(244 days)
No
The summary describes a physical implant (a spacer) and its mechanical properties and intended use. There is no mention of software, algorithms, or data processing that would indicate the presence of AI/ML.
Yes
The device is described as a vertebral body replacement system, indicated for conditions like fracture, osteomyelitis, tumor, or degenerative disorders to restore the integrity of the spinal column and decompress spinal cord/neural tissues. This clearly indicates a therapeutic purpose.
No
The device is an implantable spacer used to replace a diseased or damaged vertebral body in the cervical spine. Its purpose is to physically restore the integrity of the spinal column, not to diagnose a condition.
No
The device description explicitly states the device is manufactured from PEEK or titanium alloy and describes physical features like footprints, sizes, teeth, and surfaces, indicating it is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The ALTA Anterior Cervical Corpectomy Spacer is a physical implant designed to replace a vertebral body in the spine. It is surgically implanted into the patient's body.
- Lack of Specimen Analysis: The description and intended use do not involve the analysis of any biological specimens taken from the patient.
Therefore, based on the provided information, the ALTA Anterior Cervical Corpectomy Spacer is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ALTA Anterior Cervical Corpectomy Spacer is indicated for vertebral body replacement in the cervical spine (C3-C7) in skeletally mature patients. The Alta Anterior Cervical Corpectomy Spacer is intended to replace a diseased or damaged vertebral body caused by fracture, osteomyelitis, or tumor, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. The System is intended to be used with supplemental fixation that has been cleared by the FDA for use in the cervical spine. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion. The System is 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 expectance is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
Product codes
PLR
Device Description
The ALTA Anterior Cervical Corpectomy Spacer is a vertebral body replacement system manufactured from PEEK-OPTIMA LT120HA (HA PEEK) or titanium alloy (Ti6Al4VELI). The devices have trapezoidal footprints and multiple sizes to accommodate patient anatomy and graft windows to help facilitate bony integration. The HA PEEK spacers have unidirectional teeth on both of their inferior and superior surfaces to prevent migration/expulsion and X-ray markers in the form of tantalum pins. The titanium alloy spacers have roughened superior and inferior surfaces to prevent migration/expulsion.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C3-C7)
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
Non-clinical Test Summary: The following analyses were conducted:
- Static and dynamic compression per ASTM F2077
- Static and dynamic torsion per ASTM F2077
- Subsidence per ASTM F2267
The results of these evaluations indicate that the Alta Corpectomy implants are equivalent to predicate devices.
Clinical Test Summary: No clinical studies were performed
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
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 the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 24, 2019
Astura Medical, LLC Parker Kelch Quality Manager 3186 Lionshead Ave, Suite 100 Carlsbad, California 92010
Re: K190426
Trade/Device Name: ALTA Anterior Cervical Corpectomy System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: PLR Dated: October 10, 2019 Received: October 10, 2019
Dear Mr. Kelch:
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,
for Ronald P. Jean, PhD Director (Acting) 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 (if known)
Device Name ALTA Anterior Cervical Corpectomy System
Indications for Use (Describe)
The ALTA Anterior Cervical Corpectomy Spacer is indicated for vertebral body replacement in the cervical spine (C3-C7) in skeletally mature patients. The Alta Anterior Cervical Corpectomy Spacer is intended to replace a diseased or damaged vertebral body caused by fracture, osteomyelitis, or tumor, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. The System is intended to be used with supplemental fixation that has been cleared by the FDA for use in the cervical spine. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion. The System is 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 expectance is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
| 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
510(k) Summary
| Date Prepared | October 10, 2019 |
|---|---|
| Submitted By | Astura Medical |
| 3186 Lionshead Ave, Suite 100 | |
| Carlsbad, CA 92010 | |
| Phone: 760-814-8047 | |
| Contact | Parker Kelch |
| Email: quality@asturamedical.com | |
| Trade Name | ALTA Anterior Cervical Corpectomy Spacer |
| Common Name | vertebral body replacement device |
| Classification Name | vertebral body replacement device – cervical |
| Class | II |
| Product Code | PLR |
| CFR Section | 21 CFR section 888.3060 |
| Device Panel | Orthopedic |
| Primary Predicate | |
| Device | NuVasive Monolith Cervical Corpectomy System (K180550) |
| Secondary Predicate | |
| Device | ALTA Anterior Cervical Interbody Spacer (K160154, K173324) |
| Device Description | The ALTA Anterior Cervical Corpectomy Spacer is a vertebral body replacement |
| system manufactured from PEEK-OPTIMA LT120HA (HA PEEK) or titanium alloy | |
| (Ti6Al4VELI). The devices have trapezoidal footprints and multiple sizes to | |
| accommodate patient anatomy and graft windows to help facilitate bony | |
| integration. The HA PEEK spacers have unidirectional teeth on both of their | |
| inferior and superior surfaces to prevent migration/expulsion and X-ray markers | |
| in the form of tantalum pins. The titanium alloy spacers have roughened | |
| superior and inferior surfaces to prevent migration/expulsion. | |
| Materials | PEEK-OPTIMA LT120HA (PEEK-OPTIMA HA Enhanced) – MAF 2227 (added |
| Material) | |
| Tantalum per ASTM F560 | |
| Titanium alloy (Ti-6Al-4V ELI) per ASTM F136 | |
| Substantial | |
| Equivalence Claimed | |
| to Predicate Devices | The ALTA Anterior Cervical Corpectomy System is substantially equivalent to |
| the predicate devices in terms of intended use, design, materials | |
| used, mechanical safety and performances. | |
| Indications for Use | The ALTA Anterior Cervical Corpectomy Spacer is indicated for vertebral body |
| replacement in the cervical spine (C3-C7) in skeletally mature patients. The | |
| Alta Anterior Cervical Corpectomy Spacer is intended to replace a diseased or | |
| damaged vertebral body caused by fracture, osteomyelitis, or tumor, or for | |
| reconstruction following corpectomy performed to achieve decompression of | |
| the spinal cord and neural tissues in cervical degenerative disorders. The | |
| System is intended to be used with supplemental fixation that has been | |
| cleared by the FDA for use in the cervical spine. The System is designed for use | |
| with autogenous and/or allogeneic bone graft comprised of cancellous and/or | |
| corticocancellous bone graft as an adjunct to fusion. The System is 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 expectance is of insufficient duration | |
| to permit achievement of fusion, with bone graft used at the surgeon's | |
| discretion. | |
| Non-clinical Test | |
| Summary | The following analyses were conducted: |
| ● Static and dynamic compression per ASTM F2077 | |
| ● Static and dynamic torsion per ASTM F2077 | |
| ● Subsidence per ASTM F2267 | |
| The results of these evaluations indicate that the Alta Corpectomy implants | |
| are equivalent to predicate devices. | |
| Clinical Test | |
| Summary | No clinical studies were performed |
| Conclusions: Non- | |
| Clinical and Clinical | Astura Medical considers the ALTA Anterior Cervical Corpectomy Spacer to be |
| equivalent to the predicate devices listed above. This conclusion is based upon | |
| the devices' similarities in principles of operation, technology, materials | |
| and indications for use. |
4