Cleared Traditional

K142661 - Bi-Portal Bone Graft Delivery Device

K142661 is an FDA 510(k) clearance for Bi-Portal Bone Graft Delivery Device, manufactured by Spinal Surgical Strategies, LLC. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K142661 · Spinal Surgical Strategies, LLC · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2014
Decision
84d
Days
Class 2
Risk

K142661 is an FDA 510(k) clearance for the Bi-Portal Bone Graft Delivery Device. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Spinal Surgical Strategies, LLC (Incline Village, US). The FDA issued a Cleared decision on December 11, 2014 after a review of 84 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K142661

510(k) Number K142661 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2014
Decision Date December 11, 2014
Days to Decision 84 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
45d faster than avg
Panel avg: 129d · This submission: 84d
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 Consultant

C/O Spinal Surgical Strategies
Tim Reeves

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FMF Syringe, Piston

All 587
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K142661.
ConMed Mixing and Delivery Kit
K142535 · Conmed Corporation · Apr 2015
ANUTRA Feedback Aspiration Syringe
K143757 · Anutra Medical, Inc. · Jan 2015
InFill Graft Delivery System
K143488 · Pinnacle Spine Group, LLC · Dec 2014
Merit 10mL Syringe
K142636 · Merit Medical Systems, Inc. · Oct 2014
BIOMET GRAFT DELIVERY SYRINGES
K140710 · Biomet Spine (Aka Ebi, LLC) · Sep 2014
PERFUSE PERCUTANEOUS DECOMPRESSION SYSTEM
K141762 · Biomet, Inc. · Aug 2014