The Synergy Cannulated Screw System is intended for long and small bone fracture fixation, including: fractures of the tarsals and metatarsal and phalangeal osteotomies; fractures of the carpals and metacarpals; carpal and metacarpal arthrodesis; small fragments of the hand and wrist; ligament fixation as appropriate; sacroiliac joint disruptions; fractures of the distal femur and proximal tibia; intracapsular fractures of the hip; ankle arthrodesis; and pelvis and acetabulum fractures. This system is not indicated for use in the spine.

Device Description

Synergy Cannulated Screw System

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving a device meets acceptance criteria. The document is an FDA 510(k) clearance letter for the "Synergy Cannulated Screw System" and a separate "510(k) Summary" for "DBX® Inject".

The first document (FDA clearance letter) states that the Synergy Cannulated Screw System is substantially equivalent to legally marketed predicate devices. It lists the regulation number, name, and product code.

The second document (510(k) Summary for DBX® Inject) describes the device, its intended use, and argues for its substantial equivalence to other cleared devices based on the absence of "new types of safety and effectiveness questions." It provides a table of indications for use for DBX® Inject (Putty and Paste forms).

Neither document includes details about:

Specific acceptance criteria (e.g., performance metrics, thresholds)
A study design or results that demonstrate the device meets any such criteria
Sample sizes for test or training sets
Data provenance
Number or qualifications of experts
Adjudication methods
MRMC comparative effectiveness studies
Standalone performance studies
Types of ground truth
How ground truth was established

Summary

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Image /page/0/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Synergy Surgical Technologies, Inc. % Paxmed International, LLC Kevin Thomas 11234 El Camino Real, Suite 200 San Diego, California 92130

OCT - 2 2009

Re: K092082

Trade/Device Name: Synergy 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, HTN * Dated: July 7, 2009 Received: July 9, 2009

Dear Mr. Thomas:

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 indictions for use stated in the enclosure) to legally marketed predicate devices markets 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, isting of devices, good manufacturing practice, labeling, and prohibitions against misburanding and adulteration.

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, FTDA 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 af 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements 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 - Mr. Kevin Thomas

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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark A. Milke

Mark 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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510(k) Summary

Synergy Cannulated Screw System

Indications for Use

510(k) Number (if known): 110920832 (pg 1/1)

Device Name: Synergy Cannulated Screw System

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (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)

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Sonita for men
(Division Sign-Off)

Division of Surgical, Orthovedic, and Restorative Devices

510(k) Number K092082

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Description

DBX® Inject is completely resorbable and is composed of donated cortical and cancellous bone. The bone granules are mixed with sodium hyaluronate (Hy). DBX® Inject consists of DBX Putty or Paste with a separate, sterile plastic syringe for delivery directly into the operative site.

Intended Use (Indications)

DBX® Inject is intended for use as a Demineralized Bone Matrix for voids or gaps that are not intrinsic to the stability of the bony structure. It can be used as follows:

Indications for Use	Putty	Paste
Ridge augmentation	√	√
Filling of extraction sites	√	√
Craniofacial augmentation	√	√
Mandibular reconstruction	√	√
Repair of traumatic defects of the alveolar ridge,excluding maxillary and mandibular fracture	√	√
Filling resection defects in benign tumors, benign cysts,or other osseous defects in the alveolar ridge wall	√	√
Filling of cystic defect	√	√
Filling of lesions of periodontal origin	√	√
Filling of defects of endodontic origin	√	√

DBX® Inject is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. DBX® Inject can be used with bone marrow. DBX® Inject is for single patient use only.

Substantial Equivalence

This submission supports the position that DBX® Inject is substantially equivalent to a number of previously cleared devices, including:

DBX® Demineralized Bone Matrix - Musculoskeletal Transplant Foundation JK040262] SygnaITM DBM-Musculoskeletal Transplant Foundation [K080405]

When comparing DBX® Inject to its predicate devices, there are no new types of safety and effectiveness questions. DBX® Inject has been demonstrated to be substantially equivalent to its predicate devices.

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.