Cleared Traditional

K971705 - IMPLEX HEP ACETABULAR CUP SYSTEM

K971705 is the FDA 510(k) clearance for IMPLEX HEP ACETABULAR CUP SYSTEM by Implex Corp.. It is a Class 2 Orthopedic device (product code JDI) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K971705 · Implex Corp. · Orthopedic device
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Aug 1997
Decision
90d
Days
Class 2
Risk

K971705 is an FDA 510(k) clearance for the IMPLEX HEP ACETABULAR CUP SYSTEM, CEMENTED. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Implex Corp. (Rockville, US). The FDA issued a Cleared decision on August 6, 1997 after a review of 90 days - within the typical 510(k) review window.

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: 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 K971705 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1997
Decision Date August 06, 1997
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
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 K971705.
OSTEONICS OMNIFIT-C CEMENTED HIP STEM (LINE EXTENSION)
K972460 · Osteonics Corp. · Sep 1997
ULTIMA AND ULTIMA LX CEMENTED FEMORAL STEM
K972435 · Johnson & Johnson Professionals, Inc. · Sep 1997
RECOVERY PROTRUSIO CAGE
K971890 · Biomet, Inc. · Aug 1997
HEMISPHERE CEMENTED CUP
K971581 · Ortho Development Corp. · Jul 1997
DURATION STABILIZED UHMWPE
K963612 · Howmedica Corp. · Jun 1997
OSTEONICS NORMALIZED AD ACETABULAR COMPONENT SYSTEM
K970697 · Osteonics Corp. · Apr 1997