ASCEND SPINAL FIXATION SYSTEM WITH THE SHADOW SPINAL SYSTEM

K013196 · Spinal Innovations, LLC · KWP · Jan 30, 2002 · Orthopedic

Device Facts

• Record ID: K013196
• Device Name: ASCEND SPINAL FIXATION SYSTEM WITH THE SHADOW SPINAL SYSTEM
• Applicant: Spinal Innovations, LLC
• Product Code: KWP · Orthopedic
• Decision Date: Jan 30, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Spinal Innovations Ascend™ Spinal Fixation System with the Shadow™ Spinal System, when used as a pedicle screw fixation system, is indicated for use in patients: a) having severe spondylolisthesis (Grade 3 and 4) at the L5-S1 joint; b) who are receiving fusion using autogenous graft only; c) who are having the device fixed or attached to the lumbar or sacral spine; and d) who are having the device removed after the development of a solid fusion mass. When used for this indication, the fusion mass may not go above the L5-S1 joint, the levels of pedicle screw fixation may span from L3 to the sacrum. The Spinal Innovations Ascend™ Spinal Fixation System with the Shadow™ Spinal 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 neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). When used as a hook and sacral screw system (other than pedicle screw fixation system for high grade spondylolisthesis), the Spinal Innovations Ascend™ Spinal Fixation System with the Shadow™ Spinal System is intended for use in the treatment of degenerative disc disease (as defined by chronic back pain of discogenic origin with the degeneration of the disc confirmed by a history and radiographic studies), idiopathic scoliosis, spondylolisthesis, kyphotic or lordotic deformity of the spine, loss of stability due to tumors, spinal stenosis, vertebral fracture or dislocation, pseudoarthrosis, and previous failed spinal surgery/fusion. When used for this indication, screws of the Spinal Innovations Ascend™ Spinal Fixation System with the Shadow™ Spinal System are intended for sacral/iliac attachment only. Hooks of the system are intended for posterior thoracic and/or lumbar use only. The levels of use for hook and sacral screw fixation of this system are T1 to the sacrum.

Device Story

Temporary posterior spinal implant system; provides immobilization/stabilization to facilitate biological spinal fusion. Components: fixed/polyaxial screws, hooks, rods, locking nuts. Surgeon-implanted in thoracic, lumbar, and sacral spine. System components connected to rods to stabilize spinal segments; intended for removal after solid fusion. Benefits: correction of spinal deformity, stabilization of unstable segments. Mechanical performance validated via bench testing; equivalent to predicate systems.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included corpectomy model (ASTM F 1717-96) for static/fatigue compression bending and torsion, and interconnection testing (ASTM F 1798-97) for axial/torsional gripping capacity and polyaxial screw flexion/extension.

Technological Characteristics

Spinal fixation system consisting of hooks, rods, and fixed/polyaxial screws with locking nuts. Materials and design are substantially equivalent to the Ascend™ system. Mechanical testing performed per ASTM F 1717-96 and ASTM F 1798-97.

Indications for Use

Indicated for skeletally mature patients requiring spinal stabilization/immobilization as an adjunct to fusion. Conditions: severe spondylolisthesis (Grade 3-4), degenerative spondylolisthesis with neurological impairment, degenerative disc disease, idiopathic scoliosis, kyphosis, lordosis, spinal tumors, spinal stenosis, vertebral fracture/dislocation, pseudarthrosis, and failed previous fusion. Levels: T1 to sacrum (hooks/sacral screws); L3 to sacrum (pedicle screws).

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

• Sulzer Spine-Tech Silhouette™ Spinal System

Submission Summary (Full Text)

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K013)96

# 510 (K) Summary of Safety and Effectiveness

JAN 3 0 2002

Company Name:

510(k) Contact:

Trade Name:

Common Name:

Classification:

. . . . .

Spinal Innovations, Inc. 7850 Stage Hills Blvd. Suite 105 Bartlett, TN 38133 [phone] [phone] fax

Marc Richelsoph President and CEO [phone]

Spinal Innovations Ascend™ Spinal Fixation System with the Shadow™ Spinal System

Hook, Rod and Screw Spinal Fixation System

888.3050 Spinal Interlaminal Fixation Orthosis - class II 888.3070 Spondylolisthesis Spinal Fixation Device System - class II 888.3070 Pedicle Screw Spinal System - class II

87 KWP. MNH and MNI

Spinal Innovations Ascend™ Spinal Fixation System Sulzer Spine-Tech Silhouette™ Spinal System

Predicate Devices:

Device Product Code:

#### Device Description

The Spinal Innovations Ascend™ Spinal Fixation System with the Shadow™ Spinal System is a temporary implant system used to correct spinal deformity and facilitate the biological process of spinal fusion. This system is intended for posterior use in the thoracic. Iumbar and sacral areas of the spine. Implants of this system consist of hooks and/or screws connected to rods and are intended to be removed after solid fusion has occurred. This system includes fixed and polyaxial screws of varying diameters and

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013196 page 2 of 3

lengths, and hooks in varying designs in varying designs and lengths. The Shadow™ components are product line additions to complement the Ascend™ system components.

#### Intended Use

The Spinal Innovations Ascend™ Spinal Fixation System with the Shadow™ Spinal System, when used as a pedicle screw fixation system, is indicated for use in patients: a) having severe spondylolisthesis (Grade 3 and 4) at the L5-S1 joint; b) who are receiving fusion using autogenous graft only; c) who are having the device fixed or attached to the lumbar or sacral spine; and d) who are having the device removed after the development of a solid fusion mass. When used for this indication, the fusion mass may not go above the L5-S1 joint, the levels of pedicle screw fixation may span from L3 to the sacrum.

The Spinal Innovations Ascend™ Spinal Fixation System with the Shadow™ Spinal 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 neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

When used as a hook and sacral screw system (other than pedicle screw fixation system for high grade spondylolisthesis), the Spinal Innovations Ascend™ Spinal Fixation System with the Shadow™ Spinal System is intended for use in the treatment of degenerative disc disease (as defined by chronic back pain of discogenic origin with the degeneration of the disc confirmed by a history and radiographic studies), idiopathic scoliosis, spondylolisthesis, kyphotic or lordotic deformity of the spine, loss of stability due to tumors, spinal stenosis, vertebral fracture or dislocation, pseudoarthrosis, and previous failed spinal surgery/fusion. When used for this indication, screws of the Spinal Innovations Ascend™ Spinal Fixation System with the Shadow™ Spinal System are intended for sacral/iliac attachment only. Hooks of the system are intended for posterior thoracic and/or lumbar use only. The levels of use for hook and sacral screw fixation of this system are T1 to the sacrum.

## Technological Characteristics

The Spinal Innovations Ascend™ Spinal Fixation System with the Shadow™ Spinal System adds a locking nut to the Ascend™ screw and hook implants. This is substantially equivalent to the locking nut on other predicate devices. The remaining technological characteristics are substantially the same as Ascend™.

## Testing

Biomechanical testing demonstrated that the components of the Spinal Innovations Ascend™ Spinal Fixation System with the Shadow™ Spinal System exhibit equivalent mechanical performance compared to predicate devices. Testing included the following:

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K01396 page 3 of 3

- 1) Corpectomy model testing per ASTM F 1717-96 Standard Test Methods for Static and Fatigue for Spinal Products in a Corpectomy Model. This included static compression bending, static torsion, and compression bending fatigue.
- 2) Interconnection testing of individual system components per ASTM F 1798-97. The tests included axial gripping capacity of hooks, screws, and rod-to-rod connectors, torsional gripping capacity, and polyaxial screw flexion/extension static and fatigue testing.

Testing results of the various system components show that the data compares directly to predicate device testing and meets or exceeds other predicate devices. Therefore, the produce de results sessing Spinal Fixation System with the Shadow™ Spinal System is substantially equivalent to the predicate devices.

#### Basis for Substantial Equivalence

The Spinal Innovations Ascend™ Spinal Fixation System with the Shadow™ Spinal System is substantially equivalent in material, design and function to the predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Marc Richelsoph President and Chief Executive Officer Spinal Innovations, Inc. 7850 Stage Hills Boulevard -- Suite 105 Bartlett, Tennessee 38133

JAN 3 0 2002

Re: K013196

. K013170
Trade/Device Name: Ascend™ Spinal System with the Shadow™ Spinal System Regulation Number: 21 CFR §888.3050; §888.3070 Regulation Name: Spinal interlaminal fixation orthosis; pedicle screw spinal system Regulatory Class: Class II Product Code: KWP; MNH; MNI Dated: December 20, 20001 Received: December 21, 2001

Dear Mr. Richelsoph:

We have reviewed your Section 510(k) premarket notification of intent to market the we have revious your socures is secternined the device is substantially equivalent (for device referenced above and have enclosure) to legally marketed predicate devices the indications for abo bannerce prior to May 28, 1976, the enactment date of the marketed in micolate ochinnts, 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 with the provisions of the Featur Polication (PMA). You may, therefore, market the approval of a promation apple of an of provisions of the Act. The general controls device, subject to the general connivements for annual registration, listing of devices, provisions of the review 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 (1 hill the your device can be found in the Code of Federal Regulations, Title 21, Parts' affecting your de 100 v. 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 I loase or advised and I made a determination that your device complies with other not incurrents 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 r cart agencies: 'tion 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.

Image /page/3/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

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Page 2 - Mr. Marc Richelsoph

This letter will allow you to begin marketing your device as described in your Section 1 his letter will anow you to begill inding of substantial equivalence of your 510(K) premiarket nouticated. The FBA intensig 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 If you desire specific advice for your acviro of car car car assessed on
and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact on and additionally 21 CFN Fart 60710 101 in Additionally, for questions on the promotion Office of Compliance at [phone] - 14cms of Compliance at (301) 594-1
and advertising of your device, please contact the Office of Compliance of Compliance to promost 4639. Also, please note the regulation entitled, (Misbranding by reference openitive) 4639. Also, please note the regulation on the reneral information on your responsibilities notification((21CFK Part 607.97): Other givision of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or (301) 443

6597 or at its Internet address

0577 of ut its http://www.fda.gov/cdrh/dsma/dsmamain.html http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

Cor 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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405

## 510(K) Number

Device Name: Spinal Innovations Ascend™ Spinal Fixation System with the Shadow™ Spinal System.

kol3196

Indications for Use:

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spine; and d) who are having the device removed after the S. Ligint, the lawels of spine; and (i) who are having the device rems. For assement as a ove the LS-S1 joint, the levels of pedicle screw fixation may span from L3 to the sacrum.

The Spinal Innovations Ascend™ Spinal Fixation System with the Shadow™ Spinal System is a I he Spinal Innovations Ascella - Optim Frances of Stabilization of spinal segments in pedicle serew system miched to provit to fusion in the treatment of the following acute and Skelclary mature patients as an acjanthe thoracic, lumbar, and sacral spine: degenerative cillume instabilities of deformines of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

When used as a hook and sacral screw system (other than pedicle screw fixation system for high While used as a nook and sacra. Below of ations Ascend™ Spinal Fixation System with the grade spondyionsthesis), and Spinal Imm . In the treatment of degenerative disc disease (as Shadow - Spinal System is mended to: acc rice rice rice rigin with the degeneration of the disc confirmed by a history and radiographic studies), idiopathic scoliosis, spondylolisthesis, kyphotic or lordotic a ifistory and radiographic station, for openato tumors, spinal stenosis, vertebral fracture or uctormity of the spine, ross of backers jous failed spinal surgery/fusion. When used for this indication, screws of the Spinal Innovations Ascend™ Spinal Fixation System are intended for indication, Screws of the Opinal Innoval Innsverse connectors of the system are intended for sacrabinat anatinnent only. I 100ks and a and relect of use for hook and sacral screw fixation of this system are T1 to the sacrum.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X
(per 21 CFR 801.109) OR Over-The-Counter Use *_*_

(Optional Format 1-2-96)

(Division Sign-Off)
Division of General Restoratio

Division of General. Restorative and Neurological Devices

510(k) Number_