# K172326: Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Orthopaedics
- Decided: Oct 30, 2017 after 90 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K943462 (1994). 83 ancestors in all.
24 later devices descend from it; 14 cite it directly.
0 of 108 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031729: Triathlon Posteriorly Stabilized (PS) Total Knee System, Howmedica Osteonics Corp. (2003) Summary page 10.
- K040267: Triathlon Cruciate Retaining (CR) Total Knee, Howmedica Osteonics Corp. (2004) Summary page 10.
- K042883: Size 1 Triathlon Cruciate Retaining (CR) Tibial Insert, Howmedica Osteonics Corp. (2004) Summary page 10.
- K042993: Triathlon Posteriorly Stabilized (PS) Femoral Component, Howmedica Osteonics Corp. (2005) Summary page 10.
- K050539: Size 1 Triathlon Posterior Stabilized (PS) Tibial Insert, Howmedica Osteonics Corp. (2005) Summary page 10.
- K051146: Triathlon Knee System, Howmedica Osteonics Corp. (2005) Summary page 10.
- K051380: Triathlon Press-Fit Total Knee System, Howmedica Osteonics Corp. (2005) Summary page 10.
- K053514: Triathlon Total Knee System, Stryker Orthopaedics (2006) Summary page 10.
- K061521: Triathlon Metal Backed Patella, Howmedica Osteonics Corp. (2006) Summary page 10.
- K062037: Triathlon Low Profile Tibial Tray, Howmedica Osteonics Corp. (2006) Summary page 10.
- K063423: Triathlon CS (Condylar Stabilizing) Lipped Insert, Howmedica Osteonics (2007) Summary page 10.
- K070095: Triathlon TS Knee System, Howmedica Osteonics Corp. (2007) Summary page 10.
- K072221: Modification to Triathlon TS Knee System, Howmedica Osteonics Corp. (2007) Summary page 10.
- K072575: Triathlon Screw-Fixation Tibial Baseplate, Stryker Orthopaedics (2008) Summary page 10.
- K123166: Triathlon All-Polyethylene Condylar Stabilizing (CS) Tibial Implants Triathlon All-Polyethylene Posterior Stabilizing (P, Howmedica Osteonics Corp. (2013) Summary page 10.
- K123486: Triathlon Tritanium Tibial Baseplate, Stryker (2013) Summary page 10.
- K132624: Triathlon Tritanium Metal-Backed Patella, Stryker Orthopaedics (2013) Summary page 10.
- K141056: Triathlon Knee System Posterior Stabilized Components, Stryker Orthopaedics (2014) Summary page 10.
- K143393: Triathlon Tritanium Cone Augments, Stryker Orthopaedics (2015) Summary page 10.
- K071881: Triathlon PKR System, Howmedica Osteonics Corp. (2007) Summary page 10.
- K090763: Restoris Multicompartmental Knee (MCK) System, Mako Surgical Corporation (2009) Summary page 10.
- K150307: RESTORIS Multicompartmental Knee System, Mako Surgical Corp. (2015) Summary page 10.

## Most influential descendants
- K173849: Triathlon Total Knee System (2018), 14 descendants of its own
- K190402: Triathlon Total Knee System-Additional Components (2019), 11 descendants of its own
- K230952: Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral Component (2023), 4 descendants of its own
- K223528: Triathlon® Hinge Knee System (2023), 4 descendants of its own
- 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 (2024), 3 descendants of its own

## Recalls of this device
- Mar 5, 2021 · Class II · Z-1379-2021: The 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 Cutti

## Indications for use
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.

Source page: https://510kreport.com/device/K172326
Methodology: https://510kreport.com/methodology