Cleared Traditional

SBI FOREFOOT SET (K063635) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

Device Classification

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 403
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K063635.
DARCO HEADLESS COMPRESSION SCREW
K080850 · Wrightmedicaltechnologyinc · Apr 2008
TWINFIX PK FP SUTURE ANCHOR
K073509 · Smith & Nephew, Inc. · Mar 2008
MEGAFIX-C BIOABSORBABLE COMPOSITE INTERFERENCE SCREW, MODEL 2870719C, 2870723C, 2870823C, 2870828C, 2870928C
K071437 · KARL STORZ Endoscopy-America, Inc. · Sep 2007
ARTHREX BIO- COMPOSITE SUTURE ANCHORS: BIO-COMPOSITE PUSHLOCK, BIO-COMPOSITE TAK, BIO-COMPOSITE CORKSCREW
K071177 · Arthrex, Inc. · Jun 2007
ASNIS MICRO CANNULATED SCREW
K071092 · Howmedica Osteonics Corp. · May 2007
MODIFICATON TO: ZIMMER PERIARTICULAR LOCKING PLATES AND SCREWS
K070906 · Zimmer, Inc. · May 2007