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 a top loading anterior/posterior spinal fixation system consisting of various types and sizes of implantable components that are assembled to create a rigid spinal construct.

AI/ML Overview

The provided text is a 510(k) summary for a medical device, the ZODIAC™ Polyaxial Spinal Fixation System, seeking clearance from the FDA. It is not a study that proves the device meets acceptance criteria in the way a clinical trial or AI performance study would.

Instead, this document establishes substantial equivalence to existing predicate devices based on mechanical and dynamic testing. The "acceptance criteria" here are implied to be the performance characteristics of the predicate device, which the new device must match or exceed.

Here's the breakdown of the requested information based on the provided text, highlighting what is present and what is not:

A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical performance comparable to predicate device (MOSS Miami Spinal Fixation System)	"The test results demonstrate that the mechanical performance of the Zodiac 4.0 Polyaxial Spinal Fixation System is substantially equivalent to the predicate device."
Dynamic performance comparable to predicate device (MOSS Miami Spinal Fixation System)	"The test results demonstrate that the mechanical performance of the Zodiac 4.0 Polyaxial Spinal Fixation System is substantially equivalent to the predicate device."

Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. The document only states "Mechanical and dynamic testing... was performed." It does not provide details on the number of samples tested for each type of component or for the system as a whole.
- Data Provenance: Not specified. It's internal testing conducted by the manufacturer, Alphatec Spine, Inc., based in Carlsbad, CA, USA, but the specific location of the testing facility or the origin of the materials/components is not detailed. The testing is inherently prospective as it's performed to demonstrate equivalence for regulatory submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This summary refers to mechanical and dynamic engineering testing of a physical medical device, not a diagnostic or AI-driven device requiring expert-established ground truth from medical images or clinical data. The "ground truth" here is the measured mechanical properties of the device and its predicate.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. See point 3. Mechanical testing results are typically objective measurements, not subject to medical expert adjudication.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is a physical spinal fixation system, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a physical spinal fixation system, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Mechanical properties and performance standards. The "ground truth" for this device's performance is the established mechanical and dynamic performance of the predicate device, measured against industry standards (likely ISO or ASTM standards for implantable devices, though not explicitly stated in the summary).
The sample size for the training set
- Not applicable. This is a physical medical device, not an AI algorithm that requires a "training set."
How the ground truth for the training set was established
- Not applicable. See point 8.

Summary

{0}------------------------------------------------

510(k) SUMMARY

ZODIAC™ Polyaxial Spinal Fixation System 510(k) SUMMARY July 2007

NOV 0 9 2007

Company:	Alphatec Spine, Inc.2051 Palomar Airport Road#100Carlsbad, CA 92011 USATelephone: (760) 431-9286 x6769Direct: (760) 494-6769Fax: (760) 431-9132
Contact Person:	Paula Morgan, Director of Regulatory Affairs & Compliance
Trade/Proprietary Name:	ZODIAC™ Polyaxial Spinal Fixation System
Common Name:	Pedicle Screw Spinal Device
Classification Name:	Spinal Interlaminal Fixation OrthosisPedicle Screw Spinal System
Classification Number(s)/Product Code(s):	21 CFR 888.3050 (KWP)21 CFR 888.3070 (MNH, MNI)

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).
c.Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, degenerative spondylolisthesis, and acute pars fracture allowing spondylolisthesis).

{1}------------------------------------------------

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.
Patients having the device fixed or attached to the lumbar and sacral spine and having severe b. spondylolisthesis grade 3 or 4 at the fifth lumbar-first sacral (L.5-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.
Patients having thoracolumbar deformity (i.e., idioscoliosis, neuromuscular scollosis, or b. 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™ 4.0 Polyaxial Spinal Fixation System is substantially equivalent to the following predicate devices:

Trade/Proprietary Name MOSS Miami Spinal Fixation System

Manufacturer DePuy Spine, Inc. Clearance K030383

Performance Data:

Mechanical and dynamic testing of the polyaxial spinal fixation system was performed. The test results demonstrate that the mechanical performance of the Zodiac 4.0 Polyaxial Spinal Fixation System is substantially equivalent to the predicate device.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 0 9 2007

Alphatec Spine, Inc. % Ms. Paula Morgan Director of Regulatory Affairs & Compliance 2051 Palomar Airport Road #100 Carlsbad, CA 92011

K071890 Re: Trade/Device Name: ZODIAC® Polyaxial Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNH, MNI, KWP Dated: October 25, 2007 Received: October 26, 2007

Dear Ms. Paula Morgan:

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. Paula Morgan

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Barbara Buelup

Mark N. Melkerson
for

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

INDICATIONS FOR USE

510(k) Number (if known): TBD

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:
  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. 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).

Prescription Use X (Per 21 CFR 801.109)

Over-The Counter Use -------

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Kreud

(Division Sign-Off) (Division of General, Restorative. and Neurological Devices

510(k) Number K071890

{5}------------------------------------------------

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

Prescription Use X (Per 21 CFR 801.109)

Over-The Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.