510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K203421Substantially Equivalent

Triathlon AS-1

ConforMIS, Inc., Billerica MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K203421 is the FDA 510(k) clearance record for Triathlon AS-1, a class II device, cleared for Conformis, Inc. on under FDA product code OOG (Knee Arthroplasty Implantation System). FDA's definition for product code OOG reads: "Intended to be used to assist in the implantation of a specific knee arthroplasty device or a set of specific knee arthroplasty devices. Indicated to include guiding alignment, making or establishing cuts, selecting, sizing, attaching...". FDA records list 60 510(k) clearances for Conformis, Inc., from to . As of , FDA records show no recalls naming K203421.

Clearance record

Decision date
Received
(150 days to decision)
Product code
OOG Knee Arthroplasty Implantation System
Regulation
21 CFR 888.3560
Device class
Class II
Review panel
Orthopedic
Applicant
Conformis, Inc. 600 Technology Park Dr., 4th Floor, Billerica MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OOG

Trailing 12 months

FDA records hold no clearances under product code OOG in the trailing twelve months.

FDA records show no clearances under product code OOG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OOG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260