Cleared Traditional

K984290 - IMPLEX RADIAL HEAD REPLACEMENT SYSTEM

K984290 is an FDA 510(k) clearance for IMPLEX RADIAL HEAD REPLACEMENT SYSTEM, manufactured by Implex Corp.. The device is a Class 2 Orthopedic device with product code KWI cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K984290 · Implex Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1999
Decision
182d
Days
Class 2
Risk

K984290 is an FDA 510(k) clearance for the IMPLEX RADIAL HEAD REPLACEMENT SYSTEM. Classified as Prosthesis, Elbow, Hemi-, Radial, Polymer (product code KWI), Class II - Special Controls.

Submitted by Implex Corp. (Allendale, US). The FDA issued a Cleared decision on June 1, 1999 after a review of 182 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3170 - 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 - K984290

510(k) Number K984290 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1998
Decision Date June 01, 1999
Days to Decision 182 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
60d slower than avg
Panel avg: 122d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWI Device Classification - Class 2, Special Controls

Product Code KWI Prosthesis, Elbow, Hemi-, Radial, Polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3170
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 - KWI Prosthesis, Elbow, Hemi-, Radial, Polymer

All 31
Devices cleared under the same product code (KWI) and FDA review panel - the closest regulatory comparables to K984290.
ERS RADIAL HEAD REPLACEMENT
K000658 · DePuy Orthopaedics, Inc. · May 2000
RADIAL HEAD PROSTHESIS
K992220 · Smith & Nephew, Inc. · Feb 2000
MODULAR RADIAL HEAD
K991915 · Wrightmedicaltechnologyinc · Sep 1999
RADIAL HEAD IMPLANT
K982288 · Avanta Orthopaedics, Inc. · Sep 1998
METALLIC RADIAL HEAD IMPLANTS
K944507 · Wrightmedicaltechnologyinc · Jul 1995