The VariAx® Distal Radius Plates are intended for use for internal fixation for fractures and reconstruction of the small bones, primarily including the distal radius. Examples of these internal fixations and reconstructions include compression fractures, intra-articular and extra-articular fractures, displaced fractures, osteotomies, non-unions and mal-unions. This system can be used for palmar, dorsal or orthogonal application.

Device Description

This Special 510(k) submission is intended to add aiming blocks as an accessory to the VariAx® Distal Radius plate line which was cleared in K040022 and K100271. The aiming blocks are accessories used intra-operatively to guide the user in placement of the screws into the plate. There are 4 aiming blocks which correspond to the configurations of volar plates: Narrow Right, Narrow Left, Standard Right and Standard Left. The aiming blocks are used with a joystick tool which helps the user find the appropriate screw trajectory and is pinned in place once the desired alignment is obtained. Kirschner wires can also be used in conjunction with the aiming blocks to determine screw trajectory.

AI/ML Overview

This document describes a Special 510(k) submission for the VariAx® Distal Radius Locked Plating System Line Extension, specifically for the addition of aiming blocks. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices (K040022 and K100271).

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Mechanical Performance:
Torque to failure (joystick and block assembly) must withstand clinically relevant loads.	"Torque to failure was performed using the joystick and the block assembled and failure loads were found to be acceptable."
Lateral loads on the construct must result in acceptable failure modes (e.g., disassembly without significant damage).	"Lateral loads were also placed on the construct and the failure mode was disassembly without significant damage to the plate."
Biocompatibility:
Materials (PEEK and stainless steel) must be biocompatible.	"Biocompatibility testing of the materials in the aiming block assembly (PEEK and stainless steel) was conducted..."
Sterility:
Device must be sterile.	"...as well as cleanability testing, sterility testing..."
Cleanability:
Device must be cleanable.	"...cleanability testing..."
Corrosion Resistance:
Device must be corrosion resistant.	"...and corrosion resistance testing."

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

The document does not explicitly state the specific sample sizes for each benchtop test (torque to failure, lateral loads, biocompatibility, cleanability, sterility, corrosion resistance). It only mentions that these tests "were conducted." The data provenance is from non-clinical benchtop testing, performed by the manufacturer, Howmedica Osteonics Corp., in the USA (implied, given the company's address). This is a prospective test in the sense that it was conducted specifically for this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This submission is for a medical device accessory and relies on benchtop mechanical and material testing, not clinical data or expert evaluation of images/data for ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical study involving human judgment or interpretation, therefore no adjudication method was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "Clinical testing was not required for this submission."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in a conceptual sense. The "standalone" performance here refers to the device's intrinsic mechanical and material properties as assessed through benchtop testing, without human judgment playing a direct role in evaluating its primary function (guiding screw placement). The tests focused on the physical integrity and safety of the aiming blocks themselves.

7. The Type of Ground Truth Used

The ground truth used for this submission is based on engineering specifications, material science standards, and established regulatory requirements for mechanical performance, biocompatibility, sterility, cleanability, and corrosion resistance for medical devices. The "acceptance" of the "failure loads" for torque and lateral tests implies a pre-defined threshold or range considered safe and effective based on industry standards for bone fixation devices.

8. The Sample Size for the Training Set

Not applicable. This submission is for a hardware accessory and involves benchtop testing, not machine learning or AI, so there is no concept of a "training set."

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

Not applicable, as there is no training set for this type of device submission.

Summary

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K112455 (1/2)

SEP 2 2 2011

VariAx® Distal Radius Locked Plating System Line Extension Aiming Blocks

Special 510(k)

510(k) Summary of Safety and Effectiveness: VariAx® Distal Radius Locked Plating System Line Extension for Addition of Aiming Blocks

Howmedica Osteonics Corp. Sponsor: 325 Corporate Drive Mahwah, NJ 07430 Contact Person: Stephanie M. Fitts Sr. Director, Regulatory Affairs and Regulatory Compliance Howmedica Osteonics Corp. 325 Corporate Drive

Mahwah, NJ 07430

Phone: (201) 831-5405

August 16, 2011 Date Prepared:

Proprietary Name: VariAx® Distal Radius Locked Plating System Line Extension for addition of Aiming Blocks

Common Name: Bone plates and Screws

Classification Name: Single/multiple component metallic bone fixation appliances and

accessories, 21 CFR §888.3030

Device Product Code:87 HRS: Plate, Fixation, Bone

Legally Marketed Device to Which Substantial Equivalence is Claimed: VariAx®

Distal Radius Locked Plating System

Device Description:

Intended Use:

The VariAx® Distal Radius Locked Plating System Line Extension addition of Aiming Blocks does not alter the intended use of the predicate system as cleared in K040022 and K 100271. The indications for use for the subject plates are provided below.

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VariAx® Distal Radius Locked Plating System Line Extension Aiming Blocks

Special 510(k)

Indications for Use:

The VariAx® Distal Radius Plates are intended for use for internal fixation for fractures and reconstruction of the small bones, primarily including the distal radius. Examples of these internal fixations and reconstructions include compression fractures, intra-articular and extra-articular fractures, displaced fractures, osteotomies, non-unions and malunions. This system can be used for palmar, dorsal or orthogonal application.

Summary of Technologies:

The proposed device is substantially equivalent in intended use, materials and performance characteristics to the predicate device. Addition of the aiming block as an accessory to the bone plating system does not alter the technology.

Non-Clinical Testing:

Benchtop testing was conducted to demonstrate that the use of the aiming blocks as described in the operative technique could withstand clinically relevant loads. Torque to failure was performed using the joystick and the block assembled and failure loads were found to be acceptable. Lateral loads were also placed on the construct and the failure mode was disassembly without significant damage to the plate. Biocompatibility testing of the materials in the aiming block assembly (PEEK and stainless steel) was conducted as well as cleanability testing, sterility testing and corrosion resistance testing.

Clinical Testing:

Clinical testing was not required for this submission.

Conclusion:

The VariAx® Distal Radius Locked Plating System Line Extension addition of Aiming Blocks are substantially equivalent to the predicate devices identified in this premarket notification.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized depiction of an eagle or bird-like figure with three wing-like shapes. The bird is positioned above a wavy line, possibly representing water or movement. The logo is encircled by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

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

Howmedica Osteonics Corporation % Dr. Stephanie Fitts Regulatory Affairs Associate 325 Corporate Drive Mahwah. New Jersey 07430

SEP 22 2011

Re: K112455

Trade/Device Name: VariAx® Distal Radius Locked Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: August 16, 2011 Received: August 25, 2011

Dear Dr. Fitts:

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 is 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 - Dr. Stephanie Fitts

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

forth in the quality systems (OS) 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 vour device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/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/Safetw/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 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.

Eunol Keith

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

Enclosure

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VariAx® Distal Radius Locked Plating System Line Extension Aiming Blocks

Special 510(k)

Indications for Use

510(k) Number (if known): K | 2 4SS

Device Name: VariAx® Distal Radius Locked Plating System

Indications For Use:

The VariAx® Distal Radius Plates are intended for use for internal fixation for fractures and reconstruction of the small bones, primarily including the distal radius. Examples of these internal fixations and reconstructions include compression fractures, intra-articular and extraarticular fractures, displaced fractures, osteotomies, non-unions and mal-unions. This system can be used for palmar, dorsal or orthogonal application.

Prescription Use X

AND/OR

(21 CFR 807 Subpart C)

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Michael Oses to mxm

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

510(k) Numbe

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.