(148 days)
Not Found
No
The 510(k) summary describes a mechanical spinal implant system and does not mention any AI or ML components or functionalities.
Yes
The device aids in spinal fusion and stabilizes the spinal operative site, which are therapeutic interventions for various spinal conditions like fractures, instability, tumors, and degenerative disease.
No
The device is described as an implantable system (screws and rods) used for spinal fusion and stabilization, not for diagnosing medical conditions.
No
The device description explicitly states it consists of "implantable screws to be used with implantable rods" and that these components are made of "titanium alloy," indicating it is a hardware-based medical device.
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 designed to provide mechanical support and stabilization to the spine as an adjunct to fusion. This is a therapeutic intervention, not a diagnostic test performed on samples from the human body.
- Device Description: The device description details implantable screws and rods made of titanium alloy, which are physical components for surgical implantation. This is consistent with a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition based on in vitro testing.
Therefore, the Altus Spine Sochi OCT Spinal System is a surgical implant device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Altus Spinal System is intended to provide immobilization of spinal segments as an adjunct to fission for the following acute and chonic instabilities of the canical spine (C1 to C7), and the thoracic spine from T1-T3: Tramatic spine fracturs andor tranmatic dislocations; Instability or deformity; Fisions (e.g. pseudarthrosis); Tumors involving the cervical spine; Degenerative diseas; including intractable radiculopathy and or myelopathy new of discogenic origin as confirmed by radies, and degenerative disease of the facets with instability.
The Altus Sochi OCT System is also intentiv of the spinal column even in the absent of fusion for a linited time in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
In order to achieve additional levels of fixation, the Altus Spine Spinal Spinal Spinal System with the use of transition rods and rod connectors.
Product codes (comma separated list FDA assigned to the subject device)
NKG, KWP
Device Description
The Altus Spine Sochi OCT Spinal 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 Sochi OCT Spinal System attaches to the vertebral body by means of screws to the 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 of bone graft in the disc space. Implantable components are composed of titanium alloy meeting the requirements of ASTM F136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C1 to C7), and the thoracic spine from T1-T3, craniocervical junction
Indicated Patient Age Range
Not Found
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. The Altus Spine Sochi OCT Spinal System are manufactured the same as the primary predicate Theken Atoll OCT Spinal System (K083863).
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.
Theken Atoll OCT Spinal System (K083863)
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
§ 888.3075 Posterior cervical screw system.
(a)
Identification. Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (
e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.(b)
Classification. Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant.
(3) Device components must be demonstrated to be biocompatible.
(4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(5) Labeling must include the following:
(i) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(ii) Intended use and indications for use including levels of fixation;
(iii) Device specific warnings, precautions, and contraindications that include the following statements:
(A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies (
e.g., CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.”
(iv) Identification of magnetic resonance (MR) compatibility status;
(v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and;
(vi) Detailed instructions of each surgical step, including device removal.
0
August 20, 2021
Image /page/0/Picture/1 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
Altus Partners, LLC Mark Melton QA/RA Manager 1340 Enterprise Drive West Chester, Pennsylvania 19380
Re: K210887
Trade/Device Name: Altus Spine Sochi OCT Spinal System Regulation Number: 21 CFR 888.3075 Regulation Name: Posterior Cervical Screw System Regulatory Class: Class II Product Code: NKG, KWP Dated: May 24, 2021 Received: May 24, 2021
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
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/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 mediation-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 K210887
Device Name Altus Spine Sochi OCT Spinal System
Indications for Use (Describe)
The Altus Spinal System is intended to provide immobilization of spinal segments as an adjunct to fission for the following acute and chonic instabilities of the canical spine (C1 to C7), and the thoracic spine from T1-T3: Tramatic spine fracturs andor tranmatic dislocations; Instability or deformity; Fisions (e.g. pseudarthrosis); Tumors involving the cervical spine; Degenerative diseas; including intractable radiculopathy and or myelopathy new of discogenic origin as confirmed by radies, and degenerative disease of the facets with instability.
The Altus Sochi OCT System is also intentiv of the spinal column even in the absent of fusion for a linited time in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
In order to achieve additional levels of fixation, the Altus Spine Spinal Spinal Spinal System with the use of transition rods and rod connectors.
| 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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FORM FDA 3881 (8/14)
Page 1 of 1
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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
QA/RA Manager
mmelton@-spine.com |
| DATE PREPARED: | August 20, 2021 |
| COMMON NAME: | Altus Spine Posterior Cervical Spinal System |
| PROPRIETARY NAME: | Altus Spine Sochi OCT Spinal System |
| PREDICATE DEVICES: | The Primary predicate device are:
Theken Atoll OCT Spinal System (K083863) |
| CLASSIFICATION NAME: | 21 CFR §888.3075 Posterior Cervical Screw System |
| PRODUCT CODES: | NKG, KWP |
| DEVICE CLASS: | Class II |
| MATERIAL: | The materials used are Titanium Alloy material that conforms to ASTM
F136 |
DEVICE DESCRIPTION:
The Altus Spine Sochi OCT Spinal 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 Sochi OCT Spinal System attaches to the vertebral body by means of screws to the 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 of bone graft in the disc space. Implantable components are composed of titanium alloy meeting the requirements of ASTM F136.
INDICATIONS FOR USE:
The Altus Spine Sochi OCT Spinal System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7), and the thoracic spine from T1-T3: Traumatic spine fractures and/or traumatic dislocations; Instability or deformity; Failed previous fusions (e.g. pseudarthrosis); Tumors involving the cervical spine; Degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.
The Altus Spine Sochi OCT System is also intended to restore the integrity of the spinal column even in the absent of fusion for a limited time in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
In order to achieve additional levels of fixation, the Altus Spine Sochi OCT System may be used with the Theken Coral Spinal System with the use of transition rods and rod connectors.
4
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS:
The Altus Spine Sochi OCT Spinal System is the same as the primary predicate in regards to implant materials and surgical technique. The only difference between the primary predicate and the Altus Spine Sochi OCT Spinal System is the name. There were no design changes to the primary predicate when compared to the Altus Spine Sochi OCT Spinal System.
SUMMARY OF NON-CLINAL TESTS SUBMITTED:
No testing is required. The Altus Spine Sochi OCT Spinal System are manufactured the same as the primary predicate Theken Atoll OCT Spinal System (K083863).
SUBSTANTIAL EQUIVALENCE CONCLUSION:
The Altus Spine Sochi Spinal System is substantially equivalent to the predicate devices in terms of intended use, material used, and performance. The Altus Spine Sochi OCT Spinal System is the same design, dimensions and instrumentation to the predicate devices.