SCS CLARIS SPINAL SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL06

K021379 · Ortho Tec, LLC · MNI · May 31, 2002 · Orthopedic

Device Facts

• Record ID: K021379
• Device Name: SCS CLARIS SPINAL SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL06
• Applicant: Ortho Tec, LLC
• Product Code: MNI · Orthopedic
• Decision Date: May 31, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3070
• 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 Lengthened Lateral Connector (AL06) is a spinal implant component used to connect rods and screws within the SCS Claris Spinal System. Device provides immobilization and stabilization of spinal segments as an adjunct to fusion. Used in thoracic, lumbar, and sacral spine procedures. Operated by surgeons in clinical/OR settings. Output is mechanical stabilization of the spine; aids in treating acute/chronic instabilities or deformities. Benefits patient by facilitating fusion and correcting spinal alignment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manufactured from stainless steel (ASTM F136 / ISO 5832-1) and titanium alloy (ASTM F138 / ISO 5832-3). Mechanical spinal fixation component. No software or electronic components.

Indications for Use

Indicated for skeletally mature patients requiring spinal stabilization for degenerative disc disease, spondylolisthesis, fracture, spinal stenosis, deformities (scoliosis, kyphosis, lordosis), tumors, or pseudarthrosis. Posterior pedicle use limited to L3 and below for severe spondylolisthesis (Grades 3-4) at L5-S1, requiring autogenous bone graft and subsequent device removal.

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

• SCS Extremity Connector (AL02)

Submission Summary (Full Text)

{0}------------------------------------------------

# 510(k) SUMMARY of Safety and Effectiveness

| 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 Lengthened Lateral Connector (AL06) |
| Device<br>Description: | The SCS Claris Spinal Lengthened Lateral Connectors are available in one size<br>only and are used to connect the rods and screws of the SCS Claris Spinal<br>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 Lengthened Lateral Connector (AL06) is<br>manufactured from stainless steel (ASTM F136 / ISO 5832-1) and titanium alloy<br>(ASTM F138 / ISO 5832-3). |
| Substantial<br>Equivalence: | Documentation was provided which demonstrated the SCS Claris Lengthened<br>Lateral Connector (AL06) to be substantially equivalent to the previously<br>cleared SCS Extremity Connector (AL02). The substantial equivalence is based<br>upon equivalence in indications/intended use, manufacturing methods,<br>interconnection (attachment) mechanism, basic design and materials. |

Page 47

{1}------------------------------------------------

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAY 3 1 2002

OrthoTec. LLC c/o Ms. Karen Warden, MEBE 8202 Sherman Road Cleveland, Ohio 44026-2141

Re: K021379

Trade Name: SCS Claris Spinal System Lengthened Lateral Connector (AL06) Regulatory Number: 21 CFR 888.3070, 21 CFR 888.3050 and 21 CFR 888.3060 Regulatory Name: Pedicle screw spinal system, Spinal interlaminal fixation orthosis and Spinal intervertebral body fixation orthosis

Regulatory Class: II Product Code: MNI, MNH, KWP, KWQ Dated: April 26, 2002 Received: May 1, 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.

{2}------------------------------------------------

### Page 2 - Patrick Bertranou, M.D.

This letter will allow you to begin marketing your device as described in your Section 510(k) - rms reter with and it your finding of substantial equivalence of your device to a legally promation in a classification for your device and thus, permits 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 additionally 21 - 11 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 -Compliance at (201) 57 - 1 - 1 - 1 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation entral information on your responsibilities under the Act may be obtained from the O insi gonetar in in an 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,

Mark N Milham

Celia Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

## Indications for Use Statement

510(k) Number (if known): K (02 | 379

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, fordosis) 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 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)

(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)

OR
Over-the-Counter Use
Mark N Mellem
Division Sign-Off

ision of General. Restorative

510(k) Number

K021379

Confidential: OrthoTec - SCS Claris Lengthened Lateral Connector (AL06) Modification

Page 22