Cleared Traditional

K172634 - Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components

K172634 is an FDA 510(k) clearance for Triathlon X3 UHMWPE Tibial Inserts and ..., manufactured by Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics. The device is a Class 2 Orthopedic device with 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

FDA 510(k) Submission Details - K172634

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
Combination Product No
PCCP Authorized No
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.

MBH Device Classification - Class 2, Special Controls

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 142
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