(28 days)
Not Found
Not Found
No
The document describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as a "Polyaxial Spinal Fixation System" intended to treat various spinal conditions such as fractures, deformities, spondylolisthesis, and tumors, indicating its therapeutic purpose to fix and stabilize the spine.
No
Explanation: The device description states that the ZODIAC™ Polyaxial Spinal Fixation System is comprised of implantable components used to create a rigid spinal construct. Its intended uses involve fixation for various spinal conditions like fractures, deformities, and spondylolisthesis, which are all therapeutic interventions rather than diagnostic procedures.
No
The device description explicitly states it is comprised of various types and sizes of implantable components manufactured from titanium alloy, indicating it is a hardware-based medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used for spinal fixation in patients with various spinal conditions (fractures, deformity, spondylolisthesis, tumors, failed fusions). This is a surgical implant used directly on the patient's body.
- Device Description: The device is described as implantable components made of titanium alloy, assembled to create a rigid spinal construct. This is consistent with a surgical implant.
- Lack of IVD characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment.
Therefore, the ZODIAC™ Polyaxial Spinal Fixation System is a surgical implant, 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.
- The ZODIAC™ Polyaxial Spinal Fixation 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). - The ZODIAC™ Polyaxial Spinal Fixation 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).
- In addition, the ZODIAC™ Polyaxial Spinal Fixation 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. - The ZODIAC™ Polyaxial Spinal Fixation 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 spondylolistheses. degenerative spondylolistheses and acute pars fracture allowing spondylolisthesis).
Product codes
KWP, MNI, MNH
Device Description
The ZODIAC™ Polyaxial Spinal Fixation 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, Ti-6AI-4V ELI (ASTM F 136). System rods are available in titanium alloy or commercially pure titanium, CP Grade 4 (ASTM G67). This submission seeks clearance for a line extension.
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)
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
Mechanical and dynamic testing was performed. Test results demonstrated that the mechanical performance of the ZODIAC™ Polyaxial Spinal Fixation System is at least comparable to, if not better than, those of the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
OCT 2 7 2004
K042673 - 510(k) SUMMARY ZODIAC™ Polyaxial Spinal Fixation System September 2004 Page 1 of 2
- Alphatec Manufacturing, Inc. Company: 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 Spinal Fixation 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 Spinal Fixation 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, Ti-6AI-4V ELI (ASTM F 136). System rods are available in titanium alloy or commercially pure titanium, CP Grade 4 (ASTM G67). This submission seeks clearance for a line extension.
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.
-
- The ZODIAC™ Polyaxial Spinal Fixation 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).
1
K042673 - 510(k) SUMMARY ZODIAC™ Polyaxial Spinal Fixation System September 2004 Page 2 of 2
- c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, degenerative spondylolisthesis, and acute pars fracture allowing spondylolisthesis).
-
- The ZODIAC™ Polyaxial Spinal Fixation 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).
-
- In addition, the ZODIAC™ Polyaxial Spinal Fixation 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.
-
- The ZODIAC™ Polyaxial Spinal Fixation 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 spondvlolisthesis. degenerative spondylolistheses and acute pars fracture allowing spondylolisthesis).
Substantial Equivalence:
Documentation was provided that demonstrates that the ZODIAC™ Polyaxial Spinal Fixation System is substantially equivalent to other pedicle screw systems currently on the market.
Performance Data:
Mechanical and dynamic testing was performed. Test results demonstrated that the mechanical performance of the ZODIAC™ Polyaxial Spinal Fixation 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 & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 27 2004
Ms. Ellen A. Yarnall Director, Regulatory Affairs Alphatec Manufacturing Incorporated 6110 Corte Del Cedro Carlsbad, California 92009
Re: K042673
Trade/Device Name: ZODIAC™ Polyaxial Spinal Fixation System Regulation Numbers: 21 CFR 888.3050 and 21 CFR 888.3070 (b) (1) Regulation Names: Spinal interlaminal fixation orthosis and Pedicle screw spinal system Regulatory Class: II Product Codes: KWP, MNI, MNH Dated: September 29, 2004 Received: September 29, 2004
Dear Ms. Yarnall:
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.
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.
3
Page 2 - Ms. Ellen A. Yarnall
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 (240) 276-0120. 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. Millburn
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
510(k) Number (if known): K042673
Device Name: ZODIAC™ Polyaxial Spinal Fixation System
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.
-
- The ZODIAC™ Polyaxial Spinal Fixation System when used as a hook and sacral screw fixation system (nonpedicle screw) is intended for:
- Patients having fractures of the thoracic and lumbar spine. a.
- Patients having deformity (i.e., idioscoliosis, neuromuscular scoliosis, or kyphoscoliosis with b. associated paralysis or spasticity).
- Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, degenerative spondylolisthesis, ﻥ ﻧ and acute pars fracture allowing spondylolisthesis).
-
- The ZODIAC™ Polyaxial Spinal Fixation 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, spinal tumor and failed previous fusion (pseudoarthrosis).
-
- In addition, the ZODIAC™ Polyaxial Spinal Fixation 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.
-
- The ZODIAC™ Polyaxial Spinal Fixation System, when used as a laminar hook and bone screw system is intended for:
- Patients having fractures of thoracic and lumbar spine. a.
- Patients having thoracolumbar deformity (i.e., idioscoliosis, neuromuscular scoliosis, or b. kyphoscoliosis with associated paralysis or spasticity).
- Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, degenerative spondylolistheses ். and acute pars fracture allowing spondylolisthesis).
| Prescription Use
(Part 21 CFR 801 Subpart D) | X | AND/OR | Over-The Counter Use
(21 CFR 801 Subpart C) | |
| ------------------------------------------------- | --- | -------- | ------------------------------------------------ | -- |
|---|
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (Division Sign-Off)
Division of General, Restorative, and Neurological Devices