Cleared Special

K120998 - SOLSTICE CROSS CONNECTOR

K120998 is an FDA 510(k) clearance for SOLSTICE CROSS CONNECTOR, manufactured by Life Spine. The device is a Class 2 Orthopedic device with product code KWP cleared through the Special 510(k) pathway after a 182-day FDA review.

K120998 · Life Spine · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2012
Decision
182d
Days
Class 2
Risk

K120998 is an FDA 510(k) clearance for the SOLSTICE CROSS CONNECTOR. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Life Spine (Hoffman Estates, US). The FDA issued a Cleared decision on October 1, 2012 after a review of 182 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K120998

510(k) Number K120998 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2012
Decision Date October 01, 2012
Days to Decision 182 days
Submission Type Special
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
60d slower than avg
Panel avg: 122d · This submission: 182d
Pathway characteristics
Modification to existing cleared device.

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 429
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K120998.
VERTIFLEX SPINOUS PROCESS FIXATION PLATE
K122509 · Vertiflex, Inc. · Dec 2012
PIONEER POSTERIOR OCCIPITO-CERVICO-THORACIC (OCT) SYSTEM
K121725 · Pioneer Surgical Technology, Inc. · Nov 2012
RELIANCE POSTERIOR CERVICAL- THORACIC SYSTEM
K122292 · Reliance Medical Systems, LLC · Oct 2012
NEXTGEN ALTIUS OCT SYSTEM
K122378 · Biomet Spine (Aka Ebi, LLC) · Sep 2012
RENOIR POSTERIOR CERVIAL FIXATION SYSTEM
K121136 · Accel Spine · Aug 2012
CASIAN, 3.5/4.5 CONNECTORS
K121808 · K2m, Inc. · Jul 2012
K120998 · SOLSTICE CROSS CONNECTOR
Download PDF FDA Summary Life Spine