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-iliac screw indications are limited to the sacrum-iliac crest only.

The Zodiac® Polyaxial Spinal Fixation System, when used as a hook and sacral iliac 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 spondylolithesis.

The Zodiac® Polyaxial Spinal Fixation System, when used a pedicle screw system in the thoraco-lumbo-sacral iliac region of the spine is intended for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, spinal turnor and failed previous fusion (pseudoarthrosis).
The Zodiac® Polyaxial Spinal Fixation System, when used as a pedicle screw system is intended for:

a. Patients receiving only autogenous bone graft

b. Patient having the device fixed or attached to the lumbar and sacral iliac spine and having severe spondylolithesis 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, kyphoscoliosis or kyphoscoliosis with associated paralysis or spasticity.

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

Device Description

The Zodiac® Polyaxial Spinal Fixation System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies in the thoracolumbo-sacral iliac portion of the spine. It is intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the Zodiac® Polyaxial Spinal Fixation System are dependent in part on the configuration of the assembled device and the method of attachment to the spine.

AI/ML Overview

The provided document, K081158 for the Zodiac® Polyaxial Spinal Fixation System, is a 510(k) summary for a medical device. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, primarily based on design, materials, and mechanical performance. It does not contain information related to software-based AI/ML device performance or clinical studies with human participants that would typically evaluate acceptance criteria in the manner requested.

Therefore, I cannot provide the detailed information requested in points 1 through 9. The document focuses on mechanical performance and substantial equivalence to previously cleared spinal fixation systems, not on an algorithm's performance on medical imaging or clinical outcomes in the same way an AI/ML device would be evaluated.

Specifically, the document states:

"The mechanical performance of the Zodiac® Polyaxial Spinal Fixation System additional components is substantially equivalent to the predicate Zodiac® Polyaxial Spinal Fixation System device." This confirms the evaluation was mechanical, not clinical or AI/ML driven.
"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... to legally marketed predicate devices..." This re-emphasizes the nature of the submission as a substantial equivalence claim for a physical medical device.

Therefore, the table and details requested about acceptance criteria, study design, expert ground truth, sample sizes (for test/training sets), adjudication methods, and MRMC studies are not applicable to the information provided in this 510(k) summary.

Summary

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K081158

510(k) SUMMARY

JUL - 3 2008

Zodiac® Polyaxial Spinal Fixation System 510(k) SUMMARY APRIL 2008

Company:	Alphatec Spine, Inc.2051 Palomar Airport Road#100Carlsbad, CA 92011 USADirect: (760) 494-6770Fax: (760) 431-9132
Contact Person:	Cheryl Allen, Regulatory Affairs Specialist
Trade/Proprietary Name:	Zodiac® Polyaxial Spinal Fixation System
Common Name:	Pedicle Screw Spinal Device
Classification Names:	Spinal Interlaminal Fixation OrthosisPedicle Screw Spinal System

Classification Number(s)/Product Code(s): 21 CFR 888.3050, 888.3070 KWP, MNI, MNH

Product Description:

The intended use and indications for use of the modified device, as described in its labeling, has not changed as a result of the additional components.

Indications for Use:

The Zodiac® Polyaxial Spinal Fixation System, when used as a hook and sacral iliac screw fixation system (nonpedicle screw) is intended for:

a. Patients having fractures of the thoracic and lumbar spine.

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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 spondylolithesis.

The Zodiac® Polyaxial Spinal Fixation System, when used a pedicle screw system in the thoraco-lumbo-sacral iliac region of the spine is intended for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, spinal turnor and failed previous fusion (pseudoarthrosis).
The Zodiac® Polyaxial Spinal Fixation System, when used as a pedicle screw system is intended for:

a. Patients receiving only autogenous bone graft

b. Patient having the device fixed or attached to the lumbar and sacral iliac spine and having severe spondylolithesis 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, kyphoscoliosis or kyphoscoliosis with associated paralysis or spasticity.

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

Substantial Equivalence:

The Zodiac® Polyaxial Spinal Fixation System additional components is substantially equivalent to the following predicate device:

Trade/Proprietary/Model Name	Manufacturer	510(k) No.
Zodiac® Polyaxial Spinal Fixation System	Alphatec Spine, Inc.	K033090
Zodiac® Polyaxial Spinal Fixation System	Alphatec Spine, Inc.	K042673
Zodiac® Stainless Steel Spinal Fixation System	Alphatec Spine, Inc	K051286
Zodiac® 4.0 Polyaxial Spinal Fixation System	Alphatec Spine, Inc.	K071890

Performance Data:

The mechanical performance of the Zodiac® Polyaxial Spinal Fixation System additional components is substantially equivalent to the predicate Zodiac® Polyaxial Spinal Fixation System device.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes on its wing, symbolizing health, services, and people. 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

Alphatec Spine, Inc. % Ms. Paula Morgan Director, Regulatory Affairs 2051 Palomar Airport Road Carlsbad, CA 92011

JUL - 3 2008

Re: K081158

Trade/Device Name: Zodiac™ Polyaxial Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Names: Pedicle screw spinal system Regulatory Class: II Product Code: MNH, MNI, KWP Dated: June 25, 2008 Received: June 26, 2008

Dear Ms. 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.

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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.

Sinccrely yours,

Mark M. Millman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Eyaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known): K081158

Device Name: Zodiac® Polyaxial Spinal Fixation System

Indications for Use:

The Zodiac® Polyaxial Spinal Fixation System, when used as a hook and sacral iliac 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 or kyphosodiosis or kyphoscoliosis with associated paralysis or spasticity,

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

The Zodiac® Polyaxial Spinal Fixation System, when used a pedicle screw system in the thoraco-lumbosacral iliac 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).
The Zodiac® Polyaxial Spinal Fixation System, when used as a pedicle screw system is intended for: a. Patients receiving only autogenous bone graft

b. Patient having the device fixed or attached to the lumbar and sacral iliac spine and having severe spondylolithesis grade 3 or 4 at the fifth lumbar-first sacral (L5-S1) vertebral joint.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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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, kyphoscoliosis or kyphoscoliosis with associated paralysis or spasticity.

c. Patients having spondylolisthesis (i.e. Isthmic spondylolisthesis, degenerative spondylolisthesis 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)

Qhm

(Division Sign-O ... / Division of General, Restorative, and Neurological Devices

510(k) Number L08115V

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.