The SIDEKICK® Circular Fixator System: Struts and its components are indicated for open and closed fracture fixation, pseudoarthrosis or nonunions of long bones, limb lengthening by epiphyseal or metaphyseal distraction or bony or soft tissue defonnities, and correction of segmental or nonsegmental bony or soft tissue defects. The SIDEKICK® Circular Fixator System: Struts and Hinges is for use on all long bones including: tibia, fibula, femur, humerus, radius and ulna.

Device Description

The SIDEKICK® Circular Fixator System: Struts and Hinges is a dynamic frame that can change position or orientation from the beginning of treatment to the end of treatment for correcting deformities in soft tissue or bone. The system allows precise, controlled compression/distraction. The hinges are used to create a point of rotation and/or angulation between levels of ring fixation on the frame. The rotation/angulation of the struts is used as compressors/distractors and which provide gradual or acute movement.

AI/ML Overview

This document is a 510(k) summary for the SIDEKICK® Circular Fixator System: Struts and Hinges, which is a medical device. 510(k) submissions primarily focus on demonstrating substantial equivalence to a predicate device, rather than conducting extensive clinical studies with acceptance criteria for device performance. As such, the information typically requested in your prompt (e.g., sample sizes, expert qualifications, MRMC studies, ground truth details for AI/software devices) is not relevant or applicable to this type of submission.

Here's a breakdown of the available information based on your request, highlighting what is (and isn't) present:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implicit)	Reported Device Performance
Performance demonstrated to be "at least as well as" the legally marketed predicate device (R & R External Fixation (Ring Fixator)).	"The results of the test show that the subject SIDEKICK® Circular Fixator System: Struts and Hinges can be expected to perform at least as well as the legally marketed predicate R & R External. Fixation (Ring Fixator)." Specifically, this was shown through static compressive stress testing.
Substantially equivalent indications for use, anatomical sites, and multi-piece design compared to the predicate.	"The subject SIDEKICK® Circular Fixator System: Struts and Hinges and the legally marketed predicate R & R External Fixation (Ring Fixator) have the same indications, are used at the same anatomical sites, and are both multi-piece designs." (Note: Differences exist in number of axes of rotation, material, and type of bridge element, but these differences did not preclude a finding of substantial equivalence based on the provided evidence).
Safety and effectiveness supported by substantial equivalence information, materials information, and comparison of design characteristics.	"The safety and effectiveness of the SIDEKICK® Circular Fixator System: Struts and Hinges is adequately supported by the substantial equivalence information, materials information, and comparison of design characteristics provided within the Premarket Notification."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided as this submission relies on non-clinical (mechanical) testing for comparison to a predicate, not clinical data or a "test set" in the context of an AI/software device. The nature of static compressive stress testing typically involves a set number of devices or components, but the specific quantity isn't detailed, nor is provenance in the typical data sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable. Ground truth, as you describe it, relates to clinical interpretation or outcome data, which is not the basis for this 510(k) submission. The "ground truth" here is the established performance of the predicate device under specific mechanical tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. There was no clinical test set requiring human adjudication.

5. 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

This is not applicable. This device is a physical medical implant, not an AI/software device that would involve human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. This device is a physical medical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" (or more accurately, the reference standard for comparison) for demonstrating substantial equivalence was the established mechanical performance of the predicate device (R & R External Fixation (Ring Fixator)) as determined through static compressive stress testing.

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of this 510(k) submission for a physical device.

9. How the ground truth for the training set was established

This is not applicable. There is no "training set" or corresponding ground truth as described for an AI/software device. The comparison is against the predicate device's known mechanical properties.

Summary

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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807.92, this information serves as a Summary of Safety and Effectiveness for the SIDEKICK® Circular Fixator System: Struts and Hinges.

A.1. Submitted By:	Wright Medical Technology, Inc.5677 Airline RdArlington, TN 38002
Date:	April 23, 2010
Contact Person:	Megan McCaghRegulatory Affairs Specialist(901) 867-4120
A.2. Proprietary Name:	SIDEKICK® Circular Fixator System: Strutsand Hinges
Common Name:	External Fixation System
Device Classification Regulation:	Single/multiple component metallic bone fixationappliances and accessories -Class II per 21 CFRsection 888.3030
Device Product Code & Panel:	Orthopedics/87/KTT
A.3. Predicate Device:	R & R External Fixation (Ring Fixator) (K052005)

A.4. Device Description

A.5. Intended Use

The SIDEKICK® Circular Fixator System: Struts and Hinges and its components are indicated for open and closed fracture fixation, pseudoarthrosis or nonunions of long bones, limb lengthening by epiphyseal or metaphyseal distraction of bony or soft tissue deformities, and correction of segmental or nonsegmental bony or soft tissue defects. The SIDEKICK® Circular Fixator System: Struts and Hinges is for use on all long bones including: tibia, fibula, femur, humerus, radius and ulna.

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A.6. Technological Characteristics Comparison

The subject SIDEKICK® Circular Fixator System: Struts and Hinges and the legally marketed predicate R & R External Fixation (Ring Fixator) have the same indications, are used at the same anatomical sites, and are both multi-piece designs:

The subject SIDEKICK® Circular Fixator System: Struts and Hinges differs from the legally marketed predicate R & R External Fixation (Ring Fixator) in the number of axes of rotation, material and type of bridge element.

B.1. Substantial Equivalence - Non-Clinical Evidence

Substantial equivalence was shown through static compressive stress testing. The results of the test show that the subject SIDEKICK® Circular Fixator System: Struts and Hinges can be expected to perform at least as well as the legally marketed predicate R & R External. Fixation (Ring Fixator).

The safety and effectiveness of the SIDEKICK® Circular Fixator System: Struts and Hinges is adequately supported by the substantial equivalence information, materials information, and comparison of design characteristics provided within the Premarket Notification.

B.2. Substantial Equivalence - Clinical Evidence

N/A

B.3. Substantial Equivalence - Conclusions

The indications for use of the SIDEKICK® Circular Fixator System: Struts and Hinges are identical to the predicate device. The design features and materials of the subject device are substantially equivalent to those of the predicate device. The substantial equivalence information, materials information, and analysis data provided within this Premarket Notification adequately supports the safety and effectiveness of the SIDEKICK® Circular Fixator System: Struts and Hinges.

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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

Wright-Medical Technology, Inc. . c/o Ms. Megan McCagh Regulatory Affairs Specialist 5677 Airline Road Arlington, Tennessee 38002

JUN 1 0 2010

Re: K100137

Trade/Device Name: SIDEKICK® Circular Fixator System: Struts and Hinges Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT Dated: May 10, 2010 Received: May 13, 2010

Dear Ms. McCagh:

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 such 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

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Page 2 – Ms. Megan McCagh

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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 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.

Barbara Muchm

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

Enclosure

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Indications for Use

510(k) Number (if known): K (00)37

Device Name: SIDEKICK® Circular Fixator System: Struts and Hinges

Indications For Use:

Prescription Use AND/OR X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Omitte
(Division Sign Off) for nxm

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K100137

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.