Cleared Traditional

K001759 - HEDROCEL REVISION CUP

K001759 is the FDA 510(k) clearance for HEDROCEL REVISION CUP by Implex Corp.. It is a Class 2 Orthopedic device (product code JDI) cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K001759 · Implex Corp. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Aug 2000
Decision
76d
Days
Class 2
Risk

K001759 is an FDA 510(k) clearance for the HEDROCEL REVISION CUP, MODEL 02-2YY-ZZZZ. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Implex Corp. (Allendale, US). The FDA issued a Cleared decision on August 24, 2000 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3350 - 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 K001759 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2000
Decision Date August 24, 2000
Days to Decision 76 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
46d faster than avg
Panel avg: 122d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3350
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 - JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

All 435
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K001759.
TRIDENT ALL POLY CUP
K001956 · Howmedica Osteonics Corp. · Dec 2000
DEPUY C-STEM SYSTEM
K003421 · DePuy Orthopaedics, Inc. · Dec 2000
ONCOLOGY SALVAGE SYSTEM
K002757 · Biomet, Inc. · Nov 2000
NEW BIO-MOORE ENDO HEAD, TAPER ADAPTER
K002106 · Biomet, Inc. · Jul 2000
TI-MAX PROTRUSIO CAGE
K001376 · Biomet, Inc. · Jul 2000
TORNIER CEMENT RESTRICTOR
K001932 · Tornier · Jul 2000