Cleared Traditional

K013044 - SYNTHES 3.9 MM PELVIC SCREWS

K013044 is an FDA 510(k) clearance for SYNTHES 3.9 MM PELVIC 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 84-day FDA review.

K013044 · Synthes (Usa) · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2001
Decision
84d
Days
Class 2
Risk

K013044 is an FDA 510(k) clearance for the SYNTHES 3.9 MM PELVIC 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 December 3, 2001 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 Synthes (Usa) devices

FDA 510(k) Submission Details - K013044

510(k) Number K013044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2001
Decision Date December 03, 2001
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.

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 K013044.
RESORBABLE NO PROFILE SCREW AND WASHER
K012469 · Biomet Manufacturing, Inc. · Dec 2001
SOFT TISSUE SCREW AND WASHER
K012572 · Biomet, Inc. · Dec 2001
SYNTHES 2.4 MM CANNULATED SCREW
K012945 · Synthes (Usa) · Dec 2001
MODIFICATION TO: 1.5 BONE FIXATION KIT, MODELS BXS6114, BXS6214
K013546 · Bionx Implants, Inc. · Nov 2001
RESORBABLE SCREW ANCHOR
K012872 · Arthrotek, Inc. · Nov 2001
INTEX SCREW
K012798 · Biomet, Inc. · Nov 2001