K Number
K033090
Device Name
ICON POLYAXIAL PEDICLE SCREW SYSTEM
Date Cleared
2004-03-26

(179 days)

Product Code
Regulation Number
888.3050
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
It is intended that this device, in any system configuration be removed after development of solid fusion mass. Hook component indications are limited to T7-L5. Sacral screw indications are limited to the sacrum only. 1) The ZODIAC Polyaxial Pedicle Screw System, when used as a hook and sacral screw fixation system (nonpedicle screw) is intended for: a. Patients having fractures of the thoracic and lumbar spine. b. Patients having deformity (i.e., idioscoliosis, neuromuscular scoliosis, or kyphoscoliosis with associated paralysis or spasticity). c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, degenerative spondylolisthesis, and acute pars fracture allowing spondylolisthesis). 2) The ZODIAC Polyaxial Pedicle Screw System, when used as a pedicle screw system in the thoraco-lumbo-sacral region of the spine is intended for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis). 3) In addition, the ZODIAC Polyaxial Pedicle Screw System, when used as a pedicle screw fixation system is intended for: a. Patients receiving only autogenous bone graft. b. Patients having the device fixed or attached to the lumbar and sacral spine and having severe spondylolisthesis grade 3 or 4 at the fifth lumbar-first sacral (L5-S1) vertebral joint. 4) The ZODIAC Polyaxial Pedicle Screw System, when used as a laminar hook and bone screw system is intended for: a. Patients having fractures of thoracic and lumbar spine. b. Patients having thoracolumbar deformity (i.e., idioscoliosis, neuromuscular scoliosis, or kyphoscoliosis with associated paralysis or spasticity). c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, degenerative spondylolistheses and acute pars fracture allowing spondylolisthesis).
Device Description
The ZODIAC Polyaxial Pedicle Screw System is comprised of various types and sizes of implantable components that are assembled to create a rigid spinal construct. System components are manufactured from titanium alloy, Ti6Al-4V ELI (ASTM F 136). System rods are available in titanium alloy or commercially pure titanium, CP Grade 4 (ASTM G67). The ZODIAC Polyaxial Pedicle Screw System is designed to facilitate optimal screw and rod placement.
More Information

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

Yes
The device is used to treat various spinal conditions such as fractures, deformities, and spondylolisthesis, which aims to improve the patient's health and alleviate their conditions.

No

The device is described as an implantable system for spinal fixation, used to treat various spinal conditions. Its function is to create a rigid spinal construct and facilitate surgical procedures, not to diagnose conditions.

No

The device description explicitly states it is comprised of "implantable components" manufactured from titanium alloy, indicating it is a hardware device, not software-only.

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

Here's why:

  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
  • Device Description and Intended Use: The description clearly states that the ZODIAC Polyaxial Pedicle Screw System is comprised of implantable components (screws, hooks, rods) made of titanium alloy. Its intended use is for surgical fixation of the spine in patients with various conditions like fractures, deformities, and spondylolisthesis.
  • Lack of Diagnostic Activity: There is no mention of this device being used to analyze biological samples or provide diagnostic information. It is a physical implant used for structural support and stabilization.

Therefore, this device falls under the category of a surgical implant or spinal fixation system, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

It is intended that this device, in any system configuration be removed after development of solid fusion mass. Hook component indications are limited to T7-L5. Sacral screw indications are limited to the sacrum only.

  1. The ZODIAC Polyaxial Pedicle Screw System, when used as a hook and sacral screw fixation system (nonpedicle screw) is intended for:
    a. Patients having fractures of the thoracic and lumbar spine.
    b. Patients having deformity (i.e., idioscoliosis, neuromuscular scoliosis, or kyphoscoliosis with associated paralysis or spasticity).
    c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, degenerative spondylolisthesis, and acute pars fracture allowing spondylolisthesis).
  2. The ZODIAC Polyaxial Pedicle Screw System, when used as a pedicle screw system in the thoraco-lumbo-sacral region of the spine is intended for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).
  3. In addition, the ZODIAC Polyaxial Pedicle Screw System, when used as a pedicle screw fixation system is intended for:
    a. Patients receiving only autogenous bone graft.
    b. Patients having the device fixed or attached to the lumbar and sacral spine and having severe spondylolisthesis grade 3 or 4 at the fifth lumbar-first sacral (L5-S1) vertebral joint.
  4. The ZODIAC Polyaxial Pedicle Screw System, when used as a laminar hook and bone screw system is intended for:
    a. Patients having fractures of thoracic and lumbar spine.
    b. Patients having thoracolumbar deformity (i.e., idioscoliosis, neuromuscular scoliosis, or kyphoscoliosis with associated paralysis or spasticity).
    c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, degenerative spondylolistheses and acute pars fracture allowing spondylolisthesis).

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

KWP, MNI, MNH

Device Description

The ZODIAC Polyaxial Pedicle Screw System is comprised of various types and sizes of implantable components that are assembled to create a rigios annal construct. System components are manufactured from titanium alloy, Tri6Al-4V ELI (ASTM F 136). System rods are available in titanium allow or commercially pure titanium, CP Grade 4 (ASTM G67). The ZODIAC Polyaxial Pedicle Screw System is designed to facilitate optimal screw and rod placement.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Thoracic, lumbar, and sacral spine (T7-L5, L5-S1, sacrum).

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)

Mechanical and dynamic testing of the ZODIAC Polyaxial Pedicle Screw System was performed. The test results demonstrate that the mechanical performance of the ZODIAC Polyaxial Pedicle Screw System is at least comparable to, if not better than, those of the predicate devices.

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

Not Found

Predicate Device(s)

K031585, K001668, K982320, K022949

Reference Device(s)

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

§ 888.3050 Spinal interlaminal fixation orthosis.

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

0

K033090
1 of 2

MAR 2 6 2004

ZODIAC Polyaxial Pedicle Screw System 510(k) SUMMARY November 2003

  • Company: Alphatec Manufacturing, Inc. 6110 Corte Del Cedro Carlsbad, CA 92009 USA Telephone: (760) 431-9286 Fax: (760) 431-9132
    Contact Person: Ellen Yarnall, Director of Regulatory Affairs

Trade/Proprietary Name: ZODIAC Polyaxial Pedicle Screw System

Common Name: Pedicle Screw Spinal System

  • Classification Name: Spinal Interlaminal Fixation Orthosis (888,3050) Spondylolisthesis Spinal Fixation Device (888,3070) Pedicle Screw Spinal System (888.3070)

Product Description:

The ZODIAC Polyaxial Pedicle Screw System is comprised of various types and sizes of implantable components that are assembled to create a rigios annal construct. System components are manufactured from titanium alloy, Tri6Al-4V ELI (ASTM F 136). System rods are available in titanium allow or commercially pure titanium, CP Grade 4 (ASTM G67). The ZODIAC Polyaxial Pedicle Screw System is designed to facilitate optimal screw and rod placement.

Indications for Use:

It is intended that this device, in any system configuration be removed after development of solid fusion mass. Hook component indications are limited to T7-L.5. Sacral screw indications are limited to the sacrum only.

    1. The ZODIAC Polyaxial Pedicle Screw System, when used as a hook and sacral screw fixation system (nonpedicle screw) is intended a noon
    • a. Patients having fractures of the thoracic and lumbar spine.
    • b. Patients having deformity (i.e., idioscoliosis, neuromuscular scoliosis, or kyphoscoliosis with associated paralysis or spasticity).
    • c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, degenerative spondylolisthesis, and acute pars fracture allowing spondylolisthesis).

1

ZODIAC Polyaxial Pedicle Screw System 510(k) SUMMARY November 2003

2 Of 2

    1. The ZODIAC Polyaxial Pedicle Screw System, when used as a pedicle screw system in the thoraco-lumbo-sacral region of the spine is intended for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).
    1. In addition, the ZODIAC Polyaxial Pedicle Screw System, when used as a pedicle screw fixation system is intended for:
    • a. Patients receiving only autogenous bone graft.
    • b. Patients having the device fixed or attached to the lumbar and sacral spine and having severe spondylolisthesis grade 3 or 4 at the fifth lumbar-first sacral (L5-S1) vertebral joint.
    1. The ZODIAC Polyaxial Pedicle Screw System, when used as a laminar hook and bone screw system is intended for:
    • a. Patients having fractures of thoracic and lumbar spine.
    • b. Patients having thoracolumbar deformity (i.e., idioscoliosis, neuromuscular scoliosis, or kyphoscoliosis with associated paralysis or spasticity).
  • c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, degenerative spondylolistheses and acute pars fracture allowing spondylolisthesis).

Substantial Equivalence:

The ZODIAC Polyaxial Pedicle Screw System is substantially equivalent to the following predicate devices:

Trade/Proprietary NameManufacturerClearance
Optima Spinal SystemU&I AmericaK031585
Global Spinal Fixation SystemU&I AmericaK001668
Moss-Miami Spinal SystemDepuy Inc.K982320
Universal Spine SystemSynthesK022949

Performance Data:

Mechanical and dynamic testing of the ZODIAC Polyaxial Pedicle Screw System was performed. The test results demonstrate that the mechanical performance of the ZODIAC Polyaxial Pedicle Screw System is at least comparable to, if not better than, those of the predicate devices.

2

Image /page/2/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 forming its body and wing. The eagle is positioned to the right of a circular seal that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 6 2004

Ms. Ellen Yarnell Director, Regulatory Affairs Alphatec Manufacturing Incorporated 6110 Corte Del Cedro Carlsbad, California 92009

Re: K033090

Trade Name: ZODIAC Pedicle Screw System Regulation Number: 21 CFR 888.3050 and 888.3070 (b) (1) Regulation Name: Spinal Interlaminal Fixation Orthosis and Pedicle Screw Spinal System Regulatory Class: Class II Product Code: KWP, MNI, MNH Dated: January 8, 2004 Received: January 9, 2004

Dear Ms. Yarnell:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

3

Page 2 - Ms. Ellen Yarnell

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements 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 limited to: registration 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. This letter will allow you to begin marketing your device as described in your Section 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Mark A. Milkum

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

MAR 2 6 2004

510(k) Number (if known): K033090

Device Name: ZODIAC Polyaxial Pedicle Screw System

Indications for Use:

lt is intended that this device, in any system configuration be removed after it is intended that this dones, in any system indications are limited to T7-L5. Sacral screw indications are limited to the sacrum only.

    1. The ZODIAC Polyaxial Pedicle Screw System, when used as a hook and sacral screw fixation system (nonpedicle screw) is intended for:
    • a. Patients having fractures of the thoracic and lumbar spine.
    • b. Patients having deformity (i.e., idioscoliosis, neuromuscular scoliosis, or kyphoscoliosis with associated paralysis or spasticity).
    • c Soliobio, or Ryphoondylolisthesis (i.e., isthmic spondylolisthesis, degenerative spondylolisthesis, and acute pars fracture allowing spondylolisthesis).
    1. The ZODIAC Polyaxial Pedicle Screw System, when used as a pedicle screw system in the thoraco-lumbo-sacral region of the spine is intended for degenerative spondylolisthesis with objective evidence of intentod for abgonent, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).
    1. In addition, the ZODIAC Polyaxial Pedicle Screw System, when used as a pedicle screw fixation system is intended for:
    • a. Patients receiving only autogenous bone graft.
    • b. Patients having the device fixed or attached to the lumbar and sacral spine and having severe spondylolisthesis grade 3 or 4 at the fifth lumbar-first sacral (L5-S1) vertebral joint.
    1. The ZODIAC Polyaxial Pedicle Screw System, when used as a laminar hook and bone screw system is intended for:
    • a. Patients having fractures of thoracic and lumbar spine.
    • b. Patients having thoracolumbar deformity (i.e., idioscoliosis, neuromuscular scoliosis, or kyphoscoliosis with associated paralysis or spasticity).

Mark Milan

(Division Sign-Off)

Division of General, Restorative,
and Neurological Devices

K033090

5

  • c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, r ationto having spondylistheses and acute pars fracture allowing spondylolisthesis).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The Counter Use _________________________________________________________________________________________________________________________________________________________

Mark N. Mikkelson

On), Restorative, Division of Ge Division of General ,
and Neurological Devices KO 33090

510(k) Number