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 spondylolisthesis, degenerative spondylolistheses and acute pars fracture allowing spondylolisthesis).

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.

AI/ML Overview

The ZODIAC™ Polyaxial Spinal Fixation System is a device used in spinal surgeries. The provided text describes its substantial equivalence to other pedicle screw systems already on the market, rather than presenting a performance study with acceptance criteria and detailed results from a clinical trial or algorithm evaluation.

Here's a breakdown of the information that can be extracted, and what is not present based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (Not Explicitly Stated, Inferred as "Comparable to Predicate Devices")	Reported Device Performance
Mechanical Performance	Comparable to, or better than, predicate devices	"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."
Dynamic Performance	Comparable to, or better than, predicate devices	"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." (Implied for dynamic performance as well, as both are mentioned together).
Clinical Efficacy	(Not applicable, as this is a 510(k) for substantial equivalence, not a PMA)	Not assessed/reported in this document.
Safety	(Not applicable, as this is a 510(k) for substantial equivalence, not a PMA)	Not assessed/reported in this document.

Note: The document explicitly states "Documentation was provided that demonstrates that the ZODIAC™ Polyaxial Spinal Fixation System is substantially equivalent to other pedicle screw systems currently on the market." This implies that the acceptance criteria for the mechanical and dynamic testing were based on demonstrating equivalence, or superiority, to established predicate devices in those specific performance metrics, rather than pre-defined absolute thresholds.

2. Sample Size and Data Provenance for Test Set

Sample Size (Test Set): Not specified. The document only mentions "Mechanical and dynamic testing was performed." It does not detail the number of constructs, materials, or specific test configurations used.
Data Provenance: Not specified. It's likely that the testing was conducted internally by Alphatec Manufacturing, Inc. or by a contract testing laboratory, but the country of origin or whether it was retrospective/prospective is not mentioned. This is typical for 510(k) submissions focusing on physical device performance testing.

3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)

Not applicable. This submission focuses on the mechanical and dynamic performance of the device itself, not on the interpretation of medical data by human experts to establish ground truth for a diagnostic or AI device.

4. Adjudication Method for Test Set

Not applicable. As the "test set" refers to mechanical and dynamic testing of the device, there is no expert adjudication process involved. The results would be objective measurements from testing equipment.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. This submission is for a spinal fixation system, not a diagnostic or AI device.

6. Standalone (Algorithm Only) Performance Study

No. This is not an AI/algorithm-based device. "Standalone performance" in this context would refer to the mechanical and dynamic performance of the implant itself, which was evaluated as described in #1.

7. Type of Ground Truth Used

For the mechanical and dynamic testing, the "ground truth" would be the objective measurements obtained from laboratory testing (e.g., stiffness, fatigue limits, pull-out strength). These are compared against established industry standards or the performance of predicate devices. There is no biological or clinical "ground truth" established from patients or pathology in this type of submission for a spinal implant's physical performance.

8. Sample Size for Training Set

Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."

9. How Ground Truth for Training Set Was Established

Not applicable. As there is no training set.

Summary

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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 (888.3070Pedicle Screw Spinal System (888.3070)

Product Description:

Indications for Use:

1. 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).
1. 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).
1. 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.
1. 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.

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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.

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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

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510(k) Number (if known): K042673

Device Name: ZODIAC™ Polyaxial Spinal Fixation System

Indications for Use:

1. 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).
1. 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).
1. 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.
1. 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)

Signature
Concurrence of CDRH, Office of Device Evaluation (Division Sign-Off)

Division of General, Restorative, and Neurological Devices

K042673

Regulation Number and Section

§ 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.