# K123166: Triathlon All-Polyethylene Condylar Stabilizing (CS) Tibial Implants Triathlon All-Polyethylene Posterior Stabilizing (P

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Feb 14, 2013 after 128 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: 4 generations back to K031729 (2003). 16 ancestors in all.
33 later devices descend from it; 4 cite it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063423: Triathlon CS (Condylar Stabilizing) Lipped Insert, Howmedica Osteonics (2007) Summary page 1.
- K050539: Size 1 Triathlon Posterior Stabilized (PS) Tibial Insert, Howmedica Osteonics Corp. (2005) Summary page 1.
- K042993: Triathlon Posteriorly Stabilized (PS) Femoral Component, Howmedica Osteonics Corp. (2005) Summary page 1.
- K031729: Triathlon Posteriorly Stabilized (PS) Total Knee System, Howmedica Osteonics Corp. (2003) Summary page 1.
- K974556: Osteonics Scorpio Posterior Cruciate Retaining Total Knee System, Osteonics Corp. (1998) Summary page 1.
- K962152: Osteonics Scorpio Posteriorly Stabilized Total Knee System, Osteonics Corp. (1996) Summary page 1.
- K072221: Modification to Triathlon TS Knee System, Howmedica Osteonics Corp. (2007) Summary page 1.

## Most influential descendants
- 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
- 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

## Indications for 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), 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 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 All Polyethylene tibial components are indicated for cemented use only.

Source page: https://510kreport.com/device/K123166
Methodology: https://510kreport.com/methodology