510(k) Report

510(k) · Cleared

Cleared

Triathlon All-Polyethylene Condylar Stabilizing (CS) Tibial Implants Triathlon All-Polyethylene Posterior Stabilizing (P

K123166510(k) TraditionalCleared Feb 14, 2013128-day reviewClass II21 CFR 888.3560

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

Howmedica Osteonics Corp. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Feb 14, 2013 as substantially equivalent to K063423 (Howmedica Osteonics, 2007) and 6 other predicates after a 128-day review. Its family tree reaches back 4 generations to 2003. 33 later devices descend from it.

Decided
Feb 14, 2013
Review
128 days
Class
Class II
Product code
JWH
Recalls
None
Predicates
7

Its longest line of descent runs back 4 generations to K031729 (2003). 16 ancestors in all, the oldest K962152 (1996). 33 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2007: 1 other ancestor2005: 2 other ancestors1998: 1 other ancestor1996: 1 other ancestor2004: 2 other ancestors2003: 2 other ancestors2002: 1 other ancestor2006: 1 other ancestor1997: 1 other ancestor2014: 1 descendant cleared2015: 1 descendant cleared2017: 1 descendant cleared2026: 4 descendants cleared2025: 3 descendants cleared2024: 4 descendants cleared2019: 3 descendants cleared2023: 3 descendants cleared2020: 6 descendants cleared2018: 3 descendants cleared2022: 2 descendants cleared2021: 2 descendants clearedK031729 · Triathlon Posteriorly Stabilized (PS) Total Knee System · Howmedica Osteonics Corp. · 2003 · recalledK042993 · Triathlon Posteriorly Stabilized (PS) Femoral Component · Howmedica Osteonics Corp. · 2005 · recalledK070095 · Triathlon TS Knee System · Howmedica Osteonics Corp. · 2007 · recalledK072221 · Modification to Triathlon TS Knee System · Howmedica Osteonics Corp. · 20071995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 6 other ancestors3 generations back: 2 other ancestors 1 generation forward: 4 descendants2 generations forward: 17 descendants3 generations forward: 10 descendants4 generations forward: 2 descendants K072221 · Modification to Triathlon TS Knee System · Howmedica Osteonics Corp. · 2007K070095 · Triathlon TS Knee System · Howmedica Osteonics Corp. · 2007 · recalledK042993 · Triathlon Posteriorly Stabilized (PS) Femoral Component · Howmedica Osteonics Corp. · 2005 · recalledK031729 · Triathlon Posteriorly Stabilized (PS) Total Knee System · Howmedica Osteonics Corp. · 2003 · recalled0
  1. Root · 4 generations backK031729 Triathlon Posteriorly Stabilized (PS) Total Knee SystemHowmedica Osteonics Corp. · 2003 · Recalled
  2. 3 generations backK042993 Triathlon Posteriorly Stabilized (PS) Femoral ComponentHowmedica Osteonics Corp. · 2005 · Recalled
  3. 2 generations backK070095 Triathlon TS Knee SystemHowmedica Osteonics Corp. · 2007 · Recalled
  4. 1 generation backK072221 Modification to Triathlon TS Knee SystemHowmedica Osteonics Corp. · 2007
  5. This deviceK123166 Triathlon All-Polyethylene Condylar Stabilizing (CS) Tibial Implants…Howmedica Osteonics Corp. · 2013
  6. Descendant · cites it directly · 28 of its ownK141056 Triathlon Knee System Posterior Stabilized ComponentsStryker Orthopaedics · 2014 · Recalled
  7. Descendant · cites it directly · 24 of its ownK172326 Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee…Stryker Orthopaedics · 2017 · Recalled
  8. Descendant · 2 generations on · 14 of its ownK173849 Triathlon Total Knee SystemStryker Orthopaedics · 2018 · Recalled
  9. Descendant · 2 generations on · 11 of its ownK190402 Triathlon Total Knee System-Additional ComponentsStryker Orthopaedics (Aka Howmedica Osteonics Corp.) · 2019
  10. Descendant · 2 generations on · 4 of its ownK230952 Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023

Showing 5 of 33 descendants. See all descendants

Descendants cleared per year

2014: 12015: 12017: 12018: 32019: 32020: 62021: 22022: 22023: 32024: 42025: 32026: 4
2014high 6 (2020) · low 0 (2016)2026

Most influential descendants

Showing 5 of 33 · See all
  • 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
  • K230952Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral ComponentHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023 · 2 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K031729Triathlon Posteriorly Stabilized (PS) Total Knee SystemHowmedica Osteonics Corp.20033
−3K042993Triathlon Posteriorly Stabilized (PS) Femoral ComponentHowmedica Osteonics Corp.20051
−2K070095Triathlon TS Knee SystemHowmedica Osteonics Corp.200713
−1K072221Modification to Triathlon TS Knee SystemHowmedica Osteonics Corp.2007—
0 (this device)K123166Triathlon All-Polyethylene Condylar Stabilizing (CS) Tibial Implants Triathlon…Howmedica Osteonics Corp.2013—
+1K141056Triathlon Knee System Posterior Stabilized ComponentsStryker Orthopaedics201411
+1K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics20171
+2K173849Triathlon Total Knee SystemStryker Orthopaedics20183
+2K190402Triathlon Total Knee System-Additional ComponentsStryker Orthopaedics (Aka Howmedica Osteonics Corp.)2019—
+2K230952Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS)…Howmedica Osteonics Corp., Dba Stryker Orthopaedics2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
199710
199810
200210
200320
200420
200520
200610
200710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201510
201710
201830
201930
202060
202120
202220
202330
202440
202530
202640
FIG. 1 — Lineage of K123166, 2003–2026Source: 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? (7)

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
*K063423Triathlon CS (Condylar Stabilizing) Lipped Insert
Summary page 1
…cemented, polymer/metal/polymer Legally Marketed Device to Which Substantial Equivalence is Claimed: Triathlon'- Condylar Stabilizing (CS) Lipped Insert: K063423 Triathlont Posterior Stabilized (PS) Total Knee System: K050539, K042993 and K03 1729 Scorpio® Posterior Cruciate Retaining (CR)…
Howmedica Osteonics2007—
*K050539Size 1 Triathlon Posterior Stabilized (PS) Tibial Insert
Summary page 1
…Device to Which Substantial Equivalence is Claimed: Triathlon'- Condylar Stabilizing (CS) Lipped Insert: K063423 Triathlont Posterior Stabilized (PS) Total Knee System: K050539, K042993 and K03 1729 Scorpio® Posterior Cruciate Retaining (CR) Total Knee System All-Poly Tibia: K974556 Scorpio®D Posteriorly…
Howmedica Osteonics Corp.2005—
*K042993Triathlon Posteriorly Stabilized (PS) Femoral Component
Summary page 1
…o Which Substantial Equivalence is Claimed: Triathlon'- Condylar Stabilizing (CS) Lipped Insert: K063423 Triathlont Posterior Stabilized (PS) Total Knee System: K050539, K042993 and K03 1729 Scorpio® Posterior Cruciate Retaining (CR) Total Knee System All-Poly Tibia: K974556 Scorpio®D Posteriorly Stabilize…
Howmedica Osteonics Corp.20051
*K031729Triathlon Posteriorly Stabilized (PS) Total Knee System
Summary page 1
…tantial Equivalence is Claimed: Triathlon'- Condylar Stabilizing (CS) Lipped Insert: K063423 Triathlont Posterior Stabilized (PS) Total Knee System: K050539, K042993 and K03 1729 Scorpio® Posterior Cruciate Retaining (CR) Total Knee System All-Poly Tibia: K974556 Scorpio®D Posteriorly Stabilized (PS) Total…
Howmedica Osteonics Corp.20033
*K974556Osteonics Scorpio Posterior Cruciate Retaining Total Knee System
Summary page 1
…063423 Triathlont Posterior Stabilized (PS) Total Knee System: K050539, K042993 and K03 1729 Scorpio® Posterior Cruciate Retaining (CR) Total Knee System All-Poly Tibia: K974556 Scorpio®D Posteriorly Stabilized (PS) Total Knee System All Poly Tibia: K962 152 Triathlon® TS Knee System: K072221 Device Descr…
Osteonics Corp.19987
*K962152Osteonics Scorpio Posteriorly Stabilized Total Knee System
Summary page 1
…and K03 1729 Scorpio® Posterior Cruciate Retaining (CR) Total Knee System All-Poly Tibia: K974556 Scorpio®D Posteriorly Stabilized (PS) Total Knee System All Poly Tibia: K962 152 Triathlon® TS Knee System: K072221 Device Description: The subject devices are a line extension to the Triathlon" Total Knee Sys…
Osteonics Corp.199613
*K072221Modification to Triathlon TS Knee System
Summary page 1
…iate Retaining (CR) Total Knee System All-Poly Tibia: K974556 Scorpio®D Posteriorly Stabilized (PS) Total Knee System All Poly Tibia: K962 152 Triathlon® TS Knee System: K072221 Device Description: The subject devices are a line extension to the Triathlon" Total Knee System (K063423, K050539, K042993 and…
Howmedica Osteonics Corp.2007—

Also cleared against K063423: 9 other devices →

What descends from it? (33)

See all 33

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

NumberDeviceApplicantDecidedDescendants
K141056Triathlon Knee System Posterior Stabilized ComponentsStryker Orthopaedics201428
K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics201724
K143443VEGA Knee System, Columbus Total Knee SystemAesculap Implants Systems, LLC20153
K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics20260

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 10 years and passes through 1 company; a new generation was cleared every 2.4 years on median.
  • 10 of the 16 ancestors have a recall of any class.
  • Of its descendants, K141056 (Stryker Orthopaedics, 2014) has gone furthest, with 28 descendants of its own.
  • 9 other devices also cite its predicate K063423.

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. 2013, 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: non-inflammatory 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…

Read the full statement (139 words)

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), 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 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 All Polyethylene tibial components are indicated for cemented use only.

Indications for use as stated in the FDA summary.

Also cleared against K063423

9 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
  • K183533Unity Total Knee SystemCorin U.S.A. Limited · 2019
  • K173849Triathlon Total Knee SystemStryker Orthopaedics · 20183 recalls
  • K172634Triathlon® X3® UHMWPE Tibial Inserts and Patellar ComponentsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 20177 recalls
  • K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics · 20171 recall

More from Howmedica Osteonics Corp.

319 FDA decisions under this applicant name. See the company

  • P000013/S027Trident Alumina Insert (625-0T-XXX); Osteonics® ABC/Trident® SystemHowmedica Osteonics Corp. · 2025
  • P000013/S026Trident Acetabular System: Trident Alumina InsertsHowmedica Osteonics Corp. · 2025
  • P000013/S025Trident® Acetabular SystemHowmedica Osteonics Corp. · 2024
  • P000013/S024Trident (R), ABC (R)Howmedica Osteonics Corp. · 2024
  • P000013/S021Trident Ceramic SystemHowmedica Osteonics Corp. · 2023

Recent decisions in JWH

The JWH category page

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  • K260063GSPE SpacerThe General Hospital Corporation, d/b/a Massachusetts · 2026
  • 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
  • K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc. · 2026

https://510kreport.com/device/K123166 · printed Nov 3, 2026

Cite this page

510(k) Report. “K123166: Triathlon All-Polyethylene Condylar Stabilizing (CS) Tibial Implants Triathlon All-Polyethylene Posterior Stabilizing (P.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K123166

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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