DISCOVERY

K111484 · Intuitive Spine, LLC · ODP · Sep 12, 2011 · Orthopedic

Device Facts

• Record ID: K111484
• Device Name: DISCOVERY
• Applicant: Intuitive Spine, LLC
• Product Code: ODP · Orthopedic
• Decision Date: Sep 12, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DISCOVERY is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with the degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and autograft to facilitate fusion and is to be implanted via an open, anterior approach.

Device Story

DISCOVERY is a cervical intervertebral body fusion device; rectangular profile with hollow core for bone graft; features teeth on superior/inferior surfaces to prevent migration. Implanted via open, anterior approach by surgeons to facilitate fusion in DDD patients. Device provides structural support during bone healing; used with supplemental fixation. Benefits include stabilization of cervical spine segment.

Clinical Evidence

Bench testing only. Mechanical performance evaluated per ASTM F2077 and F2267 standards; results demonstrate substantial equivalence to predicate.

Technological Characteristics

Material: PEEK Optima LT1 (ASTM F2026); Tantalum markers (ASTM F560). Design: Rectangular intervertebral body fusion cage with hollow core and surface teeth. Energy source: None (mechanical implant).

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) with radicular symptoms at one level. Requires supplemental fixation and autograft.

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

• LDR Spine Cervical Interbody Fusion System (K091088)

Submission Summary (Full Text)

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KIII 484

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## 510(k) Summary

SEP 1 2 2011

Summary of 510(k) Safety and Effectiveness

| Submitted By: | Intuitive Spine, LLC<br>16450-3 S. Tamiami Trail #112<br>Fort Myers, Florida 33908 |
|---------------------------------|------------------------------------------------------------------------------------|
| Date: | July 27, 2011 |
| Contact Person: | Jennifer Palinchik<br>Development and Regulatory Consultant |
| Contact Telephone: | [phone] |
| Device Trade Name: | DISCOVERY |
| Device Classification Name: | Intervertebral Body Fusion Device with Bone Graft, |
| Cervical Device Classification: | Class II |
| Reviewing Panel: | Orthopedic |
| Regulation Number: | 888.3080 |
| Product Code: | ODP |
| Predicate Device: | LDR Spine Cervical Interbody Fusion System (K091088) |

#### Device Description:

The DISCOVERY is a cervical interbertebral body fusion device consisting of teeth on the inferior and superior surfaces to prevent back out and migration. The profile of the device is rectangular with a hollow core for bone graft to promote bone integration and fusion between the endplates. The device is available in various heights accommodate variability among patients and is manufactured from PEEK Optima® LT1 per ASTM F2026 and includes tantalum markers per ASTM F560.

#### Indications for Use:

The DISCOVERY is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with the degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and autograft to facilitate fusion and is to be implanted via an open, anterior approach.

#### Substantial Equivalence Information:

The design features, material, and indications for use of the DISCOVERY device are substantially equivalent to the predicate device listed above. The safety and effectiveness is

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adequately supported by the substantial equivalence, material information, and analysis data provided within this Premarket Notification.

## Summary of Non-Clinical Test:

The following mechanical testing was performed per ASTM F2077 and F2267 to demonstrate substantial equivalence of the subject device to the predicate device: Static Compression, Dynamic Compression, Static Torsion, Dynamic Torsion, Subsidence, and Expulsion. The device functioned as intended and the performance results show that the DISCOVER Y is substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol.

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

Intuitive Spine, LLC % Thogus Products Company / RP+M Ms. Jennifer Palinchik 33490 Pin Oak Parkway Avon Lake, Ohio 44012

SEP 1 2 2011

Re: K111484

Trade/Device Name: DISCOVERY Cervical Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: September 27, 2011 Received: September 27, 2011

Dear Ms. Palinchik:

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 ffor 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.

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

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Page 2 - Ms. Jennifer Palinchik

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 evenis) (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.lda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/wcm115809.html 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Erie O. Keith

for 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

K111484 510(k) Number (if known):

Device Name: DISCOVERY

### Indications for Use:

The DISCOVERY is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with the degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and autograft to facilitate fusion and is to be implanted via an open, anterior approach.

Prescription Use × (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)

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

510(k) Number_KIII 1484