Cleared Traditional

K964704 - DEPUY/ACE MODIFIED MEDICAL ASPECT (MMA) FRACTURE STEM

K964704 is an FDA 510(k) clearance for DEPUY/ACE MODIFIED MEDICAL ASPECT (MMA)..., manufactured by Depuy, Inc.. The device is a Class 2 Orthopedic device with product code LZO cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K964704 · Depuy, Inc. · Orthopedic device
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Jan 1997
Decision
60d
Days
Class 2
Risk

K964704 is an FDA 510(k) clearance for the DEPUY/ACE MODIFIED MEDICAL ASPECT (MMA) FRACTURE STEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on January 24, 1997 after a review of 60 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 Depuy, Inc. devices

FDA 510(k) Submission Details - K964704

510(k) Number K964704 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1996
Decision Date January 24, 1997
Days to Decision 60 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
62d faster than avg
Panel avg: 122d · This submission: 60d
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 510
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K964704.
PATIENT SPECIFIC IMPLANT HIP FEMORAL COMPONENT
K970346 · Kairos Orthopaedics · Feb 1997
NATURAL-HIP SYSTEM COCR STEM
K964357 · Intermedics Orthopedics · Jan 1997
PATIENT SPECIFIC IMPLANT (PSI) HIP FEMORAL COMPONENT
K964395 · Hayes Medical, Inc. · Jan 1997
BRIDGE LONG STEM FEMORAL COMPONENT
K964249 · Wrightmedicaltechnologyinc · Jan 1997
CORAIL
K953111 · Landos, Inc. · Dec 1996
WHITESIDE BIOMECHANICS ZIRCONIA CERAMIC FEMORAL HEAD
K964150 · Whiteside Biomechanics, Inc. · Dec 1996