K Number

Device Name

Flow-Screw

Manufacturer

Flow-FX, LLC

Date Cleared

2015-03-23

(178 days)

Product Code

HWC

Regulation Number

888.3040

Intended Use

The Flow-Screw is intended for the fixation of bone fractures and bone reconstructions. When used for these indications, the Flow-Screw can also be used to deliver injectable bone void fillers to a surgical site.

Device Description

The Flow-Screw is cannulated and available in fully and partially threaded designs in various lengths. The Flow-Screw is fenestrated along its length which allows it to be used as a delivery system for injectable bone void fillers. The Flow-Screw implants are made of titanium alloy (Ti-6Al-4V) conforming to ASTM F136 or stainless steel conforming to ASTM F138 or ASTM F2229.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K962823, K962011, K102528, K132244

Reference Devices

K062630, K072355, K090242, K101557

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and intended use focus on a mechanical implant for bone fixation and delivery of bone void fillers. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities.

Therapeutic

Yes
The device is intended for the fixation of bone fractures and bone reconstructions, which is a therapeutic purpose.

Diagnostic

No
The device description and intended use clearly state that the Flow-Screw is for fixation of bone fractures and delivery of bone void fillers, which are therapeutic and reconstructive purposes, not diagnostic.

SaMD (Software as a Medical Device)

The device description explicitly states it is a physical implant made of titanium or stainless steel, which are hardware components.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body (in vitro).
Flow-Screw Function: The Flow-Screw is an implantable device used for the fixation of bone fractures and bone reconstructions. It is surgically inserted into the body to provide structural support. It also has the capability to deliver bone void fillers directly to the surgical site within the body.

The Flow-Screw's function is entirely focused on providing mechanical support and delivering material within the body, not on performing diagnostic tests on samples taken from the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

HWC

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Mechanical testing demonstrates the substantial equivalence of the Flow-Screw relative to the identified predicates when subjected to static compression bending loads.
The qualification testing (i.e., Injectability Testing, Experimental Void Fill Imaging Studies, Static Extraction Torque, BVF Characterization) was performed with ETEX Beta-bsm and CarriGen (K062630, K072355, K090242, K101557)

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K962823, K962011, K102528, K132244

Reference Device(s)

K062630, K072355, K090242, K101557

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.

Summary

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure in profile, with three overlapping faces suggesting community and connection. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the figure.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 23, 2015

Flow-FX, LLC % Ms. Michelle McDonough Musculoskeletal Clinical Regulatory Advisers, LLC 1331 H Street NW, 12th Floor Washington, DC 20005

Re: K142776

Trade/Device Name: Flow-Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: February 12, 2015 Received: February 13, 2015

Dear Ms. McDonough:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

Page 2 - Ms. Michelle McDonough

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Lori A. Wiggins -S

for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known): K142776

Device Name: Flow-Screw

V Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

510(k) Summary

Device Trade Name:	Flow-Screw
Manufacturer:	Flow-FX, LLC
19110 Darvin Drive
Mokena, Illinois 60448
815.531.4424
Prepared by:	Musculoskeletal Clinical & Regulatory Advisers, LLC
1331 H Street NW, 12th Floor
Washington, DC 20005
202.552.5800
Date Prepared:	February 12, 2015
Common Name:	Bone Fixation Screw
Classification:	21 CFR 888.3040, Smooth or threaded metallic bone fixation fastener
Class:	II
Product Code:	HWC

Indications For Use:

Device Description:

Predicate Devices:

The Flow-Screw was shown to be substantially equivalent to the Synthes Cannulated Screws (K962823 and K962011) and the N-Force Fixation System (K102528 and K132244).

Substantial Equivalence:

The table below summarizes the substantial equivalence of the Flow-Screw to predicate devices with respect to its intended use, design, materials, available sizes, mechanical performance, and ability to deliver BVF to a defect site.

	Subject Device	Predicate Devices
	Flow-Screw	Synthes	InnoVision N-Force
Fixation System

	N/A	K962011
K962823	K102528
K132244
Intended Use	Intended for temporary fracture fixation and stabilization of the bone.
Indications for Use	The Flow-Screw is
intended for the
fixation of bone
fractures and bone
reconstructions.
When used for
these indications,
the Flow-Screw can
also be used to
deliver injectable
bone void fillers to
a surgical site.	The Synthes 3.0mm
Cannulated Screw is
intended for fractures
of carpals and
metacarpals, carpal
and metacarpal
arthrodesis; small
fragments of the hand
and wrist, and certain
metatarsal-phalangeal
applications (in foot).
Synthes 7.0/7.3mm
Cannulated Screws
are generally
intended for fracture
fixation of large
bones and large bone
fragments.	The N-Force Fixation
System is intended
for the fixation of
bone fractures and
bone reconstructions.
When used for these
indications, the N-
Force Fixation
System can also be
used to deliver the
following bone void
fillers to a surgical
site:
• Beta-bsm (ETEX)
• CarriGen (ETEX)
	Components	Screws	Screws	Screws
	Materials	Titanium Alloy	Titanium Alloy	Titanium Alloy
		Stainless Steel	Stainless Steel
	Screw Sizes	Within predicate
range	A range of sizes to	A range of sizes to
			accommodate various	accommodate various
			patient anatomies	patient anatomies
	Mechanical
Performance	Mechanical testing demonstrates the substantial equivalence of the
Flow-Screw relative to the identified predicates when subjected to
static compression bending loads.
	BVF Delivery	Yes	No	Yes
	BVF Delivery
System	The qualification testing (i.e., Injectability Testing, Experimental Void
Fill Imaging Studies, Static Extraction Torque, BVF Characterization)
was performed with ETEX Beta-bsm and CarriGen (K062630,
K072355, K090242, K101557)