510(k) Report

510(k) · Cleared

Recalled · Class II · 2024

Triathlon Knee System Posterior Stabilized Components

K141056510(k) TraditionalCleared Aug 5, 2014103-day reviewClass II21 CFR 888.3565Recalls 11

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

Stryker Orthopaedics · MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

Cleared on Aug 5, 2014 as substantially equivalent to K031729 (Howmedica Osteonics Corp., 2003) and 14 other predicates after a 103-day review. Its family tree reaches back 5 generations to 2003. 28 later devices descend from it. It has been recalled 11 times.

Decided
Aug 5, 2014
Review
103 days
Class
Class II
Product code
MBH
Recalls
11
Predicates
17

Its longest line of descent runs back 5 generations to K031729 (2003). 29 ancestors in all, the oldest K933785 (1995). 28 later devices descend from it, 13 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2013: 1 other ancestor2008: 1 other ancestor2007: 2 other ancestors2006: 3 other ancestors2005: 3 other ancestors2004: 2 other ancestors2003: 4 other ancestors2002: 2 other ancestors1998: 1 other ancestor1997: 1 other ancestor1996: 2 other ancestors1995: 1 other ancestor1999: 1 other ancestor2025: 2 descendants cleared2024: 4 descendants cleared2019: 2 descendants cleared2023: 3 descendants cleared2020: 6 descendants cleared2018: 3 descendants cleared2017: 1 descendant cleared2026: 4 descendants cleared2022: 2 descendants cleared2021: 1 descendant 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. · 2007K123166 · Triathlon All-Polyethylene Condylar Stabilizing (CS) Tibial Implants Triathlon All-Polyethylene Posterior Stabilizing (P · Howmedica Osteonics Corp. · 20131995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 10 other ancestors2 generations back: 9 other ancestors3 generations back: 1 other ancestor4 generations back: 3 other ancestors5 generations back: 1 other ancestor 1 generation forward: 13 descendants2 generations forward: 7 descendants3 generations forward: 7 descendants4 generations forward: 1 descendant K123166 · Triathlon All-Polyethylene Condylar Stabilizing (CS) Tibial Implants Triathlon All-Polyethylene Posterior Stabilizing (P · Howmedica Osteonics Corp. · 2013K072221 · 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 · recalled−50
  1. Root · 5 generations backK031729 Triathlon Posteriorly Stabilized (PS) Total Knee SystemHowmedica Osteonics Corp. · 2003 · Recalled
  2. 4 generations backK042993 Triathlon Posteriorly Stabilized (PS) Femoral ComponentHowmedica Osteonics Corp. · 2005 · Recalled
  3. 3 generations backK070095 Triathlon TS Knee SystemHowmedica Osteonics Corp. · 2007 · Recalled
  4. 2 generations backK072221 Modification to Triathlon TS Knee SystemHowmedica Osteonics Corp. · 2007
  5. 1 generation backK123166 Triathlon All-Polyethylene Condylar Stabilizing (CS) Tibial Implants…Howmedica Osteonics Corp. · 2013
  6. This deviceK141056 Triathlon Knee System Posterior Stabilized ComponentsStryker Orthopaedics · 2014
  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 · cites it directly · 14 of its ownK173849 Triathlon Total Knee SystemStryker Orthopaedics · 2018 · Recalled
  9. Descendant · cites it directly · 11 of its ownK190402 Triathlon Total Knee System-Additional ComponentsStryker Orthopaedics (Aka Howmedica Osteonics Corp.) · 2019
  10. Descendant · cites it directly · 4 of its ownK230952 Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023
  11. Descendant · cites it directly · 4 of its ownK223528 Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023 · Recalled

Showing 5 of 28 descendants. See all descendants

Descendants cleared per year

2017: 12018: 32019: 22020: 62021: 12022: 22023: 32024: 42025: 22026: 4
2017high 6 (2020) · low 1 (2017)2026

Most influential descendants

Showing 5 of 28 · See all
  • K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics · 2017 · cites it directly24descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K031729Triathlon Posteriorly Stabilized (PS) Total Knee SystemHowmedica Osteonics Corp.20033
−4K042993Triathlon Posteriorly Stabilized (PS) Femoral ComponentHowmedica Osteonics Corp.20051
−3K070095Triathlon TS Knee SystemHowmedica Osteonics Corp.200713
−2K072221Modification to Triathlon TS Knee SystemHowmedica Osteonics Corp.2007—
−1K123166Triathlon All-Polyethylene Condylar Stabilizing (CS) Tibial Implants Triathlon…Howmedica Osteonics Corp.2013—
0 (this device)K141056Triathlon Knee System Posterior Stabilized ComponentsStryker Orthopaedics2014—
+1K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics20171
+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

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
199620
199710
199810
199910
200220
200340
200420
200530
200630
200720
200810
201310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
201830
201920
202060
202110
202220
202330
202440
202520
202640
FIG. 1 — Lineage of K141056, 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 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. #1 K241597 Freedom® Total Knee System - Porous Tibial…score 19.9 · 8 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? (17)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
*K031729Triathlon Posteriorly Stabilized (PS) Total Knee System
Summary page 8
…MBH, JWH Legally Marketed Device to Which Substantial Equivalence is Claimed: Triathlon Knee System components cleared via the following 510(k) submissions: K031729, K042067, K042883, K042993, K050539, K051146, K051380, K053514, K061521, K062037, K063423, K070095, K072221, K072575, K123166, K1…
Howmedica Osteonics Corp.20033
Kept off the family treeK042067Triathlon Knee System components
Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree
Summary page 8
…MBH, JWH Legally Marketed Device to Which Substantial Equivalence is Claimed: Triathlon Knee System components cleared via the following 510(k) submissions: K031729, K042067, K042883, K042993, K050539, K051146, K051380, K053514, K061521, K062037, K063423, K070095, K072221, K072575, K123166, K123486, an…
*K042883Size 1 Triathlon Cruciate Retaining (CR) Tibial Insert
Summary page 8
…WH Legally Marketed Device to Which Substantial Equivalence is Claimed: Triathlon Knee System components cleared via the following 510(k) submissions: K031729, K042067, K042883, K042993, K050539, K051146, K051380, K053514, K061521, K062037, K063423, K070095, K072221, K072575, K123166, K123486, and K13262.…
Howmedica Osteonics Corp.2004—
*K042993Triathlon Posteriorly Stabilized (PS) Femoral Component
Summary page 8
…ly Marketed Device to Which Substantial Equivalence is Claimed: Triathlon Knee System components cleared via the following 510(k) submissions: K031729, K042067, K042883, K042993, K050539, K051146, K051380, K053514, K061521, K062037, K063423, K070095, K072221, K072575, K123166, K123486, and K13262. Device…
Howmedica Osteonics Corp.20051
*K050539Size 1 Triathlon Posterior Stabilized (PS) Tibial Insert
Summary page 8
…ed Device to Which Substantial Equivalence is Claimed: Triathlon Knee System components cleared via the following 510(k) submissions: K031729, K042067, K042883, K042993, K050539, K051146, K051380, K053514, K061521, K062037, K063423, K070095, K072221, K072575, K123166, K123486, and K13262. Device Descripti…
Howmedica Osteonics Corp.2005—
*K051146Triathlon Knee System
Summary page 8
…to Which Substantial Equivalence is Claimed: Triathlon Knee System components cleared via the following 510(k) submissions: K031729, K042067, K042883, K042993, K050539, K051146, K051380, K053514, K061521, K062037, K063423, K070095, K072221, K072575, K123166, K123486, and K13262. Device Description: The…
Howmedica Osteonics Corp.20053
*K051380Triathlon Press-Fit Total Knee System
Summary page 8
…Substantial Equivalence is Claimed: Triathlon Knee System components cleared via the following 510(k) submissions: K031729, K042067, K042883, K042993, K050539, K051146, K051380, K053514, K061521, K062037, K063423, K070095, K072221, K072575, K123166, K123486, and K13262. Device Description: The devices c…
Howmedica Osteonics Corp.20051
*K053514Triathlon Total Knee System
Summary page 8
…ial Equivalence is Claimed: Triathlon Knee System components cleared via the following 510(k) submissions: K031729, K042067, K042883, K042993, K050539, K051146, K051380, K053514, K061521, K062037, K063423, K070095, K072221, K072575, K123166, K123486, and K13262. Device Description: The devices covered by…
Stryker Orthopaedics20062
*K061521Triathlon Metal Backed Patella
Summary page 8
…alence is Claimed: Triathlon Knee System components cleared via the following 510(k) submissions: K031729, K042067, K042883, K042993, K050539, K051146, K051380, K053514, K061521, K062037, K063423, K070095, K072221, K072575, K123166, K123486, and K13262. Device Description: The devices covered by this sub…
Howmedica Osteonics Corp.2006—
*K062037Triathlon Low Profile Tibial Tray
Summary page 8
…Claimed: Triathlon Knee System components cleared via the following 510(k) submissions: K031729, K042067, K042883, K042993, K050539, K051146, K051380, K053514, K061521, K062037, K063423, K070095, K072221, K072575, K123166, K123486, and K13262. Device Description: The devices covered by this submission i…
Howmedica Osteonics Corp.2006—
*K063423Triathlon CS (Condylar Stabilizing) Lipped Insert
Summary page 8
…Triathlon Knee System components cleared via the following 510(k) submissions: K031729, K042067, K042883, K042993, K050539, K051146, K051380, K053514, K061521, K062037, K063423, K070095, K072221, K072575, K123166, K123486, and K13262. Device Description: The devices covered by this submission include fe…
Howmedica Osteonics2007—
*K070095Triathlon TS Knee System
Summary page 8
…n Knee System components cleared via the following 510(k) submissions: K031729, K042067, K042883, K042993, K050539, K051146, K051380, K053514, K061521, K062037, K063423, K070095, K072221, K072575, K123166, K123486, and K13262. Device Description: The devices covered by this submission include femoral com…
Howmedica Osteonics Corp.200713
*K072221Modification to Triathlon TS Knee System
Summary page 8
…stem components cleared via the following 510(k) submissions: K031729, K042067, K042883, K042993, K050539, K051146, K051380, K053514, K061521, K062037, K063423, K070095, K072221, K072575, K123166, K123486, and K13262. Device Description: The devices covered by this submission include femoral components,…
Howmedica Osteonics Corp.2007—
*K072575Triathlon Screw-Fixation Tibial Baseplate
Summary page 8
…onents cleared via the following 510(k) submissions: K031729, K042067, K042883, K042993, K050539, K051146, K051380, K053514, K061521, K062037, K063423, K070095, K072221, K072575, K123166, K123486, and K13262. Device Description: The devices covered by this submission include femoral components, tibial ba…
Stryker Orthopaedics2008—
*K123166Triathlon All-Polyethylene Condylar Stabilizing (CS) Tibial Implants Triathlon…
Summary page 8
…eared via the following 510(k) submissions: K031729, K042067, K042883, K042993, K050539, K051146, K051380, K053514, K061521, K062037, K063423, K070095, K072221, K072575, K123166, K123486, and K13262. Device Description: The devices covered by this submission include femoral components, tibial baseplates,…
Howmedica Osteonics Corp.2013—
*K123486Triathlon Tritanium Tibial Baseplate
Summary page 8
…the following 510(k) submissions: K031729, K042067, K042883, K042993, K050539, K051146, K051380, K053514, K061521, K062037, K063423, K070095, K072221, K072575, K123166, K123486, and K13262. Device Description: The devices covered by this submission include femoral components, tibial baseplates, tibial i…
Stryker20137
Kept off the family treeK132626FDA’s K132626 is Pipeline Total Hip System (Line Extension)
Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
Pipeline Biotechnology2013—

Also cleared against K031729: 14 other devices →

What descends from it? (28)

See all 28

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

NumberDeviceApplicantDecidedDescendants
K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics201724
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
K230416Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®Stryker20233
K251665Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252
K181061Corin Optimized Positioning System (OPS) FemoralCorin USA20181
K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics20260
K252898Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella…Howmedica Osteonics Corp., Dba Stryker Orthopaedics20250

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

Recalls of this device

DateClassRecallRoot causeReason
Sep 4, 2024Class IIZ-0023-2025Process controlAnterior locking tabs on the Triathlon Universal Baseplate are out of specification which may prevent engagement of either of the two locking tabs with the locking wire of the tibial insert.
Jul 1, 2021Class IIZ-2329-2021Under Investigation by firmThe internal profile of the Triathlon Prim (Baseplate) is potentially oversized; there may be a witness mark (taper) at the bottom of the internal profile of the baseplate, which prevents the insert from locking on the baseplate.
Feb 10, 2021Class IIZ-1186-2021Under Investigation by firmStryker has discovered that the internal profile of the Triathlon Tritanium Tibial Component (Baseplate), size 4, is potentially oversized. Due to a manufacturing issue in Lot Number CTD44301, there may be a witness mark (taper) at the…
Aug 19, 2019Class IIZ-2758-2019Device DesignDue to device overhang issue that protrudes beyond the medial periphery of the mating femoral component
Aug 19, 2019Class IIZ-2757-2019Device DesignDue to device overhang issue that protrudes beyond the medial periphery of the mating femoral component
Aug 19, 2019Class IIZ-2760-2019Device DesignDue to device overhang issue that protrudes beyond the medial periphery of the mating femoral component
Aug 19, 2019Class IIZ-2759-2019Device DesignDue to device overhang issue that protrudes beyond the medial periphery of the mating femoral component
Jan 30, 2018Class IIZ-1462-2018Under Investigation by firmCustomers may receive the incorrect size implant from what is labeled on the box.
Jan 12, 2018Class IIZ-1512-2018Error in labelingFirm became aware that the specific product/lot combinations referenced above may contain the incorrect size implant from what is labeled on the box.
May 29, 2015Class IIZ-2389-2015Labeling mix-upsStryker has received a report which identified that a Triathlon Tibial Bearing Insert CS X3 Size #2 9mm (5531-G-209) was reported to be in a pack that was labelled as a CR insert (5530-G-209).
May 29, 2015Class IIZ-2360-2015Under Investigation by firmStryker Orthopaedics received a report that 5537-G-319 No 3. Triathlon TS Plus Tibial Insert X3 Poly 19 mm i insert was in a package labeled as a 5532-G-511 Triathlon PS Stibialism Insert.

The 5 latest of 11 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
  • 19 of the 29 ancestors have a recall of any class.
  • Of its descendants, K172326 (Stryker Orthopaedics, 2017) has gone furthest, with 24 descendants of its own.
  • 14 other devices also cite its predicate K031729.

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. 2014, this device’s year, is highlighted.

FDA decisions per year · MBH

8in 2025

2007: 102008: 32009: 32010: 42011: 52012: 52013: 62014: 92015: 82016: 42017: 42018: 62019: 12020: 72021: 62022: 72023: 62024: 102025: 82026 (partial year): 7
2007high 10 (2007) · low 1 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MBH

98in 2025

2007: 59 days median2008: 70 days median2009: 209 days median2010: 84 days median2011: 84 days median2012: 90 days median2013: 138 days median2014: 114 days median2015: 100 days median2016: 74 days median2017: 115 days median2018: 89 days median2020: 112 days median2021: 48 days median2022: 57 days median2023: 94 days median2024: 84 days median2025: 98 days median2026 (partial year): 153 days median
2007high 209 (2009) · low 48 (2021)2026

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

Recalls per year · MBH

1in 2024

2009: 22011: 152012: 1, 1 Class I2013: 4, 4 Class I2016: 12017: 92018: 12019: 12020: 22023: 22024: 12026 (partial year): 4
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

2007: 272008: 212009: 892010: 1212011: 2472012: 3702013: 3082014: 3852015: 9552016: 1,0342017: 1,0072018: 1,1912019: 1,3942020: 1,0892021: 1,5392022: 1,2612023: 1,2632024: 1,4972025: 1,561
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071059027
2008370021
20093209289
20104840121
201158415247
20125901 (1)370
201361384 (4)308
201491140385
201581000955
201647411,034
2017411591,007
201868911,191
20191—11,394
2020711221,089
202164801,539
202275701,261
202369421,263
2024108411,497
202589801,561
202671534—

What is it indicated for?

General Total Knee Arthroplasty (TKA) 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…

Read the full statement (503 words)

General Total Knee Arthroplasty (TKA) 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.

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.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

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
  • K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics · 20171 recall
  • K140222Saiph Knee SystemMatortho · 2014

More from Stryker Orthopaedics

24 FDA decisions under this applicant name. See the company

  • K211703Insignia Hip StemStryker Orthopaedics · 2021
  • 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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https://510kreport.com/device/K141056 · printed Nov 6, 2026

Cite this page

510(k) Report. “K141056: Triathlon Knee System Posterior Stabilized Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141056

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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