P.L.U.S. SYSTEM (PIVOT LINK UNIVERSAL SYSTEM)

K013312 · Spine Vision, Inc. · KWP · Feb 13, 2002 · Orthopedic

Device Facts

• Record ID: K013312
• Device Name: P.L.U.S. SYSTEM (PIVOT LINK UNIVERSAL SYSTEM)
• Applicant: Spine Vision, Inc.
• Product Code: KWP · Orthopedic
• Decision Date: Feb 13, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

When used as a posterior, non-pedicle system of the noncervical spine, the PLUS™ Pivot Link Universal System is indicated for: degenerative disc disease (discogenic back pain 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 (pseudoarthrosis) ● The PLUS Pivot Link Universal System is also a pedicle screw system indicated for skeletally mature patients who: have severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebra; . receive fusions using autogenous bone graft only; . have the device fixed or attached to the lumbar and sacral spine (L3 to sacrum); and ● have the device removed after the development of a solid fusion. . In addition, the PLUS Pivot Link Universal System is a pedicle screw system 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 (pseudoarthrosis) ●

Device Story

PLUS Pivot Link Universal System is a posterior spinal instrumentation set comprising hooks, screws, rods, and connectors. Designed for surgical implantation by physicians to treat spinal instabilities and deformities. Components are assembled into constructs tailored to specific spinal pathologies to provide immobilization and stabilization as an adjunct to fusion. System is intended for use in thoracic, lumbar, and sacral regions. Benefits include structural support for bone healing in patients with degenerative conditions, fractures, or tumors.

Clinical Evidence

No clinical data provided; substantial equivalence supported by mechanical bench testing.

Technological Characteristics

Spinal instrumentation system (hooks, screws, rods, connectors). Materials: Stainless steel per ASTM F138 and F1586. Mechanical fixation/stabilization principle. Non-active, mechanical device.

Indications for Use

Indicated for skeletally mature patients requiring spinal stabilization/immobilization for degenerative disc disease, spondylolisthesis (including severe L5-S1 grades 3-4), fractures, spinal stenosis, deformities (scoliosis, kyphosis, lordosis), tumors, dislocations, and pseudoarthrosis. Pedicle screw use restricted to L3-sacrum with autogenous bone graft and subsequent device removal.

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 Claris Spinal System (Orthotec, Inc.)
• CD Horizon (Sofamor Danek)

Submission Summary (Full Text)

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FEB 1 3 2002

K013312

Image /page/0/Picture/2 description: The image shows the logo for SpineVision. The logo consists of a stylized black icon above the company name. The icon is shaped like an inverted triangle with a curved top, resembling a stylized spine or a downward-pointing arrow. The text "SpineVision" is written in a bold, sans-serif font below the icon, with the "TM" symbol indicating a trademark.

Spine systems for specialists

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

| NAME OF FIRM: | SpineVision, Inc.<br>3003 Summit Blvd.<br>Suite 1500<br>Atlanta, GA 30319<br>Phone: [phone] |
|--------------------------------------|--------------------------------------------------------------------------------------------------|
| 510(K) CONTACT: | Lynnette Whitaker<br>Vice President, Regulatory Affairs<br>219-269-3701 |
| TRADE NAME: | PLUS™ Pivot Link Universal System |
| COMMON NAME: | Rod, Hook and Screw Spinal Instrumentation |
| CLASSIFICATION: | 888.3050 Spinal interlaminal fixation orthosis<br>888.3070 Pedicle Screw Spinal System |
| DEVICE PRODUCT CODE: | Product code: 87 KWP, MNH, MNI |
| SUBSTANTIALLY<br>EQUIVALENT DEVICES: | SCS Claris Spinal System, Orthotec, Inc.<br>CD Horizon, Sofamor Danek |

## DEVICE DESCRIPTION:

The PLUS Pivot Link Universal System spinal instrumentation consists of hooks, screws, rods and connectors that can be assembled in a variety of constructs. The instrumentation is combined and placed to treat a variety of spinal disorders, with the constructs varying according to the nature of the spinal pathology. The PLUS System components are available in stainless steel, manufactured according to ASTMs F138 and F1586.

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#### INDICATIONS FOR USE:

When used as a posterior, non-pedicle system of the noncervical spine, the PLUS™ Pivot Link Universal System is indicated for:

- degenerative disc disease (discogenic back pain 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 (pseudoarthrosis) ●

The PLUS Pivot Link Universal System is also a pedicle screw system indicated for skeletally mature patients who:

- have severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebra; .
- receive fusions using autogenous bone graft only; .
- have the device fixed or attached to the lumbar and sacral spine (L3 to sacrum); and ●
- have the device removed after the development of a solid fusion. .

In addition, the PLUS Pivot Link Universal System is a pedicle screw system 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 (pseudoarthrosis) ●

## BASIS OF SUBSTANTIAL EQUIVALENCE:

The components of the PLUS Piyot Link Universal System are similar in design, material, and indications to other spinal instrumentation systems that have been cleared by FDA for posterior spinal use. Mechanical testing was performed to demonstrate the equivalence of the construct design to currently marketed spinal systems.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three stripes representing the department's mission to promote the health and well-being of Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Lynnette Whitaker Vice President, Regulatory Affairs SpineVision, Inc. 3003 Summit Boulevard, Suite 1500 Atlanta, Georgia 30319

Re: K013312

Trade/Device Name: PLUSTM Pivot Link Universal System Regulation Numbers: 888.3050 and 888.3070 Regulation Names: Spinal Interlaminal Fixation Orthosis; Pedicle Screw Spinal System; and Spondylolisthesis Spinal Fixation Device System Regulatory Class: II Product Codes: KWP; MNI; and MNH Dated: January 17, 2002 Received: January 18, 2002

FEB 1 3 2002

Dear Ms. Whitaker:

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. Lynnette Whitaker

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 your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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,

Miriam C. Provost

for 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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## 510(k) Number (if known): K013312

#### PLUS™ Pivot Link Universal System Device Name:

#### Indications for Use:

When used as a posterior, non-pedicle system of the noncervical spine, the PLUS™ Pivot Link Universal System is indicated for:

- degenerative disc disease (discogenic back pain 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 (pseudoarthrosis) .

The PLUS Pivot Link Universal System is also a pedicle screw system indicated for skeletally mature patients who:

- have severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebra; .
- receive fusions using autogenous bone graft only; .
- have the device fixed or attached to the lumbar and sacral spine (L3 to sacrum); and .
- have the device removed after the development of a solid fusion. .

In addition, the PLUS Pivot Link Universal System is a pedicle screw system 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 the thoracic, lumbar, and sacral spine:

- Degenerative spondylolisthesis with objective evidence of neurologic impairment .
- fracture ●
- dislocation .
- . scoliosis
- kyphosis .
- spinal tumor ●
- failed previous fusion (pseudoarthrosis) �

#### Concurrence of CDRH, Office of Device Evaluation

Miriam C. Provost

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

**510(k) Number** *K*

Prescription Use

OR (Per 21 CFR 801.109) Over-The Counter Use