Cleared Traditional

K113593 - NEXTGEN ALTIUS OCT SYSTEM

K113593 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 Traditional 510(k) pathway after a 134-day FDA review.

K113593 · Biomet Spine (Aka Ebi, LLC) · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2012
Decision
134d
Days
Class 2
Risk

K113593 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 April 17, 2012 after a review of 134 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 Biomet Spine (Aka Ebi, LLC) devices

FDA 510(k) Submission Details - K113593

510(k) Number K113593 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2011
Decision Date April 17, 2012
Days to Decision 134 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 122d · This submission: 134d
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 337
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K113593.
CASIAN, 3.5/4.5 CONNECTORS
K121808 · K2m, Inc. · Jul 2012
M.U.S.T PEDICLE SCREW SYSTEM
K121115 · Medacta International · Jul 2012
VERTEX RCCONSTRUCTION SYSTEM
K121191 · Medtronic Sofamor Danek, Inc. · Jun 2012
PIONEER POSTERIOR CERVICO THORACIC SYSTEM
K112757 · Pioneer Surgical Technology, Inc. · Mar 2012
NEON SYSTEM
K113346 · Ulrich GmbH & Co. KG · Feb 2012
OASYS SPINAL SYSTEM
K111719 · Stryker Spine · Jan 2012