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Triathlon AS-1 Knee Arthroplasty Implantation System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K203421

by Conformis, Inc.

Identifiers

510(k) Number
K203421 FDA 510(k)
FDA Product Code
OOG FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3560 FDA 510(k)
Regulation Number
888.3560 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Triathlon AS-1 is a Knee Joint Patellofemoral Polymer Semi-Constrained Cemented Prosthesis, classified under the FDA’s product code OOG. This device is designed for knee arthroplasty, providing a semi-constrained, cemented implant to restore joint function in patients with degenerative or traumatic knee conditions. Its polymer construction offers flexibility and durability for long-term use in total or partial knee replacements.

Intended for surgical use in orthopedic settings, the Triathlon AS-1 is supplied sterile and intended for single-use. It adheres to 21 CFR 888.3560 and has received FDA 510(k) clearance (K203421) under the Traditional pathway. The device is classified as Class II and must be implanted by trained surgeons in controlled environments. No MRI safety information or reusable specifications are provided in the regulatory data.

Frequently asked questions

What types of knee conditions is the Triathlon AS-1 designed to address in patients?

The Triathlon AS-1 is specifically designed for knee arthroplasty to restore joint function in patients with degenerative or traumatic knee conditions. Its semi-constrained, cemented polymer construction is intended for use in total or partial knee replacements to improve mobility and durability for long-term use.

Is the Triathlon AS-1 meant for reuse in multiple procedures, or is it intended for single-use only?

The Triathlon AS-1 is supplied sterile and explicitly intended for single-use only. This ensures patient safety and compliance with orthopedic best practices, as reuse is not supported by the manufacturer or regulatory documentation.

What regulatory pathway did the Triathlon AS-1 follow to achieve FDA clearance, and what does that mean for clinicians?

The Triathlon AS-1 received FDA 510(k) clearance (K203421) under the Traditional pathway, meaning it was determined to be substantially equivalent to a legally marketed device. This clearance confirms the device meets FDA standards for safety and effectiveness, and it is classified as Class II, requiring implantation by trained surgeons in controlled environments.

How should the Triathlon AS-1 be stored before use, and are there any special handling instructions?

While specific storage instructions aren’t detailed in the provided data, the device is supplied sterile, so it must be handled in a manner that maintains sterility until implantation. Standard orthopedic implant storage practices—such as keeping it in a sealed, dry environment and avoiding contamination—should be followed to preserve its integrity for surgical use.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K203421 FDA 510 (k) - Triathlon AS-1 | Conformis, Inc., Triathlon AS-1 (K203421) — FDA 510 (k) | Innolitics, Triathlon AS-1 — FDA 510 (k) K203421 | MedTracker, Triathlon AS-1 - BEUDAMED

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Conformis, Inc.

Sources (1)

  • FDA 510(k) K203421 24 fields · synced Sep 19, 2026