EPICAGE INTERBODY FUSION DEVICE

K130548 · Alphatec Spine, Inc. · MAX · Apr 18, 2013 · Orthopedic

Device Facts

• Record ID: K130548
• Device Name: EPICAGE INTERBODY FUSION DEVICE
• Applicant: Alphatec Spine, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: Apr 18, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Epicage Interbody Fusion Device is intended for interbody fusion procedures and is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone. Patients should have received six months of non-operative treatment with the devices. The device is intended to be used with supplemental posterior fixation approved for use in the lumbar spine such as Alphatec Spine's Zodiac Polyaxial Spinal Fixation System and/or Illico Posterior Fixation System.

Device Story

Epicage Interbody Fusion System consists of PEEK implants with titanium alloy pins and tantalum beads for radiographic visualization; used in lumbar interbody fusion procedures. Delivery system includes stainless steel portals (mid-line for modified TLIF; oblique for traditional TLIF) and surgical instruments. Surgeon implants device to facilitate fusion in DDD patients. System requires supplemental posterior fixation (e.g., Zodiac or Illico systems). Benefits include stabilization of spinal segments and promotion of fusion in patients failing conservative therapy.

Clinical Evidence

No clinical data. Evidence consists of bench testing per ASTM standards (F2077, F2267, Draft F04.25.0202) including static/dynamic axial compression, torsion, shear, subsidence, and expulsion testing. User validation performed via cadaver lab. All testing met acceptance criteria.

Technological Characteristics

Implants: PEEK Optima LT1 (ASTM F-2026), Ti-6Al-4V ELI (ASTM F-136), Tantalum markers (ASTM F-560). Portals: Stainless steel. Sizes: 25mm/30mm length; 8-14mm heights. Non-sterile and sterile options. Manual surgical instrumentation. No software or electronic components.

Indications for Use

Indicated for skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1, including those with up to Grade I spondylolisthesis or retrolisthesis. Requires six months of prior non-operative treatment. Must be used with autograft bone and supplemental posterior lumbar 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

• Epicage Interbody Fusion System (K092901)

Reference Devices

• Zodiac Polyaxial Spinal Fixation System
• Illico Posterior Fixation System

Submission Summary (Full Text)

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

# 510(k) Summary

APR 1 8 2013

Submission Date:

Submitter Information:

March 1, 2013

Alphatec Spine 5818 El Camino Real Carlsbad, CA 92008

Ph# [phone] Fax# [phone]

Nadine Smith Senior Regulatory Affairs Specialist Ph# [phone]

Trade/Model Name:

Common Name:

Contact:

Classification Regulation:

Orthosis, Intervertebral Body Fusion Device

Epicage Interbody Fusion System

21 CFR 888.3080 Class II

Product Code(s):

MAX

## Device Description:

The Epicage System implants are manufactured from implant grade PEEK with a surgical grade titanium alloy pin and 2 tantalum beads to facilitate visualization. The delivery system contains portals in sizes to match the implants sizes and general surgical instruments to assist in preparation and device delivery. The portals are integral to the system and are considered an accessory (Class II) all other instruments are Class I. The system can be used with a mid-line portal for a modified TLIF procedure or an oblique portal for a traditional TLIF approach. The implants of the system are available non-sterilized.

### Indications for Use:

The Epicage Interbody Fusion Device is intended for interbody fusion procedures and is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone. Patients should have received six months of non-operative treatment with the devices. The device is intended to be used with supplemental posterior fixation approved for use in the lumbar spine such as Alphatec Spine's Zodiac Polyaxial Spinal Fixation System and/or Illico Posterior Fixation System.

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

## Substantial Equivalence Claimed:

The subject Epicage Interbody Fusion System is substantially equivalent to the predicate Epicage Interbody Fusion System (K092901) with the same intended use and technological characteristics. The subject system is manufactured from the same materials and manufacturing processes with equivalent performance, labeling, biocompatibility, and standards.

## Technical Characteristics

The implants of the Epicage System are available in sizes 25mm and 30mm with multiple heights (8mm, 10mm, 12mm 14mm) manufactured from polyetheretherketone (PEEK Optima LT1 conforming to ASTM F-2026), surgical grade titanium alloy (TI-6AI-4V ELI conforming to ASTM F-136) with radiographic markers made from tantalum (conforming to ASTM F-560). Implants are available both non-sterile and sterile. The delivery system portals are manufactured from stainless steel in sizes to match the implants. The midline portal supports a modified TLIF procedure and the oblique portals are designed for a traditional TLIF approach. The portals and instruments are provided non-sterile with validated cleaning and sterilization parameters.

## Non-Clinical Performance Testing

The following testing was conducted to support substantial equivalence to the predicate device.

Sterilization testing:

- . Gamma Sterilization Validation
- Sterile Package Performance Validation

Performance testing:

- Static Axial Compression, Torsion, and Shear per ASTM F2077 .
- . Dynamic Axial Compression, Torsion, and Shear per ASTM F2077
- . Subsidence per ASTM 2267
- Expulsion per ASTM Draft F04.25.0202 ●
- . Epicage Portal Evaluation
- User Validation Cadaver Lab .

All testing passed the acceptance criteria and the results were substantially equivalent to the predicate device.

## Conclusion

The Epicage Interbody Fusion System, demonstrated to be substantial equivalent to the Predicate Epicage System, is based on design, materials, intended use, and performance to the predicate systems identified.

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

## 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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

April 18, 2013

Alphatec Spine, Incorporated % Ms. Nadine Smith Senior Regulatory Affairs Specialist 5818 El Camino Real Carlsbad, California 92008

Re: K130548

Trade/Device Name: Epicage Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: March 14, 2013 Received: March 19, 2013

Dear Ms. Smith:

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. 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 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

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

## Page 2 - Ms. Nadine Smith

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.

# Frin - Keith

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

Enclosure

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

## Indications for Use

#### 510(k) Number (if known): K130548

Device Name: Epicage Interbody Fusion System

## Indications For Use:

The Epicage Interbody Fusion Device is intended for interbody fusion procedures and is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone. Patients should have received six months of non-operative treatment with the devices. The device is intended to be used with supplemental posterior fixation approved for use in the lumbar spine such as Alphatec Spine's Zodiac Polyaxial Spinal Fixation System and/or Illico Posterior Fixation System.

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)

Anton E. Dmitriev, PhD Division of Orthopedic Devices

Page I of I