Cleared Traditional

K190991 - Triathlon Tritanium Central Femoral Con...

K190991 is the FDA 510(k) clearance for Triathlon Tritanium Central Femoral Con... by Howmedica Osteonics Corp. (Aka Stryker Orthopaedics). It is a Class 2 Orthopedic device (product code MBH) cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K190991 · Howmedica Osteonics Corp. (Aka Stryker Orthopaedics) · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2019
Decision
122d
Days
Class 2
Risk

K190991 is an FDA 510(k) clearance for the Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Au.... 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. (Aka Stryker Orthopaedics) (Mahwah, US). The FDA issued a Cleared decision on August 15, 2019 after a review of 122 days - within the typical 510(k) review window.

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 Howmedica Osteonics Corp. (Aka Stryker Orthopaedics) devices

Submission Details

510(k) Number K190991 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2019
Decision Date August 15, 2019
Days to Decision 122 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
At panel average
Panel avg: 122d · This submission: 122d
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 123
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