Cleared Traditional

K092754 - SBI FOOT AND ANKLE CANNULATED SCREW SYSTEM

K092754 is an FDA 510(k) clearance for SBI FOOT AND ANKLE CANNULATED SCREW SYSTEM, manufactured by Small Bone Innovations, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K092754 · Small Bone Innovations, Inc. · Orthopedic device
Download Printable Device Report (PDF)
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Jan 2010
Decision
132d
Days
Class 2
Risk

K092754 is an FDA 510(k) clearance for the SBI FOOT AND ANKLE CANNULATED SCREW SYSTEM, MODEL 100-0061. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Small Bone Innovations, Inc. (Morrisville, US). The FDA issued a Cleared decision on January 19, 2010 after a review of 132 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Small Bone Innovations, Inc. devices

FDA 510(k) Submission Details - K092754

510(k) Number K092754 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2009
Decision Date January 19, 2010
Days to Decision 132 days
Submission Type Traditional
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
10d slower than avg
Panel avg: 122d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HWC Screw, Fixation, Bone

All 725
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K092754.
OPUS SPEEDSCREW SYSTEM
K100457 · Arthrocare Corp. · Mar 2010
OMNITECH LARGE, TRIMED COMPRESSION SCREW
K093676 · TriMed, Inc. · Mar 2010
VERSALOK PEEK ANCHOR WITH ORTHOCORD SUTURE, MODELS 210818, 210819
K100532 · Depuy Mitek, A Johnson & Johnson Company · Mar 2010
SYNTHES 7.3 MM CANNULATED SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREWS (SCFE)
K092909 · Synthes (Usa) · Jan 2010
FOOT AND HAND MOTION SYSTEM
K091118 · Newclip Technics · Dec 2009
LEFORTE NEUROSYSTEM BONE SCREW
K091686 · Jeil Medical Corporation · Nov 2009