Cleared Special

K122378 - NEXTGEN ALTIUS OCT SYSTEM

K122378 is an FDA 510(k) clearance for NEXTGEN ALTIUS OCT SYSTEM, manufactured by Biomet Spine (Aka Ebi, LLC). The device is a Class 2 Orthopedic device with product code KWP cleared through the Special 510(k) pathway after a 45-day FDA review.

K122378 · Biomet Spine (Aka Ebi, LLC) · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2012
Decision
45d
Days
Class 2
Risk

K122378 is an FDA 510(k) clearance for the NEXTGEN ALTIUS OCT SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Biomet Spine (Aka Ebi, LLC) (Parsippany, US). The FDA issued a Cleared decision on September 20, 2012 after a review of 45 days - a notably fast clearance 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. Low regulatory complexity profile. 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 - K122378

510(k) Number K122378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2012
Decision Date September 20, 2012
Days to Decision 45 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
77d faster than avg
Panel avg: 122d · This submission: 45d
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 413
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K122378.
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
SOLSTICE CROSS CONNECTOR
K120998 · Life Spine · Oct 2012
RENOIR POSTERIOR CERVIAL FIXATION SYSTEM
K121136 · Accel Spine · Aug 2012
CASIAN, 3.5/4.5 CONNECTORS
K121808 · K2m, Inc. · Jul 2012
M.U.S.T PEDICLE SCREW SYSTEM
K121115 · Medacta International · Jul 2012