# K143393: Triathlon Tritanium Cone Augments

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Orthopaedics
- Decided: Jan 13, 2015 after 48 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K982302 (1998). 14 ancestors in all.
40 later devices descend from it; 6 cite it directly.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053340: Trabecular Metal Tibial and Femoral Cone Augments, Zimmer Trabecular (2006) Summary page 5.
- K100391: Depuy Universal Gription TF Cones, DePuy Orthopaedics, Inc. (2010) Summary page 5.

## Most influential descendants
- K172326: Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System (2017), 24 descendants of its own
- K173849: Triathlon Total Knee System (2018), 14 descendants of its own
- K190402: Triathlon Total Knee System-Additional Components (2019), 11 descendants of its own
- K153595: Optetrak Logic Metaphyseal Cones (2016), 8 descendants of its own
- K182346: TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws (2018), 5 descendants of its own

## Recalls of this device
- Jun 23, 2016 · Class II · Z-2377-2016: Stryker Orthopaedic is voluntarily recalling the Triathlon Modular Handle because analysis revealed that the press fit specifications between the dowel pin and the mating hole in the shaft were not be

## 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.

Source page: https://510kreport.com/device/K143393
Methodology: https://510kreport.com/methodology