Cleared Special

K013989 - ZIRCONIA CERAMIC FEMORAL HEAD - 12/14 T...

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

K013989 · Smith & Nephew, Inc. · Orthopedic device
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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.

View all Smith & Nephew, Inc. devices

Submission Details

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.

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 433
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K013989.
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