The Arthrex Fracture Plates are intended to be used 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, fibula.

The Arthrex Low Profile Screws (2.0-2.4mm 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, Small Fragment Plates, and Distal Extremity Plates.

The Arthrex Low Profile Screws (2.0-3.0mm 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, and wrist.

The Arthrex Low Profile Screws (2.5mm 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, Small Fragment Plates, Fracture Plates, Distal Extremity 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 Fracture Plates are a family of titanium and stainless steel plates and screws. The plates are flat and contoured, ranging from 50 mm to 244 mm in length. The accompanying screws are 2.5mm to 6.7mm in diameter.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Arthrex Fracture Plates, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Demonstrates Substantial Equivalence to Predicate Devices)	Reported Device Performance (Arthrex Fracture Plates)
Material Composition: Must be composed of materials substantially equivalent to predicate devices.	Composed of Titanium or Stainless Steel, which is substantially equivalent to the predicate devices.
Bending Strength: Bending strength must be substantially equivalent to predicate devices.	The mechanical testing data demonstrated that the bending strength of the proposed devices is substantially equivalent to the bending strength of the predicate devices.
Pull-out Strength: Pull-out strength must be substantially equivalent to predicate devices.	The mechanical testing data demonstrated that the pull-out strength of the proposed devices is substantially equivalent to the pull-out strength of the predicate devices.
Torque Strength: Torque strength must be substantially equivalent to predicate devices.	The mechanical testing data demonstrated that the torque strength of the proposed devices is substantially equivalent to the torque strength of the predicate devices.
Indications for Use: Must have equivalent indications for use to predicate devices.	The indications for use are the same as the predicate devices (internal bone fixation for bone fractures, fusions, osteotomies, and non-unions in various specified anatomical locations).
Technological Characteristics: Must have technological characteristics comparable to predicate devices.	The technological characteristics are comparable to the predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

This is not applicable as the study described is a benchtop mechanical testing study, not a clinical study involving patients or human data. The "test set" would refer to the physical devices (fracture plates and screws) subjected to mechanical stress tests.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This is not applicable. Ground truth, in the context of this 510(k) submission, is established by objective mechanical testing standards and comparison to predicate device performance, not expert consensus on human data.

4. Adjudication Method for the Test Set

This is not applicable. There is no adjudication method described as it's a mechanical performance study, not involving human interpretation or decision-making.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission is for a medical device (fracture plates and screws) and primarily relies on mechanical performance testing for substantial equivalence, not a comparison of human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

No, a standalone performance study (algorithm only) was not done. This device is a physical implant, not an AI algorithm.

7. Type of Ground Truth Used

The "ground truth" used for demonstrating substantial equivalence is objective mechanical performance data (bending, pull-out, and torque strength) and material composition standards, compared against that of legally marketed predicate devices.

8. Sample Size for the Training Set

This is not applicable, as this is a physical medical device submission based on mechanical testing and material equivalence, not an AI/machine learning study. There is no "training set" in this context.

9. How the Ground Truth for the Training Set Was Established

This is not applicable, as there is no "training set" for this type of device submission.

Summary

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K123241 (Page 1 of 2)

APR 0 5 2013

510(k) Summary of Safety and Effectiveness

Date Summary Prepared	September 12, 2012
Manufacturer/Distributor/Sponsor	Arthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USA
510(k) Contact	Courtney SmithManager, Regulatory AffairsArthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USATelephone: 239/643.5333, ext. 1720Fax: 239/598.5508Email: courtney.smith@arthrex.com
Trade Name	Fracture Plates
Common Name	Plate, fixation, bone
Product Code -Classification	HWC, HTN, HRS
NameCFR	21 CFR 888.8030: Single/multiple component metallic bonefixation appliances and accessories21 CFR 888.3040: Smooth or threaded metallic bone fixationfastener
Predicate Device	K011335: Synthes On-third Tubular PlatesK102998: Acumed Congruent Bone Plate SystemK103705 / K111253 / K112437: Low Profile Screw
Purpose of Submission	This traditional 510(k) premarket notification is submitted toobtain clearance for the Arthrex Fracture Plates and theaccompanying screws.
Device Description and IntendedUse	The Arthrex Fracture Plates are a family of titanium andstainless steel plates and screws. The plates are flat andcontoured, ranging from 50 mm to 244 mm in length. Theaccompanying screws are 2.5mm to 6.7mm in diameter.
Intended Use	The Arthrex Fracture Plates are intended to be used forinternal bone fixation for bone fractures, fusions, osteotomiesand non-unions in the ankle, foot, hand, wrist, clavicle,scapula, olecranon, humerus, radius, ulna, tibia, calcaneus,and fibula.The Arthrex Low Profile Screws (2.0-2.4mm solid) areintended 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, and wrist. When used with a plate, the screw may be used with the Arthrex Low Profile, Small Fragment Plates, and Distal Extremity Plates.
	The Arthrex Low Profile Screws (2.0-3.0mm 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, and wrist.
	The Arthrex Low Profile Screws (2.5mm 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, Small Fragment Plates, Fracture Plates, Distal Extremity 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.
Substantial Equivalence Summary	Fracture Plates are substantially equivalent to the predicate Synthes One-Third Tubular Plates (K011335), Acumed Congruent Bone Plate (K102998), and the cleared Low Profile Screws (K103705, K111253, and K112437) in which the basic features and intended uses are the same. Any differences between the Fracture Plates and the predicates are considered minor and do not raise questions concerning safety and effectiveness.
	The proposed devices are composed of Titanium or Stainless Steel, which is substantially equivalent to the predicate devices.
	The submitted mechanical testing data demonstrated that the bending, pull-out and torque strength of the proposed devices are substantially equivalent to the bending, pull-out and torque strength of the predicate devices.
	Based on the indication for use, technological characteristics, and the comparison to the predicate devices, Arthrex, Inc. has determined that the Fracture Plates is substantially equivalent to currently marketed predicate devices.

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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, sans-serif font. The text is centered on the image and is the only element present. The words are arranged on a single line.

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 stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the left side and top of the emblem.

Public Health Service

Letter dated: April 5, 2013

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

Arthrex, Incorporated % Ms. Courtney Smith Manager, Regulatory Affairs 1370 Creekside Boulevard Naples, Florida 34108

Re: K123241

Trade/Device Name: Arthrex Fracture Plates Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: February 13, 2013 Received: February 25, 2013

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. Iisting 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

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Page 2 - Ms. Courtnev Smith

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours.

Mark NMelkerson -S

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

Enclosure

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Indications for Use Form

Indications for Use

510(k) Number (if known): K123241

Device Name: Arthrex Fracture Plates

Indications For Use:

Prescription Use _ V __ (Per 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

AND/OR Over-The-Counter Use

(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

Elizabeth L. Frank -S

Division of Orthopedic Devices

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Indications for Use Form

Indications for Use

510(k) Number (if known): K123241

Arthrex Low Profile Screws Device Name:

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

Elizabeth | 読版ank -S

Division of Orthopedic Devices

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.