Cleared Traditional

K181610 - ActivOrtho Nitinol Compression Screw Sy...

K181610 is the FDA 510(k) clearance for ActivOrtho Nitinol Compression Screw Sy... by Activortho, Inc.. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K181610 · Activortho, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2019
Decision
266d
Days
Class 2
Risk

K181610 is an FDA 510(k) clearance for the ActivOrtho Nitinol Compression Screw System. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Activortho, Inc. (Plymouth, US). The FDA issued a Cleared decision on March 12, 2019 after a review of 266 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.

View all Activortho, Inc. devices

Submission Details

510(k) Number K181610 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2018
Decision Date March 12, 2019
Days to Decision 266 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
144d slower than avg
Panel avg: 122d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

Backroads Consulting, Inc.
Karen E. Warden

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 564
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K181610.
Arthrex TensionLoc System
K183628 · Arthrex, Inc. · Mar 2019
OsteoCentric Bone Plate and Screw System
K190430 · Osteocentric Trauma · Mar 2019
Wright Jones Fracture System
K183026 · Wrightmedicaltechnologyinc · Mar 2019
INnate Cannulated Screw System
K183603 · Exsomed Corporation · Mar 2019
CurvaFix Intramedullary Rodscrew System
K180050 · Curvafix, Inc. · Mar 2019
Vector Hammertoe Correction System
K183055 · Nvision Biomedical Technologies, LLC · Feb 2019