Cleared Traditional

K081122 - FUSION MEDICAL CANNULATED SCREW SYSTEM

K081122 is an FDA 510(k) clearance for FUSION MEDICAL CANNULATED SCREW SYSTEM, manufactured by John Riccio. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 400-day FDA review.

K081122 · John Riccio · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2009
Decision
400d
Days
Class 2
Risk

K081122 is an FDA 510(k) clearance for the FUSION MEDICAL CANNULATED SCREW SYSTEM. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by John Riccio (Waterbury, US). The FDA issued a Cleared decision on May 26, 2009 after a review of 400 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 John Riccio devices

FDA 510(k) Submission Details - K081122

510(k) Number K081122 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2008
Decision Date May 26, 2009
Days to Decision 400 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
278d slower than avg
Panel avg: 122d · This submission: 400d
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 778
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K081122.
EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM, CHARCX, INTRAMEDULLARY SCREW SYSTEM
K091577 · Extremity Medical, LLC · Jul 2009
INTERTAN CHS LIMITED COLLAPSE SET SCREW
K090656 · Smith & Nephew, Inc. · Jun 2009
MEDACTA BONE SCREWS - EVOLIS AND VERSAFIT
K091069 · Medacta International S.A. · Jun 2009
EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM
K082934 · Extremity Medical, LLC · Apr 2009
PARCUS TINTANIUM INTERFERENCE SCREW, MODELS: 10001-10012, 10014-10016, 10018-10020
K083619 · Parcus Medical, LLC · Mar 2009
APERFIX IMPLANT WITH INSERTER, 8, 9, 10, 11, MM X30 MM
K083607 · Cayenne Medical, Inc. · Mar 2009