(64 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and intended use of a traditional pedicle screw system, with no mention of AI or ML capabilities.
Yes
The device is intended to immobilize spinal segments and stabilize the operative site during spinal fusion, which are therapeutic actions to treat spinal conditions.
No
The "Altus Spine Pedicle Screw System" is described as a system of implantable screws and rods used to immobilize spinal segments as an adjunct to fusion, indicating its purpose is treatment and stabilization during surgical procedures, not diagnosis. The "Intended Use / Indications for Use" section clearly states its therapeutic purpose.
No
The device description explicitly states that the system consists of "implantable screws to be used with implantable rods" and that these components are made of "titanium alloy" and "cobalt chrome." This indicates a physical, hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system used to stabilize the spine during fusion. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details implantable screws and rods made of specific materials, designed for physical attachment to the spine. This aligns with a surgical implant, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting diseases or conditions through in vitro methods, or providing information for diagnosis.
Therefore, the Altus Spine Pedicle Screw System is a surgical implant device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Altus Spine 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 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, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
The Altus Spine Pedicle Screw System may be used for noncervical pedicle fixation via in posterior percutaneous approach with MIS instrumentations fisted above. When used as an anterolateral thoracic/umbar system the Altus Spine 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 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 Pedicle Screw System attaches to the vertebral body by means of screws to the non-cervical spinal and allows a surgeon to build a spinal implant construct with the intent to stabilize the spinal operative site during the fusion process. Implantable components are composed of titanium alloy meeting the requirements of ASTM F136 and cobalt chrome meeting the requirements of ASTM F1537. The device is supplied non-sterile and is intended for sterilization by hospital personnel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar, and sacral 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)
The following tests were performed on the Altus Spine Pedicle Screw System: static and dynamic compression bending, and static torsion per ASTM F1717, and static screw-tulip dissociation testing (neutral and max angulation) per ASTM F1798. Test results demonstrate substantially equivalent mechanical performance of the subject device as compared to the predicates.
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.
Vertebron Pedicle Screw System (K051716), Optima Pedicle Screw System (K024096), Tiger Pedicle Screw System (K121728)
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
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July 24, 2018
Altus Partners, LLC Mr. Mark Melton Regulatory Affairs Specialist 1340 Enterprise Drive West Chester, Pennsylvania 19380
Re: K181339
Trade/Device Name: Altus Spine Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB, KWO Dated: May 25, 2018 Received: May 29, 2018
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 (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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/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.
Ronald P. Jean -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K181339
Device Name Altus Spine Pedicle Screw System
Indications for Use (Describe)
The Altus Spine 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 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, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
The Altus Spine Pedicle Screw System may be used for noncervical pedicle fixation via in posterior percutaneous approach with MIS instrumentations fisted above. When used as an anterolateral thoracic/umbar system the Altus Spine 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)
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, LLC
1340 Enterprise Drive
West Chester, PA 19380
Phone: 610-356-6148
Fax: 610-300-3049 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Mark Melton
Regulatory Affairs Specialist
mmelton@-spine.com |
| DATE PREPARED: | July 20, 2018 |
| COMMON NAME: | Pedicle Screw Spinal System |
| PROPRIETARY NAME: | Altus Spine Pedicle Screw System |
| PREDICATE DEVICES: | The Primary predicate device is:
Vertebron Pedicle Screw System (K051716)
The additional predicate devices are:
Optima Pedicle Screw System (K024096)
Tiger Pedicle Screw System (K121728) |
| CLASSIFICATION NAME: | 21 CFR §888.3060 Spinal Intervertebral Fixation Orthosis
21 CFR §888.3070 Thoracolumbosacral Pedicle Screw System |
| PRODUCT CODES: | NKB, KWQ |
| DEVICE CLASS: | Class II |
DEVICE DESCRIPTION:
The Altus Spine 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 Pedicle Screw System attaches to the vertebral body by means of screws to the non-cervical spinal and allows a surgeon to build a spinal implant construct with the intent to stabilize the spinal operative site during the fusion process. Implantable components are composed of titanium alloy meeting the requirements of ASTM F136 and cobalt chrome meeting the requirements of ASTM F1537. The device is supplied non-sterile and is intended for sterilization by hospital personnel.
INDICATIONS FOR USE:
The Altus Spine 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 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, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
The Altus Spine Pedicle Screw System may be used for noncervical pedicle fixation via in
4
posterior percutaneous approach with MIS instrumentation for the indications listed above. When used as an anterolateral thoracic/lumbar system the Altus Spine 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 Pedicle Screw System is the same as the primary predicate in regards to implant materials and surgical technique.
SUMMARY OF NON-CLINIAL TESTS SUBMITTED:
The following tests were performed on the Altus Spine Pedicle Screw System: static and dynamic compression bending, and static torsion per ASTM F1717, and static screw-tulip dissociation testing (neutral and max angulation) per ASTM F1798. Test results demonstrate substantially equivalent mechanical performance of the subject device as compared to the predicates.
SUBSTANTIAL EQUIVALENCE CONCLUSION:
The Altus Spine Pedicle Screw System is the same as the primary predicate (K051716) in regards to implant materials and surgical technique.
Altus Partners has determined that the modifications to the Altus Spine Pedicle Screw System do not alter the system function, strength and stability or materials. Therefore, the Altus Spine Pedicle Screw System is substantially equivalent to the predicate devices, and raises no new questions of safety or effectiveness.