LOW PROFILE SCREWS by ARTHREX, INC.

The Arthrex Low Profile Screws (2.0-3.0mm solid) are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, and wrist. When used with a plate, the screw may be used with the Arthrex Low Profile and Small Fragment Plates,

The Arthrex Low Profile Screws (2.0-3.0mm cannulated) are intended to be used as standalone bone screws for internal bone fixation for bone fractures, fusions, osteotomies and nonunions in the ankle, foot, hand, and wrist.

The Arthrex Low Profile Screws (3.5mm and larger, solid) are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur and fibula. When used with a plate, the screws may be used with the Arthrex Low Profile and Small Fragment Plates, Humeral Fracture Plates, and Osteotomy Plates.

The Arthrex Low Profile Screws (3.5mm and larger, cannulated) are intended to be used as stand-alone bone screws for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon; humerus, radius, ulna, tibia, calcaneous, femur and fibula.

Device Description

The Arthrex Low Profile Screw is fully or partially threaded, titanium or stainless steel, self-tapping, headed screw. The screw ranges from 2.0 mm to 4.0 mm in diameter and in length from 8 mm to 80 mm. The screw may be either solid or cannulated.

AI/ML Overview

The provided text describes a 510(k) summary for the Arthrex Low Profile Screws, focusing on their substantial equivalence to predicate devices. It does not contain information about acceptance criteria or a study proving that the device meets those criteria in the context of diagnostic accuracy, which would involve concepts like sensitivity, specificity, or reader performance.

Instead, this document is a regulatory submission for a medical device (bone fixation screws) and discusses mechanical testing to demonstrate substantial equivalence, rather than clinical performance or diagnostic accuracy.

Therefore, I cannot provide the requested information about acceptance criteria, reported device performance in those terms, sample sizes for test sets (as there's no diagnostic test set), expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment in a diagnostic context.

The "study" mentioned in the document is mechanical testing. Here's what can be extracted about that:

A table of acceptance criteria and the reported device performance:
The document states: "The submitted mechanical testing data demonstrated that the torque and pull-out force of the proposed devices is substantially equivalent to the torque and pull-out force of the predicate devices."

While it indicates that mechanical testing was performed for "torque and pull-out force," it does not provide the specific numerical acceptance criteria or the reported performance values for either the proposed device or the predicate devices. It only states they were found to be "substantially equivalent."
Sample size used for the test set and the data provenance:
Not specified for the mechanical testing. "Data provenance" (country of origin, retrospective/prospective) is not applicable to mechanical bench testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Mechanical testing does not involve human experts establishing a "ground truth" in the way a diagnostic study would.
Adjudication method:
Not applicable to mechanical testing.
If a multi reader multi case (MRMC) comparative effectiveness study was done:
No. This is a medical device (bone screw) not an imaging or diagnostic device that would typically involve a MRMC study.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not an algorithm.
The type of ground truth used:
For mechanical testing, the "ground truth" would be the direct physical measurement of properties like torque and pull-out force, as measured by testing equipment. There is no biological or diagnostic "ground truth" (like pathology or outcomes data) involved for this type of testing.
The sample size for the training set:
Not applicable. This is not a machine learning model, so there is no training set.
How the ground truth for the training set was established:
Not applicable.

Summary

{0}------------------------------------------------

ぶ

MAR 1 8 2011

K103705

1 510(k) Summary of Safety and Effectiveness

Date Summary Prepared	March 10, 2011
Manufacturer/Distributor/Sponsor	Arthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USA
510(k) Contact	Courtney SmithRegulatory Affairs Project ManagerArthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USATelephone: 239/643.5553, ext. 1720Fax: 239/598.5508Email: csmith@arthrex.com
Trade Name	Low Profile Screws
Common Name	Screw, fixation, bone
Product Code -ClassificationNameCFR	HWC, HRS21CFR 888.3030: Single/multiple component metallic bonefixation appliances and accessories21 CFR 888.3040: Smooth or threaded metallic bone fixationfastener.
Predicate Device	K052614: Arthrex Low Profile Plate and Screw SystemK062863: Osteomed Extended 2.0/2.4 Cannulated Screw SystemK001941: Synthes Modular Foot SystemK043185: Synthes 3.5mm Cortex ScrewsK102343: Cannulated Screw System
Purpose of Submission	This traditional 510(k) premarket notification is submitted toobtain clearance for the Low Profile Screws. The ArthrexLow Profile Screws are a line extension of the Low ProfileScrews cleared in K052614.
Device Description and IntendedUse	The Arthrex Low Profile Screw is fully or partially threaded,titanium or stainless steel, self-tapping, headed screw. Thescrew ranges from 2.0 mm to 4.0 mm in diameter and inlength from 8 mm to 80 mm. The screw may be either solidor cannulated.The Arthrex Low Profile Screws (2.0-3.0mm solid) areintended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures,fusions, osteotomies and non-unions in the ankle, foot, hand,and wrist. When used with a plate, the screw may be usedwith the Arthrex Low Profile and Small Fragment Plates.

	The Arthrex Low Profile Screws (2.0-3.0mm cannulated)are intended to be used as stand-alone bone screws forinternal bone fixation for bone fractures, fusions, osteotomiesand non-unions in the ankle, foot, hand, and wrist.
	The Arthrex Low Profile Screws (3.5mm and larger, solid)are intended to be used as stand-alone bone screws, or in aplate-screw system for internal bone fixation for bonefractures, fusions, osteotomies and non-unions in the ankle,foot, hand, wrist, clavicle, scapula, olecranon, humerus,radius, ulna, tibia, calcaneous, femur and fibula. When usedwith a plate, the screws may be used with the Arthrex LowProfile and Small Fragment Plates, Humeral Fracture Plates,and Osteotomy Plates.
	The Arthrex Low Profile Screws (3.5mm and larger,cannulated) are intended to be used as stand-alone bonescrews for internal bone fixation for bone fractures, fusions,osteotomies and non-unions in the ankle, foot, hand, wrist,clavicle, scapula, olecranon, humerus, radius, ulna, tibia,calcaneous, femur and fibula.
Substantial EquivalenceSummary	The Low Profile Screws are substantially equivalent to thepredicate Osteomed Extended 2.0/2.4 Cannulated ScrewSystem, Synthes Modular Foot System, Synthes 3.5mmCortex Screw, and the previously cleared Arthrex Low ProfileScrews, in which the basic features and intended uses are thesame. Any differences between the Low Profile Screws andthe predicates are considered minor and do not raise questionsconcerning safety and effectiveness.
	The proposed devices are composed of Titanium or StainlessSteel that is substantially equivalent to the predicate devices.
	The submitted mechanical testing data demonstrated that thetorque and pull-out force of the proposed devices issubstantially equivalent to the torque and pull-out force of thepredicate devices.
	Based on the indication for use, technological characteristics.and the comparison to the predicate devices, Arthrex, Inc. hasdetermined that the Low Profile Screws are substantiallyequivalent to currently marketed predicate devices.

{1}------------------------------------------------

2/2

K10370S

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

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

Arthrex, Inc. % Ms. Courtney Smith 1370 Creekside Boulevard Naples, Florida 34108-1945

MAR 1 8 2011

Re: K103705

Trade/Device Name: Arthrex Low Profile Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC, HRS Dated: February 16, 2011 Received: February 18, 2011

Dear Ms. Smith.

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

{3}------------------------------------------------

Page 2 - Ms. Courtney Smith

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours,

Aty B. Duh
fen

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

Enclosure

{4}------------------------------------------------

5 of 12

1 Indications for Use Form

Indications for Use

510(k) Number (if known): K103705

Device Name: Arthrex Low Profile Screws

Indications For Use:

Prescription Use _ V _ AND/OR Over-The-Counter Use _______ (Per 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

PAGE 1 of 1

for M. Melkerson

(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number	K103705
---------------	---------

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.