Cleared Traditional

22.2/+4MM CO CR & ZIRCONIA FEMORAL HEAD (K970846) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K970846 · Landos, Inc. · Orthopedic device
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Jun 1997
Decision
90d
Days
Class 2
Risk

K970846 is an FDA 510(k) clearance for the 22.2/+4MM CO CR & ZIRCONIA 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 Landos, Inc. (Malvern, US). The FDA issued a Cleared decision on June 5, 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 Landos, Inc. devices

Submission Details

510(k) Number K970846 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 07, 1997
Decision Date June 05, 1997
Days to Decision 90 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
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 292
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K970846.
ZIRCONIA CERAMIC FEMORAL HEAD (12/14 TAPER)
K971752 · Zimmer, Inc. · Jul 1997
OSTEONICS ANTEVERTED NECK HIP STEM
K971497 · Osteonics Corp. · Jul 1997
OSTEONICS ALUMINA C-TAPER HEAD
K971409 · Osteonics Corp. · Jul 1997
RELIANCE PF FEMORAL STEMS
K970200 · Howmedica Corp. · Apr 1997
DEPUY/ACE MODIFIED MEDICAL ASPECT (MMA) FRACTURE STEM
K964704 · Depuy, Inc. · Jan 1997
BRIDGE LONG STEM FEMORAL COMPONENT
K964249 · Wrightmedicaltechnologyinc · Jan 1997