Cleared Traditional

K953925 - FINE GRAIN CAST COBALT CHROMIUM HIP STEMS

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

K953925 · Biomet, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

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 435
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K953925.
CLS STEM (MODIFICATION)
K953690 · Intermedics Orthopedics · Jun 1996
IMPLEX CERAMIC HEAD
K955117 · Implex Corp. · Apr 1996
BIMETRIC COCR HEAD/NECK REPLACEMENT HIP STEM
K955350 · Biomet, Inc. · Feb 1996
CLS ACETABULAR COMPONENT (MODIFICATION)
K953688 · Intermedics Orthopedics · Nov 1995
WAGNER REVISION STEM (MODIFICATION)
K953689 · Intermedics Orthopedics · Nov 1995
ZIRCONIA CERAMIC FEMORAL HEAD
K944689 · Wrightmedicaltechnologyinc · Oct 1995