SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE

K121129 · Spineology, Inc. · MAX · Jun 13, 2012 · Orthopedic

Device Facts

• Record ID: K121129
• Device Name: SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE
• Applicant: Spineology, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: Jun 13, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Spineology PEEK Lumbar Interbody Fusion Device is an intervertebral body fusion device indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These devices may be implanted via an open or a minimally invasive transforaminal approach. The Spineology PEEK Lumbar Interbody Fusion Device is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.

Device Story

Intervertebral body fusion device; PEEK Optima LT1 material; available in various lengths/heights. Used in lumbar spine (L2-S1) for fusion; implanted via open or minimally invasive transforaminal approach. Requires autograft and supplemental fixation. Modification adds 4th radiopaque marker to implant front. Used by surgeons in clinical/OR settings to treat discogenic back pain. Benefits patient via stabilization and fusion of degenerated spinal segments.

Clinical Evidence

Bench testing only. Static compression testing per ASTM 2077 performed to validate the addition of the 4th marker.

Technological Characteristics

Material: PEEK Optima LT1. Form factor: Interbody fusion cage with radiopaque markers. Energy source: None (mechanical). Sterilization: Provided non-sterile. Testing: Static compression per ASTM 2077.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) and up to Grade I spondylolisthesis at one or two contiguous lumbar levels (L2-S1). Requires six months of failed non-operative treatment. Must be used with autograft and supplemental fixation.

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

• Spineology PEEK Lumbar Interbody Fusion Devices (K120293)

Submission Summary (Full Text)

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KIJ 129

JUN | 3 2012

## 510(k) Summary

| Applicant: | Spineology Inc.<br>7800 3rd Street N., Suite 600<br>Saint Paul, MN 55128<br>651-256-8500 |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Bryan Becker |
| Date Prepared: | April 9, 2012 |
| Trade Name: | Spineology PEEK Lumbar Interbody Fusion Devices |
| Product Classification<br>and Code: | Class II Medical Device, Product Code MAX |
| Predicate Device(s): | Spineology PEEK Lumbar Interbody Fusion Devices (K120293) |
| Reason for this 510(k) | This Special 510(k) is to add an option 4th marker to the front of the<br>implant. |
| Device Description: | The Spineology PEEK Lumbar Interbody Fusion Device is designed for<br>use with autograft to facilitate fusion and is intended for use with<br>supplemental fixation systems cleared for use in the lumbar spine. The<br>device is available in a range of lengths and heights and is made of PEEK<br>Optima LT1. The device and associated instruments are provided non-<br>sterile. |
| Intended Use: | The Spineology PEEK Lumbar Interbody Fusion Device is an<br>intervertebral body fusion device indicated for intervertebral body fusion<br>at one level or two contiguous levels in the lumbar spine from L2 to S1 in<br>patients with degenerative disc disease (DDD) with up to Grade I<br>spondylolisthesis at the involved level(s). DDD is defined as back pain of<br>discogenic origin with degeneration of the disc confirmed by patient<br>history and radiographic studies. These patients should be skeletally<br>mature and have had six months of non-operative treatment.<br>These devices may be implanted via an open or a minimally invasive<br>transforaminal approach.<br>The Spineology PEEK Lumbar Interbody Fusion Device is designed for<br>use with autograft to facilitate fusion and is intended for use with<br>supplemental fixation systems cleared by the FDA for use in the lumbar<br>spine. |
| Summary of<br>Technological<br>Characteristics: | The device is shown to be substantially equivalent to the intended use,<br>materials, configuration, and performance characteristics of the predicate<br>products. |

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| Testing | Static compression testing per ASTM 2077 was performed. The<br>results showed that the device was substantially equivalent to the<br>identified predicate devices. |
|-------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion: | The information submitted in this premarket notification supports a<br>determination that the Spineology PEEK Lumbar Interbody Fusion<br>Device is substantially equivalent in technological characteristics and<br>intended use to the predicate devices. |

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is 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 body and wings.

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

JUN 1 3 2012

Spineology, Inc. % Mr. Bryan Becker Clinical and Regulatory Affairs Manager 7800 3rd Street North, Suite 600 Saint Paul, Minnesota 55128

Re: K121129

Trade/Device Name: Spineology PEEK Lumbar Interbody Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: May 11, 2012 Received: May 14, 2012

Dear Mr. Becker:

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 r ou may, are ere, mains 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.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I feast of a has made a determination that your device complies with other requirements of the Act

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Page 2 - Mr. Bryan Becker

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,

Eunel Keith

Cr 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 Form

Device Name: The Spineology PEEK Lumbar Interbody Fusion Device

## Indications for Use:

The Spineology PEEK Lumbar Interbody Fusion Device is an intervertebral body fusion device indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to SI1 in patients with degenerative disc disease (DDD) with up to Grade I spondvlolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

These devices may be implanted via an open or a minimally invasive transforaminal approach.

The Spineology PEEK Lumbar Interbody Fusion Device is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.

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

Over-The-Counter Use (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)

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Diffision of Surgical, Orthopedic, and Restorative Devices

K121129 510(k) Number_