Cleared Traditional

K001471 - THE IMPLEX HEDROCEL ACETABULAR AUGMENT

K001471 is the FDA 510(k) clearance for THE IMPLEX HEDROCEL ACETABULAR AUGMENT by Implex Corp.. It is a Class 2 Orthopedic device (product code LWJ) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K001471 · Implex Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2000
Decision
88d
Days
Class 2
Risk

K001471 is an FDA 510(k) clearance for the THE IMPLEX HEDROCEL ACETABULAR AUGMENT, XX-YYY-ZZZZ. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented (product code LWJ), Class II - Special Controls.

Submitted by Implex Corp. (Allendale, US). The FDA issued a Cleared decision on August 7, 2000 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3360 - 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 Implex Corp. devices

Submission Details

510(k) Number K001471 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2000
Decision Date August 07, 2000
Days to Decision 88 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
34d faster than avg
Panel avg: 122d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LWJ Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3360
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 - LWJ Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented

All 55
Devices cleared under the same product code (LWJ) and FDA review panel - the closest regulatory comparables to K001471.
INTER-OP DURASUL ACETABULAR INSERTS (4MM)
K002575 · Sulzer Orthopedics, Inc. · Nov 2000
MODIFICATION TO PROVIDENT HIP SYSTEM
K002796 · Stelkast Company · Sep 2000
ACUMATCH P-SERIES PRESS-FIT PLASMA, ACUMATCH P-SERIES PRESS-FIT, ACUMATCH L-SERIES PRESS-FIT
K002141 · Exactech, Inc. · Aug 2000
MODIFICATION TO PROVIDENT HIP SYSTEM
K001745 · Stelkast Company · Jul 2000
SL-PLUS AND SLR-PLUS STEMS
K001942 · Plus Orthopedics · Jul 2000
MODULAR-PLUS REVISION STEM
K994126 · Plus Orthopedics · May 2000