Cleared Traditional

K143393 - Triathlon Tritanium Cone Augments

K143393 is an FDA 510(k) clearance for Triathlon Tritanium Cone Augments, manufactured by Stryker Orthopaedics. The device is a Class 2 Orthopedic device with product code MBH cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K143393 · Stryker Orthopaedics · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2015
Decision
48d
Days
Class 2
Risk

K143393 is an FDA 510(k) clearance for the Triathlon Tritanium Cone Augments. Classified as Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer (product code MBH), Class II - Special Controls.

Submitted by Stryker Orthopaedics (Mahwah, US). The FDA issued a Cleared decision on January 13, 2015 after a review of 48 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 Stryker Orthopaedics devices

FDA 510(k) Submission Details - K143393

510(k) Number K143393 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2014
Decision Date January 13, 2015
Days to Decision 48 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
74d faster than avg
Panel avg: 122d · This submission: 48d
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 130
Devices cleared under the same product code (MBH) and FDA review panel - the closest regulatory comparables to K143393.
Freedom Cementless Femoral Component
K150680 · Maxx Orthopedics, Inc. · Jun 2015
Zimmer Persona Personalized Knee System
K150090 · Zimmer, Inc. · May 2015
ADVANCE Porous Coated Spiked Tibial Base
K143366 · Microport Orthopedics, Inc. · Jan 2015
VANGUARD XP FEMORAL COMPONENT(GEN II)/VANGUARD XP FEMORAL TRIAL
K141407 · Biomet, Inc. · Oct 2014
ARTHREX IBALANCE TKA SYSTEM
K141635 · Arthrex, Inc. · Sep 2014
TRABECULAR METAL TIBIAL CONE BROACH, TRABECULAR METAL COUPLED TIBIAL CONE BROACH
K141840 · Zimmer, Inc. · Sep 2014