COSMIC SYSTEM

K080841 · Ulrich GmbH & Co. KG · MNI · Jul 23, 2008 · Orthopedic

Device Facts

• Record ID: K080841
• Device Name: COSMIC SYSTEM
• Applicant: Ulrich GmbH & Co. KG
• Product Code: MNI · Orthopedic
• Decision Date: Jul 23, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The cosmic™ system is intended for posterior, noncervical pedicle fixation as an adjunct to fusion for the following indications: severe spondylolisthesis (grades 3 and 4) at L5-S1, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, spinal tumor and failed previous fusion (pseudarthrosis).

Device Story

Cosmic™ System is a posterior, noncervical pedicle screw spinal fixation system. Components include rods, pedicle screws of varying lengths/diameters, and transverse stabilizers. Pedicle screws feature calcium phosphate coating. Device used by surgeons in clinical/OR settings to provide stabilization as an adjunct to spinal fusion. System provides mechanical support to spinal column to facilitate fusion and treat conditions like spondylolisthesis, fractures, and scoliosis.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and material characteristics.

Technological Characteristics

Components manufactured from titanium alloy (Ti-6Al-4V per ASTM F136 / ISO 5832-3). Pedicle screws feature calcium phosphate (Bonit®) coating per ISO 13779-2. System includes rods, screws, and transverse stabilizers for posterior spinal fixation.

Indications for Use

Indicated for patients requiring posterior, noncervical pedicle fixation as an adjunct to fusion for severe spondylolisthesis (grades 3-4) at L5-S1, degenerative spondylolisthesis with neurologic impairment, fracture, dislocation, scoliosis, spinal tumor, or pseudarthrosis.

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

• SSCS System

Submission Summary (Full Text)

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K080841 (pg. 1 of 1)

## 510(k) Summary

| Sponsor: | ulrich GmbH & Co. KG<br>Buchbrunnenweg 12<br>89081 Ulm<br>Germany<br>Phone: [phone]<br>Fax: [phone] | JUL 23 2008 |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact Person: | Merle Symes<br>ulrich Medical USA<br>754 Spirit 40 Park Drive<br>St. Louis, MO 63005<br>[phone] Office<br>[phone] Fax<br>[phone] Mobile | |
| Proposed Trade Name: | cosmic™ System | |
| Regulation | 888.3070 - Pedicle Screw Spinal Fixation System | |
| Device Product Code: | MNI, MNH | |
| Device Description: | The cosmic™ System includes rods and pedicle screws in a variety of lengths and diameters and transverse stabilizers. The pedicle screw threads comprise a calcium phosphate coating. | |
| Intended Use: | The cosmic™ system is intended for posterior, noncervical pedicle fixation as an adjunct to fusion for the following indications: severe spondylolisthesis (grades 3 and 4) at L5-S1, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis). | |
| Materials: | The cosmic™ System components are manufactured from titanium alloy (Ti-6Al-4V per ASTM F136 / ISO 5832-3). The calcium phosphate coating (Bonit®) is manufactured according to ISO 13779-2. | |
| Substantial Equivalence: | Documentation was provided which demonstrated the cosmic™ System to be substantially equivalent to the previously cleared SSCS System. The substantial equivalence is based upon equivalence in basic design, intended use, indications, materials, anatomic sites and performance. | |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

JUL 2 3 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ulrich GMBH & Company KG % Ulrich Medical USA Mr. Merle Symes President and CEO 754 Spirit 40 Park Drive St. Louis, MO 63005

Re: K080841

Trade/Device Name: cosmic™ System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: MNI, MNH Dated: June 5, 2008 Received: June 9, 2008

Dear Mr. Symes:

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. Merle Symes

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial cquivalence 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 N. Wilkinson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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# KO80841

### Statement of Indications for Use

510(k) Number (if known): Unknown

Device Name: cosmic™ System

#### Indications for Use:

The cosmic The system is intended for posterior, noncervical pedicle fixation as an adjunct to fusion for the following indications: severe spondylolisthesis (grades 3 and 4) at L5-S1, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, spinal tumor and failed previous fusion (pseudarthrosis).

Prescription Use: X X AND/OR Over-the-Counter Use: (21 CFR § 801 Subpart D)

(21 CFR §07 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Loubara Bueno
Division Sign-Off

ivision of General, Restorative, and Neurological Devices

510(k) Number K080841

Special 510(k) - cosmic TM System