Cleared Special

K121392 - NOVATION CROWN CUP LINERS

Also marketed or referenced as:
NEUTRAL, LIPPED, +5MM LATERALIZED, +5/10 DEGREE

K121392 is an FDA 510(k) clearance for NOVATION CROWN CUP LINERS, manufactured by Exactech, Inc.. The device is a Class 2 Orthopedic device with product code LZO cleared through the Special 510(k) pathway after a 252-day FDA review.

K121392 · Exactech, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2013
Decision
252d
Days
Class 2
Risk

K121392 is an FDA 510(k) clearance for the NOVATION CROWN CUP LINERS. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on January 16, 2013 after a review of 252 days - an extended review cycle.

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.

FDA 510(k) Submission Details - K121392

510(k) Number K121392 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2012
Decision Date January 16, 2013
Days to Decision 252 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
130d slower than avg
Panel avg: 122d · This submission: 252d
Pathway characteristics
Modification to existing cleared device.

LZO Device Classification - Class 2, Special Controls

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 533
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K121392.
TRINITY NON-OCCLUDED TITANIUM PLASMA SPRAYED (TPS) ACETABULAR SHELLS
K123705 · Corin USA · Feb 2013
PROFEMUR TL CLASSIC HIP STEM
K123688 · Wrightmedicaltechnologyinc · Feb 2013
PROFEMUR Z CLASSIC STEMS
K123434 · Wrightmedicaltechnologyinc · Feb 2013
CORIN TRINITY-I ACETABULAR SHELL
K122305 · Corin USA · Nov 2012
VERSAFITCUP CC TRIO EXTENSION
K122911 · Medacta International · Oct 2012
TREGOR DUAL MOBILITY ACETABULAR SYSTEM
K111981 · Aston Medical · Oct 2012
K121392 · NOVATION CROWN CUP LINERS
Download PDF FDA Summary Exactech, Inc.