510(k) Report

510(k) · Cleared

Cleared

Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System

K261898510(k) TraditionalCleared Aug 6, 202662-day reviewClass II21 CFR 888.3510

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

Howmedica Osteonics Corp. dba Stryker Orthopaedics · KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer

Cleared on Aug 6, 2026 as substantially equivalent to K242831 (Howmedica Osteonics Corp., Dba Stryker Orthopaedics, 2024) and 18 other predicates after a 62-day review. Its family tree reaches back 17 generations to 1994.

Decided
Aug 6, 2026
Review
62 days
Class
Class II
Product code
KRO
Recalls
None
Predicates
19

Its longest line of descent runs back 17 generations to K941847 (1994). 275 ancestors in all, the oldest K810258 (1981). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2025: 2 other ancestors2024: 1 other ancestor2023: 5 other ancestors2018: 2 other ancestors2017: 2 other ancestors2014: 2 other ancestors2013: 5 other ancestors2007: 16 other ancestors2005: 18 other ancestors2004: 16 other ancestors2003: 18 other ancestors2001: 14 other ancestors2021: 1 other ancestor2019: 1 other ancestor2015: 2 other ancestors2009: 3 other ancestors2008: 7 other ancestors2006: 11 other ancestors2002: 16 other ancestors2000: 14 other ancestors1998: 9 other ancestors1996: 13 other ancestors2012: 5 other ancestors2010: 6 other ancestors1999: 6 other ancestors1997: 11 other ancestors1995: 14 other ancestors1993: 5 other ancestors1992: 6 other ancestors1991: 5 other ancestors1990: 2 other ancestors1981: 2 other ancestors2011: 1 other ancestor1994: 11 other ancestors1988: 1 other ancestor1987: 2 other ancestors1984: 1 other ancestor1985: 1 other ancestorReference device: K252898 · Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge Bumper · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025 · recalledK941847 · 5/8 Porocoat Aml Hip Porocoat Porous Coating · Depuy, Inc. · 1994K964650 · TCP-Coated Porocoat Aml Femoral Hip Prosthesis · Depuy, Inc. · 1997K980711 · Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating · Zimmer, Inc. · 1998 · recalledK001277 · Triflange Acetabular Cup System · DePuy Orthopaedics, Inc. · 2000K031495 · Pinnacle Duofix HA Acetabular Cup Prosthesis · DePuy Orthopaedics, Inc. · 2003K042344 · Excia Total Hip System · Aesculap, Inc. · 2005 · recalledK070981 · Search Evolution (LC) Total Knee System (Plasmapore) · Aesculap Implant Systems, Inc. · 2007K081023 · Evolis Total Knee System · Medacta International S.A. · 2008 · recalledK090988 · GMK Total Knee System · Medacta International S.A. · 2009 · recalledK102437 · GMK Revision Knee System · Medacta International S.A. · 2010K103170 · GMK Revision Knee SC Liners · Medacta International S.A. · 2011×2: 2 generations cleared close together, K113571 (2012), K121416 (2012) K140826 · GMK Sphere Extension · Medacta International · 2014K162035 · GMK Sphere · Medacta International S.A. · 2017K173890 · GMK Sphere - Kinematic Alignment · Medacta International S.A. · 2018K201343 · Triathlon Total KneeSystem · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 202019801990200020102020
Other ancestors, by generation 1 generation back: 18 other ancestors2 generations back: 34 other ancestors3 generations back: 27 other ancestors4 generations back: 31 other ancestors5 generations back: 44 other ancestors6 generations back: 33 other ancestors7 generations back: 24 other ancestors8 generations back: 22 other ancestors9 generations back: 16 other ancestors10 generations back: 8 other ancestors K201343 · Triathlon Total KneeSystem · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2020K173890 · GMK Sphere - Kinematic Alignment · Medacta International S.A. · 2018K162035 · GMK Sphere · Medacta International S.A. · 2017K140826 · GMK Sphere Extension · Medacta International · 2014K121416 · GMK Sphere · Medacta International · 2012K113571 · GMK Resufacing Patella Size 4 · Medacta International · 2012K103170 · GMK Revision Knee SC Liners · Medacta International S.A. · 2011K102437 · GMK Revision Knee System · Medacta International S.A. · 2010K090988 · GMK Total Knee System · Medacta International S.A. · 2009 · recalledK081023 · Evolis Total Knee System · Medacta International S.A. · 2008 · recalledK070981 · Search Evolution (LC) Total Knee System (Plasmapore) · Aesculap Implant Systems, Inc. · 2007K042344 · Excia Total Hip System · Aesculap, Inc. · 2005 · recalledK031495 · Pinnacle Duofix HA Acetabular Cup Prosthesis · DePuy Orthopaedics, Inc. · 2003K001277 · Triflange Acetabular Cup System · DePuy Orthopaedics, Inc. · 2000K980711 · Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating · Zimmer, Inc. · 1998 · recalledK964650 · TCP-Coated Porocoat Aml Femoral Hip Prosthesis · Depuy, Inc. · 1997K941847 · 5/8 Porocoat Aml Hip Porocoat Porous Coating · Depuy, Inc. · 1994−15−10−50
  1. Root · 17 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
  2. 13 generations between
  3. 3 generations backK162035 GMK SphereMedacta International S.A. · 2017
  4. 2 generations backK173890 GMK Sphere - Kinematic AlignmentMedacta International S.A. · 2018
  5. 1 generation backK201343 Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2020
  6. This deviceK261898 Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total…Howmedica Osteonics Corp. dba Stryker Orthopaedics · 2026
Show all 17 generations
  1. Root · 17 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
  2. 16 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
  3. 15 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
  4. 14 generations backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
  5. 13 generations backK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
  6. 12 generations backK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
  7. 11 generations backK070981 Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc. · 2007
  8. 10 generations backK081023 Evolis Total Knee SystemMedacta International S.A. · 2008 · Recalled
  9. 9 generations backK090988 GMK Total Knee SystemMedacta International S.A. · 2009 · Recalled
  10. 8 generations backK102437 GMK Revision Knee SystemMedacta International S.A. · 2010
  11. 7 generations backK103170 GMK Revision Knee SC LinersMedacta International S.A. · 2011
  12. 6 generations backK113571 GMK Resufacing Patella Size 4Medacta International · 2012
  13. 5 generations backK121416 GMK SphereMedacta International · 2012
  14. 4 generations backK140826 GMK Sphere ExtensionMedacta International · 2014
  15. 3 generations backK162035 GMK SphereMedacta International S.A. · 2017
  16. 2 generations backK173890 GMK Sphere - Kinematic AlignmentMedacta International S.A. · 2018
  17. 1 generation backK201343 Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2020
  18. This deviceK261898 Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total…Howmedica Osteonics Corp. dba Stryker Orthopaedics · 2026
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−17K9418475/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc.1994—
−16K964650TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc.1997—
−15K980711Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic CoatingZimmer, Inc.19981
−14K001277Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc.2000—
−13K031495Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc.2003—
−12K042344Excia Total Hip SystemAesculap, Inc.200510
−11K070981Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc.2007—
−10K081023Evolis Total Knee SystemMedacta International S.A.20081
−9K090988GMK Total Knee SystemMedacta International S.A.20091
−8K102437GMK Revision Knee SystemMedacta International S.A.2010—
−7K103170GMK Revision Knee SC LinersMedacta International S.A.2011—
−6K113571GMK Resufacing Patella Size 4Medacta International2012—
−5K121416GMK SphereMedacta International2012—
−4K140826GMK Sphere ExtensionMedacta International2014—
−3K162035GMK SphereMedacta International S.A.2017—
−2K173890GMK Sphere - Kinematic AlignmentMedacta International S.A.2018—
−1K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics2020—
0 (this device)K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198120
198410
198510
198720
198810
199020
199150
199260
199350
1994110
1995140
1996130
1997110
199890
199960
2000140
2001140
2002160
2003180
2004160
2005180
2006110
2007160
200870
200930
201060
201110
201250
201350
201420
201520
201720
201820
201910
202110
202350
202410
202520
FIG. 1 — Lineage of K261898, 1994–2026Source: 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 KRO? 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 KRO device

  1. #1 K251665 Triathlon® Hinge Knee Systemscore 19.0 · 12 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? (19)

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
*K242831Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon…
Summary page 9
…8 K261898 Subsequent Product Codes: JWH, MBH Legally Marketed Primary Predicate Device to Which Substantial Equivalence is Claimed: Primary predicate: K242831 Device Name: Triathlon Knee System Product Code: JWH Legally Marketed Additional Predicate Device Used to Support Substantial Eq…
Howmedica Osteonics Corp., Dba Stryker Orthopaedics2024—
*K040267Triathlon Cruciate Retaining (CR) Total Knee
Summary page 9
…Triathlon® Knee System Tibial Inserts Triathlon Tibial Bearing Insert - CR ® K040267 K042883 K141056 K172326 K173849 (Cruciate Retaining Insert) K201343 K242831 Triathlon Tibial Bearing Insert - CS…
Howmedica Osteonics Corp.20041
*K042883Size 1 Triathlon Cruciate Retaining (CR) Tibial Insert
Summary page 9
…thlon® Knee System Tibial Inserts Triathlon Tibial Bearing Insert - CR ® K040267 K042883 K141056 K172326 K173849 (Cruciate Retaining Insert) K201343 K242831 Triathlon Tibial Bearing Insert - CS ®…
Howmedica Osteonics Corp.2004—
*K141056Triathlon Knee System Posterior Stabilized Components
Summary page 9
…nee System Tibial Inserts Triathlon Tibial Bearing Insert - CR ® K040267 K042883 K141056 K172326 K173849 (Cruciate Retaining Insert) K201343 K242831 Triathlon Tibial Bearing Insert - CS ®…
Stryker Orthopaedics201411
*K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System
Summary page 9
…em Tibial Inserts Triathlon Tibial Bearing Insert - CR ® K040267 K042883 K141056 K172326 K173849 (Cruciate Retaining Insert) K201343 K242831 Triathlon Tibial Bearing Insert - CS ®…
Stryker Orthopaedics20171
*K173849Triathlon Total Knee System
Summary page 9
…Tibial Inserts Triathlon Tibial Bearing Insert - CR ® K040267 K042883 K141056 K172326 K173849 (Cruciate Retaining Insert) K201343 K242831 Triathlon Tibial Bearing Insert - CS ®…
Stryker Orthopaedics20183
*K201343Triathlon Total KneeSystem
Summary page 9
…s Triathlon Tibial Bearing Insert - CR ® K040267 K042883 K141056 K172326 K173849 (Cruciate Retaining Insert) K201343 K242831 Triathlon Tibial Bearing Insert - CS ® K063423 K141056 K172326 K173849…
Howmedica Osteonics Corp., Dba Stryker Orthopaedics2020—
*K063423Triathlon CS (Condylar Stabilizing) Lipped Insert
Summary page 9
…3 K141056 K172326 K173849 (Cruciate Retaining Insert) K201343 K242831 Triathlon Tibial Bearing Insert - CS ® K063423 K141056 K172326 K173849 K201343 (Condylar Stabilizing Insert) K242831 Triathlon Tibial Bearing Insert - PS ®…
Howmedica Osteonics2007—
*K031729Triathlon Posteriorly Stabilized (PS) Total Knee System
Summary page 9
…3 K141056 K172326 K173849 K201343 (Condylar Stabilizing Insert) K242831 Triathlon Tibial Bearing Insert - PS ® K031729 K050539 K141056 K173849 K172326 (Posterior Stabilized Insert) K201343 K242831 Triathlon All Poly Tibial Component - K12…
Howmedica Osteonics Corp.20033
*K050539Size 1 Triathlon Posterior Stabilized (PS) Tibial Insert
Summary page 9
…6 K172326 K173849 K201343 (Condylar Stabilizing Insert) K242831 Triathlon Tibial Bearing Insert - PS ® K031729 K050539 K141056 K173849 K172326 (Posterior Stabilized Insert) K201343 K242831 Triathlon All Poly Tibial Component - K123166 K14…
Howmedica Osteonics Corp.2005—
*K123166Triathlon All-Polyethylene Condylar Stabilizing (CS) Tibial Implants Triathlon…
Summary page 9
…K031729 K050539 K141056 K173849 K172326 (Posterior Stabilized Insert) K201343 K242831 Triathlon All Poly Tibial Component - K123166 K141056 K172326 K201343 K242831 ® CS (Condylar Stabilizing Insert) Triathlon® All Poly Tibial Component - K123166…
Howmedica Osteonics Corp.2013—
*K230416Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®
Summary page 9
…Triathlon® Hinge Knee System Hinge Knee Tibial Components Triathlon Bushing and Axle STD ® K230416 K251665 Triathlon® Hinge Insert with Sleeve K223528 K230416 K251665 Scorpio® Total Knee…
Stryker2023—
*K251665Triathlon® Hinge Knee System
Summary page 9
…n® Hinge Knee System Hinge Knee Tibial Components Triathlon Bushing and Axle STD ® K230416 K251665 Triathlon® Hinge Insert with Sleeve K223528 K230416 K251665 Scorpio® Total Knee System…
Howmedica Osteonics Corp., Dba Stryker Orthopaedics2025—
*K223528Triathlon® Hinge Knee System
Summary page 9
…inge Knee Tibial Components Triathlon Bushing and Axle STD ® K230416 K251665 Triathlon® Hinge Insert with Sleeve K223528 K230416 K251665 Scorpio® Total Knee System Tibial Ins…
Howmedica Osteonics Corp., Dba Stryker Orthopaedics20231
*K041591Scorpio-Flex Posterior Stabilized Tibial Insert Components
Summary page 9
…K251665 Scorpio® Total Knee System Tibial Inserts Scorpio-Flex™ Posterior Stabilized K041591 K243817 Tibial Insert Scorpio-Flex™ Cruciate Retaining Tibial K011643 K243817 Insert Scorpio® NRG® Tibial Bearing Insert –…
Howmedica Osteonics Corp.20041
*K243817Scorpio Universal Dome Patella; Scorpio Total Stabilizer Insert; Scorpio-Flex Posterior…
Summary page 9
…Scorpio® Total Knee System Tibial Inserts Scorpio-Flex™ Posterior Stabilized K041591 K243817 Tibial Insert Scorpio-Flex™ Cruciate Retaining Tibial K011643 K243817 Insert Scorpio® NRG® Tibial Bearing Insert – K042…
Howmedica Osteonics Corp., Dba Stryker Orthopaedics20252
*K011643Scorpio CR Superflex Tibial Insert
Summary page 9
…Tibial Inserts Scorpio-Flex™ Posterior Stabilized K041591 K243817 Tibial Insert Scorpio-Flex™ Cruciate Retaining Tibial K011643 K243817 Insert Scorpio® NRG® Tibial Bearing Insert – K042343 K243817 Cruciate Retaining Insert Scorpio® NRG® Tibial Beari…
Howmedica Osteonics Corp.20012
*K042343Scorpio NRG Knee System
Summary page 9
…Posterior Stabilized K041591 K243817 Tibial Insert Scorpio-Flex™ Cruciate Retaining Tibial K011643 K243817 Insert Scorpio® NRG® Tibial Bearing Insert – K042343 K243817 Cruciate Retaining Insert Scorpio® NRG® Tibial Bearing Insert – K030978 K243817 Posterior Stabilized Insert Legal…
Howmedica Osteonics Corp.20051
*K030978Scorpio NRG Knee System
Summary page 9
…taining Tibial K011643 K243817 Insert Scorpio® NRG® Tibial Bearing Insert – K042343 K243817 Cruciate Retaining Insert Scorpio® NRG® Tibial Bearing Insert – K030978 K243817 Posterior Stabilized Insert Legally Marketed Reference Devices Used to Support scientific methodology or standard refer…
Howmedica Osteonics Corp.200311
†K252898Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella…Howmedica Osteonics Corp., Dba Stryker Orthopaedics20251

Also cleared against K242831: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 32 years and passes through 9 companies; a new generation was cleared every 1.6 years on median.
  • 117 of the 274 ancestors have a recall of any class.
  • 2 other devices also cite its predicate K242831.

How does its category compare?

All KRO devices

KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.

FDA decisions per year · KRO

3in 2025

2007: 12008: 32009: 32010: 12011: 22012: 22013: 32014: 22015: 62016: 32017: 12019: 32020: 12021: 32022: 12023: 42024: 32025: 32026 (partial year): 1
2007high 6 (2015) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KRO

56in 2025

2008: 126 days median2009: 86 days median2013: 189 days median2015: 113 days median2016: 148 days median2019: 244 days median2021: 57 days median2023: 148 days median2024: 87 days median2025: 56 days median
2007high 244 (2019) · low 56 (2025)2026

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

Recalls per year · KRO

14so far in 2026, the most since 2007

2007: 12008: 32009: 82011: 12012: 12013: 22015: 12016: 52017: 42018: 12021: 12025: 12026 (partial year): 14
2007high 14 (2026) · low 0 (2010)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KRO

915in 2025

2007: 372008: 442009: 662010: 1102011: 1192012: 1732013: 1942014: 4062015: 3332016: 3692017: 5432018: 6142019: 7592020: 7492021: 7702022: 8922023: 7462024: 8552025: 915
2007high 915 (2025) · low 37 (2007)2025

MAUDE reports naming product code KRO, 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
20071—137
20083126344
2009386866
20101—0110
20112—1119
20122—1173
201331892194
20142—0406
201561131333
201631485369
20171—4543
20180—1614
201932440759
20201—0749
20213571770
20221—0892
202341480746
20243870855
20253561915
20261—14—

What is it indicated for?

Triathlon® Knee System 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…

Read the full statement (1,015 words)

Triathlon® Knee System

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.

Triathlon® Hinge Knee System

Triathlon® Hinge Knee System is intended to be implanted with bone cement for the following condition(s):

• There is destruction of the joint surfaces, with or without significant bone deformity.

• The cruciate and/or collateral ligaments do not stabilize the knee joint.

• The ligaments are inadequate and/or the musculature is weak. And/or

• Revision is required of a failed prosthesis where there has been gross instability, with or without bone loss or inadequate soft tissue.

When used with MRH femur and/or MRH tibial baseplate replacement indicated in revision of an existing prosthesis:

• Revision is required of a failed prosthesis where there has been gross instability, with or without bone loss or inadequate soft tissue.

When used with compatible GMRS components:

• Where segmental resection and/or replacement of femur and/or proximal tibia is required

Scorpio® Total Knee System

Indications for the Scorpio-Flex Cruciate Retaining Tibial Insert:

• 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 ligaments structures can be returned to adequate function and stability

• Revision of previous unsuccessful knee replacement or other procedure

Indications for the Scorpio NRG Tibial Bearing Insert – Posteriorly Stabilized Insert:

The Scorpio NRG Knee system components are for use in total knee arthroplasty as a result of:

• 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 ligaments structures can be returned to adequate function and stability

• Revision of previous unsuccessful knee replacement or other procedure

Additional indications for the Posterior stabilized components include:

• Ligamentous instability requiring implant bearing surface geometries with increased constraint

• Absent or non-functioning posterior cruciate ligament.

Indications for the Scorpio-Flex Posterior Stabilized Tibial Insert:

• 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 ligaments structures can be returned to adequate function and stability

• Revision of previous unsuccessful knee replacement or other procedure

• Ligamentous instability requiring implant bearing surface geometries with increased constraint

• Absent or non-functioning posterior cruciate ligament.

Indications for the Scorpio NRG Tibial Bearing Insert – Cruciate Retaining Insert:

The Scorpio NRG Knee system components are for use in total knee arthroplasty as a result of

• 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 ligaments structures can be returned to adequate function and stability

• Revision of previous unsuccessful knee replacement or other procedure

Additional Indications for Posterior Stabilized Devices:

• Ligamentous instability requiring implant bearing surface geometries with increased constraint

• Absent or non-functioning posterior cruciate ligament.

Indications for the Osteonics Scorpio Universal Dome Patella:

• 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 ligaments structures can be returned to adequate function and stability

• Revision of previous unsuccessful knee replacement or other procedure

Indications for the Scorpio Total Stabilizer Insert:

General TKR 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 ligaments structures can be returned to adequate function and stability

• Revision of previous unsuccessful knee replacement or other procedure

Additional Indications for Posterior Stabilized (PS) or Total Stabilized (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

• For Total Stabilizer (TS) Components Only: Severe instability of the knee secondary to compromised collateral ligament integrity or function

Indications for Bone Augmentation Wedges:

• 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

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K261898: Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® 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/K261898

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Record history
  • FDA decision record loaded Oct 30, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026