DEPUY PULSE CERVICAL CAGE SYSTEM

K120517 · Medos International SARL · ODP · Apr 26, 2012 · Orthopedic

Device Facts

• Record ID: K120517
• Device Name: DEPUY PULSE CERVICAL CAGE SYSTEM
• Applicant: Medos International SARL
• Product Code: ODP · Orthopedic
• Decision Date: Apr 26, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DePuy Pulse Cervical Cage System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic neck pain with degeneration of the disc confirmed by patient history and radiographic studies) at one level of the cervical spine with accompanying radicular symptoms. Patients should have six weeks of non-operative treatment prior to surgery. The DePuy Pulse Cervical Cage System implants are used to facilitate fusion in the cervical spine (C2 - T1) and are placed via an anterior approach using autogenous bone. DePuy Pulse Cervical Cage System implants are intended to be used with supplemental internal fixation system.

Device Story

DePuy Pulse Cervical Cage System is an intervertebral body fusion device; used to facilitate fusion in cervical spine (C2-T1). Implanted via anterior approach using autogenous bone; requires supplemental internal fixation. Available in various geometries/sizes to accommodate patient anatomy. Used by surgeons in clinical settings. Benefits patient by providing structural support during spinal fusion process.

Clinical Evidence

No clinical data. Bench testing only: static and dynamic compression, torsion, and compression shear testing per ASTM F-2077; subsidence testing per ASTM F-2267. All acceptance criteria met.

Technological Characteristics

Constructed from medical grade polyetheretherketone (PEEK OPTIMA LT1) per ASTM F-2026 and tantalum wires per ASTM F-560. Intervertebral body fusion device form factor. Manual surgical instruments included.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (discogenic neck pain with radiographic confirmation) at one level of the cervical spine (C2-T1) with radicular symptoms, following six weeks of failed non-operative treatment.

Regulatory Classification

Identification

An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.

Special Controls

*Classification.* (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Predicate Devices

• Bengal System (K081917, K103488)
• Concorde System (K081917)
• Lumbar I/F Cage System (P960025)
• LDR Spine Cervical Interbody Fusion System (K091088)

Submission Summary (Full Text)

{0}------------------------------------------------

# KI20217

### APR 2 6 2012

#### 510(K) SUMMARY

| Submitter: | Medos International 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: | February 17, 2012 |
| Trade Name: | DePuy Pulse Cervical Cage System |
| Device Class: | Class II |
| Product Code(s): | ODP |
| Common Name: | Intervertebral Fusion Device with Bone Graft, Cervical |
| Classification Name: | Intervertebral Body Fusion Device |
| Regulation Number: | 888.3080 |
| Predicate Devices: | Bengal System - K081917, K103488<br>Concorde System - K081917<br>Lumbar I/F Cage System - P960025'<br>LDR Spine Cervical Interbody Fusion System - K091088 |
| Device Description: | The DePuy Pulse Cervical Cage System is designed for use as a cervical<br>intervertebral body fusion device. The implant devices are available in<br>various geometries and sizes to accommodate patient anatomy. The<br>implant devices are manufactured from medical grade<br>polyetheretherketone (PEEK OPTIMA® LT1) per ASTM F-2026 and<br>also contain tantalum wires per ASTM F-560.<br>The DePuy Pulse Cervical Cage System also contains Class 1 manual<br>surgical instruments and cases that are considered exempt from<br>premarket notification. |
| Indications: | The DePuy Pulse Cervical Cage System is indicated for use as an intervertebral<br>body fusion device in skeletally mature patients with degenerative disc disease<br>(defined as discogenic neck pain with degeneration of the disc confirmed by<br>patient history and radiographic studies) at one level of the cervical spine with<br>accompanying radicular symptoms. Patients should have six weeks of non-<br>operative treatment prior to surgery. The DePuy Pulse Cervical Cage System<br>implants are used to facilitate fusion in the cervical spine (C2 - T1) and are<br>placed via an anterior approach using autogenous bone. DePuy Pulse Cervical<br>Cage System implants are intended to be used with supplemental internal fixation<br>system. |
| Materials: | Manufactured from medical grade polyetheretherketone (PEEK OPTIMA® LTI)<br>per ASTMF F-2026 and tantalum wires per ASTM F-560. |
| 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 and dynamic compression testing in accordance with ASTM F-2077<br>Standard Test Method for Intervertebral Body Fusion Devices. The<br>acceptance criteria was/were met. Static and dynamic torsion testing in accordance with ASTM F-2077<br>Standard Test Method for Intervertebral Body Fusion Devices. The<br>acceptance criteria was/were met. Static and dynamic compression shear testing in accordance with ASTM F-<br>2077 Standard Test Method for Intervertebral Body Fusion Devices. The<br>acceptance criteria was/were met. Subsidence testing in accordance with ASTM F-2267 Standard Test Method<br>for Measuring Load Induced Subsidence of Intervertebral Body Fusion<br>Device Under Static Axial Compression. The acceptance criteria was/were<br>met. |
| Clinical Test<br>Summary: | No clinical tests were performed. |
| Conclusion: | Based on the predicate comparison and testing, the subject device DePuy Pulse<br>Cervical Cage System is substantially equivalent to the predicate devices. |

¹ This device was re-classified from a Class III (PMA) device to a Class II (510K) device via petition approved on 2007

{1}------------------------------------------------

# 队120517

-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Pg 2 of 2

{2}------------------------------------------------

#### 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 features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all caps and appears to be in a sans-serif font.

#### Public Health Service

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

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

APR 2 6 2012

Re: K120517

Trade/Device Name: DePuy Pulse Cervical Cage System Regulation Number: 21 CFR 8880.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: February 17, 2012 Received: February 21, 2012

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 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

{3}------------------------------------------------

Page 2 - Mr. Eugene Bang

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 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.

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,
Mark A. Millman

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

Enclosure

{4}------------------------------------------------

## 12051

#### INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K120517

Device Name: DePuy Pulse Cervical Cage System

Indications For Use:

The DePuy Pulse Cervical Cage System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic neck pain with degeneration of the disc confirmed by patient history and radiographic studies) at one level of the cervical spine with accompanying radicular symptoms. Patients should have six weeks of non-operative treatment prior to surgery. The DePuy Pulse Cervical Cage System implants are used to facilitate fusion in the cervical spine (C2 - T1) and are placed via an anterior approach using autogenous bone. DePuy Pulse Cervical Cage System implants are intended to be used with supplemental internal fixation system.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Part 21 CFR 801 Subpart D)

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

510(k) Number K120517