MODIFICATION TO EBI OMEGA21 SPINAL FIXATION SYSTEM

K023204 · Ebi, L.P. · MNH · Oct 18, 2002 · Orthopedic

Device Facts

• Record ID: K023204
• Device Name: MODIFICATION TO EBI OMEGA21 SPINAL FIXATION SYSTEM
• Applicant: Ebi, L.P.
• Product Code: MNH · Orthopedic
• Decision Date: Oct 18, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EBI® Omega21™ Spinal Fixation System is a spinal fixation device for pedicle screw fixation and a non-pedicle hook and sacral/iliac screw fixation system of the non-cervical spine. When used as a pedicle screw fixation system, in the non-cervical spine of skeletally mature patients, the System is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocations; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). In addition, when used as a pedicle screw fixation system in skeletally mature patients, it is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar -- first sacral (L5 -- S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass. When used as a posterior hook and sacral/iliac screw fixation system, the levels of attachment are the lumbar and thoracic spine, and screw fixation is limited to the sacrum and ilium. The System is intended for the treatment of degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); pseudarthrosis; stenosis; scoliosis; spondylolisthesis; fracture; previous failed fusion; or tumor resection. When used as an anterior fixation system, the levels of attachment are the anterolateral vertebral bodies of the lumbar and thoracic spine. The System is intended for the treatment of degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); pseudarthrosis; stenosis; scoliosis; spondylolisthesis; fracture; previous failed fusion; or tumor resection.

Device Story

Spinal fixation system consisting of rods, screws, couplers, and hooks; includes 'Angulating Cross Connector'. Used by surgeons in clinical settings to provide immobilization and stabilization of thoracic, lumbar, and sacral spinal segments. Mechanical device; no electronic or software components. Provides structural support to facilitate fusion in patients with spinal instabilities or deformities. Benefits patient by stabilizing spinal segments, reducing pain, and correcting deformities.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Components manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136. Mechanical spinal fixation system utilizing rods, screws, couplers, and hooks. No energy source, software, or connectivity.

Indications for Use

Indicated for skeletally mature patients requiring spinal immobilization and stabilization as an adjunct to fusion in the non-cervical spine. Treats degenerative spondylolisthesis, fracture, dislocations, scoliosis, kyphosis, spinal tumor, failed fusion, degenerative disc disease, and stenosis. Specific constraints for pedicle screw use include L3 and below attachment, autogenous bone graft requirement, and severe L5-S1 spondylolisthesis.

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

• EBI® Omega 21™ System (K020681, K014137, K001357, K992333, K991721, K990303, K973683)

Submission Summary (Full Text)

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K023204 p1/3

# OCT 1 8 2002

#### 510(k) Summary

This 510(k) Summary for the EBI® Omega21™ Spinal Fixation System is provided as required per Section 513(3) of the Food, Drug and Cosmetic Act.

- Contact Person: Frederic Testa, RAC 1. Submitter: EBI, L.P. Telephone: [phone], ext.2208 100 Interpace Parkway Parsippany, NJ 07054
September 23, 2002 Date prepared:

The state of the second more of the consistence of the results of the programment of the program

| 2. Proprietary Name: | EBI® Omega21™ Spinal Fixation System |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Spinal Fixation Device |
| Classification Names: | Spondylolisthesis Spinal Fixation Device System<br>Spinal Intervertebral Body Fixation Orthosis<br>Spinal Interlaminal Fixation Orthosis |

## 3. Predicate or legally marketed devices that are substantially equivalent:

- EBI® Omega 21™ System (K020681, K014137, K001357, K992333, . K991721, K990303, and K973683).
- 4. Description of the device: The EBI® Omega21 Spinal Fixation System is a spinal fixation device that utilizes rods, screws, couplers and hooks. This submission is for the addition of 'Angulating Cross Connector' to the existing System.
- 5. Intended Use: The EBI® Omega21™ Spinal Fixation System is a spinal fixation device for pedicle screw fixation and a non-pedicle hook and sacral/iliac screw fixation system of the non-cervical spine.

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023204 p²/3

When used as a pedicle screw fixation system, in the non-cervical spine of skeletally mature patients, the System is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocations; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system in skeletally mature patients, it is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar -- first sacral (L5 -- S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.

When used as a posterior hook and sacral/iliac screw fixation system, the levels of attachment are the lumbar and thoracic spine, and screw fixation is limited to the sacrum and ilium. The System is intended for the treatment of degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); pseudarthrosis; stenosis; scoliosis; spondylolisthesis; fracture; previous failed fusion; or tumor resection.

When used as an anterior fixation system, the levels of attachment are the anterolateral vertebral bodies of the lumbar and thoracic spine. The System is intended for the treatment of degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); pseudarthrosis; stenosis; scoliosis; spondylolisthesis; fracture; previous failed fusion; or tumor resection.

- 6. Materials: The components of the System are manufactured from titanium alloy (Ti-6A1-4V ELI) per ASTM F136.

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# 7. Comparison of the technological characteristics of the device to predicate devices: There are no significant differences between the proposed EBI® Omega21™ Spinal Fixation System and the currently marketed EBI Omega21 Spinal Fixation System. It is substantially equivalent* to the predicate devices in regards to intended use, materials, and function.

* Any statement made in conjunction with this submission regarding a determination of substantial equivalence to any other product is intended only to relate to whether the product can be lawfully marketed without pre-market approval or reclassification and is not interpreted as an admission or any other type of evidence in patent infringement litigation. [Establishment Registration and Premarket Notification Procedures, Final Regulation, Preamble, August 23, 1977, FR 42520 (Docket No. 76N-0355.)]

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## CT 1 8 2002

Mr. Frederic Testa Regulatory Affairs Specialist EBI. L.P. 100 Interpace Parkway Parsippany, New Jersey 07054

K023204 Re:

> Trade Name: EBI Omega 21™ System Regulatory Number: 21 CFR 888.3070, 888.3050, 888.3060 Regulation Name: Pedicle Screw Spinal System, Spinal Interlaminal Fixation, Orthosis, Spinal Intervertebral Body Fixation Orthosis Regulatory Class: II

Product Code: MNH, MNI, KWP, KWQ Dated: September 24, 2002 Received: September 25, 2002

Dear Mr. Testa:

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

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Page 2 - Mr. Frederic Testa

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N Millbern

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Statement of Indications for Use

Page 1 of 1

510(k) Number (if known): K ( ( 2 3 2

Device Name: EBI® Omega21™ Spinal Fixation System

Indications For Use:

The EBI® Omega21™ Spinal Fixation System is a spinal fixation device for pedicle screw fixat non-pedicle hook and sacral/iliac screw fixation system of the non-cervical spine.

When used as a pedicle screw fixation system, in the non-cervical spine of skeletally mature patients, the System is intended to provide immobilization of spinal segments, as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocations, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system in skeletally mature patients, it is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5 - S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.

When used as a posterior hook and sacral/iliac screw fixation system, the levels of attachment are the lumbar and thoracic spine, and screw fixation is limited to the sacrum and ilium. The System is intended for the treatment of degenerative disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), pseudarthrosis, stenosis, scoliosis, spondylolisthesis, fracture, previous failed fusion, or tumor resection.

When used as an anterior fixation system, the levels of attachment are the anterolateral bodies of the lumbar and thoracic spine. The System is intended for the treatment of degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), pseudarthrosis, scoliosis, spondylolisthesis, fracture, previous failed fusion, or tumor resection.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use (Per 21 CFR 801.109) | | OR | Over-The-Counter Use (Optional Format 1-2-96) |
|---------------------------------------|--|----|-----------------------------------------------|
|---------------------------------------|--|----|-----------------------------------------------|

(Division Sign)
Division of General, Restorative
and Neurological Devices

| 510(k) Number | K023204 |
|---------------|---------|
|---------------|---------|