The CSS cannulated bone screw is indicated for bone fractures, arthodeses, osteochronditis and tendon reattachment. These screws are not intended for attachment or fixation to the posterior elements (pedicles) of cervical, thoracic, or lumbar spine.

The Cannulated Screw System is designed for bone fracture, osteotomies, arthrodesis, osteochronditis and tendon reattachment. These screws are not intended for attachment or fixation to the posterior elements (pedicles) of cervical, thoracic, or lumbar spine.

Device Description

The Cannulated Screw System implants are partially threaded devices offered in multiple lengths and diameter. The implants have a cruciate driver head. The implants are cylindrical in shape and incorporate a center cannula designed for use with a guide wire to facilitate proper placement of the implant. These screws are of self-tapping.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called the "Cannulated Screw System". This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a study. Therefore, the requested information regarding acceptance criteria, device performance tables, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details for a study cannot be found in this document.

Here's an explanation based on the document's content:

Substantial Equivalence: The FDA's 510(k) pathway is for devices that are "substantially equivalent" to a legally marketed predicate device. This means the new device has the same intended use as the predicate and either has the same technological characteristics or, if it has different technological characteristics, the differences do not raise new questions of safety or effectiveness and performance data demonstrates that the device is as safe and effective as the predicate.

The document states:

"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..." (Page 1)
"The Cannulated Screw System is technologically substantially equivalent to the predicate devices." (Page 3)
"Testing rationales related to pull out, insertion, removal and ultimate torque were provided to support the substantial equivalence of the subject device and show that no new worst-case devices are introduced in this system." (Page 4)
"The safety and effectiveness of the Cannulated Screw System is adequately supported within this premarket notification. Through the analysis of technical characteristics the new devices are substantially equivalent to the predicate devices." (Page 4)
"(b)(2). Substantial Equivalence - Clinical Evidence N/A" (Page 4) - This explicitly states no clinical evidence (which would typically involve large-scale studies with acceptance criteria) was provided or deemed necessary for this submission.

The "testing rationales" mentioned for pull-out, insertion, removal, and ultimate torque are benchtop (non-clinical) tests used to show that the new device performs at least as well as the predicate devices in these specific mechanical properties, thereby supporting substantial equivalence. They are not framed as meeting specific clinical "acceptance criteria" through a clinical study as your request implies.

In summary, this document does not contain the details of a study that proves the device meets specific acceptance criteria in the way you've outlined because it's a 510(k) submission focused on demonstrating substantial equivalence through technical characteristics and bench testing, not clinical performance against defined acceptance metrics.

Summary

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

Wright Medical Technology, Inc. Ms. Tara Conrad Regulatory Affairs Specialist II 1023 Cherry Road Memphis, Tennessee 38117

January 23, 2015

Re: K143460

Trade/Device Name: Cannulated Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: December 10, 2014 Received: December 11, 2014

Dear Ms. Tara Conrad:

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

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Page 2 - Ms. Tara Conrad

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" (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 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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Mark N. Melkerson -S

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K143460

Device Name Cannulated Screw System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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Headquarters Wright Medical Technology, Inc

Memphis, TN 38117

1867 9971 mt.com

510(K) SUMMARY

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 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the Cannulated Screw System.

(a)(1). Submitted By:	Wright Medical Technology, Inc.1023 Cherry RoadMemphis, TN 38117
Date:	December 22, 2014
Contact Person:	Tara ConradRegulatory Affairs SpecialistOffice - (901) 867-4367Fax - (901) 867-4190
(a)(2). Proprietary Name:	Cannulated Screw System
Common Name:	Smooth or threaded metallic bone fixationfastener
Classification Name and Reference:	21 CFR 888.3040 – Class II
Device Product Code, Device Panel:	HWC - Orthopedic
(a)(3). Predicate Device:	K042310: Cannulated Bone Screws SystemK082320: Wright Compression Screws

(a)(4). Device Description

(a)(5). INTENDED USE

(a)(6). Technological Characteristics Comparison

The Cannulated Screw System and the legally marketed predicate devices have similar indications, dimensions and geometry, and materials. The Cannulated Screw System is technologically substantially equivalent to the predicate devices.

(b)(1). Substantial Equivalence - Non-Clinical Evidence

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Testing rationales related to pull out, insertion, removal and ultimate torque were provided to support the substantial equivalence of the subject device and show that no new worst-case devices are introduced in this system.

The safety and effectiveness of the Cannulated Screw System is adequately supported within this premarket notification. Through the analysis of technical characteristics the new devices are substantially equivalent to the predicate devices.

(b)(2). Substantial Equivalence - Clinical Evidence

N/A

(b)(3). Substantial Equivalence - Conclusions

The design characteristics of the subject system do not raise any new types of questions of safety or effectiveness. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate device.

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.