COFLEX-F

K112595 · Paradigm Spine, LLC · KWP · Feb 13, 2012 · Orthopedic

Device Facts

• Record ID: K112595
• Device Name: COFLEX-F
• Applicant: Paradigm Spine, LLC
• Product Code: KWP · Orthopedic
• Decision Date: Feb 13, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The coflex-F Implant System 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

Posterior, non-pedicle supplemental fixation device; stabilizes spinous processes to promote fusion. U-shaped titanium alloy (Ti6Al4V) component; features two sets of wings extending from superior and inferior arms. Surgeon attaches device to spinous processes using screw and sleeve mechanism. Used in clinical/surgical settings as adjunct to interbody cage fusion. Benefits patient by providing spinal stabilization.

Clinical Evidence

Bench testing only. Finite element analysis and engineering rationale used to demonstrate equivalence. Biocompatibility testing (irritation and sensitization) conducted per ISO 10993.

Technological Characteristics

Material: Medical grade titanium alloy (Ti6Al4V). Design: U-shaped spinous process fixation device with two sets of wings. Fixation: Screw and sleeve mechanism. Biocompatibility: ISO 10993 compliant.

Indications for Use

Indicated for patients with degenerative disc disease (back pain of discogenic origin, confirmed by history/radiographic studies) 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

• coflex-F Implant (Paradigm Interspinous Fusion Plate) (K093438)

Submission Summary (Full Text)

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FEB 1 3 2012

# 5. 510(k) Summary

| Device Trade Name: | coflex-F Implant System |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | Paradigm Spine, LLC<br>505 Park Avenue, 14th Floor<br>New York, NY 10022 |
| Contact: | Ms. Michelle McDonough<br>Musculoskeletal Clinical Regulatory Advisers, LLC<br>1331 H Street NW, 12th Floor<br>Washington, DC 20005<br>Phone: [phone]<br>Fax: [phone] |
| Date Prepared: | February 10, 2012 |
| Classification: | 21 CFR 888.3050, Spinal interlaminal fixation orthosis |
| Class: | II |
| Product Code: | KWP |

### Indications For Use:

The coflex-F Implant System 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 coflex-F Implant System 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, Ushaped component, fabricated from medical grade titanium alloy (Ti6Al4V). 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.

The purpose of this Special 510(k) is to add small- and medium-sized coflex-F Short devices to the coflex-F Implant System. The modifications are intended to allow the operating surgeon to better accommodate various patient anatomies. The modifications do not affect the intended use of the device or alter the fundamental scientific technology of the device.

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#### Predicate Device(s):

The modified coflex-F Short is substantially equivalent to the predicate coflex-F Implant (Paradigm Interspinous Fusion Plate) previously cleared in K093438 with respect to indications, design, function, and materials.

#### Substantial Equivalence:

Finite element analysis and engineering rationale demonstrated that the addition of new components did not introduce a new worst case. Additionally, biocompatibility tests per ISO 10993 (i.e., irritation and sensitization) were conducted on materials used for devicespecific instruments. The results demonstrate that the acceptance criteria defined in the Design Control Activities Summary were met and the coflex-F Short is substantially equivalent to the predicate device(s).

#### Conclusion:

The coflex-F Short is substantially equivalent to previously cleared devices with respect to its indications for use, design, function, and materials.

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

FEB 1 3 2012

Paradigm Spine, LLC % Musculoskeletal Clinical Regulatory Advisers, LLC Ms. Michelle McDonough 1331 H Street NW, 12th Floor Washington, District of Columbia 20005

Re: K112595

Trade/Device Name: coflex-F Implant System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP Dated: December 20, 2011 Received: December 21, 2011

Dear Ms. McDonough: .

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 - Ms. Michelle McDonough

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/ucm11.5809.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 N. McMullen

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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# 4. Indications for Use

510(k) Number (if known): K112595

Device Name: coflex-F Implant System

The coflex-F Implant System 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)

Over-The-Counter Use AND/OR

(21 CFR 801 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 of Surgical, Orthopedic, and Restorative Devices

KII2595 510(k) Number_