Cleared Special

BIOLOX CONTOURA Ceramic Femoral Head (K191399) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K191399 · Total Joint Othopedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2019
Decision
96d
Days
Class 2
Risk

K191399 is an FDA 510(k) clearance for the BIOLOX CONTOURA Ceramic Femoral Head. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Total Joint Othopedics, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on August 28, 2019 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Total Joint Othopedics, Inc. devices

Submission Details

510(k) Number K191399 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 2019
Decision Date August 28, 2019
Days to Decision 96 days
Submission Type Special
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
26d faster than avg
Panel avg: 122d · This submission: 96d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3353
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 - LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

All 291
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K191399.
BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System
K192416 · Zimmer GmbH · Oct 2019
MiniMAX
K192352 · Medacta International S.A. · Sep 2019
Signature Ceramic Femoral Head
K190704 · Signature Orthopaedics Pty, Ltd. · Aug 2019
Libertas – Taper Uncemented Femoral Stem
K183684 · Maxx Orthopedics, Inc. · Aug 2019
Conformity Stem
K183312 · United Orthopedic Corporation · Aug 2019
BiMobile Dual Mobility System - E-Dur Inserts
K190535 · Waldemar Link GmbH & Co. KG · Aug 2019