EOI SPINAL SYSTEM

K083825 · Expanding Orthopedics, Inc. · NKB · Mar 19, 2009 · Orthopedic

Device Facts

• Record ID: K083825
• Device Name: EOI SPINAL SYSTEM
• Applicant: Expanding Orthopedics, Inc.
• Product Code: NKB · Orthopedic
• Decision Date: Mar 19, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EOI Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to spinal fusion of the thoracic, lumbar, and/or sacral spine. The EOI Spinal System is limited to non-cervical, pedicle use and is specifically indicated for treatment of one or more of the following acute and chronic instabilities or deformities: 1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); 2. Spondylolisthesis; 3. Trauma (fracture or dislocation); 4. Deformities or curvatures (scoliosis, kyphosis, and/or lordosis); 5. Tumor; 6. Spinal stenosis; 7. Pseudoarthrosis; and/or 8. Failed previous fusion.

Device Story

EOI Spinal System is a pedicle screw fixation system for non-cervical spinal stabilization. Components include polyaxial pedicle screws, straight/pre-bent rods, and cross connectors. System is implanted by surgeons in clinical settings to provide rigid immobilization of spinal segments as an adjunct to fusion. Device is assembled into patient-specific constructs during surgery. Benefits include stabilization of spinal instabilities or deformities. All components are single-use and provided non-sterile, requiring sterilization before implantation.

Clinical Evidence

Bench testing only. Mechanical testing conducted per ASTM F1717, including static and dynamic axial compression bending (n=6 for each). Results confirmed the system functioned as intended and demonstrated mechanical properties substantially equivalent to the predicate device.

Technological Characteristics

System consists of polyaxial pedicle screws, rods, and cross connectors. Materials: implant-grade titanium alloy (Ti-6Al-4V ELI) per ASTM F-136. Mechanical performance validated per ASTM F1717. Components are non-sterile, single-use, and require sterilization prior to use.

Indications for Use

Indicated for skeletally mature patients requiring immobilization/stabilization of thoracic, lumbar, or sacral spine as adjunct to fusion. Treats degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), deformities (scoliosis, kyphosis, lordosis), tumor, spinal stenosis, pseudoarthrosis, and failed previous fusion. Non-cervical, pedicle use only.

Regulatory Classification

Identification

(1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.

Special Controls

*Classification.* (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards; (ii) Compliance with mechanical testing standards; (iii) Compliance with biocompatibility standards; and (iv) Labeling that contains these two statements in addition to other appropriate labeling information: “Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.” “Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.” (2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls: (i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use. (ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant. (iii) Device components must be demonstrated to be biocompatible. (iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments. (v) Labeling must include the following: (A) A clear description of the technological features of the device including identification of device materials and the principles of device operation; (B) Intended use and indications for use, including levels of fixation; (C) Identification of magnetic resonance (MR) compatibility status; (D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and (E) Detailed instructions of each surgical step, including device removal. (3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls: (i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate. (ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.

Predicate Devices

• CD HORIZON Spinal System (K063670)

Submission Summary (Full Text)

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083825

#### 510(k) SUMMARY

## Expanding Orthopedics, Inc.'s EOI Spinal System

Expanding Orthopedics, Inc. 17 West Pontotoc Avenue Suite 200 Memphis, TN 38103

Phone: [phone] Facsimile: 901-322-0339

Contact Person: Raphael Meloul, COO Date Prepared: March 17, 2009

Proprietary Name of Device and Sponsor:

EOI Spinal System

Expanding Orthopedics, Inc. 17 West Pontotoc Avenue Suite 200 Memphis, TN 38103

Common or Usual Name:

Pedicle Screw Fixation System

Classification Identification:

Regulatory Class:

Device Panel

Product Code:

System Type:

21 CFR 888.3070

Class III

Orthopedic Devices

MNI, NKB, MNH

Noncervical, Pedicle System

Predicate Devices

CD HORIZON Spinal System from Medtronic Sofamor Danek, cleared by 510K # K063670

### Intended Use / Indications for Use

The EOI Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to spinal fusion of the thoracic, lumbar, and/or sacral spine.

K-1

page 1 of 2

MAR 1 9 2009

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K083825

The EOI Spinal system is limited to noncervical, pedicle use and is specifically indicated for treatment of one or more of the following acute and chronic instabilities or deformities;

- 1. Degenerative disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);
- 2. Spondvlolisthesis:
- Trauma (fracture of dislocation); 3.
- 4. Deformities or curvatures (scoliosis, kyphosis, and/or lordosis);
- 5. Tumor:
- 6. Spinal Stenosis;
- 7. Pseudoarthrosis; and/or
- 8. Failed previous fusion.

### Technological Characteristics

The EOI Spinal System consists of polyaxial pedicle screws in varying diameters and lengths, Ø5.5mm straight and pre-bent rods in varying lengths, and cross connectors in adjustable widths to build a soinal construct. EOI Spinal System components are manufactured from implant grade titanium alloy [Ti-6Al-4V ELI] in accordance with ASTM F-136. Instrumentation is also available to facilitate implantation of the device components. The EOI Spinal System can be rigidly locked into a variety of configurations suitable to the patient's unique anatomy. Implant components and instrumentation are provided non-sterily and must be sterilized prior to use. As with all orthopedic implants, all implant components in this system are single-use and should never be reused.

### Performance Data

Mcchanical Testing was conducted according to ASTM F1717 to validate the EOI Spinal System. Mechanical tests included static axial compression bending (n=6), and dynamic axial compression bending (n=6). In all instances, the EOI Spinal System functioned as intended and performance observed was as expected. The testing demonstrated substantially equivalent mechanical properties to the previously cleared CD HORIZON Spinal System components.

### Substantial Equivalence

The EOI Spinal System has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the EOI Spinal System and its predicate devices raise no new issues of safety or effectiveness. Thus, the EOI Spinal System is substantially equivalent to the CD HORIZON Spinal System.

K-2

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#### 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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Expanding Orthopedics, Inc. % Hogan & Hartson LLP Ms. Janice M. Hogan 1835 Market Street 29th Floor Philadelphia, Pennsylvania 19103

MAR ] 9 2009

Re: K083825

Trade/Device Name: EOI Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: III Product Code: NKB, MNH, MNI Dated: December 19, 2008 Received: December 22, 2008

Dear Ms. Hogan:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set 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.

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## Page 2 - Ms. Janice M. Hogan

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Sincerely yours,
for Pete D
Dept Dir
Mark N. Mullan

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

Enclosure

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### Indications for Use Statement

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: EOI Spinal System

Indications for Use:

The EOI Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to spinal fusion of the thoracic, lumbar, and/or sacral spine. The EOI Spinal System is limited to non-cervical, pedicle use and is specifically indicated for treatment of one or more of the following acute and chronic instabilities or deformities:

- 1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);
- 2. Spondylolisthesis;
- Trauma (fracture or dislocation); 3.
- 4. Deformities or curvatures (scoliosis, kyphosis, and/or lordosis);
- 5. Tumor;
- 6. Spinal stenosis;
- 7. Pseudoarthrosis; and/or
- 8. Failed previous fusion.

Prescription Use X

#### AND/OR

Over-The-Counter Use

(Part 21 C.F.R. 801 Subpart D)

(21 C.F.R. 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <div style="text-align:center">Pete D Rium</div> <div style="text-align:center">md</div> |
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| (Division Sign-Off) | |
| Division of General, Restorative, | |
| and Neurological Devices | |
| 510(k) Number | K083825 |
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