Cleared Traditional

K130019 - J-SCREW COMPRESSION SCREW

K130019 is an FDA 510(k) clearance for J-SCREW COMPRESSION SCREW, manufactured by Competitive Engineering, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 684-day FDA review.

K130019 · Competitive Engineering, Inc. · Orthopedic device
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Nov 2014
Decision
684d
Days
Class 2
Risk

K130019 is an FDA 510(k) clearance for the J-SCREW COMPRESSION SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Competitive Engineering, Inc. (Tucson, US). The FDA issued a Cleared decision on November 18, 2014 after a review of 684 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Competitive Engineering, Inc. devices

FDA 510(k) Submission Details - K130019

510(k) Number K130019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2013
Decision Date November 18, 2014
Days to Decision 684 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
562d slower than avg
Panel avg: 122d · This submission: 684d
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 742
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K130019.
3.Omm Biomet Cannulated Screw System
K143188 · Biomet Manufacturing Corp · Dec 2014
AIS Odontoid Fracture Fixation System
K142707 · Aesculap Implant System, Inc. · Dec 2014
PhaLinx Hammertoe System
K142585 · Wrightmedicaltechnologyinc · Nov 2014
Biomet Headless Compression and Twist-off Screws
K142658 · Biomet Manufacturing Corp · Nov 2014
MAGNA-FX AND MINI MAGNA-FX CANNULATED SCREW FIXATION SYSTEM
K142442 · Zimmer, Inc. · Oct 2014
CORTICAL SCREW 3.5, T15, SELF-TAPPING, TITANIUM, CORTICAL SCREW 4.5, T25, SELF TAPPING, TITANIUM
K141949 · Aap Implantate AG · Sep 2014