Cleared Traditional

K161489 - Syntorr K-wire and Pin System

K161489 is an FDA 510(k) clearance for Syntorr K-wire and Pin System, manufactured by Syntorr, Inc.. The device is a Class 2 Orthopedic device with product code HTY cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K161489 · Syntorr, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2016
Decision
107d
Days
Class 2
Risk

K161489 is an FDA 510(k) clearance for the Syntorr K-wire and Pin System. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Syntorr, Inc. (Palo Alto, US). The FDA issued a Cleared decision on September 16, 2016 after a review of 107 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 - K161489

510(k) Number K161489 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2016
Decision Date September 16, 2016
Days to Decision 107 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
15d faster than avg
Panel avg: 122d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HTY Device Classification - Class 2, Special Controls

Product Code HTY Pin, Fixation, Smooth
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

Musculoskeletal Clinical Regulatory Advisers, LLC
Samuel Pollard

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 - HTY Pin, Fixation, Smooth

All 196
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K161489.
dynaMX Intramedullary Implant
K170326 · Arthrex, Inc. · Jul 2017
Stryker SonicPin System
K170418 · Stryker Trauma GmbH · Jun 2017
Precifit Medical Kirschner Wires
K163327 · Precifit Medical, Ltd. · May 2017
Additive Orthopaedics Hammertoe Correction System
K160264 · Additive Orthopaedics, LLC · Jun 2016
StarFuse Interphalangeal Pin
K160194 · Phalanx Innovations · Apr 2016
S-Wire
K152662 · Spinal Resources, Inc. · Mar 2016