(134 days)
No
The summary describes a mechanical spinal fixation system and does not mention any AI or ML components or functionalities. The performance studies are mechanical tests, not related to algorithmic performance.
Yes
The device is described as an "occipito-cervico-thoracic spinal fixation system" intended for "stabilization as an adjunct to fusion of the cervical spine and occipito-cervicothoracic junction." It is used to treat various medical conditions like degenerative disc disease, spondylolisthesis, deformities, trauma, and tumors, which clearly indicates its therapeutic purpose.
No
This device is described as an "occipito-cervico-thoracic spinal fixation system" intended for "stabilization as an adjunct to fusion." Its purpose is to physically stabilize the spine, not to diagnose medical conditions.
No
The device description explicitly states it is a "spinal fixation system" and mentions "rods, and screws, as well as other system components," indicating it is a hardware-based medical device. The performance studies also focus on mechanical testing of these physical components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states the device is an "occipito-cervico-thoracic spinal fixation system." This is a surgical implant used to stabilize the spine.
- Intended Use: The intended use describes the surgical procedures and conditions for which the device is used to stabilize the spine.
- Lack of IVD Characteristics: There is no mention of testing bodily samples, analyzing biological markers, or any other activity associated with in vitro diagnostics.
Therefore, the Nextgen Altius OCT System is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
When intended for stabilization as an adjunct to fusion of the cervical spine and occipitocervico-thoracic junction (occiput -T3), the Nextgen Altius OCT System is intended for use with allograft or autograft and indicated for: DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); spondylolisthesis; deformities or curvatures (i.e., scoliosis and/or lordosis); pseudoarthrosis; spinal stenosis; trauma, (i.e., fracture or dislocation); atlanto/axial fracture with instability; occipitocervical dislocation; revision of previous cervical spine surgery; and tumors.
The occipital bone screws are limited to occipital fixation only.
The use of pedicle screws is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in or treat conditions involving the cervical spine.
The Nextgen Altius OCT System can also be linked to the Biomet Polaris Systems via transitional rods or using Altius Rod Connectors or Polaris Dominoes. Please refer to the individual system's package insert for a list of indications for use for each system.
Product codes
KWP, MNI, MNH
Device Description
The Nextgen Altius OCT System is an occipito-cervico-thoracic spinal fixation system. This submission is a line extension to Altius OCT System to add CoCr rods and alternate styles of rods, and screws, as well as other system components to the system and to update the indications for use for the system as a whole.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine and occipitocervico-thoracic junction (occiput -T3), T1-T3
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Mechanical testing was conducted in accordance with FDA's Guidance for Industry and FDA Staff - Spinal System 510(k)s dated May 3, 2004. Per the guidance document, the following testing was conducted: static compression bending, static torsion fatigue and compression bending fatigue. Testing was conducted in accordance with ASTM F2706, Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model, ASTM F1717, Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model and ASTM F1798, Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants. The mechanical testing verifies that the subject components are substantially equivalent to other spinal systems currently on the market and has met all mechanical test requirements based on the worst-case construct testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K043229, K033961, K022048, K110353, K103100, K080828, K042508, K110522, K082728, K090714, K083071, K091365
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K113593
page 1 of 2
Image /page/0/Picture/1 description: The image shows the logo for Biomet Spine. The logo is in black and white and features the word "BIOMET" in a stylized font. Below the word "BIOMET" is the word "SPINE" in a smaller, less stylized font. The logo is simple and clean, and it is likely used to represent the company and its products.
APR 1 7 2012
510(k) Summary
Summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.92.
| Preparation Date: | April 6, 2012 |
|---|---|
| Applicant/Sponsor: | Biomet Spine |
| 100 Interpace Parkway | |
| Parsippany, NJ 07054 | |
| Contact Person: | Vivian Kelly |
| Phone: 973-299-9300 x2214 | |
| Fax: 973-257-0232 | |
| Trade name: | Nextgen Altius OCT System |
| Common Name: | Occipito-cervico-thoracic spinal fixation system |
| Product Code & Classification | |
| Name: | KWP - Spinal interlaminal fixation orthosis |
| MNI & MNH - Noncervical, pedicle screw spinal system | |
| Device Panel - Regulation No.: | Orthopedic - 21 CFR 888.3050 and 888.3070 |
Device Description:
The Nextgen Altius OCT System is an occipito-cervico-thoracic spinal fixation system. This submission is a line extension to Altius OCT System to add CoCr rods and alternate styles of rods, and screws, as well as other system components to the system and to update the indications for use for the system as a whole.
Indications for Use:
When intended for stabilization as an adjunct to fusion of the cervical spine and occipitocervico-thoracic junction (occiput -T3), the Nextgen Altius OCT System is intended for use with allograft or autograft and indicated for: DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); spondylolisthesis; deformities or curvatures (i.e., scoliosis and/or lordosis); pseudoarthrosis; spinal stenosis; trauma, (i.e., fracture or dislocation); atlanto/axial fracture with instability; occipitocervical dislocation; revision of previous cervical spine surgery; and tumors.
The occipital bone screws are limited to occipital fixation only.
The use of pedicle screws is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in or treat conditions involving the cervical spine.
The Nextgen Altius OCT System can also be linked to the Biomet Polaris Systems via transitional rods or using Altius Rod Connectors or Polaris Dominoes. Please refer to the individual system's package insert for a list of indications for use for each system.
Summary of Technologies:
1
The technological characteristics of the new components are the same as, or similar to, th predicate devices in regards to design, indications for use and operational principle.
Performance Data:
Mechanical testing was conducted in accordance with FDA's Guidance for Industry and FDA Staff - Spinal System 510(k)s dated May 3, 2004. Per the guidance document, the following testing was conducted: static compression bending, static torsion fatigue and compression bending fatigue. Testing was conducted in accordance with ASTM F2706, Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model, ASTM F1717, Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model and ASTM F1798, Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants. The mechanical testing verifies that the subject components are substantially equivalent to other spinal systems currently on the market and has met all mechanical test requirements based on the worst-case construct testing.
Substantial Equivalence:
The subject components in the Nextgen Altius OCT System are substantially equivalent to the current components in the Altius OCT System (K043229, K033961 & K022048), the Depuy Mountaineer OCT Spinal System (K110353, K103100, K080828, & K042508) and the Vertex Max® & Select™ Reconstruction Systems (K110522, K082728, K090714, K083071, & K091365). The Nextgen Altius OCT System is substantially equivalent to these predicate systems with respect to intended use and indications, technological characteristics, and principles of operation and do not present any new issues of safety or effectiveness.
Conclusion:
The Nextgen Altius OCT System is substantially equivalent to the predicate systems when used as an occipito-cervico-thoracic spinal fixation device. The intended use and fundamental technology of the system remain unchanged. Furthermore, mechanical testing and other supporting information sufficiently demonstrate the substantial equivalence of the subject components to the other components in the Altius OCT System. Based on this information, the subject components do not raise any new issues regarding the safety or efficacy.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Biomet Spine % Ms. Vivian Kelly 100 Interpace Parkway Parsippany, New Jersey 07054
APR 1 7 2012
Re: K113593
Trade/Device Name: Nextgen OCT System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: KWP, MNI, MNH Dated: April 6, 2012 Received: April 9, 2012
Dear Ms. Kelly:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical Grice-related adverse events) (21 CFR 803); 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. Vivian Kelly
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K113593
Device Name: Nextgen OCT System
Indications for Use:
When intended for stabilization as an adjunct to fusion of the cervical spine and occipito-cervicothoracic junction (occiput -T3), the Nextgen Altius OCT System is intended for use with allograft or autograft and indicated for: DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); spondylolisthesis; deformities or curvatures (i.e., scoliosis, kyphosis and/or lordosis); pseudoarthrosis; trauma, (i.e., fracture or dislocation); atlanto/axial fracture with instability; occipitocervical dislocation; revision of previous cervical spine surgery; and tumors.
The occipital bone screws are limited to occipital fixation only.
The use of pedicle screws, is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in or treat conditions involving the cervical spine.
The Nextgen Altius OCT System can also be linked to the Biomet Polaris Systems via transitional rods or using Altius Rod Connectors or Polaris Dominoes. Please refer to the individual system's package insert for a list of indications for use for each system.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Dision Sign-Off) Division of Surgical, Orthopedic, /and Restorative Devices
K 113593 510(k) Number_