Cleared Traditional

K170021 - SMV Scientific Cannulated Screws

K170021 is an FDA 510(k) clearance for SMV Scientific Cannulated Screws, 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 139-day FDA review.

K170021 · Smv Scientific · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2017
Decision
139d
Days
Class 2
Risk

K170021 is an FDA 510(k) clearance for the SMV Scientific Cannulated Screws. 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 May 22, 2017 after a review of 139 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.

FDA 510(k) Submission Details - K170021

510(k) Number K170021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2017
Decision Date May 22, 2017
Days to Decision 139 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
17d slower than avg
Panel avg: 122d · This submission: 139d
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

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 K170021.
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