The system is intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions (osteotomies) of small bones of the hand, foot, radius, ulna, ankle, humerus, scapula and pelvis, particularly in osteopenic bone.

Device Description

The Dorsal, Lateral and Ulna Plating System consists of Titanium alloy plates utilizing non-locking, locking and variable angle screws manufactured from Titanium alloy and CoCr for bone fixation and the management of fractures, revisions, fusions and reconstructive surgeries. They can be provided in a pre-packaged sterile kit with accompanying single use instrumentation, individually packaged sterile units or non-sterile for further steam sterilization prior to use. Offered in left and right configurations, with the exception of the Ulna plate that is bilateral, the plates are for use with existing 2.2mm pegs and 2.7mm locking and non-locking screws and multidirectional fasteners.

AI/ML Overview

This submission does not include information about AI/ML device performance or a study demonstrating that a device meets acceptance criteria related to AI/ML performance. Instead, it is a 510(k) summary for a "Dorsal, Lateral and Ulna Plating System," which is a metallic bone fixation appliance.

The document discusses preclinical data to demonstrate substantial equivalence to predicate devices, focusing on mechanical properties of the physical implant. Therefore, the questions related to AI/ML performance, ground truth, experts, sample sizes for test/training sets, and MRMC studies are not applicable to this submission.

Here's a breakdown of the relevant information provided:

Table of acceptance criteria and reported device performance:
- Acceptance Criteria (Implied): Substantial equivalence to predicate devices in:
  - Design
  - Dimensions
  - Material
  - Performance (axial load construct testing, evaluation of galvanic corrosion potential, multidirectional screw capability).
- Reported Device Performance:
  - The Dorsal, Lateral and Ulna Plating System's technological characteristics are "similar to the predicate devices including design, dimensions and material."
  - Demonstrated with preclinical data including:
    - Axial load construct testing
    - Evaluation of galvanic corrosion potential
    - Multidirectional screw capability
Sample size used for the test set and the data provenance: Not applicable. This involves preclinical (benchtop) testing of a physical device, not a data-driven AI/ML model.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical implant's mechanical properties is typically established through standardized engineering tests, not expert consensus on medical images or patient data.
Adjudication method for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: No, this is not an AI/ML device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, this is not an AI/ML device.
The type of ground truth used: For the physical device, the "ground truth" for demonstrating substantial equivalence is established through standardized engineering tests and material evaluations. This is based on objective measurements of mechanical performance and material properties.
The sample size for the training set: Not applicable. There is no training set for an AI/ML model.
How the ground truth for the training set was established: Not applicable.

Summary

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Section 5 — 510(k) Summary

MAY 1 3 2014

Submitted by:	Biomet Trauma56 East Bell DrivePO Box 587Warsaw, IN 46581Phone: (305) 269-6386Fax:(305) 269-6400
Contact Person:	Suzana Otaño, Regulatory Affairs Manager
Date Prepared:	May 7, 2014
Proprietary Name:	Dorsal, Lateral and Ulna Plating System
Common Name:	Plate, Fixation, Bone
Classification Name/ Product Code:	Single/multiple component metallic bone fixation appliances andaccessories (21 CFR § 888.3030) / HRS
Predicate Devices:	The Dorsal, Lateral and Ulna Plating System is substantiallyequivalent to the currently marketed Small Bone Locking PlatingSystem (K081546, K083364) and Distal Volar Radius Plating System(K112345).
Device Description:	The Dorsal, Lateral and Ulna Plating System consists of Titaniumalloy plates utilizing non-locking, locking and variable angle screwsmanufactured from Titanium alloy and CoCr for bone fixation andthe management of fractures, revisions, fusions and reconstructivesurgeries. They can be provided in a pre-packaged sterile kit withaccompanying single use instrumentation, individually packagedsterile units or non-sterile for further steam sterilization prior to use.Offered in left and right configurations, with the exception of theUlna plate that is bilateral, the plates are for use with existing2.2mm pegs and 2.7mm locking and non-locking screws andmultidirectional fasteners.
Indications for Use:	The system is intended for stabilization and fixation of small bonefragments in fresh fractures, revision procedures, joint fusion andreconstructions (osteotomies) of small bones of the hand, foot,radius, ulna, ankle, humerus, scapula and pelvis, particularly inosteopenic bone.

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Technological Characteristics:

Summary of Substantial Equivalence: The technological characteristics of the Dorsal, Lateral and Ulna Plating System are similar to the predicate devices including design, dimensions and material.

The Dorsal, Lateral and Ulna Plating System is substantially equivalent to currently marketed devices as demonstrated with preclinical data including axial load construct testing, evaluation of galvanic corrosion potential and multidirectional screw capability. No new issues of safety or efficacy have been raised.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & 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 a stylized symbol that resembles a human figure embracing or supporting another, with flowing lines suggesting movement or support.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

May 13, 2014

Biomet Manufacturing Corporation Ms. Suzana Otaño Regulatory Affairs Manager 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581

. Re: K140622

Trade/Device Name: Dorsal, Lateral and Ulna Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: March 19, 2014 Received: March 20, 2014

Dear Ms. Otaño:

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

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Page 2 - Ms. Suzana Otaño

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 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" (21 CFR 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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Ronald P. Jean -S for

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

Enclosure

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SECTION 4 - INDICATIONS FOR USE STATEMENT

K140622 510(k) Number:

Dorsal, Lateral and Ulna Plating System Device Name:

Indications For Use:

× Prescription Use (Per 21 CFR 801 Subpart D)

AND/OR

Over-the-Counter (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)

Elizabet标垫蛋rank -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K140622

Page 1 of 1

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.