Cleared Traditional

K123486 - TRIATHLON TRITANIUM TIBIAL BASEPLATE

K123486 is an FDA 510(k) clearance for TRIATHLON TRITANIUM TIBIAL BASEPLATE, manufactured by Stryker. The device is a Class 2 Orthopedic device with product code MBH cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K123486 · Stryker · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2013
Decision
171d
Days
Class 2
Risk

K123486 is an FDA 510(k) clearance for the TRIATHLON TRITANIUM TIBIAL BASEPLATE. Classified as Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer (product code MBH), Class II - Special Controls.

Submitted by Stryker (Mahwah, US). The FDA issued a Cleared decision on May 3, 2013 after a review of 171 days - an extended review 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: 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 Stryker devices

FDA 510(k) Submission Details - K123486

510(k) Number K123486 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2012
Decision Date May 03, 2013
Days to Decision 171 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
49d slower than avg
Panel avg: 122d · This submission: 171d
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 K123486.
SIGNATURE PLANNER, SIGNATURE GUIDES
K140257 · Materialise NV · Apr 2014
VANGUARD XP KNEE SYSTEM
K132873 · Biomet, Inc. · Dec 2013
TRIATHLON TRITANIUM METAL-BACKED PATELLA
K132624 · Stryker Orthopaedics · Nov 2013
ADVANCE TOTAL KNEE SYSTEM-PATELLA
K122218 · Wrightmedicaltechnologyinc · Mar 2013
VANGUARD XP KNEE SYSTEM
K122160 · Biomet Manufacturing Corp · Mar 2013
ZIMMER PERSONA TM PERSONALIZED KNEE SYSTEM
K123459 · Zimmer, Inc. · Feb 2013