(59 days)
No
The document describes a physical interbody fusion system and its components, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is an interbody fusion system used in spinal fusion procedures to treat certain spinal conditions, which is a therapeutic intervention.
No
Explanation: This device is an intervertebral body fusion system intended for surgical implantation to facilitate spinal fusion, not to diagnose a condition.
No
The device description clearly states it is an intervertebral body fusion system manufactured from titanium alloy, consisting of physical components like spacers, inserters, trials, and instruments. It is a hardware medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Description and Intended Use: The Calibrate LTX Interbody System is a surgical implant designed for spinal fusion procedures. It is a physical device inserted into the body to treat structural issues in the spine.
- Lack of Mention of Samples or Testing: The text describes the device's materials, design, surgical approach, and intended use in treating spinal conditions. There is no mention of analyzing biological samples or performing diagnostic tests.
Therefore, the Calibrate LTX Interbody System falls under the category of a surgical implant or medical device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
Calibrate LTX Interbody System
The Calibrate LTX Interbody System is indicated for spinal fusion procedures from T1 to S1 in skeletally mature patients for the treatment of a symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis, spinal stenosis, and/or thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain) at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
Additionally, the Calibrate LTX Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.
The Calibrate LTX Interbody System is intended for use on patients who have had at least six months of non-operative treatment. It is intended to be used with autograft and/or allogenic bone graft comprised of cortical, cancellous, and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The system is intended to be used with supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine.
Calibrate LTX spacers expanded greater than 20° have integrated fixation tabs and must be used with LTX bone screws in addition to supplemental fixation. Calibrate LTX spacers without integrated fixation tabs may be used with AMP-LTX System as integrated fixation in addition to supplemental fixation.
Calibrate NanoTec LTX Interbody System
The Calibrate LTX Interbody System with advanced NanoTec surface treatment is indicated for spinal fusion procedures from T1 to S1 in skeletally mature patients for the treatment of a symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis, spinal stenosis, and/ or thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain) at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
Additionally, the Calibrate NanoTec LTX Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.
The Calibrate NanoTec LTX Interbody System is intended for use on patients who have had at least six months of non-operative treatment. It is intended to be used with autograft and/or allogenic bone graft comprised of cortical, cancellous, and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The system is intended to be used with supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine.
Calibrate NanoTec LTX spacers expanded greater than 20° have integrated fixation tabs and must be used with AMP-LTX bone screws in addition to supplemental fixation. Calibrate NanoTec LTX spacers without integrated fixation tabs may be used with AMP-LTX System as integrated fixation in addition to supplemental fixation.
Product codes (comma separated list FDA assigned to the subject device)
MAX, OVD, PHM
Device Description
The subject Calibrate LTX Interbody Systems are lordotic expandable thoracolumbar intervertebral body fusion systems designed to be inserted through a lateral or anterolateral surgical approach. The subject interbody spacers are manufactured from titanium alloy (Ti-6Al-4V ELD per ASTM F136. The subject Calibrate NanoTec LTX Interbody System interbody implant endplate surfaces have been treated with a 20-40 nanometer thin hydroxyapatite (HA) surface treatment. The Calibrate LTX Interbody Systems consist of a variety of shapes and sizes of interbody spacers, inserters, trials, and general instruments to create lordotic expansion, restore sagittal alignment, and provide indirect decompression. Implants are offered with anti-migration teeth and grit-blast treatment on the bone-contacting endplate surfaces. Certain Calibrate LTX Interbody Systems' offerings also accept fixation bone screws manufactured from titanium alloy per ASTM F136.
The purpose of this Traditional 510(k) is to receive clearance for the new sizes of the modified design of the interbody spacer, including a sterile offering of interbody spacer with hydroxyapatite surface treatment, sterile offering of AMP-LTX anti-migration plate and expanded indications for use for the Calibrate LTX Interbody System, previously cleared in K223611.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
T1 to S1 (thoracic and lumbar 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)
An engineering analysis was utilized to determine that no new worst-case implants are being introduced compared to the predicate devices to support clearance of Calibrate LTX Interbody Systems. The engineering analysis demonstrates that the subject Calibrate LTX Interbody Systems are substantially equivalent to other predicate devices for nonclinical testing.
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.
K203714, K222028, K223611, K211805, K202587
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.
K221926, K161363, K192938, K240951
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
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
September 20, 2024
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is in blue and consists of the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION".
Alphatec Spine, Inc. Unnati Bhuptani Sr. Regulatory Affairs Specialist 1950 Camino Vida Roble Carlsbad, California 92008
Re: K242147
Trade/Device Name: Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, OVD, PHM Dated: July 22, 2024 Received: July 23, 2024
Dear Unnati Bhuptani:
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 QS 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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 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).
2
Sincerely,
Digitally signed
by Eileen Cadel Eileen -5
Date:
2024.09.20 Cadel -S 09:07:37 -04'00' for 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
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
Calibrate LTX Interbody System
Calibrate NanoTec LTX Interbody System
Indications for Use (Describe)
Calibrate LTX Interbody System
The Calibrate LTX Interbody System is indicated for spinal fusion procedures from T1 to S1 in skeletally mature patients for the treatment of a symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis, spinal stenosis, and/or thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain) at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
Additionally, the Calibrate LTX Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.
The Calibrate LTX Interbody System is intended for use on patients who have had at least six months of non-operative treatment. It is intended to be used with autograft and/or allogenic bone graft comprised of cortical, cancellous, and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The system is intended to be used with supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine.
Calibrate LTX spacers expanded greater than 20° have integrated fixation tabs and must be used with LTX bone screws in addition to supplemental fixation. Calibrate LTX spacers without integrated fixation tabs may be used with AMP-LTX System as integrated fixation in addition to supplemental fixation.
Calibrate NanoTec LTX Interbody System
The Calibrate LTX Interbody System with advanced NanoTec surface treatment is indicated for spinal fusion procedures from T1 to S1 in skeletally mature patients for the treatment of a symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis, spinal stenosis, and/ or thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain) at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
Additionally, the Calibrate NanoTec LTX Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.
The Calibrate NanoTec LTX Interbody System is intended for use on patients who have had at least six months of non-operative treatment. It is intended to be used with autograft and/or allogenic bone graft comprised of cortical, cancellous, and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The system is intended to be used with supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine.
Calibrate NanoTec LTX spacers expanded greater than 20° have integrated fixation tabs and must
4
be used with AMP-LTX bone screws in addition to supplemental fixation. Calibrate NanoTec LTX spacers without integrated fixation tabs may be used with AMP-LTX System as integrated fixation in addition to supplemental fixation.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)
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."
5
Image /page/5/Picture/0 description: The image shows the logo for a company called "atec". The "a" in "atec" is green, while the rest of the letters are black. There is a trademark symbol in the upper right corner of the logo.
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) 494-6860
Fax: (760) 431-0289 |
|----|------------------------|----------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Unnati Bhuptani
Sr. Regulatory Affairs Specialist |
| | Date Summary Prepared: | September 19, 2024 |
II. DEVICE
| Trade or Proprietary Name: | Calibrate LTX Interbody System
Calibrate NanoTec LTX Interbody System Intervertebral |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | body fusion device |
| Classification Name: | Intervertebral fusion device with bone graft, lumbar
Intervertebral fusion device with integrated fixation, lumba
Intervertebral fusion device with bone graft, thoracic |
| Regulation Number: | 21 CFR 888.3080 |
| Classification: | Class II |
| Product Code: | MAX, OVD, PHM |
III. LEGALLY MARKETED PREDICATE DEVICES
| 510(k) | Product Name | Product Code | Clearance Date |
|---|---|---|---|
| K203714 | NuVasive Thoracolumbar Interbody | ||
| Systems and NuVasive Attrax Putty | MAX, OVD, | ||
| PHM, MQV | December 23, 2021 |
Additional Predicate Devices:
| 510(k) | Product Name | Product Code | Clearance Date |
|---|---|---|---|
| K222028 | IdentiTi and Transcend Interbody Systems | MAX, OVD, PHM | October 7, 2022 |
| K223611 | Calibrate LTX Interbody System | MAX, OVD, PHM | March 29, 2023 |
| K211805 | IdentiTi™ Porous Ti Interbody System, | ||
| Transcend™ PEEK Interbody System, | |||
| IdentiTi™ NanoTec™ Interbody System, | |||
| Transcend™ NanoTec™ Interbody System | MAX, OVD, ODP, PHM | August 26, 2021 | |
| K202587 | ATEC Lateral Interbody System | MAX, OVD, PHM | November 06, 2020 |
6
Image /page/6/Picture/1 description: The image shows the "atec" logo. The "a" is green, and the "tec" is dark blue. There is a trademark symbol in the upper right corner of the logo. A black line is underneath the logo.
| Reference Devices: | |||
|---|---|---|---|
| 510(k) | Product Name | Product Code | Clearance Date |
| K221926 | InvictusTM Spinal Fixation System | PML, NKB, KWP, KWQ | December 20, 2022 |
| K161363 | Arsenal Spinal Fixation System | NKB, KWP, MNH, MNI, OSH | June 10, 2016 |
| K192938 | Invictus Spinal Fixation System | NKB, KWP | December 12, 2019 |
| K240951 | Invictus Robotic Navigation Instruments | OLO | June 06, 2024 |
IV. DEVICE DESCRIPTION
The subject Calibrate LTX Interbody Systems are lordotic expandable thoracolumbar intervertebral body fusion systems designed to be inserted through a lateral or anterolateral surgical approach. The subject interbody spacers are manufactured from titanium alloy (Ti-6Al-4V ELD per ASTM F136. The subject Calibrate NanoTec LTX Interbody System interbody implant endplate surfaces have been treated with a 20-40 nanometer thin hydroxyapatite (HA) surface treatment. The Calibrate LTX Interbody Systems consist of a variety of shapes and sizes of interbody spacers, inserters, trials, and general instruments to create lordotic expansion, restore sagittal alignment, and provide indirect decompression. Implants are offered with anti-migration teeth and grit-blast treatment on the bone-contacting endplate surfaces. Certain Calibrate LTX Interbody Systems' offerings also accept fixation bone screws manufactured from titanium alloy per ASTM F136.
The purpose of this Traditional 510(k) is to receive clearance for the new sizes of the modified design of the interbody spacer, including a sterile offering of interbody spacer with hydroxyapatite surface treatment, sterile offering of AMP-LTX anti-migration plate and expanded indications for use for the Calibrate LTX Interbody System, previously cleared in K223611.
V. INDICATIONS FOR USE
Calibrate LTX Interbody System
The Calibrate LTX Interbody System is indicated for spinal fusion procedures from T1 to S1 in skeletally mature patients for the treatment of a symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis, spinal stenosis, and/or thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain) at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
Additionally, the Calibrate LTX Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.
7
Image /page/7/Picture/1 description: The image shows the logo for a company called "atec". The "a" in "atec" is green, while the rest of the letters are dark blue. There is a trademark symbol in the upper right corner of the logo. A black line is located underneath the logo.
The Calibrate LTX Interbody System is intended for use on patients who have had at least six months of non-operative treatment. It is intended to be used with autograft and/or allogenic bone graft comprised of cortical, cancellous, and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The system is intended to be used with supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine.
Calibrate LTX spacers expanded greater than 20° have integrated fixation tabs and must be used LTX bone screws in addition to supplemental fixation. Calibrate LTX spacers without integrated fixation tabs may be used with AMP-LTX System as integrated fixation in addition to supplemental fixation.
Calibrate NanoTec LTX Interbody System
The Calibrate LTX Interbody System with advanced NanoTec surface treatment is indicated for spinal fusion procedures from T1 to S1 in skeletally mature patients for the treatment of a symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis, spinal stenosis, and/or thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain) at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
Additionally, the Calibrate NanoTec LTX Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.
The Calibrate NanoTec LTX Interbody System is intended for use on patients who have had at least six months of non-operative treatment. It is intended to be used with autograft and/or allogeneic bone graft comprised of cortical, cancellous, and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The system is intended to be used with supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine.
Calibrate NanoTec LTX spacers expanded greater than 20° have integrated fixation tabs and must be used with AMP-LTX bone screws in addition to supplemental fixation. Calibrate NanoTec LTX spacers without integrated fixation tabs may be used with AMP-LTX System as integrated fixation in addition to supplemental fixation.
VI. TECHNOLOGICAL COMPARISON TO PREDICATES
The technological design features of the subject Calibrate LTX Interbody Systems are substantially equivalent to the primary predicate NuVasive Thoracolumbar Interbody Systems and NuVasive Attrax Putty (K203714), the additional predicates IdentiTi™ and Transcend™ Interbody Systems (K222028), IdentiTi™ and Transcend™ Interbody Systems (K211805) and Calibrate LTX Interbody Systems (K223611).
8
Image /page/8/Picture/0 description: The image shows the logo for a company called "atec". The "a" in "atec" is green, while the rest of the letters are dark blue. There is a trademark symbol in the upper right corner of the "c".
The technological design features of the subject implants 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
An engineering analysis was utilized to determine that no new worst-case implants are being introduced compared to the predicate devices to support clearance of Calibrate LTX Interbody Systems. The engineering analysis demonstrates that the subject Calibrate LTX Interbody Systems are substantially equivalent to other predicate devices for nonclinical testing.
Clinical Information
Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data.
VIII. CONCLUSION
Based upon the information provided in this 510(k) submission, it has been determined that the subject device is substantially equivalent to legally marketed devices in regard to indications for use, intended use, design, technology, and performance.