Cleared Traditional

K965002 - ZIRCONIA CERAMIC FEMORAL HEADS WITH FOU...

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 435
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
PROFORM GENERAL APPLICATION CEMENTED FEMORAL COMPONENT
K970490 · Stelkast Company · May 1997
RELIANCE PF FEMORAL STEMS
K970200 · Howmedica Corp. · Apr 1997
NATURAL-HIP SYSTEM COCR REVISION STEM
K970166 · Intermedics Orthopedics · Apr 1997