Cleared Traditional

K143249 - SOLSTICE OCT System

K143249 is the FDA 510(k) clearance for SOLSTICE OCT System by Life Spine, Inc.. It is a Class 2 Orthopedic device (product code KWP) cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K143249 · Life Spine, Inc. · Orthopedic device
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Apr 2015
Decision
146d
Days
Class 2
Risk

K143249 is an FDA 510(k) clearance for the SOLSTICE OCT System. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Life Spine, Inc. (Hoffman Estates, US). The FDA issued a Cleared decision on April 7, 2015 after a review of 146 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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

Submission Details

510(k) Number K143249 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2014
Decision Date April 07, 2015
Days to Decision 146 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
24d slower than avg
Panel avg: 122d · This submission: 146d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
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 - KWP Appliance, Fixation, Spinal Interlaminal

All 271
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K143249.
LnK Posterior Cervical Fixation System
K143278 · L & K Biomed Co., Ltd. · Jul 2015
OASYS System
K150753 · Stryker Corporation · Jun 2015
SOLSTICE OCT System
K142253 · Life Spine, Inc. · Apr 2015
SOLSTICE OCT System
K150229 · Life Spine, Inc. · Apr 2015
OASYS System
K142741 · Stryker Corporation · Jan 2015
SYNAPSE SYSTEM, SYNTHES OC FUSION SYSTEM
K141897 · Synthes USA Products, LLC · Sep 2014