ECLIPSE VERTEBRAL SPACER SYSTEM-CERVICAL

K101588 · Apollo Spine, Inc. · OVE · Jan 7, 2011 · Orthopedic

Device Facts

• Record ID: K101588
• Device Name: ECLIPSE VERTEBRAL SPACER SYSTEM-CERVICAL
• Applicant: Apollo Spine, Inc.
• Product Code: OVE · Orthopedic
• Decision Date: Jan 7, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Eclipse Vertebral Spacer System-Cervical is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2 to T1. DDD is defined as pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have completed six weeks of non-operative treatment. The Eclipse Vertebral Spacer System-Cervical implants are to be used with autogenous bone graft. Supplemental fixation is required.

Device Story

The Eclipse Vertebral Spacer-Cervical is an intervertebral body fusion device designed to maintain disc space height and angulation. It is implanted by a surgeon during spinal fusion procedures. The device is manufactured from PEEK, unalloyed titanium, and Ti6Al4V alloy. It is used in conjunction with autogenous bone graft and requires supplemental fixation to stabilize the cervical spine. By maintaining vertebral spacing, the device facilitates fusion in patients with degenerative disc disease, potentially alleviating radicular symptoms and providing spinal stability.

Clinical Evidence

Bench testing only. Testing included axial compression, compression-shear, and torsion (static and dynamic) per ASTM F2077, as well as subsidence (ASTM F2267) and expulsion testing (Draft F04.25.02.02).

Technological Characteristics

Materials: PEEK, unalloyed titanium, Ti6Al4V titanium alloy. Mechanical testing performed per ASTM F2077 (axial compression, compression-shear, torsion), ASTM F2267 (subsidence), and Draft F04.25.02.02 (expulsion).

Indications for Use

Indicated for intervertebral body fusion in skeletally mature patients with cervical degenerative disc disease (DDD) and radicular symptoms at one level (C2-T1). Requires six weeks of failed non-operative treatment. Contraindicated for patients without skeletal maturity or those not requiring 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

• BAK/Cervical (BAK/C®) (P980048)
• LDR Spine Cervical Interbody Fusion System, ROI-C
• SpineCraft ORIO-C Intervertebral Body Fusion Cervical Cage

Submission Summary (Full Text)

{0}------------------------------------------------

Apollo Spine Premarket Notification 510(k) Eclipse Vertebral Spacer June 4, 2010

#### 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

JAN - 7 2011

## Submitter Information

| Submitter's Name: | Apollo Spine |
|--------------------|------------------------------------------------------|
| Address: | 3700 Campus Dr. Suite 105<br>Newport Beach, CA 92660 |
| Telephone: | 949-645-1615 |
| Fax: | 949-757-0460 |
| Contact Person: | Christine Santagate, STD Medical |
| Telephone : | 781-828-4400 |
| Fax : | 781-344-5895 |
| Date Prepared: | June 4, 2010 |
| Device Trade Name: | Eclipse Vertebral Spacer-Cervical |
| Common/Usual Name: | Intervertebral body fusion device |
| Classification: | 21 CFR §888.3080 |
| Class: | II |
| Product Code(s): | ODP |

# Predicate Device(s):

- Eate Device(s).
BAK/Cervical (BAK/C®), P980048, Zimmer Spine, Approved 4/20/01 ●
- LDR Spine Cervical Interbody Fusion System, ROI-C, Approved 4/15/09 .
- SpineCraft ORIO-C Intervertebral Body Fusion Cervical Cage, Approved . 10/30/09

# Substantial Equivalence:

The Eclipse Vertebral Spacer-Cervical was shown to be substantially equivalent to The Lonpo Vertobial Space. Sen the same indications for use, design, function, and materials used.

. ・

{1}------------------------------------------------

101588
Page 2 of 2

Apollo Spine . Premarket Notification 510(k) Eclipse Vertebral Spacer June 4, 2010

JAN - 7 2011

### Device Description:

The Eclipse Vertebral Spacer-Cervical acts as a spacer to maintain proper Intervertebral and vertebral body spacing and angulation. The Eclipse Vertebral Spacer is manufactured from PEEK, unalloyed titanium, and Ti6Al4V titanium alloy. "

### Indications:

When used as an Intervertebral Body Fusion System:

The Eclipse Vertebral Spacer System-Cervical is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2 to T1. DDD is defined as pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have completed six weeks of non-operative treatment. The Eclipse Vertebral Spacer System-Cervical implants are to be used with autogenous bone graft. Supplemental fixation is required.

#### Mechanical Test Data:

The following testing was performed on this device:

- Axial Compression Static & Dynamic per ASTM F 2077 .
- Compression-Shear Static & Dynamic per ASTM F 2077 .
- Torsion Static & Dynamic per ASTM F 2077 .
- Subsidence per ASTM F 2267 ●
- Expulsion per ASTM Draft F04.25.02.02 ●

#### Conclusion:

ASTM Standards F2077, F2667 and Draft F04.25.02.02 (Expulsion Testing) were adhered to and all applicable requirements were met. Test results demonstrate that the Eclipse Spacer is substantially equivalent to publically available data for the predicate devices and therefore demonstrate its suitability for its intended use

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird-like figure with three heads, depicted in a flowing, abstract manner.

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

Apollo Spine % STD Medical, Inc. Ms. Christine Santagate 3700 Campus Drive, Suite 105 Newport Beach, CA 92660

SEP 12 2311

Re: K101588

Trade/Device Name: Eclipse Vertebral Spacer System-Cervical Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: December 20, 2010 Received: December 29, 2010

Dear Ms. Santagate:

This letter corrects our substantially equivalent letter of January 7, 2011.

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 (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 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

{3}------------------------------------------------

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,
Mark A Milheim

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

Enclosure

{4}------------------------------------------------

Apollo Spine Premarket Notification 510(k) Eclipse Vertebral Spacer - Cervical June 4, 2010

Page 1//

JAN - 7 2911

#### Indications for Use Statement

510(k) Number (if known):

101588

Device Name: Eclipse Vertebral Spacer System

Indications for Use:

The Eclipse Vertebral Spacer System-Cervical is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2 to T1. DDD is defined as pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have completed six weeks of non-operative treatment. The Eclipse Vertebral Spacer System-Cervical implants are to be used with autogenous bone graft. Supplemental fixation is required.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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)

.

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

KIO1588 510(k) Number_