ESL SPINAL SYSTEM

K092574 · Ebi, L.P. · MAX · Feb 4, 2010 · Orthopedic

Device Facts

• Record ID: K092574
• Device Name: ESL SPINAL SYSTEM
• Applicant: Ebi, L.P.
• Product Code: MAX · Orthopedic
• Decision Date: Feb 4, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ESL® Spinal System is indicated for vertebral body replacement and intervertebral fusion. When used for vertebral body replacement, the ESL® Spinal System is indicated for use in the thoracolumbar spine (i.e., T1- L5) for partial replacement of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The ESL Spinal System is also indicated for treating fractures of the thoracic and lumbar spine. The ESL® Spinal System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period of time. As an intervertebral body fusion device, the ESL® Spinal System is 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 1 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 nonoperative treatment. The ESL® Spinal System is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The ESL® Spinal System may also be implanted using the Accu Vision System to provide the surgeon with a minimally invasive approach for posterior or posterolateral spinal surgery.

Device Story

ESL Spinal System consists of medical-grade PEEK spacers with tantalum radiographic markers; used for vertebral body replacement (thoracolumbar) and intervertebral fusion (lumbar). Implanted by surgeons in clinical settings; often used with autograft and supplemental fixation systems. May be implanted via Accu Vision System for minimally invasive posterior/posterolateral approaches. Device restores spinal column biomechanical integrity and height; facilitates fusion. Output is physical structural support; surgeon uses radiographic markers to verify placement via imaging. Benefits include spinal decompression, stabilization, and fusion support.

Clinical Evidence

No clinical data provided; substantial equivalence based on mechanical testing and design comparison to predicate devices.

Technological Characteristics

Constructed from medical-grade Polyetheretherketone (PEEK) with tantalum radiographic markers. Designed for spinal intervertebral fusion and vertebral body replacement. Standalone device used with supplemental fixation. Sterilization method not specified.

Indications for Use

Indicated for skeletally mature patients requiring vertebral body replacement (T1-L5) for tumors or fractures, or intervertebral fusion (L2-S1) for degenerative disc disease with up to Grade 1 spondylolisthesis. Requires 6 months of prior non-operative treatment.

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

• Expandable PEEK Implant (K040928)
• ESL® Spinal System (K061016)

Submission Summary (Full Text)

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# 510(k) Summary

| Preparation Date: | January 28, 2010 | |
|----------------------------|-------------------------------------------------------------------------------------------------------------------|--------------|
| Applicant/Sponsor: | Biomet Spine<br>100 Interpace Parkway<br>Parsippany, NJ 07054 | |
| Contact Person: | Vivian Kelly<br>Phone: [phone]<br>Fax: [phone] | FEB - 4 2010 |
| Trade name: | ESL® Spinal System | |
| Common Name: | Non-cervical spinal spacer | |
| Classification Name: | Intervertebral fusion device, 21 CFR §888.3080<br>Spinal Intervertebral Body Fixation Orthosis, 21 CFR § 888.3060 | |
| Device Panel/Product Code: | Orthopedic MAX & MQP | |

### Device Description:

The ESL® Spinal System is a device constructed medical grade Polyetheretherketone (PEEK) with tantalum radiographic markers for spinal applications.

## Indications for Use:

The ESL® Spinal System is indicated for vertebral body replacement and intervertebral fusion. When used for vertebral body replacement, the ESL® Spinal System is indicated for use in the thoracolumbar spine (i.e., T1- L5) for partial replacement of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The ESL Spinal System is also indicated for treating fractures of the thoracic and lumbar spine. The ESL® Spinal System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period of time.

As an intervertebral body fusion device, the ESL® Spinal System is 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 1 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 nonoperative treatment.

The ESL® Spinal System is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The ESL® Spinal System may also be implanted using the Accu Vision System to provide the surgeon with a minimally invasive approach for posterior or posterolateral spinal surgery.

#### Summary of Technologies:

The technological characteristics (material, design and sizing) of the ESL® Spinal Spacer is the same as, or similar to, the predicate devices.

#### Substantial Equivalence:

The ESL Spinal System is substantially equivalent to its predicate devices with respect to intended use and indications, technological characteristics, and principles of operation and do not present any new issues of safety or effectiveness. An example of a predicate intervertebral body fusion device distributed for the similar indications includes the Expandable PEEK Implant (K040928 and the ESL® Spinal System (K061016) has similar design features. Based upon the mechanical testing, ESL Spinal System is substantially equivalent for its intended use to other spacers currently on the market.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Vivian Kelly, MS, RAC Regulatory Affairs Project Manager Biomet Spine 100 Interpace Parkway Parsippany, NJ 07054

FEB - 4 2010

Re: K092574

Trade/Device Name: EBI ESL Spinal System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, MQP Dated: January 28, 2010 Received: January 29, 2010

Dear Ms. Kelly:

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

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Page 2 - Vivian Kelly, MS, RAC

forth in the quality systems (OS) 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,

Barbara Buell

Mark N. Melke 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

510(k) Number (if known): K092574

Device Name: ESL® Spinal System

Indications for Use:

The ESL® Spinal System is indicated for vertebral body replacement and intervertebral fusion. When used for vertebral body replacement, the ESL® Spinal System is indicated for use in the thoracolumbar spine (i.e., T1- L5) for partial replacement of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The ESL® Spinal System is also indicated for treating fractures of the thoracic and lumbar spine. The ESL® Spinal System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period of time.

As an intervertebral body fusion device, the ESL® Spinal System is 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 1 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.

The ESL® Spinal System is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The ESL® Spinal System may also be implanted using the Accuvision System to amount the surgeon with a minimally invasive approach for posterolateral spinal survery.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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4g4i4g4i4g4i4g4i4g4i4g4i4g4i4g4i4g4i4g4i4g4i4g4i4g4i4g4i4g4i4g4i4g4i4g4i4g4i4g4i4g4i4g4i4g4i4g4i4g4i4g4i4g4i4g4i4g4i4g4i4g4i4g4i4g4i4g4i4g4i4g4i4g4i4g4i4g4i4g4i4g4i4g4i4g4i4g4i4g4i4g4i4g4i4g4i4g4i4g4i4g4i4g4g==

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

K092574 510(k) Number_

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