Cleared Traditional

K971705 - IMPLEX HEP ACETABULAR CUP SYSTEM, CEMENTED

K971705 is an FDA 510(k) clearance for IMPLEX HEP ACETABULAR CUP SYSTEM, manufactured by Implex Corp.. The device is a Class 2 Orthopedic device with 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

FDA 510(k) Submission Details - K971705

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.

JDI Device Classification - Class 2, Special Controls

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 514
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