Howmedica Osteonics Corp., Dba Stryker Orthopaedics20243
K230416Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®Stryker20233
K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20203
K180612Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial InsertsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20183
K251665Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252
K200395LOSPA II Knee System (EXULT Knee Replacement System)Corentec Co., Ltd.20202

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

Recalls of this device

DateClassRecallRoot causeReason
Mar 5, 2021Class IIZ-1379-2021Under Investigation by firmThe posterior condyle of the Specialty Triathlon TS Trial Cutting Guide(s), sizes 1 through 8, (Left and Right) has the potential to fracture at the augment cut slot. This can occur in the Trial Cutting Guide packaging during transport or…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 23 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
  • 45 of the 83 ancestors have a recall of any class.
  • Of its descendants, K173849 (Stryker Orthopaedics, 2018) has gone furthest, with 14 descendants of its own.
  • 14 other devices also cite its predicate K031729.

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. 2017, this device’s year, is highlighted.

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 (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…

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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.

The Triathlon® Tritanium® Total Knee System components are indicated for both uncemented and cemented use.

The Triathlon® Total Knee System beaded and beaded with Peri-Apatite components are intended for uncemented use only.

The Triathlon® All Polyethylene tibial components are indicated for cemented use only.

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.

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 total knee replacement or other surgical procedure, accompanied by bone loss.

Additional Indications for Cone Augments:

Severe degeneration or trauma requiring extensive resection and replacement

Femoral and Tibial bone voids

Metaphyseal reconstruction

The Triathlon TS Cone Augment components are intended for cemented or cementless use.

General Total Knee Arthroplasty (TKR) Indications:

Painful, disabling joint disease of the knee resulting from: non-inflammatory 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 General Total Knee Arthroplasty (TKR) Indications specific to the PS implant:

Ligamentous instability requiring implant bearing surface geometries with increased constraint

Absent or non-functioning posterior cruciate ligament

Severe anteroposterior instability of the knee joint

The Triathlon Tritanium Tibial Baseplates are indicated for both cemented and uncemented use.

The Triathlon Low Profile Tibial Tray is intended to be used with commercially available Triathlon® femoral components and associated patellar components, and tibial bearing inserts in primary cemented total knee arthroplasty. The indications for the Triathlon® Low Profile Tibial Tray are outlined below:

Indications for Use:

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.

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.

Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis

Revision of previous unsuccessful surgical procedures, either involving, or not involving, previous use of a unicompartmental knee prosthesis

As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis

Where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated by deficiencies of the femoral condyle/tibial plateau.

These components are intended for implantation with bone cement.

Restoris MCK is indicated for single or multi-compartmental knee replacement used in conjunction with RIO, the Robotic Arm Interactive Orthopedic System, in individuals with osteoarthritis, or post-traumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces.

The specific knee replacement configurations include:

Medial unicondylar

Lateral unicondylar

Patellofemoral

Medial bi-compartmental (medial unicondylar and patellofemoral)

Restoris Multi Compartmental Knee is for single use only and is intended for implantation with bone cement.

Indications for use as stated in the FDA summary.

Also cleared against K031729

14 other devices cite the same predicate.

  • K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics · 2026
  • K190402Triathlon Total Knee System-Additional ComponentsStryker Orthopaedics (Aka Howmedica Osteonics Corp.) · 2019
  • K180493A3 Total Knee SystemBeijing AK Medical Co., Ltd. · 2018
  • K173849Triathlon Total Knee SystemStryker Orthopaedics · 20183 recalls
  • K140222Saiph Knee SystemMatortho · 2014
  • K141056Triathlon Knee System Posterior Stabilized ComponentsStryker Orthopaedics · 201411 recalls

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https://510kreport.com/device/K172326 · printed Nov 6, 2026

Cite this page

510(k) Report. “K172326: Triathlon Total Knee System, Triathlon PKR System, Restoris MCK 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/K172326

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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