Cleared Traditional

K143249 - SOLSTICE OCT System

K143249 is an FDA 510(k) clearance for SOLSTICE OCT System, manufactured by Life Spine, Inc.. The device is a Class 2 Orthopedic device with 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

FDA 510(k) Submission Details - K143249

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.

KWP Device Classification - Class 2, Special Controls

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 384
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K143249.
Reliance Posterior Cervical-Thoracic System
K142867 · Reliance Medical Systems, LLC · Apr 2015
Streamline OCT Occipito-Cervico-Thoracic System
K150254 · Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · Apr 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
Caspian OCT/MESA Mini/DENALI Mini Spinal System
K142558 · K2m · Dec 2014