Cleared Traditional

K013786 - DRG ORTHOHEX SS BONE SCREW

K013786 is an FDA 510(k) clearance for DRG ORTHOHEX SS BONE SCREW, manufactured by Doctor'S Research Group, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K013786 · Doctor'S Research Group, Inc. · Orthopedic device
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Dec 2001
Decision
33d
Days
Class 2
Risk

K013786 is an FDA 510(k) clearance for the DRG ORTHOHEX SS BONE SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Doctor'S Research Group, Inc. (Plymouth, US). The FDA issued a Cleared decision on December 17, 2001 after a review of 33 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 Doctor'S Research Group, Inc. devices

FDA 510(k) Submission Details - K013786

510(k) Number K013786 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2001
Decision Date December 17, 2001
Days to Decision 33 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 122d · This submission: 33d
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 921
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K013786.
INION CPS BSSO SCREW
K020266 · Inion , Ltd. · Feb 2002
AOS CANNULATED BONE SCREW SYSTEM
K014185 · Advanced Orthopaedic Solutions, Inc. · Feb 2002
SELF-COUNTERSINKING BONE SCREW
K013534 · Biomet Orthopedics, Inc. · Dec 2001
SURGICAL DYNAMICS MENISCAL STAPLE
K013890 · United States Surgical, A Division of Tyco Healthc · Dec 2001
REUNITE FUSION SCREW
K011451 · Biomet, Inc. · Dec 2001
RESORBABLE NO PROFILE SCREW AND WASHER
K012469 · Biomet Manufacturing, Inc. · Dec 2001