Cleared Traditional

K953925 - FINE GRAIN CAST COBALT CHROMIUM HIP STEMS

K953925 is an FDA 510(k) clearance for FINE GRAIN CAST COBALT CHROMIUM HIP STEMS, manufactured by Biomet, Inc.. The device is a Class 2 Orthopedic device with product code LZO cleared through the Traditional 510(k) pathway after a 166-day FDA review.

K953925 · Biomet, Inc. · Orthopedic device
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Jan 1996
Decision
166d
Days
Class 2
Risk

K953925 is an FDA 510(k) clearance for the FINE GRAIN CAST COBALT CHROMIUM HIP STEMS. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on January 31, 1996 after a review of 166 days - an extended review 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: 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 Biomet, Inc. devices

FDA 510(k) Submission Details - K953925

510(k) Number K953925 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 18, 1995
Decision Date January 31, 1996
Days to Decision 166 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
44d slower than avg
Panel avg: 122d · This submission: 166d
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 511
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K953925.
IMPLEX CERAMIC HEAD
K955117 · Implex Corp. · Apr 1996
CONSENSUS ZIRCONIA FEMORAL HEAD
K955386 · U.S. Medical Products, Inc. · Feb 1996
BIMETRIC COCR HEAD/NECK REPLACEMENT HIP STEM
K955350 · Biomet, Inc. · Feb 1996
BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD
K954768 · Biologically Oriented Prostheses · Jan 1996
CLS ACETABULAR COMPONENT (MODIFICATION)
K953688 · Intermedics Orthopedics · Nov 1995
WAGNER REVISION STEM (MODIFICATION)
K953689 · Intermedics Orthopedics · Nov 1995