Cleared Special

K083310 - SPINE & TRAUMA ICT

K083310 is an FDA 510(k) clearance for SPINE & TRAUMA ICT, manufactured by Brainlab AG. The device is a Class 2 Orthopedic device with product code OLO cleared through the Special 510(k) pathway after a 142-day FDA review.

K083310 · Brainlab AG · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2009
Decision
142d
Days
Class 2
Risk

K083310 is an FDA 510(k) clearance for the SPINE & TRAUMA ICT. Classified as Orthopedic Stereotaxic Instrument within the OLO classification (a category covering orthopedic stereotaxic and surgical navigation instruments), Class II - Special Controls.

Submitted by Brainlab AG (Feldkirchen, DE). The FDA issued a Cleared decision on April 1, 2009 after a review of 142 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 882.4560 - 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 - K083310

510(k) Number K083310 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 2008
Decision Date April 01, 2009
Days to Decision 142 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
20d slower than avg
Panel avg: 122d · This submission: 142d
Pathway characteristics
Modification to existing cleared device.

OLO Device Classification - Class 2, Special Controls

Product Code OLO Orthopedic Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
Definition Stereotaxic Guidance During Orthopedic Surgery Procedures. Indicated For Orthopedic Joint Or Spine Surgery. Neurological Stereotaxic Instruments Are Classified Under Product Code Haw.
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 - OLO Orthopedic Stereotaxic Instrument

All 444
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K083310.
MAKO SURGICAL TACTILE GUIDANCE SYSTEM-HIP
K083644 · Mako Surgical Corp. · Jun 2009
SMITH & NEPHEW PIGALILEO SCREW TARGETING SYSTEM V 1.0
K090420 · Smith & Nephew, Inc. · May 2009
BRAINLAB HIP UNLIMITED, CI HIP UNLIMITED
K083483 · Brainlab AG · Apr 2009
PIGALILEO TKR BASE V2.3 AND CAS V4.1
K090313 · Smith & Nephew, Inc. · Mar 2009
ORTHO-MAP-ONCOLOGY NAVIGATION SOFTWARE, MODELS 6005-650-000, 6005-651-000
K083009 · Stryker Leibinger GmbH & Co KG · Feb 2009
IMNS MEDACTA NAVIGATION SYSTEM
K083872 · Medacta International S.A. · Jan 2009
K083310 · SPINE & TRAUMA ICT
Download PDF FDA Summary Brainlab AG