# K261898: Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp. dba Stryker Orthopaedics
- Decided: Aug 6, 2026 after 62 days
- Product code: KRO (Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3510
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 17 generations back to K941847 (1994). 275 ancestors in all.
No later device cites it as a predicate yet.
0 of 275 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242831: Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon Tritanium Tibial Baseplate; Triathlon Low Profile Tibial Tray; Triathlon Metal Backed Patella; Triathlon Partial Knee System; Avon Patello-femoral Joint Prosthesis; Restoris Multi-Compartmental Knee System, Howmedica Osteonics Corp., Dba Stryker Orthopaedics (2024) Summary page 9.
- K040267: Triathlon Cruciate Retaining (CR) Total Knee, Howmedica Osteonics Corp. (2004) Summary page 9.
- K042883: Size 1 Triathlon Cruciate Retaining (CR) Tibial Insert, Howmedica Osteonics Corp. (2004) Summary page 9.
- K141056: Triathlon Knee System Posterior Stabilized Components, Stryker Orthopaedics (2014) Summary page 9.
- K172326: Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System, Stryker Orthopaedics (2017) Summary page 9.
- K173849: Triathlon Total Knee System, Stryker Orthopaedics (2018) Summary page 9.
- K201343: Triathlon Total KneeSystem, Howmedica Osteonics Corp., Dba Stryker Orthopaedics (2020) Summary page 9.
- K063423: Triathlon CS (Condylar Stabilizing) Lipped Insert, Howmedica Osteonics (2007) Summary page 9.
- K031729: Triathlon Posteriorly Stabilized (PS) Total Knee System, Howmedica Osteonics Corp. (2003) Summary page 9.
- K050539: Size 1 Triathlon Posterior Stabilized (PS) Tibial Insert, Howmedica Osteonics Corp. (2005) Summary page 9.
- K123166: Triathlon All-Polyethylene Condylar Stabilizing (CS) Tibial Implants Triathlon All-Polyethylene Posterior Stabilizing (P, Howmedica Osteonics Corp. (2013) Summary page 9.
- K230416: Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®, Stryker (2023) Summary page 9.
- K251665: Triathlon® Hinge Knee System, Howmedica Osteonics Corp., Dba Stryker Orthopaedics (2025) Summary page 9.
- K223528: Triathlon® Hinge Knee System, Howmedica Osteonics Corp., Dba Stryker Orthopaedics (2023) Summary page 9.
- K041591: Scorpio-Flex Posterior Stabilized Tibial Insert Components, Howmedica Osteonics Corp. (2004) Summary page 9.
- K243817: Scorpio Universal Dome Patella; Scorpio Total Stabilizer Insert; Scorpio-Flex Posterior Stabilized Tibial Insert; Scorpio-Flex Cruciate Retaining Tibial Insert; Scorpio NRG Tibial Bearing Insert – Cruciate Retaining Insert; Scorpio NRG Tibial Bearing Insert – Posteriorly Stabilized Insert, Howmedica Osteonics Corp., Dba Stryker Orthopaedics (2025) Summary page 9.
- K011643: Scorpio CR Superflex Tibial Insert, Howmedica Osteonics Corp. (2001) Summary page 9.
- K042343: Scorpio NRG Knee System, Howmedica Osteonics Corp. (2005) Summary page 9.
- K030978: Scorpio NRG Knee System, Howmedica Osteonics Corp. (2003) Summary page 9.

## Indications for use
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

Source page: https://510kreport.com/device/K261898
Methodology: https://510kreport.com/methodology