(309 days)
Not Found
No
The summary describes a physical implantable device for spinal fusion, made of PEEK and Titanium. There is no mention of software, algorithms, image processing, or any terms related to AI or ML. The performance studies focus on mechanical testing of the implant.
Yes
The device is indicated for use as an adjunct to fusion in patients with degenerative disc disease, which describes a therapeutic purpose.
No
The device is an interbody fusion system used as an adjunct to fusion for treating degenerative disc disease, not for diagnosing it. Its purpose is therapeutic (fusion), not diagnostic.
No
The device description clearly states the device is made of physical materials (PEEK, Tantalum, Titanium alloy) and is an implantable system, indicating it is a hardware device, not software-only.
Based on the provided text, 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 Altus Spine Interbody Standalone Fusion System is a physical implant made of PEEK and Titanium, designed to be surgically placed in the spine to aid in fusion.
- Intended Use: The intended use is to provide structural support and facilitate bone fusion in patients with degenerative disc disease. This is a surgical intervention, not a diagnostic test performed on a sample.
The description clearly indicates a medical device intended for surgical implantation, not for analyzing biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Altus Spine Interbody Standalone Fusion System is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device.
When used with both the cover plate and four (4) provided screws, the Altus Spine Interbody Standalone Fusion System requires no additional supplemental fixation. In any other instance, additional supplemental fixation systems cleared by the FDA for use in the lumbar spine must be used.
Implants with hyperlordotic angles > 20 degrees, regardless of screw usage, must also be used with additional supplemental fixation (e.g. posterior pedicle screw and rod systems).
The interior of the interbody spacer component is intended to be packed with autogenous bone graft and/or allogeneic bone graft material composed of cancellous and/or corticocancellous bone.
Product codes (comma separated list FDA assigned to the subject device)
OVD
Device Description
The Altus Spine Interbody Standalone 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 device is used singly or in pairs to better approximate the anatomical variations observed in different vertebral levels and/or patient anatomy.
The Altus Spine Interbody Standalone Fusion System implants are made of Polyetheretherketone (PEEK) with Tantalum that conforms to ASTM 2026 and ASTM 560 and Titanium alloy (Ti-6Al-4V) that conforms to ASTM F136.
The Altus Spine Interbody Standalone Fusion System has a hollow chamber to permit packing with autogenous bone graft to facilitate fusion, but is the sufficient strength to provide column support even in the absence of fusion for prolonged periods. 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. The anterior superior and inferior surface of the interbody has holes to accept screw to penetrate the intervertebral body endplates for added stability.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2 to 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing in accordance with ASTM F2077-14, ASTM 2267-04, and ASTM Draft Std. F04.25.20.02 demonstrates that the Altus Spine Interbody Standalone Fusion System is substantially equivalent to previously FDA cleared integrated ALIFs with standalone indications.
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.
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
§ 888.3080 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/0 description: The image shows 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 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.
April 19, 2022
Altus Partners, LLC Rand Baker QA/RA Manager 1340 Enterprise Drive West Chester, Pennsylvania 19380
Re: K211837
Trade/Device Name: Altus Spine Interbody Standalone Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: March 24, 2022 Received: March 24, 2022
Dear Mr. Baker:
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.
1
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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K211837
Device Name
Altus Spine Interbody Standalone Fusion System
Indications for Use (Describe)
The Altus Spine Interbody Standalone Fusion System is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device.
When used with both the cover plate and four (4) provided screws, the Altus Spine Interbody Standalone Fusion System requires no additional supplemental fixation. In any other instance, additional supplemental fixation systems cleared by the FDA for use in the lumbar spine must be used.
Implants with hyperlordotic angles > 20 degrees, regardless of screw usage, must also be used with additional supplemental fixation (e.g. posterior pedicle screw and rod systems).
The interior of the interbody spacer component is intended to be packed with autogenous bone graft and/or allogeneic bone graft material composed of cancellous and/or corticocancellous bone.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
K211837 510(k) Summary
| SUBMITTER: | Altus Partners
1340 Enterprise Drive
West Chester, PA 19380
Phone: 610-355-4156
Fax: 610-300-3049 |
|-------------------------------|---------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Rand Baker
QA/RA
rbaker@altus-spine.com |
| DATE PREPARED: | April 7, 2022 |
| COMMON NAME: | Interbody Fusion Device |
| PROPRIETARY NAME: | Altus Spine Interbody Standalone Fusion System |
| PRIMARY PREDICATE DEVICES: | SeaSpine® Vu a POD™ Prime NanoMetalele® Interbody Fusion
Device K162351 |
| ADDITIONAL PREDICATE DEVICES: | Altus Spine Interbody Fusion System (K182406) |
| CLASSIFICATION NAME: | 21 CFR §888.3080 Intervertebral Body Fusion Device |
| PRODUCT CODES: | OVD |
| 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:
ADD
The Altus Spine Interbody Standalone 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 device is used singly or in pairs to better approximate the anatomical variations observed in different vertebral levels and/or patient anatomy.
The Altus Spine Interbody Standalone Fusion System implants are made of Polyetheretherketone (PEEK) with Tantalum that conforms to ASTM 2026 and ASTM 560 and Titanium alloy (Ti-6Al-4V) that conforms to ASTM F136.
The Altus Spine Interbody Standalone Fusion System has a hollow chamber to permit packing with autogenous bone graft to facilitate fusion, but is the sufficient strength to provide column support even in the absence of fusion for prolonged periods. 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. The anterior superior and inferior surface of the interbody has holes to accept screw to penetrate the intervertebral body endplates for added stability.
4
INDICATIONS FOR USE:
The Altus Spine Interbody Standalone Fusion System is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device.
When used with both the cover plate and four (4) provided screws, the Altus Spine Interbody Standalone Fusion System requires no additional supplemental fixation.
In any other instance, additional supplemental fixation systems cleared by the FDA for use in the lumbar spine must be used.
Implants with hyperlordotic angles > 20 degrees, regardless of screw usage, must also be used with additional supplemental fixation (e.g. posterior pedicle screw and rod systems).
The interior of the interbody spacer component is intended to be packed with autogenous bone graft and/or allogeneic bone graft material composed of cancellous and/or corticocancellous bone.
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS:
The Altus Spine Interbody Standalone Fusion System is the same as the primary predicate (K162351) in regard to implant material, intended use, surgical technique, target population, biocompatibility, chemical safety, and sterilization. Both systems utilize screws for intrinsic fixation with a backout plate; however, the Altus Spine Interbody Standalone Fusion System requires 4 screws and the SeaSpine® Vu a POD™ utilizes 2 or 3 screws. Both systems require additional supplemental fixation for implants with hyperlordotic angles > 20 degrees, regardless of screw usage (e.g. posterior pedicle screw and rod systems).
The geometry of the Altus Spine Interbody Standalone Fusion system is similar to the SeaSpine® Vu a POD™, but not identical with a smaller range of sizes (11-20mm vs. 8-30mm) and a marginally larger footprint (32x24mm, 38x27mm, 42x30mm vs. 31x24mm); however, the size, footprint, lordotic angles, as well as graft volume and graft area are substantially equivalent to the 2nd predicate (Altus Spine Interbody Fusion System K182406).
SUMMARY OF NON-CLINAL TESTS SUBMITTED:
Testing in accordance with ASTM F2077-14, ASTM 2267-04, and ASTM Draft Std. F04.25.20.02 demonstrates that the Altus Spine Interbody Standalone Fusion System is substantially equivalent to previously FDA cleared integrated ALIFs with standalone indications.
5
SUBSTANTIAL EQUIVALENCE CONCLUSION:
The Altus Spine Interbody Standalone Fusion System is the same as the predicate (K162351) in regard to implant materials and surgical technique. The Indications for Use have remained the same. Components are substantially equivalent to predicate devices, SeaSpine® Vu a POD™ Prime NanoMetalene® (K162351) and Altus Spine Interbody Fusion System (K182406).
Altus Partners has determined that the modifications to the Altus Spine Interbody Standalone Fusion System do not alter the system function, strength and stability or materials. Therefore, the Altus Spine Interbody Standalone Fusion System is substantially equivalent to the predicate devices and raises no new questions of safety or effectiveness.