Cleared Traditional

K970166 - NATURAL-HIP SYSTEM COCR REVISION STEM

K970166 is an FDA 510(k) clearance for NATURAL-HIP SYSTEM COCR REVISION STEM, manufactured by Intermedics Orthopedics. The device is a Class 2 Orthopedic device with product code LZO cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K970166 · Intermedics Orthopedics · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
82d
Days
Class 2
Risk

K970166 is an FDA 510(k) clearance for the NATURAL-HIP SYSTEM COCR REVISION STEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Intermedics Orthopedics (Austin, US). The FDA issued a Cleared decision on April 8, 1997 after a review of 82 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Intermedics Orthopedics devices

FDA 510(k) Submission Details - K970166

510(k) Number K970166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1997
Decision Date April 08, 1997
Days to Decision 82 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
40d faster than avg
Panel avg: 122d · This submission: 82d
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 K970166.
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 STEM
K964357 · Intermedics Orthopedics · Jan 1997
DEPUY/ACE MODIFIED MEDICAL ASPECT (MMA) FRACTURE STEM
K964704 · Depuy, Inc. · Jan 1997
BRIDGE LONG STEM FEMORAL COMPONENT
K964249 · Wrightmedicaltechnologyinc · Jan 1997