Cleared Special

K062903 - SBI CARPAL FUSION PLATE

K062903 is an FDA 510(k) clearance for SBI CARPAL FUSION PLATE, manufactured by Small Bone Innovations, Inc.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Special 510(k) pathway after a 23-day FDA review.

K062903 · Small Bone Innovations, Inc. · Orthopedic device
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Oct 2006
Decision
23d
Days
Class 2
Risk

K062903 is an FDA 510(k) clearance for the SBI CARPAL FUSION PLATE. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Small Bone Innovations, Inc. (New York, US). The FDA issued a Cleared decision on October 20, 2006 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 Small Bone Innovations, Inc. devices

FDA 510(k) Submission Details - K062903

510(k) Number K062903 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2006
Decision Date October 20, 2006
Days to Decision 23 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
99d faster than avg
Panel avg: 122d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

HRS Device Classification - Class 2, Special Controls

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - HRS Plate, Fixation, Bone

All 1033
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K062903.
ACUMED CONGRUENT BONE PLATE SYSTEM
K063460 · Acumed, LLC · Dec 2006
UNIVERSAL LOCKING SYSTEM, 2.7MM PLATES & SCREWS
K063303 · Zimmer, Inc. · Nov 2006
PROFYLE SYSTEM
K062498 · Howmedica Osteonics Corp. · Oct 2006
EBI OPTILOCK UPPER EXTREMITY PLATING SYSTEM
K062494 · Ebi, L.P. · Oct 2006
SYNTHES LCP DISTAL FEMUR PLATES
K062564 · Synthes (Usa) · Oct 2006
ARTHREX RETROBUTTON, 15MM, 60MM, RETROBUTTON, LONG, 15MM, 60MM
K062747 · Arthrex, Inc. · Sep 2006