Cleared Traditional

K131471 - SELF-COMPRESSIVE SCREW

K131471 is an FDA 510(k) clearance for 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 98-day FDA review.

K131471 · Neosteo · Orthopedic device
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Aug 2013
Decision
98d
Days
Class 2
Risk

K131471 is an FDA 510(k) clearance for the SELF-COMPRESSIVE SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Neosteo (Round Rock, US). The FDA issued a Cleared decision on August 28, 2013 after a review of 98 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Neosteo devices

FDA 510(k) Submission Details - K131471

510(k) Number K131471 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2013
Decision Date August 28, 2013
Days to Decision 98 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
24d faster than avg
Panel avg: 122d · This submission: 98d
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 691
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K131471.
DEPUY SYNTHES SPINE DENS ACCESS SYSTEM
K132910 · Synthes USA Products, LLC · Dec 2013
ARTHREX COMPRESSION FT SCREWS
K132217 · Arthrex, Inc. · Nov 2013
ZIMMER MOTIONLOC SCREW FOR PERIARTICULAR LOCKING PLATE SYSTEM
K130810 · Zimmer, Inc. · Sep 2013
HAMMERTOE CORRECTION SYSTEM
K130859 · Arthrosurface, Inc. · Jul 2013
MEDLINE CANNULATED SCREW
K130319 · Medline Industries, Inc. · May 2013
MAXTORQUE SCREW SYSTEM
K131324 · Orthohelix Surgical Designs, Inc. · May 2013