(171 days)
Not Found
No
The summary describes a physical implant device and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is used to treat degenerative disc disease, facilitating fusion of vertebrae to alleviate pain and restore stability.
No
The text describes an "Interbody Fusion System" which is a surgical implant designed to facilitate spinal fusion. It is used in patients already diagnosed with degenerative disc disease, and its purpose is therapeutic (fusion), not diagnostic.
No
The device description clearly details physical implants made of PEEK, Tantalum, and Titanium alloy, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for spinal fusion in patients with degenerative disc disease. This is a surgical procedure involving the implantation of a device into the body.
- Device Description: The device is a physical implant made of PEEK and titanium, designed to be placed between vertebrae.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the human body (like blood, urine, or tissue) to provide diagnostic information. Its purpose is structural support and facilitating bone fusion.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is used in vivo (inside the body) as a therapeutic implant.
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 is to be combined with cleared supplemental fixation systems.
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 PEEK with Tatalum conforming to ASTM F2026 and ASTM F560 and 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
spinal levels from L2-S1
Indicated Patient Age Range
skeletally mature patients
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
Engineering analysis was presented to demonstrate that the Altus Spine Interbody Fusion System does not present a new worst case in performance and is substantially equivalent to the predicates.
Key Metrics
Not Found
Predicate Device(s)
K073502, K160976, K171329, K141358
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 22, 2019
Altus Partners, LLC Mark Melton Regulatory Affairs & Ouality Assurance 1340 Enterprise Drive West Chester, Pennsylvania 19380
Re: K182406
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 6, 2018 Received: January 23, 2019
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Melissa Hall -S
For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K182406
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 is to be combined with cleared supplemental fixation systems.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(k) Summary
| SUBMITTER: | Altus Partners
1340 Enterprise Drive
West Chester, PA 19380
Phone: 610-355-4156
Fax: 610-300-3049 |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Mark Melton
RA&QA
mmelton@altus-spine.com |
| DATE PREPARED: | February 14, 2019 |
| COMMON NAME: | Interbody Fusion Device |
| PROPRIETARY NAME: | Altus Spine Titanium Interbody Fusion System |
| PRIMARY PREDICATE DEVICES: | Vertebron Interbody Fusion System (K073502) |
| ADDITIONAL PREDICATE DEVICES: | Altus Spine Interbody Fusion System (K160976)
Altus Spine Interbody Fusion System (K171329)
Xenco Medical Set-X Hyperlordotic Implant (K141358) |
| CLASSIFICATION NAME: | 21 CFR §888.3080 Intervertebral Body Fusion Device |
| PRODUCT CODES: | MAX |
| DEVICE CLASS: | Class II |
| MATERIAL: | PEEK that conforms to ASTM F2026, Tantalum that conforms to
ASTM F560 and 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 PEEK with Tatalum conforming to ASTM F2026 and ASTM F560 and 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 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
4
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.
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS:
The Altus Spine Interbody Fusion System and the predicate(s) (K073502), (K160976) and (K171329) share the same indications for use and same implant design. The purpose of this 510(k) submission is to include PEEK and Titanium alloy intervertebral body fusion device into the Altus Spine Interbody Fusion System family, which is currently offered in polyetheretherketone (PEEK and Titanium alloy). 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 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 Interbody Fusion System is the same as the predicate (K073502), (K160976) and (K171329) in regards to indications for use and surgical technique.
Altus Spine has determined that the modification of the Altus Spine Interbody Fusion System do not alter the system function, strength and stability. Therefore, the Altus Spine Interbody Fusion System is substantially equivalent to the predicate devices.