Cleared Traditional

K161037 - Tarsa-Link Stand-Alone Wedge Fixation System

K161037 is an FDA 510(k) clearance for Tarsa-Link Stand-Alone Wedge Fixation S..., manufactured by Life Spine, Inc.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K161037 · Life Spine, Inc. · Orthopedic device
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Aug 2016
Decision
124d
Days
Class 2
Risk

K161037 is an FDA 510(k) clearance for the Tarsa-Link Stand-Alone Wedge Fixation System. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Life Spine, Inc. (Huntley, US). The FDA issued a Cleared decision on August 15, 2016 after a review of 124 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 Life Spine, Inc. devices

FDA 510(k) Submission Details - K161037

510(k) Number K161037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2016
Decision Date August 15, 2016
Days to Decision 124 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
2d slower than avg
Panel avg: 122d · This submission: 124d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRS Device Classification - Class 2, Special Controls

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - HRS Plate, Fixation, Bone

All 1251
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K161037.
ARIX Hand System
K161746 · Jeil Medical Corporation · Sep 2016
Additive Orthopaedics Bone Wedge System
K153207 · Additive Orthopaedics, LLC · Sep 2016
Alians Elbow Locking Plating System
K152289 · Newclip Technics · Aug 2016
Distal Radius Plating System
K161292 · Miami Device Solutions, LLC · Aug 2016
Converge
K153573 · Biomedical Enterprises, Inc. · Aug 2016
ARIX Foot System
K161864 · Jeil Medical Corporation · Aug 2016