MODIFICATION TO ISOLA SPINAL SYSTEM

K993030 · Depuyacromed · KWQ · Dec 29, 1999 · Orthopedic

Device Facts

• Record ID: K993030
• Device Name: MODIFICATION TO ISOLA SPINAL SYSTEM
• Applicant: Depuyacromed
• Product Code: KWQ · Orthopedic
• Decision Date: Dec 29, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Posterior ISOLA Spinal System, when used with pedicle screws, is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis). Levels of fixation are for the thoracic, lumbar and sacral spine. The Posterior ISOLA Spinal System is also indicated for pedicle screw fixation for severe spondylolisthesis (Grades 3 and 4) at L5-S1, when autogenous bone graft is used, when affixed to the posterior lumosacral spine, and intended to be removed after solid fusion is attained. Levels of fixation are from L3-S1. The Posterior ISOLA Spine System, when not used with pedicle screws, is intended for hook, wire, and/or sacral/iliac screw fixation from T1 to the illium/sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis and kyphosis), tumor, fracture, and previous failed fusion surgery. The Anterior ISOLA Spine System is intended for use in correcting scoliotic, lordotic or kyphotic spinal deformities by establishing an axially and rotationally rigid fixation bridge parallel to the long axis of the spine. The system is indicated in situations where loss of correction is expected, where severe scoliosis exists or where pelvic obliquity is present. The Anterior ISOLA Spine System is used for the correction and stabilization of scoliotic curves, for the prevention or recurrence of undesired scoliotic curves, and for the stabilization of weakened trunks. Specific indications include: 1. Collapsing and unstable paralytic deformity 2. Progressively increasing scollosis. 3. Decreasing cardio-respiratory function, secondary to spinal or rib deformity or collapse. 4. Inability to maintain sitting balance, necessitating the use of the hands. 5. Increasing pelvic obliquity coincident with back pain or loss of sitting balance. 6. Spinal fractures (acute reduction or late deformity). 7. Degenerative Disc Disease (Defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). 8. Spinal tumor. 9. Previous failed fusion surgery. Spinal levels for Anterior ISOLA are from T5-L4.

Device Story

ISOLA Spinal System; spinal fixation hardware including pedicle screws, hooks, wires, and sacral/iliac screws. Used by surgeons in clinical/OR settings to stabilize spine; correct scoliotic, lordotic, or kyphotic deformities; and facilitate fusion. System creates rigid fixation bridge parallel to spine axis. Provides mechanical stabilization for weakened trunks or collapsing deformities. Benefits include improved spinal alignment, stabilization of fractures, and support for fusion. System components implanted surgically; pedicle screws for severe spondylolisthesis intended for removal after fusion.

Clinical Evidence

Bench testing only. Static and fatigue testing performed to demonstrate mechanical performance consistent with previously cleared spinal fixation systems.

Technological Characteristics

Materials: Stainless steel (ASTM F-138 or F-1314) or titanium alloy (ASTM F-136). Components: Pedicle screws, hooks, wires, sacral/iliac screws. Function: Mechanical spinal fixation/stabilization. Energy source: None (mechanical).

Indications for Use

Indicated for patients with degenerative disc disease, spondylolisthesis (including severe grades 3-4 at L5-S1), spinal deformities (scoliosis, lordosis, kyphosis), spinal tumors, fractures, dislocations, and failed previous fusion. Applicable to thoracic, lumbar, and sacral spine (Posterior) or T5-L4 (Anterior).

Regulatory Classification

Identification

A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.

Submission Summary (Full Text)

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K993030

## ISOLA SPINAL SYSTEM DEC 2 9 1999 Pedicle Screw Indications 510(k) SUMMARY

- SUBMITTER: DePuy AcroMed 325 Paramount Drive Raynham, MA 02767-0350
- CONTACT PERSON: William Christianson

September 29, 1999 DATE PREPARED:

## Spinal Interlaminal Fixation Orthosis CLASSIFICATION NAME: Pedicle Screw Spinal System

Spinal Fixation System COMMON NAME:

PROPRIETARY NAME: ISOLA Spinal System

The primary purpose of this premarket notification is to DESCRIPTION: add indications to the marketing clearance for the pedicle screws which may be used as a spinal anchor in the ISOLA Spinal System

- The Posterior ISOLA Spinal System, when used with INTENDED USE: pedicle screws, is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis). Levels of fixation are for the thoracic, lumbar and sacral spine.
The Posterior ISOLA Spinal System is also indicated for pedicle screw fixation for severe spondylolisthesis (Grades 3 and 4) at L5-S1, when autogenous bone graft is used, when affixed to the posterior lumosacral spine, and intended to be removed after solid fusion is attained. Levels of fixation are from L3-S1.

The Posterior ISOLA Spine System, when not used with pedicle screws, is intended for hook, wire, and/or sacral/iliac screw fixation from T1 to the illium/sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis and kyphosis), tumor, fracture, and previous failed fusion surgery.

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PACE 2 OF 2

The Anterior ISOLA Spine System is intended for use in correcting scoliotic, lordotic or kyphotic spinal deformities by establishing an axially and rotationally rigid fixation bridge parallel to the long axis of the spine. The system is indicated in situations where loss of correction is expected, where severe scoliosis exists or where pelvic obliquity is present.

The Anterior ISOLA Spine System is used for the correction and stabilization of scoliotic curves, for the prevention or recurrence of undesired scoliotic curves, and for the stabilization of weakened trunks. Specific indications include:

- 1. Collapsing and unstable paralytic deformity
- 2. Progressively increasing scollosis.
- Decreasing cardio-respiratory function, secondary to 3. spinal or rib deformity or collapse.
- Inability to maintain sitting balance, necessitating the 4. use of the hands.
- Increasing pelvic obliquity coincident with back pain or 5. loss of sitting balance.
- Spinal fractures (acute reduction or late deformity). 6.
- Degenerative Disc Disease (Defined as discogenic 7. back pain with degeneration of the disc confirmed by history and radiographic studies).
- Spinal tumor. 8.
- 9. Previous failed fusion surgery.

Spinal levels for Anterior ISOLA are from T5-L4.

MATERIALS: The ISOLA Spine System is manufactured from either stainless steel conforming to ASTM F-138 or F-1314 specifications, or titanium alloy conforming to ASTM F-136 specifications.

PERFORMANCE DATA:

Static and fatigue testing show the constructs of the ISOLA Spinal System to perform consistently with previously cleared components.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing right and is enclosed in a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 9 1999

Ms. Karen F. Jurczak Regulatory Affairs Associate 325 Paramount Drive Raynham, Massachusetts 02767-0350

Re: K993030 Trade Name: ISOLA Spinal System Regulatory Class: II, III Product Code: KWO. KWP. MNH and MNI Dated: September 30, 1999 Received: October 1, 1999

Dear Ms. Jurczak:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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.

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Page 2 - Ms. Karen F. Jurczak

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Thos. C. Lyon

Sar James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## II.

510(k) Number (if known): K993030

ISOLA Spinal System Device Name:

Indications For Use:

The Posterior ISOLA Spinal System, when used with pedicle screws, is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis). Levels of fixation are for the thoracic. lumbar and sacral spine.

The Posterior ISOLA Spinal System is also indicated for pedicle screw fixation for severe spondylolisthesis (Grades 3 and 4) at L5-S1, when autogenous bone graft is used, when affixed to the posterior lumosacral spine, and intended to be removed after solid fusion is attained. Levels of fixation are from L3-S1.

The Posterior ISOLA Spine System, when not used with pedicle screws, is intended for hook, wire, and/or sacral/iliac screw fixation from T1 to the ilium/sacrum. The nonpedicle screw indications are spondylolisthesis, degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis and kyphosis), tumor, fracture, and previous failed fusion surgery.

The Anterior ISOLA Spine System is intended for use in correcting scolictic, lordotic or kyphotic spinal deformities by establishing an axially and rotationally rigid fixation bridge parallel to the long axis of the system is indicated in situations where loss of correction is expected, where severe scoliosis exists or where pelvic obliquity is present.

The Anterior ISOLA Spine System is used for the correction and stabilization of scoliotic curves, for the prevention or recurrence of undesired scoliotic curves, and for the stabilization of weakened trunks. Specific indications include:

- 1. Collapsing and unstable paralytic deformity
- 2. Progressively increasing scollosis.
- 3. Decreasing cardio-respiratory function, secondary to spinal or rib deformity or collapse.
- 4. Inability to maintain sitting balance, necessitating the use of the hands.
- 5. Increasing pelvic obliquity coincident with back pain or loss of sitting balance.
- 6. Spinal fractures (acute reduction or late deformity).
- 7. Degenerative Disc Disease (Defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies).
- 8. Spinal turnor.
- 9. Previous failed fusion surgery.

Spinal levels for Anterior ISOLA are from T5-L4.

Russell L. Rogers Jr.

**Prescription Use**
**(Per 21 CFR 801.109)**