Cleared Traditional

K160946 - 4.0 and 6.5 Cancellous Bone Screw and Washer

K160946 is an FDA 510(k) clearance for 4.0 and 6.5 Cancellous Bone Screw and W..., manufactured by Smv Scientific. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 244-day FDA review.

K160946 · Smv Scientific · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2016
Decision
244d
Days
Class 2
Risk

K160946 is an FDA 510(k) clearance for the 4.0 and 6.5 Cancellous Bone Screw and Washer. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Smv Scientific (Austin, US). The FDA issued a Cleared decision on December 5, 2016 after a review of 244 days - an extended review 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: 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.

FDA 510(k) Submission Details - K160946

510(k) Number K160946 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2016
Decision Date December 05, 2016
Days to Decision 244 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
122d slower than avg
Panel avg: 122d · This submission: 244d
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

Empirical Testing Corp
Kenneth C. Maxwell II

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 1042
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K160946.
RASL Repair Kit
K161334 · Radicle Orthopaedics, Inc. · Feb 2017
GEO Bone Screw System
K161904 · Gramercy Extremity Orthopeidics, LLC · Jan 2017
KLS Martin Cannulated Headless Screws
K161259 · KLS-Martin L.P. · Dec 2016
ToeTac™ 10° Hammertoe Fixation System
K161778 · Restore Surgical, LLC Dba Instratek · Nov 2016
Tyber Medical BioTy® Nanotopography Trauma Screw
K161597 · Tyber Medical, LLC · Nov 2016
AmorChem Titanium Porous Fixation Device
K160791 · Amorchem Holdings, Inc. · Nov 2016