(77 days)
No
The 510(k) summary describes a physical implant (vertebral body replacement system) and its materials and mechanical testing. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
The device is intended to replace a collapsed, damaged, or unstable vertebral body and restore the integrity of the spinal column, which are therapeutic actions.
No
Explanation: The Ascend VBR System is a vertebral body replacement system designed to replace collapsed, damaged, or unstable vertebral bodies. Its purpose is to restore the integrity of the spinal column, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states the device consists of physical components (VBR cores and endplates) made of titanium alloy, which are hardware. The performance studies also focus on the mechanical properties of these physical components.
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 designed to replace vertebral bodies in the spine. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the materials and construction of a physical implant for surgical insertion.
- Performance Studies: The performance studies listed (mechanical testing, biocompatibility) are typical for surgical implants, not IVDs which would involve analytical and clinical performance related to testing biological samples.
- No mention of biological samples or diagnostic testing: There is no indication that this device is used to examine specimens derived from the human body to provide information for diagnostic purposes.
Therefore, the Ascend VBR System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Ascend VBR System is intended for use in skeletally mature patients in the cervical spine (C2-T1) and in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e., fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders.
The Ascend VBR 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, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
The Ascend VBR System is intended to be used with supplemental spinal fixation systems cleared for use in the cervical, thoracic, and/or lumbar spine. The use of bone grafting material with the Ascend VBR System is optional.
The Ascend NanoTec VBR System with advanced NanoTec surface treatment is intended for use in skeletally mature patients in the cervical spine (C2-T1) and in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e., fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders.
The Ascend NanoTec VBR 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, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
The Ascend NanoTec VBR System is intended to be used with supplemental spinal fixation systems cleared for use in the cervical, thoracic, and/or lumbar spine. The use of bone grafting material with the Ascend NanoTec VBR System is optional.
Product codes (comma separated list FDA assigned to the subject device)
MQP, PLR
Device Description
The Ascend VBR Systems are cervical and thoracolumbar vertebral body replacement systems designed to be inserted in the anterior, anterolateral, and posterior approaches. The implants consist of VBR cores and endplates offered in a range of diameters and heights, endplates, footprints, and lordotic angles to accommodate individual patient anatomy.
The cores are made of titanium alloy per ASTM F136 and the endplates are made of titanium alloy per ASTM F136 or are made of hybrid titanium consisting of commercially pure porous titanium CP-Ti Grade 2 per ASTM F67 and titanium alloy per ASTM F136.
The modular endplates are offered with an optional 20-40 nanometer thin hydroxyapatite surface treatment. The surface treatment presents nano-scale topography on the entirety of the implant surface, in addition to macro-/micro-scale topography existing from prior to treatment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C2-T1), thoracolumbar spine (T1-L5)
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 performance testing was conducted or adopted for the subject Ascend VBR Systems:
- Static and Dynamic Axial Compression per ASTM F2077
- Static and Dynamic Torsion per ASTM F2077
- Static Subsidence per ASTM F2267
- Static Push-out
- Gravimetric Analysis per ASTM F1714
- Particulate Analysis per ASTM F1877
- Bacterial endotoxin testing (BET) per ANSI/AAMI ST72:2019
- Biocompatibility Testing per ISO 10993-1
Testing results demonstrated the subject Ascend VBR Systems are substantially equivalent when compared to other legally marketed devices cleared by FDA.
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.
K222028, K180480, K211805, K161363, K192938, K222973
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
§ 888.3060 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 contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The Department of Health & Human Services logo is a stylized representation of a human figure, while the FDA part includes the acronym "FDA" in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 6, 2023
Alphatec Spine, Inc. Sandy Gill Sr. Regulatory Affairs Specialist 1950 Camino Vida Roble Carlsbad, California 92008
Re: K232173
Trade/Device Name: Ascend™ VBR System, Ascend™ NanoTec™ VBR System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: MQP, PLR Dated: July 21, 2023 Received: July 21, 2023
Dear Sandy Gill:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Brent Showalter -S
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
2
Indications for Use
510(k) Number (if known)
K232173
Device Name
Ascend™ VBR System
Indications for Use (Describe)
The Ascend VBR System is intended for use in skeletally mature patients in the cervical spine (C2-T1) and in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e., fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders.
The Ascend VBR 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, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
The Ascend VBR System is intended to be used with supplemental spinal fixation systems cleared for use in the cervical, thoracic, and/or lumbar spine. The use of bone grafting material with the Ascend VBR System is optional.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
510(k) Number (if known)
Device Name
Ascend™ NanoTec™ VBR System
Indications for Use (Describe)
The Ascend NanoTec VBR System with advanced NanoTec surface treatment is intended for use in skeletally mature patients in the cervical spine (C2-T1) and in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e., fracture), or for reconstruction following corpectorny performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders.
The Ascend NanoTec VBR 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 turnors involving the cervical, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
The Ascend NanoTec VBR System is intended to be used with supplemental spinal fixation systems cleared for use in the cervical, thoracic, and/or lumbar spine. The use of bone grafting material with the Ascend NanoTec VBR System is optional.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Image /page/4/Picture/0 description: The image shows the word "atec" in a stylized font. The "a" is green, while the "tec" is dark blue. There is a trademark symbol to the right of the "c". A black line is underneath the word.
This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92.
| I. | SUBMITTER: | Alphatec Spine, Inc.
1950 Camino Vida Roble
Carlsbad, CA 92008
Phone: (760) 431-9286
Fax: (760) 431-0289 |
|-----|--------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Sandy Gill
Sr. Regulatory Affairs Specialist |
| | Date Summary Prepared: | October 5, 2023 |
| II. | DEVICE | |
| | Trade or Proprietary Name: | Ascend™ VBR Systems:
Ascend™ VBR System,
Ascend™ NanoTec™ VBR System |
| | Common Name:
Classification Name: | Vertebral Body Replacement Device
Spinal Vertebral Body Replacement Device
Spinal Vertebral Body Replacement Device
Cervical |
| | Regulation Number:
Classification:
Product Code: | 21 CFR 888.3060
Class II
MQP, PLR |
III. LEGALLY MARKETED DEVICES
Primary Predicate Device:
| 510(k) | Product Name | Clearance Date |
|---|---|---|
| K192117 | Small VBRTM | 11/1/2019 |
Additional Predicate Devices:
| 510(k) | Product Name | Clearance Date |
|---|---|---|
| K050553 | Novel Spinal Spacer System | 04/18/2005 |
| K193506 | NuVasive X-Core® Expandable VBR System, NuVasive | |
| X-Core® Mini Cervical Expandable VBR System | 02/26/2020 |
References Devices:
| 510(k) | Product Name | Clearance Date |
|---|---|---|
| K222028 | IdentiTi™ and Transcend™ Interbody Systems | 10/07/2022 |
| K180480 | IdentiTi™ Porous Ti Interbody System | 05/31/2018 |
| K211805 | IdentiTi™ and Transcend™ Interbody Systems | 09/22/2021 |
| K161363 | Arsenal Spinal Fixation System | 06/10/2016 |
| K192938 | Invictus™ Spinal Fixation System | 12/12/2019 |
5
Image /page/5/Picture/1 description: The image shows the logo for "atec". The "a" is green, while the "tec" is a dark blue. There is a trademark symbol to the right of the "c". There is a black line underneath the logo.
| 510(k) | Product Name | Clearance Date |
|---|---|---|
| K222973 | IdentiTi™ and Transcend™ Interbody Systems | 11/17/2022 |
IV. DEVICE DESCRIPTION
The Ascend VBR Systems are cervical and thoracolumbar vertebral body replacement systems designed to be inserted in the anterior, anterolateral, and posterior approaches. The implants consist of VBR cores and endplates offered in a range of diameters and heights, endplates, footprints, and lordotic angles to accommodate individual patient anatomy.
The cores are made of titanium alloy per ASTM F136 and the endplates are made of titanium alloy per ASTM F136 or are made of hybrid titanium consisting of commercially pure porous titanium CP-Ti Grade 2 per ASTM F67 and titanium alloy per ASTM F136.
The modular endplates are offered with an optional 20-40 nanometer thin hydroxyapatite surface treatment. The surface treatment presents nano-scale topography on the entirety of the implant surface, in addition to macro-/micro-scale topography existing from prior to treatment.
V. INDICATIONS FOR USE
Ascend VBR System
The Ascend VBR System is intended for use in skeletally mature patients in the cervical spine (C2-T1) and in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e., fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders.
The Ascend VBR 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, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
The Ascend VBR System is intended to be used with supplemental spinal fixation systems cleared for use in the cervical, thoracic, and/or lumbar spine. The use of bone grafting material with the Ascend VBR System is optional.
Ascend NanoTec VBR System
The Ascend NanoTec VBR System with advanced NanoTec surface treatment is intended for use in skeletally mature patients in the cervical spine (C2-T1) and in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e., fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders.
6
Image /page/6/Picture/1 description: The image shows the word "atec" in a stylized font. The "a" is green, while the "tec" is a dark blue color. There is a trademark symbol to the right of the "c". A black line is underneath the word.
The Ascend NanoTec VBR 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, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
The Ascend NanoTec VBR System is intended to be used with supplemental spinal fixation systems cleared for use in the cervical, thoracic, and/or lumbar spine. The use of bone grafting material with the Ascend NanoTec VBR System is optional.
VI. TECHNOLOGICAL COMPARISON TO PREDICATES
The technological design features of the subject devices were compared to the predicates in intended use, indications for use, design, function and technology and it was demonstrated that they are substantially equivalent.
VII. PERFORMANCE DATA
The following performance testing was conducted or adopted for the subject Ascend VBR Svstems:
- . Static and Dynamic Axial Compression per ASTM F2077
- Static and Dynamic Torsion per ASTM F2077 ●
- Static Subsidence per ASTM F2267 ●
- Static Push-out
- Gravimetric Analysis per ASTM F1714 ●
- Particulate Analysis per ASTM F1877
- Bacterial endotoxin testing (BET) per ANSI/AAMI ST72:2019
- . Biocompatibility Testing per ISO 10993-1
Testing results demonstrated the subject Ascend VBR Systems are substantially equivalent when compared to other legally marketed devices cleared by FDA.
CONCLUSION VIII.
Based upon the information provided in this 510(k) submission, it has been determined that the subject devices are substantially equivalent to legally marketed devices in regard to indications for use, intended use, design, technology, and performance.