NUVASIVE SPHERX II -MAS DEFORMITY SPINAL SYSTEM

K102514 · Nuvasive, Inc. · NKB · Dec 1, 2010 · Orthopedic

Device Facts

• Record ID: K102514
• Device Name: NUVASIVE SPHERX II -MAS DEFORMITY SPINAL SYSTEM
• Applicant: Nuvasive, Inc.
• Product Code: NKB · Orthopedic
• Decision Date: Dec 1, 2010
• 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 MAS Deformity 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: 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. Degenerative spondylolisthesis with objective evidence of neurologic impairment 3. Fracture 4. Dislocation 5. Scoliosis 6. Kyphosis 7. Spinal tumor and/or 8. Failed previous fusion (pseudoarthrosis) The NuVasive SpheRx MAS Deformity 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 4. Spinal deformities 5. Fracture 6. Pseudoarthosis 7. Tumor resection and/or 8. Failed previous fusion

Device Story

SpheRx II-MAS Deformity Spinal System; pedicle screw system comprising polyaxial screws, reduction screws, offset connectors, rods, locking nuts, transverse connectors. Implant components configured to patient anatomy; provides rigid immobilization/stabilization of spinal segments. Used in posterior thoracic, lumbar, sacral spine or anterolateral thoracic/lumbar spine. Operated by surgeons in clinical/OR settings. Output is mechanical stabilization of spine; facilitates fusion. Benefits include correction of deformities and stabilization of instabilities.

Clinical Evidence

No clinical data. Bench testing only: static and dynamic compression and static torsion testing performed per ASTM F1717.

Technological Characteristics

Polyaxial pedicle screw system; components include screws, rods, connectors, locking nuts. Materials and design equivalent to predicate. Testing per ASTM F1717 for mechanical performance. Non-active, mechanical implant system.

Indications for Use

Indicated for skeletally mature patients requiring spinal immobilization/stabilization as adjunct to fusion. Conditions: degenerative disc disease, degenerative spondylolisthesis with neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis, spinal stenosis, and tumor resection. Severe spondylolisthesis (Grades 3-4) at L5-S1 requires autogenous bone graft and fixation from L3 to sacrum.

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 II-Pedicle Screw System (K091502)

Submission Summary (Full Text)

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NUVASIVE
Creative Spine Technology"

K102-514- Page I of 2 510(k) Premarket Notification SpheRx® II - MAS Deformity Spinal System

## 510(k) Summary

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

#### A. Submitted by:

Elias Ketchum Regulatory Affairs Associate NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: [phone] Fax: [phone]

DEC 1-2010

Date Prepared: August 17, 2010

#### B. Device Name

Trade or Proprietary Name: NuVasive® SpheRx II – MAS Deformity Spinal System Common or Usual Name: Pedicle Screw System Classification Name: Pedicle Screw Spinal System, Spinal Interlaminal Fixation Orthosis, Spinal Intervertebral Body Fixation orthosis Device Class: Class III \$888.3050, \$888.3060, \$888.3070 Classification: Product Code: NKB, KWP, MNI, MNH, KWQ

#### C. Predicate Devices

The subject SpheRx II - MAS Deformity Spinal System is substantially equivalent to the SpheRx II-Pedicle Screw System (K091502) currently distributed commercially in the U.S. by NuVasive.

#### D. Device Description

The NuVasive SpheRx II-Pedicle Screw System consists of a variety of polyaxial screws, reduction screws, offset connectors, rods, 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. This 510(k) is for the additional sizes of screw shanks, tulips, lock screws, load rings, and split rings that have been added to the SpheRx II-Pedicle Screw System platform and are designated as SpheRx II - MAS Deformity Spinal System.

#### E. Intended Use

When used as a pedicle screw fixation system, the NuVasive SpheRx MAS Deformity 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:

- 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. Degenerative spondylolisthesis with objective evidence of neurologic impairment
- 3. Fracture
- 4. Dislocation

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Image /page/1/Picture/0 description: The image shows the Nuvasive logo. The logo consists of a stylized "N" with a dot above it, followed by the word "NUVASIVE" in all caps. Below the word "NUVASIVE" is the tagline "Creative Spine Technology" in a smaller font.

- 5. Scoliosis
- 6. Kyphosis
- 7. Spinal tumor and/or
- 8. Failed previous fusion (pseudoarthrosis)

The NuVasive SpheRx MAS Deformity 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
- 4. Spinal deformities
- 5. Fracture
- 6. Pseudoarthosis
- 7. Tumor resection and/or
- 8. Failed previous fusion

#### F. Technological Characteristics

As was established in this submission, the subject SpheRx II - MAS Deformity Spinal System is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent and have the same technological characteristics to its predicate devices through comparison in areas including design, intended use, material composition, function, and range of sizes.

#### G. Performance Data

Nonclinical testing was performed to demonstrate that the subject SpheRx II - MAS Deformity Spinal System is substantially equivalent to other predicate devices. The following testing was performed:

- . Static and dynamic compression testing per ASTM F1717
- Static torsion testing per ASTM F1717 ●

The results of these studies showed that the subject SpheRx II - MAS Deformity Spinal System meets or exceeds the performance of the predicate device, and the device was therefore found to be substantially equivalent.

#### H. Conclusions

Based on the indications for use, technological characteristics, performance testing, and comparison to predicate devices, the subject SpheRx II-Pedicle Screw System has been shown to be substantially equivalent to legally marketed predicate devices, and safe and effective for its intended use.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus.

### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

NuVasive Inc. % Mr. Elias Ketchum Associate, Regulatory Affairs 7475 Lusk Boulevard San Diego, California 92121

Re: K102514

Trade/Device Name: NuVasive® SpheRx® II MAS Deformity Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH, KWP, KWQ Dated: October 29, 2010 Received: November 01, 2010

Dear Mr. Ketchum:

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

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Page 2 -- Mr. Elias Ketchum

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.

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,
Mark A. Milken

Mark N. Melkerson 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

# DEC 1 2010

510(k) Number (if known): K102514

Device Name:

Indications For Use:

When used as a pedicle screw fixation system, the NuVasive SpheRx MAS Deformity Spinal System is intended to provide immobilization 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:

- 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. Degenerative spondylolisthesis with objective evidence of neurologic impairment
- 3. Fracture
- 4. Dislocation
- 5. Scoliosis
- 6. Kyphosis
- 7. Spinal tumor and/or
- 8. Failed previous fusion (pseudoarthrosis)

The NuVasive SpheRx MAS Deformity 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 MAS Deformity 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
- Spondylolisthesis ကဲ
- Spinal deformities ধ
- 5. Fracture
- 6. Pseudoarthosis
- 7. Tumor resection and/or
- 8. Failed previous fusion

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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

KID 251 4 510(k) Number_

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