MONOPOLY PEDICLE SCREW SYSTEM

K081108 · Signus Medical, LLC · NKB · Jul 14, 2008 · Orthopedic

Device Facts

• Record ID: K081108
• Device Name: MONOPOLY PEDICLE SCREW SYSTEM
• Applicant: Signus Medical, LLC
• Product Code: NKB · Orthopedic
• Decision Date: Jul 14, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MonoPoly Pedicle Screw System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral spine (T1-S1), specifically as follows: When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the is indicated for one of the following: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (4) dislocation, (5) spinal tumor, and/or (6) failed previous fusion (pseudarthrosis). When used as a non-cervical and non-pedicle screw fixation system, the MonoPoly Pedicle Screw System is 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) trauma (fracture, dislocation), (5) pseudarthrosis, (6) tumor resection and/or (7) failed previous fusion.

Device Story

System consists of monoaxial and polyaxial pedicle screws, couplers, set screws, cross links, washers, rods, and hooks. Used by surgeons in clinical settings to provide spinal immobilization and stabilization as an adjunct to fusion. Components are implanted into the thoracic, lumbar, and sacral spine to address degenerative conditions, trauma, or tumors. Device provides mechanical support to stabilize spinal segments, facilitating fusion and potentially reducing patient pain and neurologic impairment.

Clinical Evidence

Bench testing only.

Technological Characteristics

Constructed from medical grade titanium alloy (Ti6Al4V-Eli). System includes monoaxial and polyaxial pedicle screws, couplers, set screws, cross links, washers, rods, and hooks.

Indications for Use

Indicated for skeletally mature patients requiring spinal immobilization/stabilization as an adjunct to fusion (T1-S1). Conditions include degenerative disc disease, degenerative spondylolisthesis with neurologic impairment, spinal stenosis, trauma (fracture/dislocation), spinal tumor/tumor resection, and pseudarthrosis (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

• Cross Medical Synergy VLS System (K974749)
• U&I Optima Xia System (K031585)
• GSS Medical GS System (K053573)
• Signus Medical OvalTwist System (K061577)

Submission Summary (Full Text)

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K081/108 (pg. 1 of 2)

Confidential

April 17, 2008

## 5. 510(k) Summary according to 807.92(c) JUL 14 2008

| Contact: | Thomas Hoghaug<br>Signus Medical<br>18888 Lake Drive East<br>Chanhassen, MN 55317<br>952-294-8700 |
|-----------------|---------------------------------------------------------------------------------------------------|
| Trade Name: | MonoPoly Pedicle Screw System |
| Classification: | 21 CFR §888.3070 Pedicle screw spinal system<br>§888.3050 Spinal interlaminal fixation orthosis |
| Class: | III |
| Product Codes: | NKB KWP MNH MNI |

#### Indications for Use:

The MonoPoly Pedicle Screw System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral spine (T1-S1), specifically as follows:

When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the is indicated for one of the following: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (4) dislocation, (5) spinal tumor, and/or (6) failed previous fusion (pseudarthrosis).

When used as a non-cervical and non-pedicle screw fixation system, the MonoPoly Pedicle Screw System is 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) trauma (fracture, dislocation), (5) pseudarthrosis, (6) tumor resection and/or (7) failed previous fusion.

### Device Description:

The MonoPoly Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle screws sizes, couplers, a set screw, cross links, a washer, rods and hooks. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-Eli).

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K081108 (pg. 2 of 2)

Signus Medical, LLC MonoPoly Pedicle Screw System 510(k) Confidential

April 17, 2008

#### Predicate Device(s):

The MonoPoly Pedicle Screw System was shown to be substantially equivalent to previously cleared devices and has the same indications for use, design, function, and materials used. These devices include the Cross Medical Synergy VLS System (K974749), the U&I Optima Xia System (K031585), The GSS Medical GS System (K053573) and the Signus Medical OvalTwist System (K061577)

#### Performance Testing:

The pre-clinical testing performed indicated that the MonoPoly Pedicle Screw System is substantially equivalent to predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, topped by a pair of wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Signus Medical % Mr. Thomas Hoghaug 18888 Lake Drive East Chanhassen, MN 55317

Re: K081108

Trade/Device Name: MonoPoly Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Names: Pedicie screw spinal system Regulatory Class: III Product Code: NKB, MNI, MNH, KWP Dated: April 17, 2008 Received: April 18, 2008

Dear Mr. Hoghaug:

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.

# JUL 1 4 2008

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Page 2 - Mr. Thomas Hoghaug

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 [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 yours,

Mark M. Millican

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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Confidential

## 4. Indications for Use

510(k) Number (if known): _ KO81108

Indications for Use:

The MonoPoly Pedicle Screw System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral spine (T1-S1), specifically as follows:

When used as a pedicle screw fixation system of the non-cervical posterior spinc in skeletally mature patients, the is indicated for one or more of the following: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (4) dislocation, (5) spinal tumor, and/or (6) failed previous fusion (pseudarthrosis).

When used as a non-cervical and non-pedicle screw fixation system, the MonoPoly Pedicle Screw System is 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) trauma (fracture, dislocation), (5) pseudarthrosis, (6) tumor resection and/or (7) failed previous fusion.

Prescription Use ﮨﮯ (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)

Salome Brielund Forman
Division Sign Off

Restorative. and Neurological Devices

510(k) Number K081108