NUVASIVE SPHERX II SYSTEM

K061778 · Nuvasive, Inc. · MNH · Jul 18, 2006 · Orthopedic

Device Facts

• Record ID: K061778
• Device Name: NUVASIVE SPHERX II SYSTEM
• Applicant: Nuvasive, Inc.
• Product Code: MNH · Orthopedic
• Decision Date: Jul 18, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

When used as a pedicle screw fixation system, the NuVasive SpheRx Spinal System is 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 posterior thoracic, lumbar, and sacral spine: - Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) - Degenerative spondylolisthesis with objective evidence of neurologic impairment 2. - 3. Fracture - 4. Dislocation - 5. Scoliosis - Kyphosis 6. - 7. Spinal tumor and/or - 8. Failed previous fusion (pseudoarthrosis) The NuVasive SpheRx Spinal System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum), with removal of the implants after attainment of a solid fusion. When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the NuVasive SpheRx Spinal System is also intended for the following indications: - 1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) - 2. Spinal stenosis - 3. Spondylolisthesis - Spinal deformities 4. - 5. Fracture - 6. Pseudoarthosis - 7. Tumor resection and/or - 8. Failed previous fusion

Device Story

SpheRx II System; spinal fixation hardware including polyaxial screws, fixed angle screws, rods, hooks, locking nuts, transverse connectors. Used by surgeons in clinical settings to immobilize/stabilize spinal segments; adjunct to fusion. Components configured to patient anatomy/pathology; rigidly locked to provide structural support. Benefits patient by stabilizing spine during fusion process; severe spondylolisthesis cases require implant removal post-fusion.

Clinical Evidence

Bench testing only.

Technological Characteristics

System consists of polyaxial screws, fixed angle screws, rods, hooks, locking nuts, and transverse connectors. Metallic spinal fixation hardware. No software or electronic components.

Indications for Use

Indicated for skeletally mature patients requiring spinal immobilization/stabilization as an adjunct to fusion. Treats acute/chronic instabilities or deformities of posterior thoracic, lumbar, and sacral spine (e.g., DDD, spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, tumor, failed fusion). Also indicated for severe spondylolisthesis (Grades 3-4) at L5-S1 using autogenous bone graft. Anterolateral non-pedicle use indicated for DDD, stenosis, spondylolisthesis, deformities, fracture, pseudoarthrosis, tumor resection, and failed fusion.

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

• SpheRx System

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a stylized "N" followed by the word "NUVASIVE" in all caps. Below the word "NUVASIVE" is the tagline "Creative Spine Technology" in a smaller font.

# JUL 1 8 2006

# VII. 510(k) Summary

In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular \$807.92, the following summary of information is provided:

#### A. Submitted by:

Laetitia Cousin Director of Regulatory Affairs and Quality Assurance NuVasive, Incorporated 4545 Towne Centre Court San Diego, California 92121 Telephone: [phone] Fax: [phone]

#### B. Device Name

| Trade or Proprietary Name: | NuVasive SpheRx II System |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Common or Usual Name: | Pedicle Screw System |
| Classification Name: | Spinal Pedicle Screw Spinal System, Spinal Interlaminal<br>Fixation Orthosis, Spinal Intervertebral Body Fixation<br>orthosis. |
| Device Class: | Class III |
| Classification: | §888.3050, §888.3060, §888.3070 |
| Product Code: | KWP, MNI, MNH, KWQ |

#### C. Predicate Devices

The subject SpheRx II System is substantially equivalent to the SpheRx System currently distributed commercially in the U.S. by NuVasive.

#### D. Device Description

The NuVasive SpheRx II System consists of a variety of polyaxial screws, fixed angle screws, rods, hooks, locking nuts, and transverse connectors. Implant components can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the patient.

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### E. Intended Use

When used as a pedicle screw fixation system, the NuVasive SpheRx Spinal System is 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 posterior thoracic, lumbar, and sacral spine:

- Degenerative disc disease (as defined by back pain of discogenic origin with し、 degeneration of the disc confirmed by patient history and radiographic studies)
- Degenerative spondylolisthesis with objective evidence of neurologic impairment 2.
- 3. Fracture
- 4. Dislocation
- 5. Scoliosis
- Kyphosis 6.
- 7. Spinal tumor and/or
- 8. Failed previous fusion (pseudoarthrosis)

The NuVasive SpheRx Spinal System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum), with removal of the implants after attainment of a solid fusion.

When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the NuVasive SpheRx Spinal System is also intended for the following indications:

- 1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
- 2. Spinal stenosis
- 3. Spondylolisthesis
- Spinal deformities 4.
- 5. Fracture
- 6. Pseudoarthosis
- 7. Tumor resection and/or
- 8. Failed previous fusion

### F. Comparison to Predicate Devices

The subject device has indications for use identical to those of its predicate, and employs the same principles of operation.

## (G. Summary of Non-Clinical Tests

Mechanical testing was presented.

- H. Summary of Clinical Tests (Not Applicable).

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which is a stylized human figure with outstretched arms, representing care and protection. The symbol is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the symbol.

JUL 3 0 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Public Health Service

NuVasive, Inc. % Ms. Laetitia Cousin 7475 Lusk Boulevard San Diego, California 92121

Re: K061778

Trade/Device Name: NuVasive SpheRx II System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: III Product Code: NKB, MNH, MNI, KWP, KWQ Dated: June 23, 2006 Received: June 26, 2006

Dear Ms. Cousin:

This letter corrects our substantially equivalent letter of July 18, 2006.

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 (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 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 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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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 vours.

Kubař Buchm

Mark Melk erson 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): | K061778 |
|---------------------------|---------|
|---------------------------|---------|

Device Name: SpheRx® II System

Indications For Use:

When used as a pedicle screw fixation system, the NuVasive SpheRx Spinal System is intended to orovide immobilization and stabilization of soinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the posterior thoracic, lumbar, and sacral spine:

- 1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
- Degenerative spondylolisthesis with objective evidence of neurologic impairment 2.
- 3. Fracture
- Dislocation ধ
- Scoliosis ട്.
- Kyphosis 6.
- Spinal tumor and/or 7.
- Failed previous fusion (pseudoarthrosis) 8.

The NuVasive SpheRx Spinal System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum), with removal of the implants after attainment of a solid fusion.

When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the NuVasive SpheRx Spinal System is also intended for the following indications:

- Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc 1. confirmed by patient history and radiographic studies)
- 2. Spinal stenosis
- ന് Spondylolisthesis
- 4. Spinal deformities
- 5. Fracture
- Pseudoarthosis 6.
- Tumor resection and/or 7.
- Failed previous fusion 8.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Arbare Anelns
(Division Sign Office of CDRH, Office of Device Evaluation (ODE)

neral, Restorative, and Neurological Devices

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510(k) Number_ 0 61778