DEPUY PULSE ANTERIOR CERICAL PLATE SYSTEM

K112724 · Medos International SARL · KWQ · Nov 21, 2011 · Orthopedic

Device Facts

• Record ID: K112724
• Device Name: DEPUY PULSE ANTERIOR CERICAL PLATE SYSTEM
• Applicant: Medos International SARL
• Product Code: KWQ · Orthopedic
• Decision Date: Nov 21, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DePuy Pulse Anterior Cervical Plate System is indicated for stabilization of the cervical spine from C2 to T1 employing unicortical screw fixation at the anterior face of the vertebral bodies. Specific clinical indications for anterior plating include: instability caused by trauma; instability associated with correction of cervical lordosis and kyphosis deformity; instability associated with pseudoarthrosis as a result of previously failed cervical spine surgery; instability associated with major reconstructive surgery for primary tumors or metastatic malignant tumors of the cervical spine; instability associated with single or multiple level corpectomy in advanced degenerative disc disease, spinal canal stenosis and cervical myelopathy.

Device Story

DePuy Pulse Anterior Cervical Plate System provides anterior spinal fixation; consists of titanium alloy plates and self-tapping bone screws. Used by surgeons in clinical settings to stabilize cervical spine (C2-T1) via anterior approach. System includes manual surgical instruments. Device provides mechanical stabilization to vertebral bodies; intended to address instability from trauma, tumors, or degenerative disease. Benefits include structural support for spinal fusion and deformity correction.

Clinical Evidence

No clinical data. Bench testing only: static compression bending, static torsion, and dynamic compression bending performed per ASTM F-1717.

Technological Characteristics

Manufactured from ASTM F-136 implant grade titanium alloy. System comprises plates and self-tapping screws. Mechanical performance validated via ASTM F-1717 static and dynamic testing. Manual surgical instruments included.

Indications for Use

Indicated for stabilization of cervical spine (C2-T1) via anterior unicortical screw fixation. Patient population includes those with instability due to trauma, deformity (lordosis/kyphosis), pseudoarthrosis from failed surgery, primary or metastatic tumors, or degenerative conditions (disc disease, stenosis, myelopathy) requiring corpectomy.

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

• Skyline Anterior Cervical Plate System (K103491)
• Slim-Loc Anterior Cervical Plate System (K013877)
• Uniplate Anterior Cervical Plate System (K082273)

Submission Summary (Full Text)

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## K112724
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## 510(K) SUMMARY

| Submitter: | Medos Internation Sàrl<br>Chemin-Blanc 38<br>Le Locle, CH-NE 2400, Switzerland |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Eugene Bang<br>Regulatory Affairs Associate<br>DePuy Spine, Inc.<br>Voice: [phone]<br>Fax: [phone] |
| Date Prepared: | September 16, 2011 |
| Trade Name: | DePuy Pulse Anterior Cervical Plate System |
| Device Class: | Class II |
| Product Code(s): | KWQ |
| Common Name: | Appliance, Fixation, Spinal Intervertebral Body |
| Classification Name: | Spinal Intervertebral Body Fixation Orthosis |
| Regulation Number: | 888.3060 |
| Predicate Devices: | Skyline Anterior Cervical Plate System - K103491<br>Slim-Loc Anterior Cervical Plate System - K013877<br>Uniplate Anterior Cervical Plate System - K082273 |
| Device Description: | The DePuy Pulse Anterior Cervical Plate System is intended for<br>anterior screw fixation of the plate to the cervical spine. The fixation<br>construct consists of a cervical plate that is attached to the vertebral body<br>of the cervical spine with self-tapping bone screws using an anterior<br>approach. The DePuy Pulse Anterior Cervical Plate System consists of<br>an assortment of implantable titanium alloy plates and screws in various<br>sizes.<br><br>The DePuy Pulse Anterior Cervical Plate System also contains Class 1<br>manual surgical instruments and cases that are considered exempt from<br>premarket notification. |
| Indications: | The DePuy Pulse Anterior Cervical Plate System is indicated for stabilization of<br>the cervical spine from C2 to T1 employing unicortical screw fixation at the<br>anterior face of the vertebral bodies. Specific clinical indications for anterior<br>plating include: instability caused by trauma; instability associated with<br>correction of cervical lordosis and kyphosis deformity; instability associated with<br>pseudoarthrosis as a result of previously failed cervical spine surgery; instability<br>associated with major reconstructive surgery for primary tumors or metastatic<br>malignant tumors of the cervical spine; instability associated with single or<br>multiple level corpectomy in advanced degenerative disc disease, spinal canal<br>stenosis and cervical myelopathy. |
| Materials: | Manufactured from ASTM F-136 implant grade titanium alloy. |
| 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><i>Standard Test Method for Spinal Implant Constructs in a Vertebrectomy<br/> Mode</i> The acceptance criteria was/were met. Static torsion testing in accordance with ASTM F-1717 <i>Standard Test<br/> Method for Spinal Implant Constructs in a Vertebrectomy Mode</i> . The<br>acceptance criteria was/were met. Dynamic compression bending testing in accordance with ASTM F-1717<br><i>Standard Test Method for Spinal Implant Constructs in a Vertebrectomy<br/> Mode</i> . 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 Plate System is substantially equivalent to the predicate<br>devices. |

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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" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus, which is a traditional symbol of medicine.

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

NOV 2 1 2011

Medos International, Sarl % DePuy Spine, Inc. Mr. Eugene Bang 325 Paramount Drive Raynham, Massachusetts 02767

Re: K112724

Trade/Device Name: DePuy Pulse Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWO Dated: September 16, 2011 Received: September 19, 2011

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, 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

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Page 2 - Mr. Eugene Bang

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 forth in the quality systems (OS) 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/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,
for Poffro

N.A

N.A

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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## INDICATIONS FOR USE STATEMENT

510(k) Number: K112724

Device Name: DePuy Pulse Anterior Cervical Plate System

Indications For Use:

The DePuy Pulse Anterior Cervical Plate System is indicated for stabilization of the cervical spine from C2 to T1 employing unicortical screw fixation at the anterior face of the vertebral bodies. Specific clinical indications for anterior plating include: instability caused by trauma; instability associated with correction of cervical lordosis and kyphosis deformity; instability associated with pseudoarthrosis as a result of previously failed cervical spine surgery; instability associated with major reconstructive surgery for primary tumors or metastatic malignant tumors of the cervical spine; instability associated with single or multiple level corpectomy in advanced degenerative disc disease, spinal canal stenosis and cervical myelopathy.

Prescription Use

(Part 21 CFR 801 Subpart D)

Over-The-Counter Use

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign Off)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

KII2724 510(k) Number_