Cleared Traditional

K051747 - SBI WRISTFIT

K051747 is an FDA 510(k) clearance for SBI WRISTFIT, manufactured by Small Bone Innovations, LLC. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K051747 · Small Bone Innovations, LLC · Orthopedic device
Download Printable Device Report (PDF)
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Sep 2005
Decision
69d
Days
Class 2
Risk

K051747 is an FDA 510(k) clearance for the SBI WRISTFIT. 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, LLC (New York, US). The FDA issued a Cleared decision on September 6, 2005 after a review of 69 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Small Bone Innovations, LLC devices

FDA 510(k) Submission Details - K051747

510(k) Number K051747 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2005
Decision Date September 06, 2005
Days to Decision 69 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
53d faster than avg
Panel avg: 122d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 1100
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K051747.
LOW PROFILE PLATE AND SCREW SYSTEM
K052614 · Arthrex, Inc. · Sep 2005
B-BOP PLATE
K052152 · New Deal, S.A. · Sep 2005
SYNTHES 4.5 MM LCP STRAIGHT RECONSTRUCTION PLATES
K051986 · Synthes (Usa) · Sep 2005
MIOT PLATING SYSTEM
K051945 · Orthofix Srl · Sep 2005
CHARLOTTE COMPRESSION PLATE
K051908 · Wrightmedicaltechnologyinc · Aug 2005
CHARLOTTE SMALL MTP FUSION PLATE
K051884 · Wrightmedicaltechnologyinc · Aug 2005