Cleared Traditional

K080259 - JMEA CANNULATED BONE SCREW SYSTEM

K080259 is an FDA 510(k) clearance for JMEA CANNULATED BONE SCREW SYSTEM, manufactured by Jmea Corporation. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K080259 · Jmea Corporation · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2008
Decision
202d
Days
Class 2
Risk

K080259 is an FDA 510(k) clearance for the JMEA CANNULATED BONE SCREW SYSTEM. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Jmea Corporation (Rockville, US). The FDA issued a Cleared decision on August 20, 2008 after a review of 202 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 Jmea Corporation devices

FDA 510(k) Submission Details - K080259

510(k) Number K080259 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2008
Decision Date August 20, 2008
Days to Decision 202 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
80d slower than avg
Panel avg: 122d · This submission: 202d
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 784
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K080259.
OPUS MAGNUM SPEEDSCREW KNOTLESS FIXATION DEVICE, MODEL OM-6500
K081893 · Arthrocare Corp. · Oct 2008
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM HEXALOBULAR BONE SCREWS
K082516 · Smith & Nephew, Inc. · Sep 2008
EXTREMITY MEDICAL COMPRESSION SCREW
K081934 · Extremity Medical, LLC · Aug 2008
BIOPRO GO-EZ SCREW
K081149 · Biopro, Inc. · Aug 2008
MERETE 3.0 AND 3.5 MM LOCKING SCREWS
K081513 · Merete Medical GmbH · Jul 2008
SYNTHES (USA) STERNAL FIXATION SYSTEM - LINE EXTENSION
K081700 · Synthes (Usa) · Jul 2008