Cleared Traditional

K150772 - Snap-Off Self-Compressive Screw

K150772 is an FDA 510(k) clearance for Snap-Off Self-Compressive Screw, manufactured by Neosteo. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K150772 · Neosteo · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2015
Decision
45d
Days
Class 2
Risk

K150772 is an FDA 510(k) clearance for the Snap-Off Self-Compressive Screw. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Neosteo (Nantes, FR). The FDA issued a Cleared decision on May 8, 2015 after a review of 45 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 Neosteo devices

FDA 510(k) Submission Details - K150772

510(k) Number K150772 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2015
Decision Date May 08, 2015
Days to Decision 45 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
77d faster than avg
Panel avg: 122d · This submission: 45d
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 Consultant

The OrthoMedix Group, Inc.
JD Webb

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HWC Screw, Fixation, Bone

All 1019
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K150772.
Arthrex RetroFusion Screw
K151078 · Arthrex, Inc. · May 2015
Life Spine Cannulated Screws
K150126 · Life Spine, Inc. · May 2015
Subtalar Spacer System (STS)
K150213 · Wrightmedicaltechnologyinc · May 2015
SMV Scientific 4.5 mm Bone Screws
K150188 · Summit Medventures · Apr 2015
PHALINX Hammertoe System
K150252 · Wrightmedicaltechnologyinc · Apr 2015
aap Cortical Screw 1.5, self-tapping, aap Cortical Screw 1.5, self-tapping, Titanium
K150974 · Aap Implantate AG · Apr 2015