FRONTIER ANTERIOR SCOLIOSIS SYSTEM

K012916 · Depuy Acromed, Inc. · KWQ · Nov 27, 2001 · Orthopedic

Device Facts

• Record ID: K012916
• Device Name: FRONTIER ANTERIOR SCOLIOSIS SYSTEM
• Applicant: Depuy Acromed, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Nov 27, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The FRONTIER Anterior Scoliosis System is intended for anterolateral screw fixation to the T4 to L4 levels of the spine, with all metal at least 1 cm from a major vessel. The FRONTIER Anterior Scoliosis System may be used in either thoracoscopic procedures or open procedures. The FRONTIER Anterior Scoliosis System is intended to provide temporary stabilization as an adjunct to spinal bone grafting processes. Specific indications are: 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. The FRONTIER 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 obliquity coincident with back pain or loss of sitting balance.

Device Story

Frontier Anterior Scoliosis System comprises spinal rods, screws, staples, and washers; designed for anterolateral fixation of T4-L4 spinal levels. Used in open or thoracoscopic surgical procedures by surgeons to provide temporary stabilization as an adjunct to spinal bone grafting. System corrects/stabilizes scoliotic curves and weakened trunks; prevents recurrence of deformity. Benefits include improved spinal alignment, stabilization of collapsing/unstable deformities, and potential restoration of sitting balance or respiratory function in patients with severe spinal/rib deformities.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Materials: ASTM F-136 titanium alloy. Components: spinal rods, screws, staples, washers. Configuration: anterolateral fixation system. Energy source: none (mechanical). Connectivity: none. Sterilization: not specified.

Indications for Use

Indicated for patients requiring anterolateral spinal fixation (T4-L4) for 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 and trunk stabilization in cases of paralytic deformity, progressive scoliosis, respiratory decline due to deformity, loss of sitting balance, or pelvic obliquity. Contraindicated if metal cannot be placed at least 1 cm from major vessels.

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

• MOSS MIAMI Spinal System (K953915)
• KANEDA™ Anterior Scoliosis System (K974757)
• CD HORIZON® ECLIPSE™ (K001066)

Submission Summary (Full Text)

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\$\k012916 p^\prime\$

| XIII. 510(k) Summary | NOV 2 7 2001 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SUBMITTER: | DePuy AcroMed, Inc.<br>325 Paramount Drive<br>Raynham, MA 02780 |
| CONTACT PERSON: | Lisa A. Gilman |
| DATE PREPARED: | August 22, 2001 |
| CLASSIFICATION NAME: | Spinal Intervertebral Body Fixation Orthosis |
| PROPRIETARY NAME: | Frontier Anterior Scoliosis System |
| PREDICATE DEVICES: | MOSS MIAMI Spinal System (K953915)<br>KANEDA™ Anterior Scoliosis System (K974757)<br>CD HORIZON® ECLIPSE™ (K001066) |
| DESCRIPTION: | The FRONTIER Anterior Scoliosis System consists of<br>spinal rods, spinal screws, spinal staples, and spinal<br>washers. The implants of the FRONTIER Anterior<br>Scoliosis System have been designed for use in<br>either open or thoracoscopic approaches. |
| INTENDED USE: | The FRONTIER Anterior Scoliosis System is intended<br>for anterolateral screw fixation to the T4 to L4 levels<br>of the spine, with all metal at least 1 cm from a major<br>vessel. The FRONTIER Anterior Scoliosis System<br>may be used in either thoracoscopic procedures or<br>open procedures.<br><br>The FRONTIER Anterior Scoliosis System is intended<br>to provide temporary stabilization as an adjunct to<br>spinal bone grafting processes. Specific indications<br>are:<br>1. Idiopathic scoliosis.<br>2. Degenerative disc disease (defined as discogenic<br>back pain with degeneration of the disc confirmed<br>by history and radiographic studies).<br>3. Scoliosis with deficient posterior elements such as<br>that resulting from laminectomy or<br>myelomeningocele |

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- 4. Neuromuscular scoliosis/kyphoscoliosis.
- reduction or late 5. Spinal fractures (acute deformity).
- 6. Revision surgery.
- 7. Tumor.

The FRONTIER 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 obliquity coincident with back pain or loss of sitting balance.

Manufactured from ASTM F-136 implant grade MATERIALS: titanium alloy.

## PERFORMANCE DATA:

Performance data were submitted to characterize the FRONTIER Anterior Scoliosis System.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 7 2001

Ms. Lisa Gilman Regulatory Affairs Associate DePuy Acromed, Inc. 325 Paramount Drive Raynham, Massachusetts 02767-0350

Re: K012916

Trade/Device Name: FRONTIER™ Anterior Scoliosis System Regulatory Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: II Product Code: KWQ Dated: August 29, 2001 Received: August 30, 2001

Dear Ms. Gilman:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have have determined the device is substantially equivalent (for the indications for use above and in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the sured in the oneroune) to ical Device Amendments, or to devices that have been reclassified in enceentence 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 therefore, mailions 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 Marufacturing 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 mspotions, and 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.

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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 noutication. The I Dri incing of basicin 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 If you desire spoonly an in vitro diagnostic devices), please contact the Office of Compliance at additionally 607.10 for in 10 for questions on the promotion and advertising of your device, (2017) 594-4639. 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 monifacturers Assistance at its toll-free number [phone] or at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Micheal N Milliken

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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### Indications for Use IV.

K012916

012910 510(k) Number (if known): __

FRONTIER™ Anterior Scoliosis System Device Name:

### Indications For Use:

The FRONTIER Anterior Scoliosis System is intended for anterolateral screw fixation to The FRONTILITY Antenor Society with all metal at least 1 cm from a major vessel. The the 14 to L4 levels of the opino, wan may be used in either thoracoscopic procedures or open procedures.

The FRONTIER Anterior Scoliosis System is intended to provide temporary stabilization as an adjunct to spinal bone grafting processes. Specific indications are:

- 1. Idiopathic scoliosis.
- 1. Tulopatino Socillone.
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.

The FRONTIER Anterior Scoliosis System can also be used for the correction and The TRONTIE. Antonor of scoliotic curves, for the prevention or recurrence of undesired scoliotic Stablization of Soollow Garroof, Yorks, Yorks. Indications for these scollotic 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 obliquity coincident with back pain or Joss of sitting ba

back pain or loss of sitting balance.

Division Sign-Off)
Division of General, Restorative

(Division of General, Restorative and Neurological Devices

K012916

# 510(k) Number -

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Concurrence of CDRH, Office of Device Evaluation (ODE)

OR Over-The-Counter Use:_

Prescription Use: (Per 21 CFR 801.109)