Cleared Traditional

K972690 - ZIRCONIA CERAMIC FEMORAL HEAD

K972690 is the FDA 510(k) clearance for ZIRCONIA CERAMIC FEMORAL HEAD by Zimmer, Inc.. It is a Class 2 Orthopedic device (product code LZO) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K972690 · Zimmer, Inc. · Orthopedic device
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Oct 1997
Decision
90d
Days
Class 2
Risk

K972690 is an FDA 510(k) clearance for the ZIRCONIA CERAMIC FEMORAL HEAD. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on October 15, 1997 after a review of 90 days - within the typical 510(k) review window.

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 Zimmer, Inc. devices

Submission Details

510(k) Number K972690 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 17, 1997
Decision Date October 15, 1997
Days to Decision 90 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 435
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K972690.
S-ROM ZIRCONIA CERAMIC FEMORAL HIP HEAD
K973307 · Johnson & Johnson Professionals, Inc. · Nov 1997
MOST HEX INTRAMEDULLARY (I/M) STEM
K973087 · Sulzer Orthopedics, Inc. · Nov 1997
PARTNERSHIP REVISION FEMORAL STEMS
K972893 · Howmedica Corp. · Nov 1997
PRECEDENT REVISION HIP SYSTEM
K972637 · Sulzer Orthopedics, Inc. · Oct 1997
V40 ZIRCONIA FEMORAL HEADS
K972361 · Howmedica, Inc. · Sep 1997
HEADLOC CERAMIC HEAD
K970675 · Ortho Development Corp. · Aug 1997