GSO GS1 SPINAL SYSTEM

K070966 · Gold Standard Orthopaedics, LLC · KWP · Jul 20, 2007 · Orthopedic

Device Facts

• Record ID: K070966
• Device Name: GSO GS1 SPINAL SYSTEM
• Applicant: Gold Standard Orthopaedics, LLC
• Product Code: KWP · Orthopedic
• Decision Date: Jul 20, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The GSO GS1 Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. It is intended to be used as a temporary construct that assists normal healing and is not intended to replace normal body structures. The GSO GS1 Spinal System should be removed after fusion.

Device Story

GSO GS1 Spinal System is a posterior spinal fixation construct consisting of rods, screws, hooks, and adjustable crosslinks. Components are assembled into rigid configurations to provide spinal immobilization and stabilization as an adjunct to fusion. System is implanted by surgeons during spinal procedures. Components are manufactured from CP Titanium (ASTM F67) and Ti-6Al-4V alloy (ASTM F136). Device is temporary and intended for removal after solid fusion mass development. Benefits include stabilization of spinal segments in patients with acute or chronic instabilities, deformities, or degenerative conditions. System is compatible with standard surgical instrumentation.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via bench testing (mechanical testing per ASTM F-1717).

Technological Characteristics

Materials: CP Titanium (ASTM F67) and Ti-6Al-4V Titanium alloy (ASTM F136). Components: rods, screws, hooks, adjustable crosslinks. Configuration: posterior, non-cervical, rigid construct. Mechanical testing: ASTM F-1717.

Indications for Use

Indicated for skeletally mature patients requiring spinal immobilization/stabilization as an adjunct to fusion. Pedicle screw use: severe spondylolisthesis (Grade 3-4) at L5-S1; fixation at L3 and below; fusions using autogenous bone graft; treatment of acute/chronic instabilities/deformities (degenerative spondylolisthesis with neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudarthrosis). Non-pedicle/hook use: degenerative disc disease, idiopathic/paralytic/neuromuscular scoliosis, kyphotic deformities, pelvic obliquity, vertebral fracture/dislocation, tumors, stenosis, pseudarthrosis, failed previous fusion. Contraindications: instrumentation must be at least 1 cm from major vessels.

Regulatory Classification

Identification

A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.

Predicate Devices

• CD Horizon Spinal System Medtronic Sofamor Danek, Inc. (K031833)
• Synergy Spinal System Interpore Cross International (K010515)

Submission Summary (Full Text)

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K070966

### 510(K) SUMMARY

| 1. | Applicant/Sponsor: | Gold Standard Orthopaedics, LLC.<br>1226 Rowan St.<br>Louisville, KY 40203 | JUL 20 200 |
|----|-----------------------|--------------------------------------------------------------------------------------------------------|------------|
| 2. | Contact Person: | David Baughman, President<br>[e-mail]<br>Phone [phone] | |
| 3. | Proprietary Name: | GSO GS1 Spinal System | |
| 4. | Common Name: | Spinal Implants | |
| 5. | Classification Names: | Pedicle screw spinal system, 21 CFR 888.3070<br>Spinal interlaminal fixation orthosis, 21 CFR 888.3050 | |

Product Codes: MNI, KWP, MNH

- Legally Marketed Devices to which Substantial Equivalence is claimed: 6.
- CD Horizon Spinal System Medtronic Sofamor Danek, Inc. (K031833) .
- Synergy Spinal System Interpore Cross International (K010515) .

#### 7. Device Description:

The GSO GS1 Spinal System consists of rods, screws, hooks, and adjustable crosslink that can be locked rigidly into various configurations to build a spinal construct specific to the needs of each individual patient. The implants are a vophed to the spine posteriorly by means of screws and/or hooks joined with rods. Crosslink components are used to attach two rods in parallel. The GSO GS1 Spinal System can be installed with any suitable instrumentation.

The GSO GS1 Spinal System components are manufactured from CP Titanium conforming to ASTM F67 and Ti-6A1-4V Titanium alloy conforming to ASTM F136. Devices are available in various diameters, lengths and sizes.

- 8. Intended Use:
The GSO GS1 Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. It is intended to be used as a temporary construct that assists normal healing and is not intended to replace normal body structures. The GSO GS1 Spinal System should be removed after fusion.

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K070966

As a pedicle screw system, the GSO GS1 Spinal System is intended for patients: (a) having severe spondylolisthesis (Grade 3 and 4) of the fifth lumbar-first sacral (1.5-S1) vertebral joint; (b) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); (c) who are receiving fusions using autogenous bone graft only; and (d) who are having the device removed after the development of a solid fusion mass.

In addition, when used as a pedicle screw system, the GSO GS1 Spinal System is indicated for the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

When used as a posterior, non-cervical, non-pedicle screw and/or hook fixation system, the GSO GS1 Spinal System is indicated for:

- 1. Degenerative disc disease (as defined by chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
- 2. Idiopathic scollosis
- Kyphotic deformities of the spine 3.
- 4. Paralytic scoliosis and/or pelvis obliquity
- 5. Vertebral fracture or dislocation
- 6. Neuromuscular scoliosis associated with pelvic obliquity
- 7. Vertebral fracture or dislocation
- 8. Tumors
- 9. Spondylolisthesis
- 10. Stenosis
- 11. Pseudarthrosis
- 12. Unsuccessful previous attempts at spinal fusion

For posterior, non-pedicle, screw use, the GSO GS1 screws are intended for sacral/illac attachment only and the GSO GS1 hooks and crosslinks are intended for thoracic and/or lumbar use only.

In all cases, instrumentation must be at least 1 cm from any major vessel.

### 9. Summary of Technologies/Substantial Equivalence:

The GSO GS1 Spinal System has a similar design and is manufactured from the same materials as the CD Horizon Spinal System - Medtronic Sofamor Danek, Inc. (K031833) and the Synergy Spinal System – Interpore Cross International (K010515). When used as a pedicle screw system, the GSO GS1 Spinal System has the same indications as both of the predicate devices. When used as a posterior, non-

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K676966

cervical, non-pedicle screw and/or hook fixation system the GSO GS1 Spinal System has the same indications as the Synergy Spinal System.

### 10. Non-Clinical Testing:

Mechanical testing conducted according to ASTM I-1717 demonstrates that the failure loads for the GSO GS1 Spinal System are greater than published failure loads for the Synergy Spinal System.

- 11. Clinical Testing:
Clinical testing was not necessary to demonstrate the substantial equivalence of the GSO GS1 Spinal System to the predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an image of an eagle with its wings spread, with three lines emanating from the eagle's head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 U 2007

Gold Standards Orthopaedics, LLC % Mr. David Baughman President 1226 Rowan St. Louisville, Kentucky 40203

K070966 Re:

> Trade/Device Name: GS0 GS1 Spinal System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP, MNI, MNH Dated: June 11, 2007 Received: June 13, 2007

Dear Mr. Baughman:

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 (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.

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### Page 2 – Mr. David Baughman

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 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.

Barbara Bonell

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

## 510(k) Number (if known): KO70966

Device Name: GSO GS1 Spinal System

### Indications for Use:

The GSO GS1 Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. It is intended to be used as a temporary construct that assists normal healing and is not intended to replace normal body structures. The GSO GS1 Spinal System should be removed after fusion.

As a pedicle screw system, the GSO GS1 Spinal System is intended for patients: (a) having severe spondylolisthesis (Grade 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); (c) who are receiving fusions using autogenous bone graft only; and (d) who are having the device removed after the development of a solid fusion mass.

In addition, when used as a pedicle screw system, the GSO GS1 Spinal System is indicated for the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

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)

nce of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of General, Restorative, and Neurological Devices

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Koznalage 8 510(k) Number_

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# Ko70966

When used as a posterior, non-cervical, non-pedicle screw and/or hook fixation system, the GSO GS1 Spinal System is indicated for:

- 1. Degenerative disc disease (as defined by chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
- 2. Idiopathic scoliosis
- 3. Kyphotic deformities of the spine
- 4. Paralytic scoliosis and/or pelvis obliquity
- 5. Vertebral fracture or dislocation
- 6. Neuromuscular scoliosis associated with pelvic obliquity
- 7. Vertebral fracture or dislocation
- 8. Tumors
- 9. Spondylolisthesis
- 10. Stenosis
- 11. Pseudarthrosis
- 12. Unsuccessful previous attempts at spinal fusion

For posterior, non-pedicle, screw use, the GSO GS1 screws are intended for sacral/iliac attachment only and the GSO GS1 hooks and crosslinks are intended for thoracic and/or lumbar use only.

In all cases, instrumentation must be at least 1 cm from any major vessel.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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