Cleared Traditional

K140710 - BIOMET GRAFT DELIVERY SYRINGES

K140710 is an FDA 510(k) clearance for BIOMET GRAFT DELIVERY SYRINGES, manufactured by Biomet Spine (Aka Ebi, LLC). The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K140710 · Biomet Spine (Aka Ebi, LLC) · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2014
Decision
167d
Days
Class 2
Risk

K140710 is an FDA 510(k) clearance for the BIOMET GRAFT DELIVERY SYRINGES. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Biomet Spine (Aka Ebi, LLC) (Parsippany, US). The FDA issued a Cleared decision on September 4, 2014 after a review of 167 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital device 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K140710

510(k) Number K140710 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2014
Decision Date September 04, 2014
Days to Decision 167 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 129d · This submission: 167d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMF Device Classification - Class 2, Special Controls

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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 General Hospital devices follow this clearance model.

Regulatory Peers - FMF Syringe, Piston

All 587
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K140710.
InFill Graft Delivery System
K143488 · Pinnacle Spine Group, LLC · Dec 2014
Bi-Portal Bone Graft Delivery Device
K142661 · Spinal Surgical Strategies, LLC · Dec 2014
Merit 10mL Syringe
K142636 · Merit Medical Systems, Inc. · Oct 2014
PERFUSE PERCUTANEOUS DECOMPRESSION SYSTEM
K141762 · Biomet, Inc. · Aug 2014
HARD PACK SYRINGE
K141359 · Jiangyin Caina Technology Co., Ltd. · Jul 2014
ETEX MIXING AND DELIVERY SYSTEM
K141245 · Etex Corporation · Jul 2014