Cleared Traditional

K180612 - Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K180612 · Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · Orthopedic device
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Jun 2018
Decision
91d
Days
Class 2
Risk

K180612 is an FDA 510(k) clearance for the Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts. Classified as Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer (product code HSX), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics (Mahwah, US). The FDA issued a Cleared decision on June 7, 2018 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3520 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics devices

Submission Details

510(k) Number K180612 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2018
Decision Date June 07, 2018
Days to Decision 91 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 122d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HSX Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3520
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - HSX Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer

All 113
Devices cleared under the same product code (HSX) and FDA review panel - the closest regulatory comparables to K180612.
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