PATHWAY AVID

K090566 · Custom Spine, Inc. · MAX · Jun 1, 2009 · Orthopedic

Device Facts

• Record ID: K090566
• Device Name: PATHWAY AVID
• Applicant: Custom Spine, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: Jun 1, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PATHWAY Intervertebral body fusion device is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by the history and radiographic studies. DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. The patient may have had a previous non-fusion spinal surgery at the involved level(s). The device is intended to be used with supplemental spinal fixation systems that have been cleared for lumbosacral spine (i.e. posterior pedicle screws and rods systems and anterior screw and rod systems). The device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the PATHWAY AVID device. The PATHWAY AVID Intervertebral body fusion device must be inserted using a transforaminal approach.

Device Story

PATHWAY AVID is an articulated intervertebral body fusion device; constructed from multiple PEEK segments linked by titanium pins and linkage. Device footprint: 8-14mm height, 20mm width, 35mm length. Implanted via transforaminal approach by surgeons in clinical settings. Titanium pins serve as radiographic markers for intra/postoperative positioning. Used with supplemental spinal fixation (pedicle screws/rods) and autogenous bone graft to facilitate spinal fusion. Non-sterile; requires facility-based sterilization. Benefits include stabilization of spinal segments in DDD patients.

Clinical Evidence

No clinical trials performed. Substantial equivalence supported by bench testing per ASTM F2077 (static/dynamic compression, shear) and ASTM F2267 (subsidence), and cadaver testing to validate surgical approach and usability.

Technological Characteristics

Materials: PEEK (ASTM F2026) and Ti-6Al-4V titanium alloy (ASTM F136). Articulated, multi-segment design. Dimensions: 8-14mm height, 20mm width, 35mm length. Non-sterile; user-sterilized. Mechanical fixation via titanium pins/linkage. No software or energy source.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1), including those with Grade I Spondylolisthesis or retrolisthesis, or prior non-fusion spinal surgery. Requires 6 months of failed non-operative treatment. Contraindicated for patients without discogenic back pain or those not meeting skeletal maturity.

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)
• Vertebration XYcor™ (K070082)

Submission Summary (Full Text)

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### Section 22. 510(k) Summary

:

# JUN - 1 2009

## As Required By Section 807.92(c)

| Submitter: | Custom Spine<br>1140 Parsippany Blvd, Suite 201<br>Parsippany, NJ 07054 | |
|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact Person: | Saad Attiyah<br>Manager of Regulatory Affairs and Quality Assurance<br>Voice: [phone]<br>Fax: [phone] | |
| Date Prepared: | May 15, 2009 | |
| Device Class: | II | |
| | Classification Names: Per 21 CFR § 888.3080, Intervertebral Body Fusion Device | |
| Classification Panel: | Orthopedics | |
| Product Code:<br>Proprietary Name: | MAX<br>PATHWAY AVID | |
| Predicate Devices: | Spinal Elements Lucent® (K071724)<br>Depuy Acromed™ Stackable Cage™ System<br>(K990148, K001340, K030833)<br>Vertebration XYcor™ (K070082) | |
| Device Description: | The PATHWAY AVID Intervertebral Body Fusion Device is made from PEEK<br>Optima. The device is made from multiple PEEK segments. The segments are<br>serrated on the superior and inferior surfaces. The PEEK segments are attached<br>with titanium pins and have a titanium linkage that attaches the segments. This<br>pins and the linkage provide the means to form into its final articulated shape. | |
| | The titanium alloy pins serve as markers providing visual aid in determining the<br>location of the implant both intra and postoperatively. | |
| | The articulated device foot print ranges from 8 mm through 14 mm in height,<br>20mm in width and 35 mm in length. | |
| | The implants are non-sterile and instruments are provided clean and non-sterile.<br>These devices are to be sterilized by the user facility. | |
| Intended Use: | The PATHWAY Intervertebral body fusion device is intended for spinal fusion<br>procedures at one or two contiguous levels (L2-S1) in skeletally mature patients<br>with degenerative disc disease (DDD). DDD is defined as back pain of<br>discogenic origin with degeneration of the disc confirmed by the history and<br>radiographic studies. DDD patients may also have up to Grade I<br>Spondylolisthesis or retrolisthesis at the involved levels. The patient may have<br>had a previous non-fusion spinal surgery at the involved level(s).<br>The device is intended to be used with supplemental spinal fixation systems that<br>have been cleared for lumbosacral spine (i.e. posterior pedicle screws and rods<br>systems and anterior screw and rod systems). The device is intended to be used<br>with autogenous bone graft. | |
| | | |
| | Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the PATHWAY AVID device. | |
| | The PATHWAY AVID Intervertebral body fusion device must be inserted using a transforaminal approach. | |
| Materials: | This product is manufactured from Polyetheretherketone (PEEK) as per ASTM F2026 and contains titanium (Ti-6Al-4V) as per ASTM F136, implant grade titanium. | |
| Performance Data: | Performance data per ASTM 2077 and ASTM 2267 and compared to the predicate devices. In addition, cadaver testing demonstrated the PATHWAY AVID is substantially equivalent to its predicates, as it was shown that the device can be used as intended by the intended user population per its labeling following a standard training program. | |
| Summary of<br>Technological<br>Characteristics | PATHWAY AVID has been evaluated in accordance with the "Class II Special Controls Guidance Document: Intervertebral Body Fusion Devices", June 12, 2007 and demonstrates substantial equivalent performance to the identified predicate device systems. | |

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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 stylized eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 1 2009

Custom Spine, Inc. % Saad Attivah 1140 Parsippany Blvd., Suite 201 Parsippany, NJ 07054

Re: K090566

Trade/Device Name: Pathway Avid Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: February 19, 2009 Received: March 3, 2009

Dear Mr. Attivah:

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, Or us 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 misburandi, nomd adulteration.

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 devise ( ran 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 liating (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.

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Page 2 - Mr. Saad Attiyah

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/cdrh/comp/ 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/cdrb/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours,

Clarence Buchholz

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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## Section 6. Indication For Use

The PATHWAY Intervertebral body fusion device is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by the history and radiographic studies. DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. The patient may have had a previous non-fusion spinal surgery at the involved level(s).

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

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

The PATHWAY AVID Intervertebral body fusion device must be inserted using a transforaminal approach.

Prescription Use × AND/OR

Over-The-Counter Use

(Part 21 C.F.R. 801 Subpart D)

(21 C.F.R. 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Aun Her

ivision of Surgical, Orthopedic, and Restorative Devices

510(k) Numb