DEPUY PULSE ANTERIOR CERVICAL IN-LINE PLATE SYSTEM

K123167 · Medos International SARL · KWQ · Dec 28, 2012 · Orthopedic

Device Facts

• Record ID: K123167
• Device Name: DEPUY PULSE ANTERIOR CERVICAL IN-LINE PLATE SYSTEM
• Applicant: Medos International SARL
• Product Code: KWQ · Orthopedic
• Decision Date: Dec 28, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DePuy PULSE Anterior Cervical In-Line Plate System is intended for anterior cervical intervertebral body fixation. This system is indicated for patients in which stability is desired following anterior cervical fusion for the indications listed below. The intended levels for treatment range from C2 to T1. Indication includes symptomatic cervical spondylosis, trauma, fracture, post-traumatic kyphosis or lordosis, tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, re-operation for failed fusion, or instability following surgery for the above indications.

Device Story

System consists of titanium alloy plates and bone screws for anterior cervical spine fixation. Used by surgeons to provide stability following anterior cervical fusion. Implanted via anterior approach to vertebral bodies. Benefits patient by stabilizing cervical spine segments (C2-T1) to facilitate fusion and address conditions like spondylosis, trauma, or degenerative disc disease.

Clinical Evidence

No clinical data. Bench testing only: static compression bending, static torsion, and dynamic compression bending performed in accordance with ASTM F-1717 (Standard Test Method for Spinal Implant Constructs in a Vertebrectomy Model). All acceptance criteria met.

Technological Characteristics

Titanium alloy (Ti-6Al-4V ELI) per ASTM F-136. Implantable plate and screw system. Mechanical performance validated via ASTM F-1717 testing. No software or electronic components.

Indications for Use

Indicated for patients requiring anterior cervical intervertebral body fixation (levels C2-T1) for stability following fusion. Conditions include symptomatic cervical spondylosis, trauma, fracture, post-traumatic kyphosis/lordosis, tumor, degenerative disc disease, spinal stenosis, re-operation for failed fusion, or post-surgical instability.

Regulatory Classification

Identification

A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.

Predicate Devices

• AcroPlate Anterior Cervical Plate System (DePuy Spine) - K914362
• Uniplate Anterior Cervical Plate System (DePuy Spine) - K042544
• Skyline Anterior Cervical Plate System (DePuy Spine) - K103491
• PULSE Anterior Cervical Plate System (DePuy Spine) - K112724

Submission Summary (Full Text)

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## 510(K) SUMMARY

Submitter:

Medos International Sàrl Chemin-Blanc 38 Le Locle, CH-NE 2400, Switzerland

Contact Person:

Eugene Bang Regulatory Affairs Associate Voice: [phone] [phone] Fax:

October 8, 2012

Class II

KWQ

888.3060

Date Prepared: Trade Name: Device Class: Product Code(s): Common Name: Classification Name: Regulation Number:

Predicate Devices:

Device Description:

AcroPlate Anterior Cervical Plate System (DePuy Spine) - K914362 Uniplate Anterior Cervical Plate System (DePuy Spine) - K042544 Skyline Anterior Cervical Plate System (DePuy Spine) - K 103491 PULSE Anterior Cervical Plate System (DePuy Spine) - K112724

DePuy PULSETM Anterior Cervical In-Line Plate System

Appliance, Fixation, Spinal Intervertebral Body

Spinal Intervertebral Body Fixation Orthosis

The DePuy PULSE Anterior Cervical In-Line Plate System is intended for anterior screw fixation of the plate to the cervical spine. The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with bone screws using an anterior approach. The DePuy PULSE Anterior Cervical In-Line Plate System consists of an assortment of implantable titanium alloy plates and screws in various sizes.

DEC 2 8 2012

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| Indications: | The DePuy PULSE Anterior Cervical In-Line Plate System is intended for<br>anterior cervical intervertebral body fixation. This system is indicated for patients<br>in which stability is desired following anterior cervical fusion for the indications<br>listed below. The intended levels for treatment range from C2 to T1. |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Indication includes symptomatic cervical spondylosis, trauma, fracture, post-<br>traumatic kyphosis or lordosis, tumor, degenerative disc disease (defined as<br>discogenic pain with degeneration of the disc confirmed by history and<br>radiographic studies), spinal stenosis, re-operation for failed fusion, or instability<br>following surgery for the above indications. |
| Materials: | Manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F-136. |
| 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, manufacturing methods, performance, sterility,<br>biocompatibility, safety and packaging design. |
| Non-clinical Test<br>Summary: | The following mechanical tests were conducted:<br>• Static compression bending testing in accordance with ASTM F-1717<br>Standard Test Method for Spinal Implant Constructs in a Vertebrectomy<br>Model. The acceptance criteria was/were met.<br>• Static torsion testing in accordance with ASTM F-1717 Standard Test<br>Method for Spinal Implant Constructs in a Vertebrectomy Model. The<br>acceptance criteria was/were met.<br>• Dynamic compression bending testing in accordance with ASTM F-1717<br>Standard Test Method for Spinal Implant Constructs in a Vertebrectomy<br>Model. The acceptance criteria was/were met. |
| Clinical Test<br>Summary: | No clinical tests were performed. |
| Conclusion: | Based on the predicate comparison and testing, the subject device DePuy PULSE<br>Anterior Cervical In-Line Plate System is substantially equivalent to the<br>predicate devices. |

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird-like figure with three stylized lines forming its body and wings.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Letter dated: December 28, 2012

Medos International, Sarl % John & Johnson Company Mr. Eugene Bang Regulatory Affairs Associate 325 Paramount Drive Raynham, Massachusetts 02767

Re: K123167

Trade/Device Name: DePuy PULSE™ Anterior Cervical In-Line Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: October 08, 2012 Received: October 09, 2012

Dear Mr. Bang:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewe 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, de noos that have been 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 manier the Act include requirements for annual registration, listing of I ho general bonators proving practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability addition: Triouse noter, 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 may be subject to additions, 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 I least of advisou that I Drivice and sever device complies with other requirements of the Act that I Dri has made a and regulations administered by other Federal agencies. You must or any I ederal statures and regimments, including, but not limited to: registration and listing (21 Comply with an the Act 8 require mart 801); medical device reporting (reporting of medical CITY att 6077, laboring (21 CFR 803); good manufacturing practice requirements as set

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## Page 2 - Mr. Eugene Bang

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 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/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,

Mark N. Melkerson

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

Enclosure

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## INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K123167

Device Name: DePuy PULSE™ Anterior Cervical In-Line Plate System

Indications For Use:

The DePuy PULSE Anterior Cervical In-Line Plate System is intended for anterior cervical intervertebral body fixation. This system is indicated for patients in which stability is desired following anterior cervical fusion for the indications listed below. The intended levels for treatment range from C2 to T1.

Indication includes symptomatic cervical spondylosis, trauma, fracture, post-traumatic kyphosis or lordosis, tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, re-operation for failed fusion, or instability following surgery for the above indications.

Prescription Use __ X

AND/OR

Over-The-Counter Use _

(Part 21 CFR 801 Subpart D)

(Part 21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off) Division of Orthopedic Devices 510(K) Number: K123167