DEPUY PULSE LUMBAR CAGE SYSTEM

K120966 · Medos International SARL · MAX · Jul 3, 2012 · Orthopedic

Device Facts

• Record ID: K120966
• Device Name: DEPUY PULSE LUMBAR CAGE SYSTEM
• Applicant: Medos International SARL
• Product Code: MAX · Orthopedic
• Decision Date: Jul 3, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DePuy PULSE Lumbar Cage System is indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Patients should have six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via a PLIF or TLIF approach using autogenous bone. When used as intervertebral body fusion devices these implants are intended for use with DePuy Spine supplemental internal fixation products.

Device Story

The DePuy PULSE Lumbar Cage System is an intervertebral body fusion device designed for lumbar spinal fusion. The system consists of implants available in various geometries and sizes to accommodate patient anatomy. Implants are placed by surgeons via posterior lumbar intervertebral fusion (PLIF) or transforaminal lumbar intervertebral fusion (TLIF) approaches, packed with autogenous bone graft to facilitate fusion. The device is intended to be used in conjunction with DePuy Spine supplemental internal fixation products to provide stability during the fusion process. The implants serve as a structural spacer to maintain disc space height while bone healing occurs.

Clinical Evidence

No clinical data. Bench testing only, including static and dynamic axial compression and compression shear testing (ASTM F-2077) and subsidence testing (ASTM F-2267).

Technological Characteristics

Constructed from medical grade polyetheretherketone (PEEK OPTIMA LT1) per ASTM F-2026 and tantalum markers per ASTM F-560. The device is a structural intervertebral spacer designed for use with supplemental internal fixation.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (discogenic back pain) at one or two contiguous lumbar levels (L2-S1) who have failed six months of 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

• Concorde System (K081917, K103488)
• Concorde Curve System (K101923)
• Concorde Inline System (K110694)
• Genesys Spine Interbody Fusion System (K103034)
• RAY Threaded Fusion Cage (P950019)

Submission Summary (Full Text)

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# 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: | March 29, 2012 |
| Trade Name: | DePuy PULSE™ Lumbar Cage System |
| Device Class: | Class II |
| Product Code(s): | MAX |
| Common Name: | Intervertebral Fusion Device with Bone Graft, Lumbar |
| Classification Name: | Intervertebral Body Fusion Device |
| Regulation Number: | 888.3080 |
| Predicate Devices: | Concorde System - K081917, K103488<br>Concorde Curve System - K101923<br>Concorde Inline System - K110694<br>Genesys Spine Interbody Fusion System - K103034<br>RAY Threaded Fusion Cage - P950019 |
| Device Description: | The DePuy PULSE Lumbar Cage System is designed for use as a<br>lumbar intervertebral body fusion device. The implant devices are<br>available in various geometries and sizes to accommodate patient<br>anatomy. The implant devices are manufactured from medical grade<br>polyetheretherketone (PEEK OPTIMA® LT1) per ASTM F-2026 and<br>tantalum markers per ASTM F-560. |
| Indications: | The DePuy PULSE Lumbar Cage System is indicated for use as intervertebral<br>body fusion devices in skeletally mature patients with degenerative disc disease<br>(defined as discogenic back pain with degeneration of the disc confirmed by<br>patient history and radiographic studies) at one or two contiguous levels of the<br>lumbar spine (L2-S1). Patients should have six months of non-operative<br>treatment prior to surgery. These implants are used to facilitate fusion in the<br>lumbar spine and are placed via a PLIF or TLIF approach using autogenous bone.<br>When used as intervertebral body fusion devices these implants are intended for<br>use with DePuy Spine supplemental internal fixation products. |
| Materials: | Manufactured from medical grade polyetheretherketone (PEEK OPTIMA® LT1)<br>per ASTMF F-2026 and tantalum markers 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: |
| | • Static and dynamic axial compression testing in accordance with ASTM F-<br>2077 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>Lumbar Cage System is substantially equivalent to the 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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle emblem, with three curved lines representing the eagle's wings and a wavy line representing its body.

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

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

3 2012 JUL

Re: K120966

> Trade/Device Name: DePuy PULSE™ Lumbar Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: June 08, 2012 Received: June 11, 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.

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### Page 2- Mr. Eugene Bang

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 (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 vours.

Evinl Keith

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 (if known):

Device Name: DePuy PULSE™ Lumbar Cage System

Indications For Use:

The DePuy PULSE Lumbar Cage System is indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Patients should have six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via a PLIF or TLIF approach using autogenous bone. When used as intervertebral body fusion devices these implants are intended for use with DePuy Spine supplemental internal fixation products.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use __

(21 CFR 807 Subpart C)

(Part 21 CFR 801 Subpart D)

(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 of Surgical, Orthopedic, and Restorative Devices

510(k) Number K120966