DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient . history and radiographic studies)
Spondylolisthesis .
◆ Spinal stenosis
◆ Fracture/dislocation
Atlantoaxial fracture with instability .
. Occipitocervical dislocation
. Revision of previous cervical spine surgery
. Tumors

The occipital bone screws are limited to occipital fixation only.

The Altius OCT System can be linked to the Synergy Spinal System using the Transitional Rods and Rod Connectors from the Altius OCT System.

Device Description

The Altius OCT System is a titanium system composed of rods, bone screws, hooks, set screws, nuts, cross connectors, plates. For occipito-cervico-thoracic fusion, the occipital plate is fixed to the occiput with bone screws. The pre-bent rod is cut to the appropriate length. Bonc screws are placed in the thoracic spine (T1-T3) and hooks are placed in the cervical spine. The rod is inserted and the construct is locked with screws and nuts. Cross connectors can be added to the construct.

AI/ML Overview

The provided text is a 510(k) summary for the Altius OCT System, a spinal interlaminal orthosis fixation device. It details the device description, indications for use, and its comparison to a predicate device for substantial equivalence.

Based on the information provided, no specific acceptance criteria or results from a study proving the device meets those criteria are described.

Instead, the document states:

Comparison to the Predicate Device: "Based on the same indications for use, intended use, similarity in materials of construction and equivalent biomechanical performance, the Altius OCT System is considered substantially equivalent to the legally marketed predicate device."

This indicates that the FDA granted clearance based on the device's substantial equivalence to an already legally marketed predicate device, rather than requiring a standalone study with specific performance acceptance criteria. The "equivalent biomechanical performance" mentioned suggests that some biomechanical testing was likely performed to demonstrate similarity to the predicate, but specific acceptance criteria or detailed study results are not included in this summary.

Therefore, for your requested information, the following applies:

A table of acceptance criteria and the reported device performance: Not provided. The basis for clearance is substantial equivalence to a predicate device.
Sample size used for the test set and the data provenance: Not provided. No specific test set for clinical performance is described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical test set requiring ground truth establishment is described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This is a spinal implant device, not an AI-powered diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a spinal implant device, not an AI-powered algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no clinical test set requiring ground truth is described. The assessment focused on similarity to a predicate device based on indications, materials, and biomechanical performance.
The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
How the ground truth for the training set was established: Not applicable.

Summary

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510(k) SUMMARY

K033961

SUBMITTED BY

APR 1 4 2004

Wendy Spielberger Lead Regulatory and Clinical Affairs Staff Interpore Cross International 181 Technology Drive Irvine, California 92618 (949) 453-3200

December 18, 2003

This summary of 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR 8807.92.

CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME

Classification Name:	Appliance, Fixation, Spinal Interlaminal Orthosis
Common/Usual Name:	Spinal Interlaminal Orthosis Fixation
Product Classification:	Class II
Proprietary Name:	Altius OCT System

PREDICATE DEVICE

Predicate device information is included in this premarket notification.

INDICATIONS-FOR-USE

When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Altius OCT System is indicated for:

DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient . history and radiographic studies)
Spondylolisthesis .
◆ Spinal stenosis
◆ Fracture/dislocation
Atlantoaxial fracture with instability .
. Occipitocervical dislocation
. Revision of previous cervical spine surgery
. Tumors

The occipital bone screws are limited to occipital fixation only.

The Altius OCT System can be linked to the Synergy Spinal System using the Transitional Rods and Rod Connectors from the Altius OCT System.

DEVICE DESCRIPTION

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

COMPARISON TO THE PREDICATE DEVICE

Based on the same indications for use, intended use, similarity in materials of construction and equivalent biomechanical performance, the Altius OCT System is considered substantially equivalent to the legally marketed predicate device.

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 emblem featuring a stylized depiction of an eagle or bird with three curved lines representing its wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 4 2004

Wendy Spielberger Lead Regulatory and Clinical Affairs Staff Interpore Cross International 181 Technology Drive Irvine, California 92618-2402

Re: K033961

Trade/Device Name: Altius OCT System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: KWP Dated: March 18, 2004 Received: March 19, 2004

Dear Ms. Spielberger:

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 (Scctions 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

Page 2 - Wendy Spielberger

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. Mellekas

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): K033961

Device Name: Altius OCT System

Indications-For-Use:

When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Interpore Cross International Altius OCT System is indicated for:

DDD (neck pain of discogenic origin with degeneration of the disc as confirmed . by patient history and radiographic studies)
Spondyloslisthesis b
�-Spinal stenosis
Fracture/dislocation .
Atlantoaxial fracture with instability �-
Occipitocervical dislocation .
Revision of previous cervical spine surgery .
� Tumors

The occipital bone screws are limited to occipital fixation only.

The Altius OCT System can be linked to the Synergy Spinal System using the Transitional Rods and Rod Connectors from the Altius OCT System.

(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)

n Division of General, Restorative, and Neurological Devices

Over-The-Counter Use

(Optional Format 1-2-96)

510(k) Number.

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.