Cleared Traditional

K203698 - CoLink Sfx Implant System

K203698 is an FDA 510(k) clearance for CoLink Sfx Implant System, manufactured by In2bones USA, LLC. The device is a Class 2 Orthopedic device with product code HTY cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K203698 · In2bones USA, LLC · Orthopedic device
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May 2021
Decision
137d
Days
Class 2
Risk

K203698 is an FDA 510(k) clearance for the CoLink Sfx Implant System. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by In2bones USA, LLC (Memphis, US). The FDA issued a Cleared decision on May 4, 2021 after a review of 137 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 In2bones USA, LLC devices

FDA 510(k) Submission Details - K203698

510(k) Number K203698 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2020
Decision Date May 04, 2021
Days to Decision 137 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 slower than avg
Panel avg: 122d · This submission: 137d
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 Peers - HTY Pin, Fixation, Smooth

All 158
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K203698.
Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires
K213982 · Pacific Instruments · Feb 2022
restor3d Pin Implants
K211789 · Restor3d · Jan 2022
Small Bone Nailing System
K211439 · Skeletal Dynamics, Inc. · Sep 2021
LimaCorporate Kirschner Wire
K203475 · Lima Corporate S.P.A. · Feb 2021
PediFlex Flexible Nail System
K201838 · OrthoPediatrics Corp. · Jan 2021
OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated Design
K203465 · OSSIO , Ltd. · Jan 2021