MANTIS SPINAL SYSTEM

K061813 · Stryker Spine · MNH · Sep 19, 2006 · Orthopedic

Device Facts

• Record ID: K061813
• Device Name: MANTIS SPINAL SYSTEM
• Applicant: Stryker Spine
• Product Code: MNH · Orthopedic
• Decision Date: Sep 19, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MANTISTM Spinal System is intended for percutaneous, posterior, non-cervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion.

Device Story

MANTIS Spinal System consists of cannulated polyaxial screws and straight or pre-bent rods; designed for percutaneous, posterior, non-cervical spinal fixation. Implants are fabricated from titanium alloy. System accommodates various patient anatomies via multiple diameters and lengths. Used by surgeons in clinical settings to stabilize the spine; provides mechanical support to facilitate fusion. Benefits include minimally invasive percutaneous approach for treating degenerative disc disease, trauma, and spinal deformities.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and design comparison to legally marketed predicate devices.

Technological Characteristics

System components include cannulated polyaxial screws and straight/pre-bent rods. Fabricated from titanium alloy. Designed for percutaneous, posterior, non-cervical pedicle fixation. Non-sterile delivery.

Indications for Use

Indicated for patients requiring non-cervical posterior pedicle fixation for degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), spinal stenosis, spinal curvatures (scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, or failed previous 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

• Stryker Spine Xia® Titanium Spinal System polyaxial cannulated screws (K043473, K060361)
• Stryker Spine Xia® Titanium Spinal System polyaxial screws (K002858, K013823)
• Stryker Spine Straight and pre-bent rods (K951725, K984251, K060361)
• Sofamor Danek CD Horizon® Spinal System (K001255)
• DePuy Spine, Inc. VIPERTM Spine System (K061520)

Submission Summary (Full Text)

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MANTIS™ Spinal System

K061813
Traditional 510(k) Premarket Notification

## 510(k) Summary of Safety and Effectiveness: MANTISTM Spinal System

| Proprietary Name: | MANTIS™ Spinal System | SEP 1 9 2006 |
|----------------------------|-----------------------------------------------------------------------------|--------------|
| Common Name: | Spinal Fixation Appliances | |
| Proposed Regulatory Class: | Class III | |
| Device Product Code: | Pedicle Screw Spinal System, 21 CFR 888.3070 | |
| | 87 MNH: Spondylolisthesis Spinal Fixation System | |
| | 87 MNI: Orthosis, Spinal, Pedicle Fixation | |
| | 87 NKB: Orthosis, Spinal Pedicle Fixation, for<br>Degenerative Disc Disease | |
| For Information contact: | Simona Voic | |
| | Regulatory Affairs Project Manager | |
| | 2 Pearl Court | |
| | Allendale, NJ 07401 | |
| | Telephone: [phone] | |
| | Fax: [phone] | |
| | Email: [e-mail] | |
| Date Summary Prepared: | July 31, 2006 | |

# Predicate Device Identification

The predicate devices are:

Stryker Spine Xia® Titanium Spinal System polyaxial cannulated screws (510(k) #K043473 and #K060361),

Stryker Spine Xia® Titanium Spinal System polyaxial screws (K002858, K013823),

Stryker Spine Straight and pre-bent rods (510(k) #K951725, #K984251 and #K060361),

Sofamor Danek CD Horizon® Spinal System (K001255), and

DePuy Spine, Inc. VIPERTM Spine System (K061520).

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#### Device Description

This 510(k) submission is intended to introduce the MANTIS™ Spinal System. The MANTIS™ Spinal System includes cannulated polyaxial screw and straight or pre-bent rod components that can be used via a percutaneous surgical approach. The components are available in a variety of diameters and lengths in order to accommodate patient anatomy and are fabricated from titanium alloy. The implants will be provided non-sterile.

#### Intended Use:

The MANTISTM Spinal System is intended for percutaneous, posterior, non-cervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion.

### Summary of the Technological Characteristics:

Documentation is provided which demonstrates that the Stryker Spine MANTIS Spinal System is substantially equivalent to its predicate devices in terms of its material, design, and indications for use, and performance characteristics.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of a human figure, represented by three abstract shapes, with arms raised in a gesture of support or assistance.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Stryker Spine c/o Ms. Simona Voic Regulatory Affairs Project Manager 2 Pearl Court Allendale, New Jersey 07401

SEP 1 9 2006

Re: K061813

Trade/Device Name: MANTISTM Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: MNH, MNI, NKB Dated: June 26, 2006 Received: June 27, 2006

Dear Ms. Voic:

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 – Ms. Simona Voic

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. 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Karhare Buettm
for

Mark N. Mel 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): K061813

Device Name: MANTIS™ Spinal System

Indications for Use:

The MANTIS™ Spinal System is intended for percutaneous, posterior, non-cervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), ansocgently of girl frauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Norlave Hudson

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

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510(k) Number <0/81'3