Cleared Special

K100107 - SMITH & NEPHEW SURESHOT DISTAL TARGETIN...

K100107 is the FDA 510(k) clearance for SMITH & NEPHEW SURESHOT DISTAL TARGETIN... by Smith & Nephew, Inc.. It is a Class 2 Orthopedic device (product code OLO) cleared through the Special 510(k) pathway after a 40-day FDA review.

K100107 · Smith & Nephew, Inc. · Orthopedic device
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Feb 2010
Decision
40d
Days
Class 2
Risk

K100107 is an FDA 510(k) clearance for the SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V2.0. Classified as Orthopedic Stereotaxic Instrument within the OLO classification (a category covering orthopedic stereotaxic and surgical navigation instruments), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on February 23, 2010 after a review of 40 days - a notably fast clearance cycle.

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. 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.

View all Smith & Nephew, Inc. devices

Submission Details

510(k) Number K100107 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 2010
Decision Date February 23, 2010
Days to Decision 40 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
82d faster than avg
Panel avg: 122d · This submission: 40d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 364
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K100107.
ORTHOMAP 3D 1.1 MODULE
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ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-HIP
K091998 · Mako Surgical Corp. · Sep 2009
SMITH & NEPHEW PIGALILEO SCREW TARGETING SYSTEM, VERSION 1.1
K092497 · Smith & Nephew, Inc. · Sep 2009
MAKO SURGICAL TACTILE GUIDANCE SYSTEM-HIP
K083644 · Mako Surgical Corp. · Jun 2009