DEPUY SYNTHES SPINE DENS ACCESS SYSTEM

K132910 · Synthes USA Products, LLC · HWC · Dec 16, 2013 · Orthopedic

Device Facts

• Record ID: K132910
• Device Name: DEPUY SYNTHES SPINE DENS ACCESS SYSTEM
• Applicant: Synthes USA Products, LLC
• Product Code: HWC · Orthopedic
• Decision Date: Dec 16, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For fracture fixation of small bones and small bone fragments including odontoid fractures.

Device Story

DePuy Synthes Spine Dens Access System consists of metallic bone screws and associated surgical instruments. Screws feature self-drilling, self-tapping tips, reverse cutting flutes, and cancellous threads. Used by surgeons for internal fixation of small bone fractures, specifically odontoid fractures. Mechanical performance characterized by torque to failure, cantilever bend, pull-out strength, and insertion torque testing. Device provides stable fixation to facilitate bone healing.

Clinical Evidence

No clinical data was necessary to demonstrate substantial equivalence, safety, or effectiveness. Evidence is based on bench-top mechanical testing.

Technological Characteristics

Manufactured from Titanium-6Aluminum-7Niobium alloy (ASTM F-1295). Features self-drilling, self-tapping tips, reverse cutting flutes, and cancellous threads. Non-sterile. Mechanical testing includes torque to failure, cantilever bend, pull-out strength, and insertion torque.

Indications for Use

Indicated for fracture fixation of small bones and small bone fragments, including odontoid fractures.

Regulatory Classification

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.

Predicate Devices

• Synthes 4.0mm Cannulated Screw (K963192)
• HBS Headless Bone Screw (K020791)
• Headless Compression Screw (K112672)

Submission Summary (Full Text)

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## 510(k) Summary

| Submitter: | Synthes Spine<br>1302 Wrights Lane East<br>West Chester, PA 19380 | DEC 16 2013 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact Person: | Eugene Bang<br>Regulatory Affairs Associate<br>Telephone: [phone]<br>Fax: [phone] | |
| Date Prepared: | November 25, 2013 | |
| Trade Name: | DePuy Synthes Spine Dens Access System | |
| Device Class: | Class II | |
| Product Code(s): | HWC | |
| Common Name: | Screw, Fixation, Bone | |
| Classification Name: | Smooth or Threaded Metallic Bone Fixation Fastener | |
| Regulation Number: | 21 CFR 888.3040 | |
| Predicate Devices: | Synthes 4.0mm Cannulated Screw - K963192<br>HBS Headless Bone Screw - K020791<br>Headless Compression Screw - K112672 | |
| Device Description: | DePuy Synthes Spine Dens Access System is comprised of screws and<br>instruments. The screws are available in multiple lengths and will be<br>offered non-sterile. The screws feature self-drilling, self-tapping tips,<br>reverse cutting flutes and cancellous threads. | |
| Indications: | For fracture fixation of small bones and small bone fragments including<br>odontoid fractures. | |
| Materials: | Manufactured from Titanium-6Aluminum-7Niobium Alloy conforming<br>to ASTM F-1295 | |

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## K132910

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and the comments of the comments of the comments of

and the comments of the comments of

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| Comparison to<br>Predicate Device: | The substantial equivalence of the subject device to the predicates indentified<br>above is based upon the equivalence of intended use, design (fundamental<br>scientific technology), materials, performance, sterility, and biocompatibility. |
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| Non-clinical Test<br>Summary: | Mechanical testing was provided in order to provide data to support a<br>substantial equivalence determination. These tests were performed to<br>characterize the properties and functionality of the screw, as well as to<br>allow comparison with established acceptance criteria. |
| | The following mechanical tests were conducted on the screw: |
| | Torque to failure test Cantilever bend test Pull-out strength test Insertion torque test |
| Clinical Test<br>Summary: | No clinical data was necessary to demonstrate substantial equivalence, nor<br>safety and effectiveness of this system. |

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes extending from its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-00002

December 16, 2013

Synthes (USA) Products, LLC Mr. Eugene Bang Regulatory Affairs Associate 1302 Wrights Lane East West Chester, Pennsylvania 19380

Re: K132910

Trade/Device Name: DePuy Synthes Spine Dens Access System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: September 23, 2013 Received: September 24, 2013

Dear Mr. Bang:

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. Drue. 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 111 (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 - Mr. Eugene Bang

ﺍﻟﻤﺎﻟﻴﺔ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﻘﺎﺑﻠﺔ ﻭﺍﻟﻘﺎﺑﻠﺔ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤ

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 Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/Safetv/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Ronald院剑ean -S for

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

Enclosure

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* 1135-17 1944 1994 1994 1994 1999 1999 11

#### Indications for Use Statement

510(k) Number (if known): K132910

Device Name: DePuy Synthes Spine Dens Access System

Indications For Use:

For fracture fixation of small bones and small bone fragments including odontoid fractures.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use _

(Part 21 CFR 801 Subpart D)

Х

(21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

# Elizabeth L. Frank -S

Division of Orthopedic Devices

DePuy Synthes Spine Dens Access System