# K203421: Triathlon AS-1

- Pathway: 510(k) (Traditional)
- Applicant: Conformis, Inc.
- Decided: Apr 19, 2021 after 150 days
- Product code: OOG (Knee Arthroplasty Implantation System)
- 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: 18 generations back to K810258 (1981). 177 ancestors in all.
No later device cites it as a predicate yet.
0 of 178 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180906: Conformis iTotal Cruciate Retaining (CR) Knee Replacement System, Conformis, Inc. (2018) Summary page 4.
- K201023: iTotal® Identity Posterior Stabilized Knee Replacement System, Conformis, Inc. (2020) Summary page 5.

## Indications for use
The Triathlon AS-I patient specific cutting guides are disposable, single-use surgical instruments intended to assist orthopedic surgeons in the positioning of femoral and tibial total knee arthroplasty components intraoperatively, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. They are intended for use with the Cruciate Retaining (CR), Condylar Stabilizing (CS), Posterior Stabilized (PS) and Tritanium@ components of the Triathlon@ Total Knee System and the Total Stabilizer (TS) and Posterior Stabilized Rotation (PSR) Triathlon@ tibial inserts.

Source page: https://510kreport.com/device/K203421
Methodology: https://510kreport.com/methodology