Cleared Traditional

K981670 - DEPUY PROFILE ROUND HEAD INTERFERENCE SCREW AND DEPUY PHANTOM RESORBABLE INTERFERENCE SCREW

K981670 is an FDA 510(k) clearance for DEPUY PROFILE ROUND HEAD INTERFERENCE S..., manufactured by Depuy, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K981670 · Depuy, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1998
Decision
41d
Days
Class 2
Risk

K981670 is an FDA 510(k) clearance for the DEPUY PROFILE ROUND HEAD INTERFERENCE SCREW AND DEPUY PHANTOM RESORBABLE INTE.... Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on June 22, 1998 after a review of 41 days - a notably fast clearance cycle.

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: 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 Depuy, Inc. devices

FDA 510(k) Submission Details - K981670

510(k) Number K981670 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1998
Decision Date June 22, 1998
Days to Decision 41 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
81d faster than avg
Panel avg: 122d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

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 974
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K981670.
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
CROSS MEDICAL BONE PLATE SYSTEM/ CM BONE PLATE SYSTEM/CROSS TI BONE PLATE SYSTEM
K961320 · Buckman Co., Inc. · Jun 1998
RCI FIXATION SCREWS
K980841 · Smith & Nephew, Inc. · May 1998
OSTEO 4.0MM CANNULATED SCREW SYSTEM
K981259 · Osteonics Corp. · May 1998
SYNTHES 3.0 MM PC-FIX SYSTEM
K981372 · Synthes (Usa) · May 1998