PARADIGM INTERSPINOUS FUSION PLATE

K093438 · Paradigm Spine, LLC · KWP · Oct 6, 2010 · Orthopedic

Device Facts

• Record ID: K093438
• Device Name: PARADIGM INTERSPINOUS FUSION PLATE
• Applicant: Paradigm Spine, LLC
• Product Code: KWP · Orthopedic
• Decision Date: Oct 6, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Paradigm Interspinous Fusion Plate is a posterior, non-pedicle supplemental fixation device intended for use with an interbody cage as an adjunct to fusion at a single level in the lumbar spine (L1 - S1). It is intended for attachment to the spinous processes for the purpose of achieving stabilization to promote fusion in patients with degenerative disc disease - defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies - with up to Grade 1 spondylolisthesis.

Device Story

Paradigm Interspinous Fusion Plate is a posterior, non-pedicle supplemental fixation device; used as an adjunct to interbody cage fusion at a single lumbar level (L1-S1). Device consists of a U-shaped titanium alloy (Ti6Al4V) component with two sets of wings extending from superior and inferior arms. Surgeon attaches device to spinous processes; screw and sleeve mechanism fixes crimped wings to processes to provide stabilization. Used in clinical settings by surgeons to promote fusion in patients with degenerative disc disease and Grade 1 spondylolisthesis.

Clinical Evidence

Clinical data was provided to demonstrate substantially equivalent performance to predicate devices, in addition to preclinical bench testing (static tension, static compression, static torsion, dynamic compression, dynamic compression-tension, screw loosening and tightening).

Technological Characteristics

Constructed from medical grade titanium alloy (Ti6Al4V). Features a U-shaped design with two sets of wings and a screw/sleeve fixation mechanism. Mechanical stabilization principle. No software or electronic components.

Indications for Use

Indicated for patients with degenerative disc disease (back pain of discogenic origin confirmed by history/radiography) and up to Grade 1 spondylolisthesis requiring single-level lumbar (L1-S1) fusion.

Regulatory Classification

Identification

A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.

Predicate Devices

• Medtronic SPIRE (K032037)
• Lanx Spinous Process Plate (K071877)
• NuVasive Spinous Process Plate System (K073278)

Submission Summary (Full Text)

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K093438

# OCT 6 2010

## 510(k) Summary according to 807.92(c)

| Contact: | Justin Eggleton<br>Director, Spine Regulatory Affairs<br>Musculoskeletal Clinical Regulatory Advisers, LLC<br>1331 H Street NW, 12th Floor<br>Washington, DC 20005<br>[phone] |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | August 10, 2010 |
| Trade Name: | Paradigm Interspinous Fusion Plate |
| Common Name: | Spinous Process Plate |
| Device Regulatory Class: | Spinal interlaminal fixation orthosis<br>21 CFR §888.3050, Class II |
| Product Code: | KWP |

#### Indications for Use:

The Paradigm Interspinous Fusion Plate is a posterior, non-pedicle supplemental fixation device intended for use with an interbody cage as an adjunct to fusion at a single level in the lumbar spine (L1 - S1). It is intended for attachment to the spinous processes for the purpose of achieving stabilization to promote fusion in patients with degenerative disc disease - defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies - with up to Grade 1 spondylolisthesis.

#### Device Description:

The Paradigm Interspinous Fusion Plate is a spinous process fixation device that stabilizes the spinous processes and spine to act as an adjunct to fusion. It consists of a single, U-shaped component, fabricated from medical grade titanium alloy (Ti6A14V). A set of two wings extends vertically from the superior long arm of the device, with a second set of wings extending below the inferior long arm. A screw and sleeve are inserted through a prepared hole and fixes the crimped wings to the superior and inferior spinous processes.

#### Predicate Device(s):

The Paradigm Interspinous Fusion Plate was shown to be substantially equivalent to previously cleared devices (e.g., Medtronic SPIRE (K032037), Lanx Spinous Process Plate (K071877), and NuVasive Spinous Process Plate System (K073278)) and has the same indications for use, design, function, and materials used.

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# K093438

### Performance Standards:

Performance testing demonstrated Paradigm Interspinous Fusion Plate is substantially equivalent to predicate devices. Preclinical testing (Static tension, static compression, static torsion, dynamic compression, dynamic compression-tension, screw loosening and tightening) demonstrated substantial equivalence to predicate devices. In addition, clinical data was provided to demonstrate substantially equivalent performance of the subject device to predicate devices.

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Image /page/2/Picture/0 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 forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

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

### OCT 0 6 2010

Paradigm Spine, LLC % Musculoskeletal Clinical Regulatory Advisers, LLC Mr. Justin Eggleton 1331 H Street NW, 12th Floor Washington, District of Columbia 20005

Re: K093438

Trade/Device Name: Paradigm Interspinous Fusion Plate Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP Dated: August 11, 2010 Received: August 12, 2010

Dear Mr. Eggleton:

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. Justin Eggleton

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 yours,
for DEP Dir
Ruma

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

510(k) Number (if known):

Device Name: Paradigm Interspinous Fusion Plate

The Paradigm Interspinous Fusion Plate is a posterior, non-pedicle supplemental fixation device intended for use with an interbody cage as an adjunct to fusion at a single level in the lumbar spine (L1 - S1). It is intended for attachment to the spinous processes for the purpose of achieving stabilization to promote fusion in patients with degenerative disc disease - defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies - with up to Grade 1 spondylolisthesis.

Prescription Use V (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Ko93438 510(k) Number_