Cleared Traditional

K970846 - 22.2/+4MM CO CR & ZIRCONIA FEMORAL HEAD

K970846 is an FDA 510(k) clearance for 22.2/+4MM CO CR & ZIRCONIA FEMORAL HEAD, manufactured by Landos, Inc.. The device is a Class 2 Orthopedic device with product code LZO cleared through the Traditional 510(k) pathway after a 90-day FDA review.

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

FDA 510(k) Submission Details - K970846

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
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.

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 491
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K970846.
HEADLOC CERAMIC HEAD
K971426 · Ortho Development Corp. · Jul 1997
HEADLOC CERAMIC FEMORAL HEADS
K971435 · Ortho Development Corp. · Jul 1997
ZIRCONIA CERAMIC FEMORAL HEADS WITH FOUNDATION FORGED, TEXTURED AND POROUS STEMS, THE ENCORE VITALITY STEMS AND SL AND
K965002 · Encore Orthopedics, Inc. · Jun 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