(295 days)
Not Found
No
The device description and intended use focus solely on the physical components and their function in spinal fusion. There is no mention of software, algorithms, or any capabilities that would suggest the use of AI or ML. The performance studies section also indicates no testing was required, further suggesting a lack of complex software or AI/ML components.
Yes
The device is intended to provide immobilization of spinal segments as an adjunct to fusion in the treatment of various spinal conditions, indicating it is used to treat or alleviate a disease or condition.
No
Explanation: This device is described as an implantable system of screws and rods used for spinal fusion and stabilization, not for diagnosing medical conditions.
No
The device description clearly states it consists of "implantable screws to be used with implantable rods" and other "implantable components," indicating it is a physical hardware device, not software only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "immobilization of spinal segments... as an adjunct to fusion." This describes a surgical implant used to stabilize the spine, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details implantable screws and rods made of specific materials, designed to be surgically attached to the vertebral body. This aligns with a surgical implant, not an IVD.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Performing tests in a laboratory setting
The device is a surgical implant intended for mechanical support and stabilization during spinal fusion.
N/A
Intended Use / Indications for Use
The Altus Spine HA Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.
The Altus Spine HA Pedicle Screw System is intended for noncervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origins with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
The Altus Spine HA Pedicle Screw System may be used for noncervical pedicle fixation via in posterior percutaneous approach with MIS instrumentation for the indications listed above. When used as an anterolateral thoracic/lumbar system the Altus Spine HA Pedicle Screw System may also be used for the same indications listed above as an adjunct to fusion.
Product codes (comma separated list FDA assigned to the subject device)
NKB, KWQ
Device Description
The Altus Spine HA Pedicle Screw System consists of a system of implantable screws to be used with implantable rods for the purpose of aiding in spinal fusion. The Altus Spine HA Pedicle Screw System attaches to the vertebral body by means of screws to the non-cervical spine and allows a surgeon to build a spinal implant construct with the intent to stabilize the spinal operative site during the fusion process of bone graft in the disc space. Implantable components are composed of titanium alloy meeting the requirements of ASTM F136, cobalt chrome meeting the requirements of ASTM F1537 and Hydroxyapatite meeting the requirements of ASTM F1185. Other components included in this submission are (e.g., cross connectors, lateral connectors, inline connectors, dominos, etc.). Only the HA coated screws are supplied sterile packaged. All other components are supplied non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar, and sacral spine, non-cervical spine
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)
No testing is required. (e.g., engineering rational demonstrated that no new worst-case was introduced with the addition of the HA screws and all other components were previously cleared in (K200322). Altus Spine HA Pedicle Screw System are manufactured the same as the primary predicate Altus Spine Pedicle Screw System (K200322). Hydroxyapatite coating and sterile packing are processed the same as the primary predicate Whistler Modular Pedicle Screw System (K182478).
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
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
0
January 26, 2021
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized symbol. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
Altus Partners, LLC Mark Melton, QA/RA Manager 1340 Enterprise Drive West Chester. Pennsylvania 19380
Re: K200922
Trade/Device Name: Altus Spine HA Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB, KWQ Dated: December 29, 2020 Received: December 29, 2020
Dear Mark 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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 (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 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.
Colin O'Neill, M.B.E. 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
2
Indications for Use
510(k) Number K200922
Device Name Altus Spine HA Pedicle Screw System
Indications for Use (Describe)
The Altus Spine HA Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.
The Altus Spine HA Pedicle Screw System is intended for noncervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origins with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
The Altus Spine HA Pedicle Screw System may be used for noncervical pedicle fixation via in posterior percutaneous approach with MIS instrumentation for the indications listed above. When used as an anterolateral thoracic/lumbar system the Altus Spine HA Pedicle Screw System may also be used for the same indications listed above as an adjunct to fusion.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
| SUBMITTER: | Altus Partners
1340 Enterprise Drive
West Chester, PA 19380
Phone: 610-356-6148
Fax: 610-300-3049 |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Mark Melton
Regulatory Affairs Specialist
mmelton@altus-spine.com |
| DATE PREPARED: | January 26, 2021 |
| COMMON NAME: | Pedicle Screw Spinal System |
| PROPRIETARY NAME: | Altus Spine HA Pedicle Screw System |
| PRIMARY PREDICATE: | Altus Spine Pedicle Screw System (K200322) |
| ADDITIONAL PREDICATE: | Whistler Modular Pedicle Screw System (K182478) |
| CLASSIFICATION NAME: | 21 CFR §888.3070 Thracolumbosacral Pedicle Screw System |
| PRODUCT CODES: | NKB, KWQ |
| DEVICE CLASS: | Class II |
| MATERIAL: | The materials used are Titanium Alloy material that conforms to ASTM
F136, Cobalt Chrome that conforms to ASTM F1537 and ASTM F1185
Hydroxyapatite |
DEVICE DESCRIPTION:
The Altus Spine HA Pedicle Screw System consists of a system of implantable screws to be used with implantable rods for the purpose of aiding in spinal fusion. The Altus Spine HA Pedicle Screw System attaches to the vertebral body by means of screws to the non-cervical spine and allows a surgeon to build a spinal implant construct with the intent to stabilize the spinal operative site during the fusion process of bone graft in the disc space. Implantable components are composed of titanium alloy meeting the requirements of ASTM F136, cobalt chrome meeting the requirements of ASTM F1537 and Hydroxyapatite meeting the requirements of ASTM F1185. Other components included in this submission are (e.g., cross connectors, lateral connectors, inline connectors, dominos, etc.). Only the HA coated screws are supplied sterile packaged. All other components are supplied non-sterile.
INDICATIONS FOR USE:
The Altus Spine HA Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.
The Altus Spine HA Pedicle Screw System is intended for noncervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origins with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis,
4
kyphosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.
The Altus Spine HA Pedicle Screw System may be used for noncervical pedicle fixation via in posterior percutaneous approach with MIS instrumentation for the indications listed above. When used as an anterolateral thoracic/lumbar system, the Altus Spine HA Pedicle Screw System may also be used for the same indications listed above as an adjunct to fusion.
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS:
The Altus Spine HA Pedicle Screw System is the same as the primary predicate in regards to indications for use /intended use, technological characteristics, implant materials and surgical technique.
SUMMARY OF NON-CLINAL TESTS SUBMITTED:
No testing is required. (e.g., engineering rational demonstrated that no new worst-case was introduced with the addition of the HA screws and all other components were previously cleared in (K200322). Altus Spine HA Pedicle Screw System are manufactured the same as the primary predicate Altus Spine Pedicle Screw System (K200322). Hydroxyapatite coating and sterile packing are processed the same as the primary predicate Whistler Modular Pedicle Screw System (K182478).
SUBSTANTIAL EQUIVALENCE CONCLUSION:
The Altus Spine HA Pedicle Screw System is substantially equivalent to the predicate devices in terms of intended use, material used, and performance. The Altus Spine HA Pedicle Screw System has a similar design, dimensions and instrumentation to the predicate devices.