Cleared Traditional

K980440 - DEPUY ORTHOTECH PHANTOM SOF-THREAD SOFT TISSUE INTERFERENCE SCREW

K980440 is an FDA 510(k) clearance for DEPUY ORTHOTECH PHANTOM SOF-THREAD SOFT..., 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 58-day FDA review.

K980440 · Depuy, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1998
Decision
58d
Days
Class 2
Risk

K980440 is an FDA 510(k) clearance for the DEPUY ORTHOTECH PHANTOM SOF-THREAD SOFT TISSUE INTERFERENCE SCREW. 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 April 3, 1998 after a review of 58 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 - K980440

510(k) Number K980440 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received February 04, 1998
Decision Date April 03, 1998
Days to Decision 58 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 122d · This submission: 58d
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 K980440.
SYNTHES 3.0 MM PC-FIX SYSTEM
K981372 · Synthes (Usa) · May 1998
HOWMEDICA AND HOWMEDICA LEIBINGER BONE SCREW WASHERS
K980364 · Howmedica Corp. · Apr 1998
INNOVASIVE DEVICES MENISCAL SCREW
K980681 · Innovasive Devices, Inc. · Apr 1998
BIOFIX BIOABSORBABLE SELF-REINFORCED POLY-L-LACTIDE THREADED BROWLIFT SCREW
K972919 · Bionx Implants, Inc. · Mar 1998
AUTO-DRIVE BONE SCREW
K974785 · Osteomed Corp. · Mar 1998
BTI LARGE (7.0MM) CANNULATED TRANSFIXING SCREWS
K974756 · Biodynamic Technologies, Inc. · Mar 1998