Cleared Traditional

K172634 - Triathlon X3 UHMWPE Tibial Inserts and ...

K172634 is the FDA 510(k) clearance for Triathlon X3 UHMWPE Tibial Inserts and ... by Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics. It is a Class 2 Orthopedic device (product code MBH) cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K172634 · Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2017
Decision
76d
Days
Class 2
Risk

K172634 is an FDA 510(k) clearance for the Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components. Classified as Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer (product code MBH), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics (Mahwah, US). The FDA issued a Cleared decision on November 16, 2017 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3565 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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

Submission Details

510(k) Number K172634 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2017
Decision Date November 16, 2017
Days to Decision 76 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
46d faster than avg
Panel avg: 122d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MBH Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3565
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 - MBH Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer

All 124
Devices cleared under the same product code (MBH) and FDA review panel - the closest regulatory comparables to K172634.
EVOLUTION® Knee Systems – MR Labeling, EVOLUTION® BIOFOAM® Tibial System, EVOLUTION® Revision Tibial System, EVOLUTION® Revision CCK System
K180317 · Microport Orthopedics, Inc. · May 2018
Triathlon Total Knee System
K173849 · Stryker Orthopaedics · Feb 2018
Zimmer Persona Personalized Knee System
K173417 · Zimmer, Inc. · Jan 2018
Arthrex Knee Systems
K171365 · Arthrex, Inc. · Nov 2017
EMPOWR Porous Knee System
K171991 · Encore Medical, L.P. · Oct 2017
BIOFOAM® Additive Manufacturing (BIOFOAM® AM), ADVANCE® BIOFOAM® Tibial Base, EVOLUTION® BIOFOAM® Tibial Base, DYNASTY® BIOFOAM® Acetabular Shell
K170288 · Microport Orthopedics, Inc. · Jun 2017