(29 days)
Not Found
Not Found
No
The summary describes a mechanical spinal fixation system made of titanium components and does not mention any software, algorithms, or data processing capabilities that would suggest the use of AI/ML.
No.
The Altius OCT System is an implantable device used for spinal fusion, which is a surgical procedure, not a therapeutic device for treatment modalities like therapy.
No
The Altius OCT System is described as a titanium system composed of rods, bone screws, hooks, etc., intended for promoting fusion of the cervical spine and occipito-cervico-thoracic junction. This description indicates it is an implantable medical device used for surgical treatment, not for diagnosing conditions.
No
The device description explicitly lists physical components made of titanium, such as rods, bone screws, hooks, etc., indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description: The Altius OCT System is a surgical implant made of titanium components (rods, screws, hooks, etc.) used to stabilize and promote fusion of the spine.
- Intended Use: The intended use is to provide structural support and promote fusion in the cervical and occipito-cervico-thoracic spine for various conditions like DDD, spondylolisthesis, fractures, etc. This is a surgical intervention, not a diagnostic test performed on a sample.
The description clearly indicates a physical implant used in surgery, not a test performed on a biological sample.
N/A
Intended Use / 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 t
- . 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.
Product codes
KWP
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. Bone 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine and occipito-cervico-thoracic junction (occiput-T3), occipital bone, thoracic spine (T1-T3)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(k) SUMMARY
SUBMITTED BY
Wendy Spielberger, RAC Lead Regulatory and Clinical Affairs Staff Interpore Cross International 181 Technology Drive Irvine, California 92618 (949) 453-3200
This summary of 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR §807.92.
CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME
| Classification Name: | Appliance, Fixation, Spinal Interlaminal Orthosis |
|---|---|
| Common/Usual Name: | Spinal Interlaminal Orthosis Fixation |
| Product Classification: | 21 CFR §888.3050, Class II |
| Product Code: | KWP |
| 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 t
- . 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. Bone 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.
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 21 2004
Ms. Wendy Spielberger, RAC Lead Regulatory and Clinical Affairs Staff INTERPORE CROSS International 181 Technology Drive Irvine. CA 92618-2402
Re: K043229
Trade/Device Name: Altius OCT System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP Dated: November 19, 2004 Received: November 22, 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 for abovenoveior 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. Wendy Spielberger
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to organ market of substantial equivalence of your device to a legally premarket notification: "The PPF Intelligestion 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 If you desire specific davice 101 Jour 2019 276-0120. Also, please note the regulation entitled, contact the Office of Comptimation" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational 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,
Clawill
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
Indications for Use
510(k) Number (if known): KO4 3229
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 .
- 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.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
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510(k) Number K043225