(293 days)
Not Found
No
The document describes a passive implant made of PEEK with tantalum markers and a hollow chamber for bone graft. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI or ML. The performance studies are mechanical tests, not algorithmic performance evaluations.
Yes
The device is indicated for treating degenerative disc disease by facilitating spinal fusion and pain relief, which aligns with the definition of a therapeutic device.
No
The device is an interbody fusion system designed to facilitate spinal fusion in patients with degenerative disc disease. Its purpose is to provide structural support and promote bone growth, not to diagnose a condition.
No
The device description clearly states the device is made of PEEK and Tantalum wire markers, indicating it is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Altus Spine Interbody Fusion System is an implantable device designed to be surgically placed in the spine to facilitate fusion. It is used in conjunction with bone graft and supplemental fixation systems. Its purpose is structural support and promoting bone growth, not analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological specimens. The "radiographic studies" mentioned are used for patient assessment and confirming the condition, not as input for the device itself to perform a diagnostic test.
Therefore, the Altus Spine Interbody Fusion System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Altus Spine Interbody Fusion System is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spiral surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis at the involved level(s).
The Altus Spine Interbody Fusion System is to be combined with cleared supplemental fixation systems, such as the Altus Spine Pedicle Screw System.
Product codes
MAX
Device Description
The Altus Spine Interbody Fusion System implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.
The Altus Spine Interbody Fusion System implants are made of Polyetheretherketone (PEEK) that conforms to ASTM F2026. This material is utilized due to its radiolucent properties, which aid the surgeon in determining if fusion in the operative site has occurred. Tantalum wire markers are inserted into the components to give surgeons a visual aid in determining the location of the implant, both inter and poster-operatively.
The Altus Spine Interbody Fusion System has a hollow chamber to permit packing with autogenous bone graft to facilitate fusion. The superior and inferior surfaces of the construct have a pattern of teeth to provide increased stability and to help prevent movement of the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
spinal levels from L2-S1
Indicated Patient Age Range
skeletally mature patients
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
Mechanical testing was performed as follows:
- Static Compression Shear and Compression, Dynamic Compression Shear and Compression per ASTM F2077-14 – Test Methods for Intervertebral Body Fusion Devices
- Subsidence per ASTM F2267 Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
- Expulsion per FDA Guidance
Key Metrics
Not Found
Predicate Device(s)
K073502, K121254, K151140, K081614, K123207, K153107, K111553
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 abstract symbol that resembles a stylized caduceus, with three human profiles facing right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 25, 2017
Altus Partners, LLC Claudia Hill Regulatory Affairs Specialist 5149 West Chester Pike Newtown Square, Pennsylvania 19073
Re: K160976
Trade/Device Name: Altus Spine Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: December 22, 2016 Received: December 27, 2016
Dear Claudia Hill:
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 devicerelated 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K160976
Device Name Altus Spine Interbody Fusion System
Indications for Use (Describe)
The Altus Spine Interbody Fusion System is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spiral surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis at the involved level(s).
The Altus Spine Interbody Fusion System is to be combined with cleared supplemental fixation systems, such as the Altus Spine Pedicle Screw System.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
| SUBMITTER: | Altus Partners
1340 Enterprise Drive, Suite 200
West Chester, PA 19380
Phone: 610-355-4156
Fax: 610-300-3049 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Claudia Hill, MSME, RAC
Regulatory Affairs & Quality Assurance
chill@altus-spine.com |
| DATE PREPARED: | January 23, 2017 |
| COMMON NAME: | Interbody Fusion Device |
| PROPRIETARY NAME: | Altus Spine Interbody Fusion System |
| PRIMARY PREDICATE
DEVICE: | Vertebron Interbody Fusion System (K073502) |
| ADDITIONAL PREDICATE
DEVICES: | Camber Spine Technologies TLS 5.0 Interbody Cage (K121254); LnK Lumbar
Interbody Fusion Cage System (K151140); Interbody Innovation Zeus
Intervertebral Fusion Devices (K081614); OsteoMed Spine PrimaLIF LLIF
Unitary PEEK Lateral Lumbar Interbody Fusion System (K123207); Choice
Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon) (K153107);
SpineFrontier Lumbar IBF System (K111553) |
| CLASSIFICATION NAME: | 21 CFR §888.3080 Intervertebral Body Fusion Device |
| PRODUCT CODES: | MAX |
| DEVICE CLASS: | Class II |
| MATERIAL: | The material used is PEEK conforming to ASTM F2026, and titanium alloy
conforming to ASTM F136 or tantalum conforming to ASTM F560. |
DEVICE DESCRIPTION:
The Altus Spine Interbody Fusion System implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.
The Altus Spine Interbody Fusion System implants are made of Polyetheretherketone (PEEK) that conforms to ASTM F2026. This material is utilized due to its radiolucent properties, which aid the surgeon in determining if fusion in the operative site has occurred. Tantalum wire markers are inserted into the components to give surgeons a visual aid in determining the location of the implant, both inter and poster-operatively.
The Altus Spine Interbody Fusion System has a hollow chamber to permit packing with autogenous bone graft to facilitate fusion. The superior and inferior surfaces of the construct have a pattern of teeth to provide increased stability and to help prevent movement of the device.
4
INDICATIONS FOR USE:
The Altus Spine Interbody Fusion System is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).
The Altus Spine Interbody Fusion System is to be combined with cleared supplemental fixation systems, such as the Altus Spine Pedicle Screw System.
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS:
The Altus Spine Interbody Fusion System and the predicate (K073502) share the same indications for use, the same material and similar designs. All of the heights, lengths and widths are within range covered by its predicate devices.
SUMMARY OF NON-CLINICAL TESTS SUBMITTED:
Mechanical testing was performed as follows:
- Static Compression Shear and Compression, Dynamic Compression Shear and Compression per ASTM F2077-14 – Test Methods for Intervertebral Body Fusion Devices
- · Subsidence per ASTM F2267 Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
- . Expulsion per FDA Guidance
SUBSTANTIAL EQUIVALENCE CONCLUSION:
The revised Altus Spine Interbody Fusion System is the predicate (K073502) in regards to implant materials and surgical technique. The Indications for Use have remained the same. Components have been added that are substantially equivalent to predicate devices.
Altus Partners has determined that the modifications to the Altus Spine Interbody Fusion System do not alter the system function, strength and stability or materials. Therefore, the revised Altus Spine Interbody Fusion System is substantially equivalent to the predicate devices.