Cleared Traditional

OSTEO 4.0MM CANNULATED SCREW SYSTEM (K983165) - FDA 510(k) Clearance

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

K983165 · Osteonics Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
84d
Days
Class 2
Risk

K983165 is an FDA 510(k) clearance for the OSTEO 4.0MM CANNULATED SCREW SYSTEM. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on December 3, 1998 after a review of 84 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 Osteonics Corp. devices

Submission Details

510(k) Number K983165 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1998
Decision Date December 03, 1998
Days to Decision 84 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
38d faster than avg
Panel avg: 122d · This submission: 84d
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 403
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K983165.
STAINLESS STEEL TAPER FOREMAN NAIL CANNULATED SCREW, STAINLESS STEEL CANNULATED SCREW, SHORT THREAD, STAINLESS STEEL PED
K984209 · Biomet, Inc. · Feb 1999
BIOABSORBABLE INTERFERENCE SCREWS
K984320 · Smith & Nephew, Inc. · Jan 1999
OSTEO COMPRESSION CONDYLE SCREW SYSTEM
K983508 · Osteonics Corp. · Dec 1998
DEPUY PROFILE ROUND HEAD INTERFERENCE SCREW, DEPUY PHANTOM RESORBABLE INTERFERENCE SCREW
K982662 · DePuy Orthopaedics, Inc. · Oct 1998
ARTHROTEK INTERFERENCE SCREW
K982497 · Biomet, Inc. · Oct 1998
SYNTHES (USA) DISTAL FEMUR PLATE (DFP) SYSTEM
K982222 · Synthes (Usa) · Jul 1998