Cleared Traditional

K050462 - SBI HAND FIXATION SYSTEM (TM)

K050462 is an FDA 510(k) clearance for SBI HAND FIXATION SYSTEM (TM), 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 62-day FDA review.

K050462 · Small Bone Innovations, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2005
Decision
62d
Days
Class 2
Risk

K050462 is an FDA 510(k) clearance for the SBI HAND FIXATION SYSTEM (TM). 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 April 26, 2005 after a review of 62 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 - K050462

510(k) Number K050462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2005
Decision Date April 26, 2005
Days to Decision 62 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
60d faster than avg
Panel avg: 122d · This submission: 62d
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 1101
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K050462.
SOLCO 4CIS GENERAL PLATE SYSTEM
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SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES
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SYNTHES 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (HAND & NEURO)
K050607 · Synthes (Usa) · Apr 2005
STRYKER LOCKED PLATING SYSTEM
K050512 · Howmedica Osteonics Corp. · Mar 2005