The WRIGHT™ Compression Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. Screws are intended for single use only.

Device Description

The design features of the WRIGHT™ Compression Screws are described below.

Manufactured from Titanium Alloy .
Available headed or headless .
Available in various diameters and lengths .
. Cannulated

AI/ML Overview

The provided text is a 510(k) summary for the WRIGHT™ Compression Screws, which details the device's intended use, description, and substantial equivalence to previously cleared predicate devices. However, this document does not contain the acceptance criteria or a study proving the device meets specific performance criteria.

The 510(k) summary focuses on demonstrating "substantial equivalence" of the new device to legally marketed predicate devices, rather than providing detailed performance studies against specific acceptance criteria. This is a common pathway for medical devices that are similar to existing ones.

Therefore, I cannot provide the requested information, including:

A table of acceptance criteria and the reported device performance: This information is not present in the provided text. The document states that the safety and effectiveness are "adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification," but it does not specify what these acceptance criteria or the specific performance results are.
Sample size used for the test set and the data provenance: Not applicable, as detailed performance studies are not described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: No such study is mentioned.
If a standalone performance (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
The type of ground truth used: Not applicable, as no specific performance study against a ground truth is described.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

The document states: "The safety and effectiveness of the WRIGHT™ Compression Screws is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification." This implies that the submission contained information on material properties and potentially mechanical testing, but these details are not part of the provided 510(k) summary itself. The clearance is based on the device being "substantially equivalent" to predicate devices, meaning it shares similar technological characteristics and is intended for the same use.

Summary

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K0r2320

NOV - 5 2008

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, this information serves as a Summary of Safety and Effectiveness for the use of the DARCO® Small Screws.

Submitted By:	Wright Medical Technology, Inc.
Date:	August 11, 2008
Contact Person:	Sarah Holtgrewe
	Regulatory Affairs Specialist
Proprietary Name:	WRIGHT™ Compression Screws
Common Name:	Bone Screws
Device Classification Regulation:	21 CFR 888.3040--Class II
Device Product Code & Panel:	HWC: Screw, Fixation, Bone/ Orthopedics

DEVICE INFORMATION

A. INTENDED USE

B. DEVICE DESCRIPTION

The design features of the WRIGHT™ Compression Screws are described below.

Manufactured from Titanium Alloy .
Available headed or headless .
Available in various diameters and lengths .
. Cannulated

. . . . .

The design features of the WRIGHT™ Compression Screws are substantially equivalent to the design features of other devices previously cleared for market.

C. SUBSTANTIAL EQUIVALENCE INFORMATION

The design features, material, and indications for use of the WRIGHT™ Compression Screws are substantially equivalent to previously cleared predicate devices. The safety and effectiveness of the WRIGHT™ Compression Screws is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.

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Image /page/1/Picture/12 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Wright Medical Technology, Inc. % Ms. Sarah Holtgrewe Regulatory Affairs Specialist 5677 Airline Road Arlington, Tennessee 38002

NOV - 5 2008

Re: K082320

Trade/Device Name: WRIGHT™ Compression Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: August 11, 2008 Received: August 13. 2008

Dear Ms. Holtgrewe:

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. ·

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 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 (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.

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Page 2 - Ms. Sarah Holtgrewe

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket, Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark M. Mullen

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: WRIGHT™ Compression Screws

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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)

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number 16082320

1 of 1

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.