K Number
K012916
Device Name
FRONTIER ANTERIOR SCOLIOSIS SYSTEM
Date Cleared
2001-11-27

(89 days)

Product Code
Regulation Number
888.3060
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 Description
The FRONTIER Anterior Scoliosis System consists of spinal rods, spinal screws, spinal staples, and spinal washers. The implants of the FRONTIER Anterior Scoliosis System have been designed for use in either open or thoracoscopic approaches.
More Information

Not Found

No
The summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.

Yes
The device is intended to provide temporary stabilization as an adjunct to spinal bone grafting processes and for the correction and stabilization of scoliotic curves, among other medical indications. Its purpose is to treat or alleviate specific medical conditions, which aligns with the definition of a therapeutic device.

No
The provided text describes the device as an implantable system (rods, screws, staples, washers) intended for stabilization and correction of the spine as an adjunct to spinal bone grafting processes. It specifies therapeutic uses like idiopathic scoliosis, degenerative disc disease, and spinal fractures, rather than diagnostic purposes such as identifying or characterizing a medical condition.

No

The device description explicitly lists hardware components (spinal rods, screws, staples, and washers) and describes their intended use in surgical procedures.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
  • Device Description and Intended Use: The FRONTIER Anterior Scoliosis System is a system of implants (rods, screws, staples, washers) intended for surgical fixation and stabilization of the spine. It is used within the body during a surgical procedure.
  • Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens.

Therefore, the FRONTIER Anterior Scoliosis System is a surgical implant device, not an In Vitro Diagnostic device.

N/A

Intended Use / Indications for 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.

Product codes (comma separated list FDA assigned to the subject device)

KWQ

Device Description

The FRONTIER Anterior Scoliosis System consists of spinal rods, spinal screws, spinal staples, and spinal washers. The implants of the FRONTIER Anterior Scoliosis System have been designed for use in either open or thoracoscopic approaches.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

T4 to L4 levels of the spine

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K953915, K974757, K001066

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
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.(b)
Classification. Class II.

0

$[K012916](https://510k.innolitics.com/search/K012916) p^\prime$

XIII. 510(k) SummaryNOV 2 7 2001
SUBMITTER:DePuy AcroMed, Inc.
325 Paramount Drive
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)
KANEDA™ Anterior Scoliosis System (K974757)
CD HORIZON® ECLIPSE™ (K001066)
DESCRIPTION:The FRONTIER Anterior Scoliosis System consists of
spinal rods, spinal screws, spinal staples, and spinal
washers. The implants of the FRONTIER Anterior
Scoliosis System have been designed for use in
either open or thoracoscopic approaches.
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 |

1

    1. Neuromuscular scoliosis/kyphoscoliosis.
  • reduction or late 5. Spinal fractures (acute deformity).
    1. Revision surgery.
    1. 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.
    1. Progressively increasing scoliosis.
    1. Decreasing cardio-respiratory function, secondary to spinal or rib deformity or collapse.
    1. Inability to maintain sitting balance, necessitating the use of hands.
    1. 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.

2

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus features a staff with two snakes coiled around it and a pair of wings at the top.

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.

3

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 (800) 638-2041 or at (301) 443-6597, 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

4

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.
  1. Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies).
    1. Scoliosis with deficient posterior elements such as that resulting from laminectomy or myelomeningocele.
    1. Neuromuscular scoliosis/kyphoscoliosis.
    1. Spinal fractures (acute reduction or late deformity).
    1. Revision surgery.
    1. 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.
    1. Progressively increasing scoliosis.
    1. Decreasing cardio-respiratory function, secondary to spinal or rib deformity or collapse.
    1. Inability to maintain sitting balance, necessitating the use of hands.
    1. 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 -

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR Over-The-Counter Use:_

Prescription Use: (Per 21 CFR 801.109)