Cleared Traditional

K965002 - ZIRCONIA CERAMIC FEMORAL HEADS WITH FOUNDATION FORGED, TEXTURED AND POROUS STEMS, THE ENCORE VITALITY STEMS AND SL AND

K965002 is an FDA 510(k) clearance for ZIRCONIA CERAMIC FEMORAL HEADS WITH FOU..., manufactured by Encore Orthopedics, Inc.. The device is a Class 2 Orthopedic device with product code LZO cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K965002 · Encore Orthopedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1997
Decision
193d
Days
Class 2
Risk

K965002 is an FDA 510(k) clearance for the ZIRCONIA CERAMIC FEMORAL HEADS WITH FOUNDATION FORGED, TEXTURED AND POROUS ST.... Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Encore Orthopedics, Inc. (Austin, US). The FDA issued a Cleared decision on June 27, 1997 after a review of 193 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. 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 Encore Orthopedics, Inc. devices

FDA 510(k) Submission Details - K965002

510(k) Number K965002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1996
Decision Date June 27, 1997
Days to Decision 193 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
71d slower than avg
Panel avg: 122d · This submission: 193d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 513
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K965002.
OSTEONICS ALUMINA C-TAPER HEAD
K971409 · Osteonics Corp. · Jul 1997
HEADLOC CERAMIC HEAD
K971426 · Ortho Development Corp. · Jul 1997
HEADLOC CERAMIC FEMORAL HEADS
K971435 · Ortho Development Corp. · Jul 1997
22.2/+4MM CO CR & ZIRCONIA FEMORAL HEAD
K970846 · Landos, Inc. · Jun 1997
PROFORM GENERAL APPLICATION CEMENTED FEMORAL COMPONENT
K970490 · Stelkast Company · May 1997
RELIANCE PF FEMORAL STEMS
K970200 · Howmedica Corp. · Apr 1997