PATHWAY

K080281 · Custom Spine, Inc. · MAX · May 1, 2008 · Orthopedic

Device Facts

• Record ID: K080281
• Device Name: PATHWAY
• Applicant: Custom Spine, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: May 1, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PATHWAY Interbody Fusion Device(s) is intended for spinal fusion procedure at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative Disc Diseases (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). The PATHWAY Interbody Fusion device is intended to be used with supplemental spinal fixation systems that have been cleared for lumbosacral spine (i.e. posterior pedicle screws and rod systems , anterior plate systems, and anterior screw and rod systems. The device(s) is intended to be used with autogenous bone graft. Patients must have undergone a regiment of at least (6) months of non-operative treatment prior to being treated with the PATHWAY Device. The PATHWAY device can be used in one of two methods: Transforaminal Lumbar Interbody Fusion (TLIF) Used as a TLIF, a single device is implanted in the appropriate location to provide support for a transforaminal approached surgery Posterior Lumbar Interbody Fusion (PLIF) Used as a PLIF, multiple devices are implanted in the appropriate locations to provide support to the spine for a posterior surgery.

Device Story

PATHWAY Interbody Fusion Device is a PEEK-OPTIMA implant with titanium markers for intra-operative and post-operative radiographic localization. Rectangular geometry with serrated superior/inferior surfaces for anchorage; contains internal void for autogenous bone graft. Implanted by surgeons via TLIF (single device) or PLIF (multiple devices) approaches in the lumbosacral spine. Used in conjunction with cleared supplemental spinal fixation systems (pedicle screws/rods, plates). Provides structural support to the intervertebral space to facilitate spinal fusion. Single-use device provided non-sterile; requires facility-based sterilization.

Clinical Evidence

Bench testing only. Performance data compared to predicate devices per ASTM F2077 and ASTM F2267.

Technological Characteristics

Materials: PEEK-OPTIMA (ASTM F2026) and Titanium alloy Ti-6Al-4V (ASTM F136). Form factor: Rectangular, various widths/lengths/heights, 0 or 6-degree lordosis. Serrated surface for anchorage. Non-sterile; user-sterilized. Standalone mechanical implant.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD defined as discogenic back pain with degeneration confirmed by history/radiography, including up to Grade I spondylolisthesis or retrolisthesis. Includes patients with prior non-fusion spinal surgery. Requires 6 months of failed non-operative treatment. Must be used with supplemental fixation and autogenous bone graft.

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

• Spinal Elements Lucent (K071724)
• Depuy Acromed Stackable Cage System (K990148, K001340, K030833)

Submission Summary (Full Text)

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### Traditional Pre-market Submission PATHWAY

# 7. 510(k) Summary

MAY - 1 2008

# As Required By Section 807.92 (c)

| Submitter: | Custom Spine, Inc.<br>1140 Parsippany Blvd<br>Suite 201<br>Parsippany, NJ 07054 |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Saad Attivah<br>Manager of Regulatory Affairs and Quality Assurance<br>[phone]<br>Voice :<br>Fax :<br>[phone]<br>[e-mail]<br>E-Mail: |
| Date Prepared: | April 11, 2008 |
| Device Class: | II |
| | Classification Name: Per 21 CFR §888.3080, Intervertebral body fusion device |
| Classification Panel: Orthopedics | |
| Product Code: | MAX |
| Proprietary Name: | PATHWAY |
| Predicate Devices: | Spinal Elements Lucent (K071724), Depuy Acromed" Stackable<br>System (K990148, K001340, K030833)<br>Cage™ |
| Device Description: | The PATHWAY Interbody Fusion Device is made from<br>Polyetheretherketone (PEEK OPTIMA TM) and contain titanium<br>markers. The titanium markers serve a means for the<br>end user of the device to determine the location of the implant<br>intra-operatively and post- operatively. |
| | The device(s) is rectangular in nature and have various widths,<br>lengths, heights and degrees of lordosis (0 Degree and 6 Degree).<br>The devices contain empty space for the practitioner to insert<br>autogenous bone graft. The devices have serrated teeth on the<br>superior and inferior sides to provide anchorage stability to the<br>vertebrae. They are single use devices. |

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Traditional Pre-market Submission PATHWAY

The 0 Degree PLIF has a width of 10 mm, a length of 23 mm, and ranges in height from 7 to 15 mm.

The 6 Degree PLIF is lordotic in nature and has a width of 8 mm, a length of 23 mm, and ranges in height from 7 to 15 mm

The TLIF is a rectangular in nature and has a width of 10 mm, a length of 28 mm, and ranges in height from 7 to 15 mm.

The implants are provided non-sterile and the instruments are provided cleaned, decontaminated and non-sterile. These devices must be sterilized by the user facility.

Intended Use: The PATHWAY Interbody Fusion Device(s) is intended for spinal fusion procedure at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative Disc Diseases (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).

> The PATHWAY Interbody Fusion device is intended to be used with supplemental spinal fixation systems that have been cleared for lumbosacral spine (i.e. posterior pedicle screws and rod systems , anterior plate systems, and anterior screw and rod systems. The device(s) is intended to be used with autogenous bone graft.

Patients must have undergone a regiment of at least (6) months of non-operative treatment prior to being treated with the PATHWAY Device.

The PATHWAY device can be used in one of two methods:

#### Transforaminal Lumbar Interbody Fusion (TLIF)

Used as a TLIF, a single device is implanted in the appropriate location to provide support for a transforaminal approached surgery

Posterior Lumbar Interbody Fusion (PLIF)

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| | Traditional Pre-market Submission PATHWAY |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Used as a PLIF, multiple devices are implanted in the appropriate<br>locations to provide support to the spine for a posterior surgery. |
| Materials : | This product is manufactured from polyetheretherketone (PEEK<br>OPTIMA) as per ASTM F2026 and contains Titanium (Ti-6Al-4V)<br>as per ASTM F-136 implant grade titanium alloy. |
| Performance Data: | Performance data per ASTM 2077 and ASTM 2267 and compared<br>to the predicate device. |

Summary of Technological Characteristics:

Documentation is provided that demonstrates PATHWAY Interbody Fusion Device is substantially equivalent to the predicate devices in terms of materials, design, indications for use, and mechanical properties. The testing information and physiological data support the rational for equivalence with the predicate devices.

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Image /page/3/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 emblem featuring a symbol that resembles an abstract caduceus or a stylized human figure with outstretched arms.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 1 2008

Custom Spine, Inc. % Mr. Saad Attiyah 1140 Parsippany Boulevard Suite 201 Parsippany, NJ 07054

K080281 Re:

Trade/Device Name: PATHWAY Intervertebral Body Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: April 11, 2008 Received: April 14, 2008

Dear Mr. Attiyah:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 CFR Part 807); labeling (21 CFR Part 801); 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.

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Page 2 – Mr. Saad Attiyah

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark H. Miller

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

Enclosure

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## 5. Indications for Use

K080281 510(k) Number (if known):

Device Name: PATHWAY Intervertebral body fusion device

The PATHWAY Interbody Fusion Device(s) is intended for spinal fusion procedure at one of two contiguous levels (L2-S1) in skeletally mature patients with degenerative Disc Diseases (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD may also have up to Grade I spondylolisthesis or retrolisthcsis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).

The PATHWAY Interbody Fusion device is intended to be used with supplemental spinal fixation systems that have been cleared for lumbosacral spine (i.e. posterior pedicle screws and rod systems , anterior plate systems, and anterior screw and rod systems. The device(s) is intended to be used with autogenous bone graft.

Patients must have undergone a regiment of at least (6) months of non-operative treatment prior to being treated with the PATHWAY Device.

The PATHWAY device can be used in one of two methods:

Transforaminal Lumbar Interbody Fusion (TLIF)

Used as a TLIF, a single device is implanted in the appropriate location to provide support for a transforaminal approached surgery

Posterior Lumbar Interbody Fusion (PLIF)

Used as a PLIF, multiple devices are implanted in the appropriate locations to provide support to the spine for a posterior surgery.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (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)

Nil RP Ql fr mkm

Division of General, Restorativ and Neurological Devices

**510(k) Number** K080281