Cleared Special

K013989 - ZIRCONIA CERAMIC FEMORAL HEAD - 12/14 TAPER

K013989 is an FDA 510(k) clearance for ZIRCONIA CERAMIC FEMORAL HEAD - 12/14 TAPER, manufactured by Smith & Nephew, Inc.. The device is a Class 2 Orthopedic device with product code LZO cleared through the Special 510(k) pathway after a 15-day FDA review.

K013989 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2001
Decision
15d
Days
Class 2
Risk

K013989 is an FDA 510(k) clearance for the ZIRCONIA CERAMIC FEMORAL HEAD - 12/14 TAPER. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on December 19, 2001 after a review of 15 days - a notably fast clearance 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. Low regulatory complexity profile. 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 - K013989

510(k) Number K013989 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2001
Decision Date December 19, 2001
Days to Decision 15 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
107d faster than avg
Panel avg: 122d · This submission: 15d
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 K013989.
MS-30 LATERAL FEMORAL STEM
K020713 · Sulzer Orthopedics, Inc. · May 2002
2 PIECE MODULAR HIP STEM
K013106 · Howmedica Osteonics Corp. · Apr 2002
DEPUY FEMORAL HEADS
K011533 · DePuy Orthopaedics, Inc. · Jan 2002
ALLOFIT ACETABULAR SYSTEM 32MM ALPHA DURASUL INSERTS
K013935 · Sulzer Orthopedics, Inc. · Dec 2001
APEX MODULAR ALUMINA FEMORAL HEAD
K012918 · Apex Surgical, LLC · Nov 2001
PRO-FEMUR
K012091 · Wrightmedicaltechnologyinc · Oct 2001
K013989 · ZIRCONIA CERAMIC FEMORAL HEAD - 12/14 TAPER
Download PDF FDA Summary Smith & Nephew, Inc.