SCS CLARIS SPINAL SYSTEM,REXTENDED OMNIAXIAL CONNECTOR-,MEDIUM, MODEL CO05, SCS CLARIS SPINAL SYSTEM,EXTENDED OMNIAXIALO

K021919 · Ortho Tec, LLC · KWP · Jul 3, 2002 · Orthopedic

Device Facts

• Record ID: K021919
• Device Name: SCS CLARIS SPINAL SYSTEM,REXTENDED OMNIAXIAL CONNECTOR-,MEDIUM, MODEL CO05, SCS CLARIS SPINAL SYSTEM,EXTENDED OMNIAXIALO
• Applicant: Ortho Tec, LLC
• Product Code: KWP · Orthopedic
• Decision Date: Jul 3, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

When used as a nonpedicle posterior system, the SCS system is indicated for patients with: degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e., scoliosis, kyphosis, lordosis), tumors, failed previous fusion (pseudarthrosis). When used as an anterolateral/anterior system the SCS system is indicated for patients with: degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e., scoliosis, kyphosis, lordosis), tumors, failed previous fusion (pseudarthrosis) When used as a posterior pedicle system, the SCS system is indicated for use in skeletally mature patients L3 and below who are: having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint, receiving fusions using autogenous bone graft only, having the device fixed or attached to the lumbar and sacral spine, having the device removed after the development of a solid fusion mass. Screw fixation is limited to L3 and below. Posterior pedicle systems are 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: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, failed previous fusion (pseudarthrosis).

Device Story

SCS Claris Spinal System Extended OmniAxial Connectors are spinal hardware components used to connect rods and screws within the SCS Claris Spinal System. Available in medium and long sizes; manufactured from titanium alloy. Used by surgeons in clinical settings to provide immobilization and stabilization of spinal segments during fusion procedures. Device functions as a mechanical connector to maintain structural integrity of the spinal construct. Benefits include stabilization of acute/chronic spinal instabilities or deformities.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Titanium alloy (ASTM F136 / ISO 5832-3). Mechanical spinal connector. OmniAxial design. Medium and long form factors. Non-implantable software/electronics.

Indications for Use

Indicated for skeletally mature patients requiring spinal immobilization/stabilization as an adjunct to fusion. Conditions: degenerative disc disease, spondylolisthesis (including severe Grades 3-4 at L5-S1), fracture, spinal stenosis, deformities (scoliosis, kyphosis, lordosis), tumors, pseudarthrosis. Posterior pedicle use limited to L3 and below.

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

• SCS OmniAxial Connector (CO04)

Submission Summary (Full Text)

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## K021919 - -

# 510(k) SUMMARY of Safety and Effectiveness

page I of 1

| Sponsor: | OrthoTec, LLC<br>9595 Wilshire Blvd. Suite 502<br>Beverly Hills, CA 90212<br>Phone: [phone] & [phone]<br>Fax: [phone] |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact<br>Person: | Patrick Bertranou, MD |
| Proprietary<br>Trade Name: | SCS Claris Spinal System Extended OmniAxial Connectors (CO05 & CO07) |
| Device<br>Description: | The SCS Claris Extended OmniAxial Connectors are available in two sizes<br>(medium and long) and are used to connect the rods and screws of the SCS<br>Claris Spinal System. |
| Intended Use: | When used as a nonpedicle posterior system, the SCS system is indicated for<br>patients with: degenerative disk disease defined as back pain of discogenic<br>origin with degeneration of the disc confirmed by history and radiographic<br>studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e., scoliosis,<br>kyphosis, lordosis), tumors, failed previous fusion (pseudarthrosis).<br><br>When used as an anterolateral/anterior system the SCS system is indicated<br>for patients with: degenerative disk disease defined as back pain of discogenic<br>origin with degeneration of the disc confirmed by history and radiographic<br>studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e., scoliosis,<br>kyphosis, lordosis), tumors, failed previous fusion (pseudarthrosis)<br><br>When used as a posterior pedicle system, the SCS system is indicated for use<br>in skeletally mature patients L3 and below who are: having severe<br>spondylolisthesis (Grades 3 and 4) at the L5-S1 joint, receiving fusions using<br>autogenous bone graft only, having the device fixed or attached to the lumbar<br>and sacral spine, having the device removed after the development of a solid<br>fusion mass. Screw fixation is limited to L3 and below.<br><br>Posterior pedicle systems are intended to provide immobilization and<br>stabilization of spinal segments in skeletally mature patients as an adjunct<br>to fusion in the treatment of the following acute and chronic instabilities or<br>deformities of the thoracic, lumbar, and sacral spine: degenerative<br>spondylolisthesis with objective evidence of neurologic impairment, fracture,<br>dislocation, scoliosis, kyphosis, spinal tumor, failed previous fusion<br>(pseudarthrosis). |
| Materials: | The SCS Claris Spinal System Extended OmniAxial Connectors (CO05 &<br>CO07) are manufactured from titanium alloy (ASTM F136 / ISO 5832-3). |
| Substantial<br>Equivalence: | Documentation was provided which demonstrated the SCS Claris Extended<br>OmniAxial Connectors (CO05 & CO07) to be substantially equivalent to the<br>previously cleared SCS OmniAxial Connector (CO04). The substantial<br>equivalence is based upon equivalence in indications/intended use,<br>manufacturing methods, interconnection (attachment) mechanism, basic design<br>and materials. |

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol is a stylized representation of a caduceus, a staff with two snakes entwined around it, which is often associated with medicine and healthcare.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 3 2002

OrthoTec. LLC c/o Ms. Karen E. Warden, MEBE 8202 Sherman Road Chesterland, OH 44026-2141

Re: K021919

Trade/Device Name: SCS Claris Spinal System - Extended OmniAxial Connectors 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 II Product Code: KWP, KWQ, MNH, MNI Dated: May 29, 2002 Received: June 11, 2002

Dear Ms. Warden:

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 - Ms. Karen E. Warden

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of vour device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

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 Statement

#### 510(k) Number (if known): KO2 19 | 9

#### Device Name: SCS Claris Spinal System

Indications for Use:

#### When used as a nonpedicle posterior system, the SCS system is indicated for patients with:

degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies spondylolisthesis fracture spinal stenosis deformities (i.e., scoliosis, kyphosis, lordosis) tumors failed previous fusion (pseudarthrosis)

#### When used as an anterolateral/anterior system the SCS system is indicated for patients with:

degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies spondylolisthesis fracture spinal stenosis deformities (i.e., scoliosis, kyphosis, lordosis) tumors failed previous fusion (pseudarthrosis)

When used as a posterior pedicle system, the SCS system is indicated for use in skeletally mature patients who are:

having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 ioint

receiving fusions using autogenous bone graft only having the device fixed or attached to the lumbar and sacral soine having the device removed after the development of a

solid fusion mass. screw fixation is limited to L3 and below.

Posterior pedicle systems are 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:

degenerative spondylolisthesis with objective evidence of neurologic impairment fracture dislocation scoliosis kyphosis spinal tumor failed previous fusion (pseudarthrosis)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use >> (Per 21 CFR 801.109)

Over-the-Counter Use

Sty Ruda

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

OR

KOL 919 510(k) Number -