CORAL SPINAL SYSTEM

K041592 · Theken Surgical · KWP · Sep 16, 2004 · Orthopedic

Device Facts

• Record ID: K041592
• Device Name: CORAL SPINAL SYSTEM
• Applicant: Theken Surgical
• Product Code: KWP · Orthopedic
• Decision Date: Sep 16, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Coral(tm) 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 for all of the following indications regardless of the intended use: 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; non-cervical spinal fixation hardware; includes screws, rods, hooks, cross-connectors. Components assembled into rigid constructs to promote spinal fusion. Used in posterior pedicle, posterior non-pedicle, or anterolateral approaches. Operated by surgeons in clinical/OR settings. Provides mechanical stabilization of spinal segments. Benefits patients by correcting deformities or stabilizing unstable spinal segments due to trauma or degenerative disease.

Clinical Evidence

Bench testing only; mechanical testing conducted per ASTM F-1717 to demonstrate substantial equivalence.

Technological Characteristics

Materials: Medical grade titanium alloy (ASTM F67, ASTM F136, ISO 5832-3, ISO 5832-2) or medical grade stainless steel (ASTM F138, ISO 5832-1, ISO 5832-9). System consists of screws, rods, hooks, and cross-connectors. Components are rigidly locked to form a construct. Dissimilar metals must not be used in combination.

Indications for Use

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

Regulatory Classification

Identification

A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.

Predicate Devices

• Sofamor Danek Colorado II Spinal System (K991031)
• DePuy-Motech Moss Miami Spinal System (K955348)

Submission Summary (Full Text)

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K041592 Page 1 of 1

## 510(k) Summary

.

| Submitter: | Theken Surgical<br>283 E. Waterloo Rd.<br>Akron, Ohio 44319 | SEP 16 2004 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact Person: | Randy Theken<br>Manager, Theken Surgical | |
| Trade Name: | Coral™ Spinal System | |
| Common Name: | Screw/Rod spinal instrumentation | |
| Classification: | KWP 888.3050 - Spinal Interlaminal Fixation Orthosis<br>MNI 888.3070 - Pedicle Screw Spinal System<br>MNH 888.3070 - Spondylolisthesis Spinal Fixation System<br>KWQ 888.3060 - Spinal Intervertebral Body Fixation Orthosis<br>NKB 888.3060 - Spondylolisthesis Spinal Fixation System | |
| Predicate Device: | Sofamor Danek Colorado II Spinal System, K991031 (et al)<br>DePuy-Motech Moss Miami Spinal System, K955348 (et al) | |
| Device Description: | The Coral™ Spinal System consists of a variety of shapes and sizes of<br>screws, rods, hooks, cross-connectors, and connecting components.<br>Coral™ Spinal System components can be rigidly locked creating a<br>rigid construct for promoting fusion. Coral™ Spinal System implant<br>components are fabricated from medical grade titanium alloy described<br>by such standards as ASTM F67, ASTM F136, ISO 5832-3, and ISO<br>5832-2. Alternatively, the entire system may be made out of medical<br>grade stainless steel described by such standards as ASTM F138, ISO<br>5832-1, and ISO 5832-9. Caution use of dissimilar metals, i.e.<br>stainless steel and titanium must not be used in combination, but<br>must be used independently. | |
| Intended Use: | The Coral(tm) 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 mature<br>patients. The device is indicated for all of the following indications<br>regardless of the intended use: 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 (i.e.,<br>scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed<br>previous fusion. | |
| Substantial Equivalence: | The Theken Surgical Coral™ Spinal System is substantially equivalent<br>to other legally marketed devises. Mechanical testing data under<br>ASTM F-1717 was provided or referenced to demonstrate substantial equivalence. | |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure with three flowing lines representing the body and head.

SEP 16 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Randy R. Theken President Theken Surgical 283 East Waterloo Road Akron, Ohio 44319

Re: K041592

Trade/Device Name: Coral™ Spinal System Regulation Number: 21 CFR 888.3050, 888.3060, 888.3070 Regulation Name: Spinal interlaminal fixation orthosis; spinal intervertebral body fixation orthosis; pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, KWQ, KWP, MNH, MNI Dated: June 7, 2004 Received: June 14, 2004

Dear Mr. Theken:

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 r hat 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 - Mr. Randy Theken

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 100-1050.
product radiation control provisions (Sections 531-542 of the Actil; in were Sections product radiation control provisions (Dections 991 - 12 view as described in your Section 510(k)
This letter will allow you to begin marketing your device to leggion of secti I his letter will anow you to begin manxeanty of substantial equivalence of your device to a legally prematication. The PDA muling of backland of 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 If you desire specific advice for your ac 110 % 4649. Also, please note the regulation entitled, contact the Office of Compliance at [phone] Part 807.97). You may obtain Misoralianing by Icrerchee to premainters in the Act from the Division of Small other general intormation on your response Assistance at its toll-free number [phone] or Manufacturers, International and Consumer institutions www.fda.gov/cdrh/dsmarmain.html

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. 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):____K041592

Coral™ Spinal System Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The Coral™ Spinal System is a non-cervical spinal fixation device intended for use as a The Coral™ Spinal System is a not-cervical spinal nation edicle screw fixation system,
posterior pedicle screw fixation system, a posterior non-pedicle screw fixation system, posterior pedicle screw fixation system. Pedicle screw fixation is limited to skeletally
or as an anterolateral fixation system. Pedicle screw fixations regardless of or as an anterolateral lixation system. "I cullowing indications regardless of
mature patients. The device is indicated for all of the following including in mature patients. The device is included for and of the last pain with degeneration of the disc confirmed by history and radiographic studies),
degeneration of the disc confirmed by history aninol stoposis deformities or spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or spondylolisthesis, traditia (f.e., fracture of disistance), of the sources and failed previous fusion.

X_____________________________________________________________________________________________________________________________________________________________________________ Prescription Use __ (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Miriam C. Provost

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

510(k) Number_________________________________________________________________________________________________________________________________________________________________