(116 days)
No
The summary describes a physical implant device made of titanium alloy for spinal fusion. There is no mention of software, algorithms, image processing, or any terms related to AI or ML. The performance studies focus on engineering analysis of the physical device.
Yes
The device is indicated for degenerative disc disease, which is a medical condition, and aims to facilitate fusion and prevent movement, indicating a direct therapeutic action.
No
The device is an interbody fusion system designed to treat degenerative disc disease by facilitating spinal fusion, not to diagnose medical conditions. Its purpose is therapeutic, involving implantation and not diagnostic analysis.
No
The device description explicitly states the implants are made of titanium alloy and have physical features like a hollow chamber and teeth, indicating it is a hardware device.
Based on the provided information, 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 (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the Altus Spine Titanium Interbody Fusion System is an implantable device used in spinal fusion surgery. It is a physical structure designed to be placed within the body to facilitate bone fusion.
- Lack of Diagnostic Function: The device does not perform any tests on biological samples to diagnose a condition or provide diagnostic information. Its purpose is therapeutic and structural.
Therefore, the Altus Spine Titanium Interbody Fusion System falls under the category of an implantable surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Altus Spine Titanium 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 Titanium Interbody Fusion 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 Titanium 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 Titanium Interbody Fusion System implants are made of titanium alloy (Ti-6Al-4V) that conforms to ASTM F136.
The Altus Spine Titanium 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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Engineering analysis was presented to demonstrate that the Altus Spine Titanium Interbody Fusion System does not present a new worst case in performance and is substantially equivalent to the predicates. Altus Spine has determined that the modification of the Altus Spine Titanium Interbody Fusion System do not alter the system function, strength and stability.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Altus Spine Titanium Interbody Fusion System (K170512), Altus Spine Interbody Fusion System (K160976)
Reference Device(s)
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
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Altus Partners, LLC Mark Melton Senior Engineer 1340 Enterprise Drive
West Chester, Pennsylvania 19380
August 29, 2017
Re: K171329
Trade/Device Name: Altus Spine Titanium Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: July 12, 2017 Received: August 4, 2017
Dear Mr. Melton:
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 device
1
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.
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 (DICE) 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 (DICE) 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,
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)
K171329
Device Name Altus Spine Titanium Interbody Fusion System
Indications for Use (Describe)
The Altus Spine Titanium 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 Titanium Interbody Fusion 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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8. 510(k) Summary
| SUBMITTER: | Altus Partners, LLC
1340 Enterprise Drive
West Chester, PA 19380
Phone: 610-355-4156
Fax: 610-300-3049 |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Mark Melton
mmelton@altus-spine.com |
| DATE PREPARED: | August 28, 2017 |
| COMMON NAME: | Interbody Fusion Device |
| PROPRIETARY NAME: | Altus Spine Titanium Interbody Fusion System |
| PRIMARY PREDICATE DEVICES: | Altus Spine Titanium Interbody Fusion System (K170512) |
| ADDITIONAL PREDICATE DEVICES: | Altus Spine Interbody Fusion System (K160976) |
| CLASSIFICATION NAME: | 21 CFR §888.3080 Intervertebral Body Fusion Device |
| PRODUCT CODES: | MAX |
| DEVICE CLASS: | Class II |
| MATERIAL: | Titanium Alloy that conforms to ASTM F136 |
DEVICE DESCRIPTION:
The Altus Spine Titanium 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 Titanium Interbody Fusion System implants are made of titanium alloy (Ti-6Al-4V) that conforms to ASTM F136.
The Altus Spine Titanium 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.
INDICATIONS FOR USE:
The Altus Spine Titanium 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 Titanium Interbody Fusion System is to be combined with cleared supplemental fixation systems, such as the Altus Spine Pedicle Screw System.
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SUMMARY OF TECHNOLOGICAL CHARACTERISTICS:
K171329 Page 2 of 2
The Altus Spine Titanium Interbody Fusion System is a modification to the predicate (K170512). The modification includes larger graft windows and an additional implant footprint The Altus Spine Interbody Fusion System and the predicate (K073502) share the same indications for use and surgical technique. The design is essentially the same fundamental technology with minor dimensional changes.
SUMMARY OF NON-CLINAL TESTS SUBMITTED:
Engineering analysis was presented to demonstrate that the Altus Spine Titanium Interbody Fusion System does not present a new worst case in performance and is substantially equivalent to the predicates.
SUBSTANTIAL EQUIVALENCE CONCLUSION:
The Altus Spine Titanium Interbody Fusion System is the predicate (K170512) in regards to indications for use and surgical technique.
Altus Spine has determined that the modification of the Altus Spine Titanium Interbody Fusion System do not alter the system function, strength and stability. Therefore, the Altus Spine Titanium Interbody Fusion System is substantially equivalent to the predicate devices, and raises no new questions of safety or effectiveness.