Cleared Traditional

K102343 - EMERGE MEDICAL CANNULATED SCREW FIXATIO...

K102343 is an FDA 510(k) clearance for EMERGE MEDICAL CANNULATED SCREW FIXATIO..., manufactured by Emerge Medical. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K102343 · Emerge Medical · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2010
Decision
98d
Days
Class 2
Risk

K102343 is an FDA 510(k) clearance for the EMERGE MEDICAL CANNULATED SCREW FIXATION SYSTEM. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Emerge Medical (Shelton, US). The FDA issued a Cleared decision on November 23, 2010 after a review of 98 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 Emerge Medical devices

FDA 510(k) Submission Details - K102343

510(k) Number K102343 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2010
Decision Date November 23, 2010
Days to Decision 98 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
24d faster than avg
Panel avg: 122d · This submission: 98d
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 742
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K102343.
GRYPHON PEEK DS ANCHOR W/ ORTHOCORD, GRYPHON PEEK ANCHOR W/ ORTHOCORD
K103712 · Depuy Mitek, A Johnson & Johnson Company · Mar 2011
TRANSTEND BR ANCHOR W/ ORTHOCORD, TRANSTEND TI ANCHOR W/ORTHOCORD, TRANSTEND PEEK ANCHOR W/ORTHOCORD, HEALIX TRANSTEND
K102298 · Depuy Mitek, A Johnson & Johnson Company · Jan 2011
MATRYX INTERFERENCE SCREW (5.0-6.5MM)
K102410 · Conmed Linvatec · Dec 2010
PARCUS 3.5MM PEEK CF PUSH-IN SUTURE ANCHOR
K102326 · Parcus Medical, LLC · Nov 2010
PARCUS PEEK CF PUSH-IN SUTURE ANCHOR
K102162 · Parcus Medical, LLC · Nov 2010
PIONEER CANNULATED SCREW SYSTEM
K102903 · Pioneer Surgical Technology, Inc. · Oct 2010