MODIFICATION TO CORAL SPINAL SYSTEM

K081414 · Theken Spine, LLC · NKB · Jun 17, 2008 · Orthopedic

Device Facts

• Record ID: K081414
• Device Name: MODIFICATION TO CORAL SPINAL SYSTEM
• Applicant: Theken Spine, LLC
• Product Code: NKB · Orthopedic
• Decision Date: Jun 17, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Coral™ Spinal System is a non-cervical spinal fixation device intended for use as a posterior pedicle screw fixation system, a posterior non-pedicle screw fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients. The device is indicated as an adjunct to fusion for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

Device Story

Coral Spinal System is a spinal fixation device consisting of rods, screws, and connectors; used for posterior pedicle, posterior non-pedicle, or anterolateral fixation. Components are rigidly locked together to stabilize the spine and promote fusion. Operated by surgeons in a clinical/OR setting. Output is mechanical stabilization of spinal segments. Benefits include correction of deformities and stabilization of diseased or injured spinal segments. This submission adds rod-to-rod and lateral rod connectors to the existing system.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and engineering analysis.

Technological Characteristics

Implant grade titanium alloy Ti 6Al-4V (ELI) per ASTM F-136 and ISO 5832-3. System consists of rods, screws, and connectors for rigid fixation. Mechanical assembly via locking mechanisms.

Indications for Use

Indicated for skeletally mature patients requiring non-cervical spinal fixation as an adjunct to fusion. Conditions include degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), spinal stenosis, deformities (scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, and 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

• Theken Surgical Coral™ Spinal System (K041592)
• Theken Surgical Coral™ Spinal System (K070962)

Submission Summary (Full Text)

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KC81414

Page 1 of 2

5/19/2008

## Theken Spine, LLC

Submitter's Name:

Submitter Information

A.

Coral Spinal System

## 510(k) Summary (21 CFR Part 807.92)

Theken Spine, LLC

21 CFR Part 807.92}

JUN 1 7 2008

| Address: | 1800 Triplett Blvd<br>Akron, Ohio 44306 |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone Number: | 330-475-8600 |
| Fax Number: | 330-773-7697 |
| Contact Person: | Dale Davison |
| Date Prepared: | 5/19/2008 |
| B. Device Information | |
| Trade Name: | Coral™ Spinal System |
| Common Name: | Pedicle Screw Spinal System |
| Classification: | MNI 888.3070 - Pedicle Screw Spinal System<br>MNH 888.3070 - Pedicle Screw Spinal System<br>KWQ 888.3060 - Spinal Intervertebral Body Fixation Orthosis<br>KWP 888.3050 - Spinal Interlaminal Fixation Orthosis<br>NKB 888.3070 - Spondylolisthesis Spinal Fixation System |
| Predicate Device: | Theken Surgical Coral™ Spinal System, K041592<br>Theken Surgical Coral™ Spinal System, K070962 |
| Device Description: | The purpose of this submission is to add rod to rod connectors and<br>lateral rod connectors to the Coral™ Spinal System. The Coral™<br>Spinal System components can be rigidly locked together in a<br>variety of configurations to promote fusion for a wide variety of<br>patient anatomies. |
| Intended Use: | The Coral™ Spinal System is a non-cervical spinal fixation device<br>intended for use as a posterior pedicle screw fixation system, a<br>posterior non-pedicle screw fixation system, or as an anterolateral<br>fixation system. Pedicle screw fixation is limited to skeletally<br>mature patients. The device is indicated as an adjunct to fusion for<br>the following indications: degenerative disc disease (defined as<br>discogenic back pain with degeneration of the disc confirmed by<br>history and radiographic studies), spondylolisthesis, trauma (i.e.,<br>fracture or dislocation), spinal stenosis, deformities or curvatures<br>(i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis,<br>and failed previous fusion. |
| Material Composition: | Implant grade titanium alloy Ti 6Al-4V (ELI) per ASTM F-136 |

and ISO 5832-3.

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K081414

# Coral Spinal System

5/19/2008

#### C. Substantial Equivalence

Theken Spine believes sufficient evidence exists to reasonably conclude that the additional components are substantially equivalent to the predicate devicc Coral™ Spinal System (K041592 SE 9/04 and K070962 SE 8/07), manufactured by Theken Spine, LLC. This is based on the design concept, the use of established, known materials, feature comparisons, mechanical testing, indications for use, pre-production quality assurance planning and engineering analysis. All implants are used to treat the same conditions, possess the same precautions and contraindications for use, and equivalent potential for complications for the risk of use.

The subject device similarities include:

- The same indications for use .
- The same operating principle ●
- . The same materials
- Implanted using the same surgical techniques and equipment type .
- The same manufacturing environment .
- The same sterilization process D
- The same packaging configurations

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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 eagle with three stripes forming its wing and tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 7 2008

Theken Spine, LLC % Mr. Dale Davison Vice President of Engincering 1800 Triplett Boulevard Akron, Ohio 44306

Re: K081414

Trade/Device Name: Coral™ Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system. Regulatory Class: III Product Code: NKB, KWP, KWO, MNI, MNH Dated: May 19, 2008 Received: May 20, 2008

Dear Mr. Davison:

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. Dale Davison

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 N. Wilkinson

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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K081414

Theken Spine, LLC

Coral Spinal System

Page 1 of 1

5/19/2008

# Indications for Use

510(k) Number (if known):

The Coral™ Spinal System is a non-cervical spinal fixation device intended for use as a posterior pedicle screw fixation system, a posterior non-pedicle screw fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients. The device is indicated as an adjunct to fusion for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

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

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nilre D. for mkm

Division of General, Restorative, and Neurological Devices

510(k) Number_