# K172634: Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics
- Decided: Nov 16, 2017 after 76 days
- Product code: MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3565
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K031729 (2003). 14 ancestors in all.
18 later devices descend from it; 4 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051146: Triathlon Knee System, Howmedica Osteonics Corp. (2005) Summary page 5.
- K063423: Triathlon CS (Condylar Stabilizing) Lipped Insert, Howmedica Osteonics (2007) Summary page 5.
- K072221: Modification to Triathlon TS Knee System, Howmedica Osteonics Corp. (2007) Summary page 5.

## 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
- Feb 6, 2024 · Class II · Z-1261-2024: Potential packaging breaches of inner blister and outer sterile blister.
- Feb 6, 2024 · Class II · Z-1262-2024: Potential packaging breaches of inner blister and outer sterile blister.
- Feb 6, 2024 · Class II · Z-1265-2024: Potential packaging breaches of inner blister and outer sterile blister.
- Feb 6, 2024 · Class II · Z-1263-2024: Potential packaging breaches of inner blister and outer sterile blister.
- Feb 6, 2024 · Class II · Z-1264-2024: Potential packaging breaches of inner blister and outer sterile blister.
- Feb 6, 2024 · Class II · Z-1266-2024: Potential packaging breaches of inner blister and outer sterile blister.
- Apr 13, 2023 · Class II · Z-1654-2023: Mislabeled:Labeled Catalog Number: 5531-G-312-E, TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM, may contain Catalog Number: 5532-G-413-E, TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM, and vice versa

## Indications for use
General Total Knee Arthroplasty (TKR) Indications: x 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. x Post-traumatic loss of knee joint configuration and function. x Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. x Revision of previous unsuccessful knee replacement or other procedure. x 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: x Ligamentous instability requiring implant bearing surface geometries with increased constraint. x Absent or non-functioning posterior cruciate ligament. x Severe anteroposterior instability of the knee joint. Additional Indications for Total Stabilizer (TS) Components: x Severe instability of the knee secondary to compromised collateral ligament integrity or function. Indications for Bone Augments: x Painful, disabling joint disease of the knee secondary to: degenerative arthritis, rheumatoid arthritis, or post-traumatic arthritis, complicated by the presence of bone loss. x Salvage of previous unsuccessful total knee replacement or other surgical procedure, accompanied by bone loss. Additional Indications for Cone Augments: x Severe degeneration or trauma requiring extensive resection and replacement x Femoral and Tibial bone voids x Metaphyseal reconstruction The Triathlon TS Cone Augment components are intended for cemented or cementless use.

Source page: https://510kreport.com/device/K172634
Methodology: https://510kreport.com/methodology