Cleared Traditional

K221737 - InstaFill Graft Delivery System

K221737 is the FDA 510(k) clearance for InstaFill Graft Delivery System by Globus Medical, Inc.. It is a Class 2 General & Plastic Surgery device (product code FMF) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K221737 · Globus Medical, Inc. · General & Plastic Surgery device
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Aug 2022
Decision
57d
Days
Class 2
Risk

K221737 is an FDA 510(k) clearance for the InstaFill Graft Delivery System, SIGNIFY Bioactive. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Globus Medical, Inc. (Audubon, US). The FDA issued a Cleared decision on August 11, 2022 after a review of 57 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5860 - the FDA general and plastic surgery 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.

View all Globus Medical, Inc. devices

Submission Details

510(k) Number K221737 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2022
Decision Date August 11, 2022
Days to Decision 57 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 115d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FMF Syringe, Piston

All 285
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K221737.
Sterile Hypodermic Syringes for Single Use
K221079 · Sichuan Prius Biotechnology Co., Ltd. · Oct 2022
Sterile Hypodermic Syringe for Single Use, with/without Needle, Sterile Hypodermic Needle for Single Use
K212846 · Jiangsu Jichun Medical Devices Co., Ltd. · Aug 2022
Disposable Sterile Syringe, with/without needle
K212033 · Shandong Zhushi Pharmaceutical Group Co., Ltd. · Aug 2022
Syringe with permanently attached needle
K213158 · Berpu Medical Technology Co., Ltd. · Jul 2022
Pump Alignment Syringe
K220184 · Jiangsu Caina Medical Co.,Ltd · Jul 2022
Disposabel Syringe with permanently attached needle, Safety Syringe with permanently attached needle
K220204 · Anhui Tiankang Medical Technology Co., Ltd. · Jul 2022