Cleared Traditional

K993762 - I.CO.S SCREW

K993762 is an FDA 510(k) clearance for I.CO.S SCREW, manufactured by New Deal, S.A.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K993762 · New Deal, S.A. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2000
Decision
88d
Days
Class 2
Risk

K993762 is an FDA 510(k) clearance for the I.CO.S SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by New Deal, S.A. (Potomac, US). The FDA issued a Cleared decision on February 4, 2000 after a review of 88 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 New Deal, S.A. devices

FDA 510(k) Submission Details - K993762

510(k) Number K993762 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1999
Decision Date February 04, 2000
Days to Decision 88 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
34d faster than avg
Panel avg: 122d · This submission: 88d
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 985
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K993762.
NONLINEAR TAPER LAG SCREW
K994382 · Theken Surgical · Mar 2000
THE LIGAMENT ANCHOR SOFT SCREW
K994152 · Corin USA · Mar 2000
ACUFEX SPIKED WASHER SYSTEM, ACUFEX SUTURE WASHER SYSTEM, ACUFEX CANCELLOUS SCREW AND SPIKED WASHER SYSTEM
K994202 · Smith & Nephew, Inc. · Feb 2000
SYNTHES 4.0 AND 5.0 MM LOCKING SCREWS
K000089 · Synthes (Usa) · Feb 2000
BIORCI SCREW
K992396 · Smith & Nephew Endoscopy, Inc. · Jan 2000
EIS THREADED SCREW FRACTURE FIXATION
K991964 · Groupe Lepine · Dec 1999