Cleared Traditional

K955117 - IMPLEX CERAMIC HEAD

K955117 is the FDA 510(k) clearance for IMPLEX CERAMIC HEAD by Implex Corp.. It is a Class 2 Orthopedic device (product code LZO) cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K955117 · Implex Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1996
Decision
148d
Days
Class 2
Risk

K955117 is an FDA 510(k) clearance for the IMPLEX CERAMIC HEAD. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Implex Corp. (Allendale, US). The FDA issued a Cleared decision on April 5, 1996 after a review of 148 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 Implex Corp. devices

Submission Details

510(k) Number K955117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1995
Decision Date April 05, 1996
Days to Decision 148 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
26d slower than avg
Panel avg: 122d · This submission: 148d
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 419
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K955117.
NATURAL-HIP SYSTEM - CALCAR REPLACEMENT HIP STEM
K961727 · Intermedics Orthopedics · Jul 1996
APR FULLY TEXTURED HIP STEM
K961589 · Intermedics Orthopedics · Jul 1996
CLS STEM (MODIFICATION)
K953690 · Intermedics Orthopedics · Jun 1996
BIMETRIC COCR HEAD/NECK REPLACEMENT HIP STEM
K955350 · Biomet, Inc. · Feb 1996
FINE GRAIN CAST COBALT CHROMIUM HIP STEMS
K953925 · Biomet, Inc. · Jan 1996
CLS ACETABULAR COMPONENT (MODIFICATION)
K953688 · Intermedics Orthopedics · Nov 1995