KANEDA ANTERIOR SCOLIOSIS SYSTEM KASS

K974757 · Acromed Corp. · KWQ · Mar 5, 1998 · Orthopedic

Device Facts

• Record ID: K974757
• Device Name: KANEDA ANTERIOR SCOLIOSIS SYSTEM KASS
• Applicant: Acromed Corp.
• Product Code: KWQ · Orthopedic
• Decision Date: Mar 5, 1998
• Decision: SN
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Kaneda Anterior Spinal System is intended for use in: 1. Idiopathic scoliosis. 2. Degenerative Disc Disease defined as discogenic back pain Degeneration of the disc confirmed by history and radiographic studies. 3. Scoliosis with deficient posterior elements such as that resulting from laminectomy or myelomeningocele. 4. Neuromuscular scoliosis/kyphoscoliosis 5. Spinal fractures (acute reduction or l'ate deformity). 6. Revision surgery. 7. Tumor. In addition, the Kaneda Anterior Scoliosis System can also be used In addition, the is and stabilization of scoliotic curves, for the prevention or recurrence of undesired scoliotic curves, and for the prevention of weakened trunks. Indications for these scoliotic uses include: 1. Collapsing and unstable paralytic deformity. 2. Progressively increasing scoliosis. 2. Decreasing cardio-respiratory function, secondary to spinal or rib deformity or collapse. 4. Inability to maintain sitting balance, necessitating the use of hands. 5. Increasing pelvic obliquity coincident with back pain or loss of sitting balance. The intended levels for treatment with the Kaneda Anterior Spinal System, are T4 to L4. The Kaneda Anterior Spinal System is intended to treat one motion segment per section with System is mended to nessunt. The Kaneda Anterior Scoliosis multiple scettors por conned to accommodate a left or right anterior approach.

Device Story

Kaneda Anterior Scoliosis System (KASS) is a spinal intervertebral body fixation orthosis; used for anterior spinal stabilization. System components include stainless steel spinal staples (single/two-hole), 6.25mm diameter spinal screws (blunt tip for bi-cortical purchase), and 3/16 inch diameter spinal rods. Staples feature tetraspikes for fixation and etchings for correct anatomical alignment. Screws are available in open (with removable cap) and closed designs; rods are secured via set screws. Device is implanted by surgeons during anterior spinal procedures. System provides mechanical stabilization of the vertebral column to correct deformities, prevent curve progression, and support weakened trunks. Benefits include improved spinal alignment, restoration of sitting balance, and stabilization of fractures or tumors. Not for pedicular screw fixation.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by non-clinical mechanical characterization, including static compressive bending, static torsion, and compressive bending fatigue testing.

Technological Characteristics

Construct consists of ASTM F-138 stainless steel spinal staples, 6.25mm diameter screws, and 3/16 inch (4.75mm) diameter spinal rods. Staples feature tetraspikes and anatomical contouring. Screws include blunt-tip designs for bi-cortical purchase and set-screw locking mechanisms. System is designed for anterior approach, T4-L4 levels. Mechanical fixation via screw-rod-staple construct.

Indications for Use

Indicated for patients with idiopathic scoliosis, degenerative disc disease, scoliosis with deficient posterior elements, neuromuscular scoliosis/kyphoscoliosis, spinal fractures, revision surgery, or tumor. Also indicated for correction/stabilization of scoliotic curves, prevention of curve recurrence, and stabilization of weakened trunks in patients with collapsing/unstable paralytic deformity, progressive scoliosis, decreased cardio-respiratory function, loss of sitting balance, or pelvic obliquity. Intended for T4-L4 levels.

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.

Predicate Devices

• Kaneda SR Anterior Spinal System

Submission Summary (Full Text)

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K974757 pg 1 of 3

# KANEDA ANTERIOR SPINAL SYSTEM

510(k) Summary

MAR - 5 1998

COMPANY:

| AcroMed Corporation |
|-----------------------|
| 3303 Carnegie Avenue |
| Cleveland, Ohio 44115 |

Kaneda Anterior Spinal System (KASS)

CLASSIFICATION:

Spinal Intervertebral body fixation orthosis. Class II

DESCRIPTION:

TRADE NAME:

The Kaneda Anterior Scoliosis System is a construct that consists of two spinal staples, KASS blunt tip open and closed screws, standard Isola open and closed screws and 3/16 inch diameter Isola spinal rods.

KASS Spinal Staple:

The KASS spinal staple is made from ASTM F-138 implant grade stainless steel. The KASS spinal staple is available in a single or two-hole design.

The single hole KASS spinal staple is intended to be utilized in the thoracic spine, specifically when the anatomy of the spine restricts the use of a two-holed spinal staple. The single hole KASS spinal staple contains a centered single machined hole designed to accommodate a 6.25mm open or closed screw. The single hole KASS spinal staple is contoured in two planes. This design provides a more suitable fit when utilized in the thoracic spine. The single hole KASS spinal staple is available in one size.

The two-hole KASS spinal staple contains two machined holes placed diagonally across from one another. Both holes are designed to accommodate a 6.25mm open or closed screw. The two-hole KASS spinal staple is contoured in one plane which compliments the vertebral anatomy. The two-hole KASS spinal staple is etched with a ";" or "@" indicating the correct alignment of the spinal staples within a construct. In addition, a directional arrow (->) with the word "APEX" is etched on the twoholed KASS spinal staple. These etchings aid in the correct positioning of the two-hole spinal staple to ensure that the shortest spinal rod is posteriorly positioned in the construct. The two-hole KASS spinal staple is available in small, medium and large sizes.

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K974757 pg2 of 3

Both the single and two-holed spinal staple are etched with an "A" for anterior placement and a "P" for posterior placement to the vertebral anatomy. All spinal staples are designed with four tetraspikes on the underneath side of the staple.

## Spinal Screws:

The KASS and Isola standard screws are made from ASTM F-138 implant grade stainless steel. The KASS and Isola standard screws have a cancellous diameter of 6.25mm and connect to a 3/16 (4.75mm) diameter Isola spinal rod. The spinal screws are available in two designs. A standard Isola open and closed design and a KASS open and closed screw containing a blunt tip at the end of the cancellous portion of the screw. The KASS screw is intended for bi-cortical purchase of the vertebral body.

The closed KASS and standard Isola screws are designed to thread the spinal rod through the closed screw head. The open KASS and standard Isola screws are designed with a removable cap which allows the rod to be placed into the open screw head. The cap is re-applied to the head of the open screw capturing the spinal rod. Both the open and closed design KASS and standard Isola screws utilize a Isola set screw that tightens the spinal rod into the KASS screw.

The 6.25mm diameter KASS open and closed screws are available in twelve lengths which range from 25mm to 60mm in varying millimeter increments. The 6.25mm diameter standard Isola open and closed KASS screws are available in eleven lengths which range from 20mm to 70mm in 5 millimeter increments.

### Spinal Rod:

The Isola spinal rod is made from ASTM F-138 implant grade stainless steel. The spinal rod is 3/16 inch (4.75mm) diameter and has a smooth surface. The spinal rod is cut to the required length needed for the KASS construct. The spinal rod is available in a 18 and 24mm length.

## PERFORMANCE DATA:

Non-Clinical:

Mechanical characterization of the 3/16 inch Kaneda Anterior Scoliosis System is tested for the following mechanical testing modes:

Static compressive bending

Static torsion

Compressive Bending Fatigue

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K974757 pg. 3 of 3

## INTENDED USE:

The Kaneda Anterior Spinal System is intended for use in:

- 1. Idiopathic scoliosis.
- 2. Degenerative Disc Disease defined as discogenic back pain Degeneration of the disc confirmed by history and radiographic studies.
- 3. Scoliosis with deficient posterior elements such as that resulting from laminectomy or myelomeningocele.
- 4. Neuromuscular scoliosis/kyphoscoliosis
- 5. Spinal fractures (acute reduction or l'ate deformity).
- 6. Revision surgery.
- 7. Tumor.

In addition, the Kaneda Anterior Scoliosis System can also be used In addition, the is and stabilization of scoliotic curves, for the prevention or recurrence of undesired scoliotic curves, and for the prevention of weakened trunks. Indications for these scoliotic uses include:

- 1. Collapsing and unstable paralytic deformity.
- 2. Progressively increasing scoliosis.
- 2. Decreasing cardio-respiratory function, secondary to spinal or rib deformity or collapse.
- 4. Inability to maintain sitting balance, necessitating the use of hands.
- 5. Increasing pelvic obliquity coincident with back pain or loss of sitting balance.

The intended levels for treatment with the Kaneda Anterior Scoliosis System, are T4 to L4. The Kaneda Anterior Scoliosis System is intended to treat one motion segment per section with System is mended to nessunt. The Kaneda Anterior Scoliosis multiple scettors por conned to accommodate a left or right anterior approach.

## SUBSTANTIAL EQUIVALENCY:

Kaneda SR Anterior Spinal System

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 5 1999

Mr. Gregory D. Cannedy Regulatory Affairs AcroMed® Corporation 3303 Carnegie Avenue Cleveland, Ohio 44115

Re : K974757 Kaneda Anterior Scoliosis System (KASS) Regulatory Class: II Product Code: KWQ Dated: December 18, 1997 Received: December 19, 1997

### Dear Mr. Cannedy:

We have reviewed your Section 510(k) notification of intent to market the device system referenced above and we have determined the device system is substantially equivalent (for the indications for use stated in the enclosure) to device systems marketed in interstate commerce prior to May 28, 1976 or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act You may, therefore, market your device system subject (Act) . . to the general controls provisions of the Act and the limitations identified below.

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. Note that labeling or otherwise promoting this device system for pedicular screw fixation/attachment would cause the device system to be adulterated under 501(f) (1) of the Act.

FDA identifies that any device system, if intended for use in pedicular screw fixation/attachment, except for some limited indications, would be found not substantially equivalent and would be a class III device under Section 513 (f) of the Act. Class III devices are required to have an approved premarket approval (PMA) application prior to marketing. Accordingly:

- You may not label or in any way promote this device 1. system for pedicular screw attachment to, or fixation of the cervical, thoracic or lumbar vertebral column. Therefore, in order to prevent off-label promotion, the

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package insert must include the following statement, This device system is not approved for screw "WARNING: attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.";

- All labeling for this device system, including the 2. package label, must state that there are labeling limitations. The package insert must prominently state that the device system is intended for the specific use(s) described in the enclosure only; and
- Pedicular screw fixation/attachment to the cervical, 3. thoracic or lumbar vertebral column, except for limited indications, of any device system is considered investigational and may only be investigated as a siqnificant risk device in accordance with the investigational device exemption (IDE) regulations under All users of the device system for 21 CFR, Part 812. pedicular screw fixation/attachment must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) prior to conducting an investigation.

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 Failure to Administration (FDA) will verify such assumptions. 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.

FDA advises that the use of the subject device system and/or device components with any other device components but those identified in this 510(k) would require submission of a new 510 (k) providing documentation of design, material, and labeling compatibility between the device components. Mechanical testing of a spinal system consisting of the

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### Page 3 - Mr. Gregory D. Cannedy

subject device components and other device components, whether yours or other manufacturers', may also be required. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and 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 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 [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

C. Colby Mc Whitney, Ph.D.

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

Enclosure

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510(k) Number (if known): K974757

Device Name: Kaneda Anterior Scoliosis System (KASS)

## Indications for Use:

The Kaneda Anterior Scoliosis System is intended for use in:

- 1. Idiopathic scoliosis.
- 2. Degenerative Disc Disease defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies.
- 3. Scoliosis with deficient posterior elements such as that resulting from laminectomy or myelomeningocele.
- 4. Neuromuscular scoliosis/kyphoscoliosis
- 5. Spinal fractures (acute reduction or late deformity).
- 6. Revision surgery.
- 7. Tumor.

In addition, the Kaneda Anterior Scoliosis System can also be 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. Indications for these scoliotic uses include:

- 1. Collapsing and unstable paralytic deformity.
- 2. Progressively increasing scoliosis.
- 3. Decreasing cardio-respiratory function, secondary to spinal or rib deformity or collapse.
- 4. Inability to maintain sitting balance, necessitating the use of hands.
- 5. Increasing pelvic obliguity coincident with back pain or loss of sitting balance.

The intended levels for treatment with the Kaneda Anterior Scoliosis System. are T4 to L4.

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

| | | Concurrence of CDRH, Office of Device Evaluation (ODE) |
|----------------------|------|---------------------------------------------------------------------------------------------------|
| Prescription Use | | <div style="display:inline-block;"> <span style="text-decoration: overline;">X</span> </div> |
| (per 21 CRF 801.109) | OR : | Over-The-Counter Use |
| | | <div style="display:inline-block;"> <span style="text-decoration: overline;">pcolle</span> </div> |
| | | (Division Sign-Off) |
| | | Division of General Restorative Devices |
| | | 510(k) Number: k974757 |

(Optional Format 1-2-96)

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