Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts— 510(k) K180612

Clearance details

Applicant

Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics

Product code

Code HSX

Device class

Class 2

Regulation

21 CFR 888.3520

Advisory panel

Orthopedic

Date received

2018-03-08

Decision date

2018-06-07

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Mahwah, NJ, US

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Injury

1,003

Other

1

Total

1,004

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →