Cleared Traditional

K063635 - SBI FOREFOOT SET

K063635 is an FDA 510(k) clearance for SBI FOREFOOT SET, 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 266-day FDA review.

K063635 · Small Bone Innovations, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2007
Decision
266d
Days
Class 2
Risk

K063635 is an FDA 510(k) clearance for the SBI FOREFOOT SET. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Small Bone Innovations, Inc. (New York, US). The FDA issued a Cleared decision on August 29, 2007 after a review of 266 days - an extended review cycle.

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 - K063635

510(k) Number K063635 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2006
Decision Date August 29, 2007
Days to Decision 266 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
144d slower than avg
Panel avg: 122d · This submission: 266d
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 K063635.
MEGAFIX-C BIOABSORBABLE COMPOSITE INTERFERENCE SCREW, MODEL 2870719C, 2870723C, 2870823C, 2870828C, 2870928C
K071437 · KARL STORZ Endoscopy-America, Inc. · Sep 2007
SBI TWISTOFIX
K071541 · Small Bone Innovations, Inc. · Sep 2007
DOMINATOR
K072127 · Biocomposites, Ltd. · Aug 2007
SBI ARTFIX
K071656 · Small Bone Innovations, Inc. · Aug 2007
GRAFTLOCK SCREW, ST SCREW
K071952 · Biocomposites, Ltd. · Aug 2007
HEALIX ANCHOR
K071481 · Depuy Mitek, A Johnson & Johnson Company · Aug 2007