# K072221: Modification to Triathlon TS Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Oct 15, 2007 after 66 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K031729 (2003). 5 ancestors in all.
35 later devices descend from it; 6 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070095: Triathlon TS Knee System, Howmedica Osteonics Corp. (2007) Summary page 2.

## Most influential descendants
- K123166: Triathlon All-Polyethylene Condylar Stabilizing (CS) Tibial Implants Triathlon All-Polyethylene Posterior Stabilizing (P (2013), 33 descendants of its own
- K141056: Triathlon Knee System Posterior Stabilized Components (2014), 28 descendants of its own
- K172326: Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System (2017), 24 descendants of its own
- K172634: Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components (2017), 18 descendants of its own
- K173849: Triathlon Total Knee System (2018), 14 descendants of its own

## Indications for use
General Total Knee Arthroplasty (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 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 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. The Triathlon TS Total Knee System components are intended for cemented use only.

Source page: https://510kreport.com/device/K072221
Methodology: https://510kreport.com/methodology