Cleared Traditional

K042356 - SYNTHES 1.0/1.2 MM PLUSDRIVE SCREWS

K042356 is an FDA 510(k) clearance for SYNTHES 1.0/1.2 MM PLUSDRIVE SCREWS, manufactured by Synthes (Usa). The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K042356 · Synthes (Usa) · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2004
Decision
37d
Days
Class 2
Risk

K042356 is an FDA 510(k) clearance for the SYNTHES 1.0/1.2 MM PLUSDRIVE SCREWS. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on October 7, 2004 after a review of 37 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 Synthes (Usa) devices

FDA 510(k) Submission Details - K042356

510(k) Number K042356 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2004
Decision Date October 07, 2004
Days to Decision 37 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
85d faster than avg
Panel avg: 122d · This submission: 37d
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 923
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K042356.
ARTHREX TENODESIS SCREW FAMILY
K041356 · Arthrex, Inc. · Nov 2004
BIOANCHOR WITH DISPOSABLE DRIVER, PRELOADED WITH ONE #2 HERCULINE SUTURE
K042778 · Linvatec Corp. · Nov 2004
SCANDIUS ABSORBABLE ACL RECONSTRUCTION SYSTEM
K041961 · Scandius Biomedical, Inc. · Oct 2004
ENDOTINE MIDFACE B 4.5 DEVICE
K041835 · Coapt Systems, Inc. · Sep 2004
HYPROCURE SUBTALAR IMPLANT SYSTEM
K042030 · Graham Medical Technologies, LLC · Sep 2004
BONE-LOK MVP CORTICAL-CANCELLOUS COMPRESSION DEVICE
K042244 · Triage Medical, Inc. · Sep 2004