Cleared Traditional

K980486 - IMPLEX HEP ACETABULAR REVISION CUP, CEMENTED OR CEMENTLESS MODEL A-240 SYSTEM (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K980486 · Implex Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1998
Decision
64d
Days
Class 2
Risk

K980486 is an FDA 510(k) clearance for the IMPLEX HEP ACETABULAR REVISION CUP, CEMENTED OR CEMENTLESS MODEL A-240 SYSTEM. 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 April 14, 1998 after a review of 64 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 K980486 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1998
Decision Date April 14, 1998
Days to Decision 64 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 122d · This submission: 64d
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 561
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K980486.
Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners
K243571 · Zimmer Biomet · Jul 2025
Anthology Hip Stems
K240783 · Smith & Nephew, Inc. · Oct 2024
Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component
K241716 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Aug 2024
Stryker Orthopaedics Hip Systems Labeling Update
K240418 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Apr 2024
Global Modular Replacement System
K233261 · Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · Dec 2023
Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee
K222056 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Jan 2023