Cleared Traditional

DEPUY PROFILE ROUND HEAD INTERFERENCE SCREW, DEPUY PHANTOM RESORBABLE INTERFERENCE SCREW (K982662) - FDA 510(k) Clearance

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

K982662 · DePuy Orthopaedics, Inc. · Orthopedic device
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Oct 1998
Decision
90d
Days
Class 2
Risk

K982662 is an FDA 510(k) clearance for the DEPUY PROFILE ROUND HEAD INTERFERENCE SCREW, DEPUY PHANTOM RESORBABLE INTERFE.... Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by DePuy Orthopaedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on October 28, 1998 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 888.3040 - 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 DePuy Orthopaedics, Inc. devices

Submission Details

510(k) Number K982662 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1998
Decision Date October 28, 1998
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 HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HWC Screw, Fixation, Bone

All 416
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K982662.
BIOABSORBABLE INTERFERENCE SCREWS
K984320 · Smith & Nephew, Inc. · Jan 1999
OSTEO COMPRESSION CONDYLE SCREW SYSTEM
K983508 · Osteonics Corp. · Dec 1998
OSTEO 4.0MM CANNULATED SCREW SYSTEM
K983165 · Osteonics Corp. · Dec 1998
ARTHROTEK INTERFERENCE SCREW
K982497 · Biomet, Inc. · Oct 1998
SYNTHES (USA) DISTAL FEMUR PLATE (DFP) SYSTEM
K982222 · Synthes (Usa) · Jul 1998
ACL AVULSION LAG SCREW WITH SHEATH MODEL NUMBER AR-6001
K981187 · Arthrex, Inc. · Jul 1998