(50 days)
Not Found
No
The 510(k) summary describes a physical interbody fusion system made of various materials and designs. There is no mention of software, algorithms, or any functionality that would suggest the use of AI or ML. The device's function is purely mechanical and biological (promoting fusion).
Yes.
The device is intended for "spinal fusion procedures" for conditions like "cervical disc degeneration and/or cervical spinal instability" that result in symptoms such as "radiculopathy, myelopathy, and/or pain." These uses directly address and treat medical conditions, defining it as a therapeutic device.
No
This device is an interbody fusion system designed for spinal fusion procedures, specifically treating cervical disc degeneration and instability. It is an implantable surgical device, not a device used for diagnosis. While its use is confirmed by imaging studies, the device itself does not perform diagnostics.
No
The device description clearly states that the device is an interbody fusion system manufactured from physical materials like PEEK, tantalum, and titanium, and includes physical features like teeth and a graft aperture. This indicates it is a physical medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description and Intended Use: The text clearly describes the device as an "anterior cervical interbody fusion system" and "interbody spacers" intended for surgical implantation in the spine to promote fusion. It is a physical implant used in the body, not a device used to test samples from the body.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory tests.
Therefore, the IdentiTi and Transcend Interbody Systems are surgical implants, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The IdentiTi Cervical Porous Ti Interbody System is an anterior cervical interbody fusion system intended for spinal fusion procedures in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at multiple contiguous levels from C2-T1. The IdentiTi Cervical Porous Ti Interbody System is intended for use with supplemental fixation systems. The system is designed for use with autograft comprised of cortical, cancellous, and/or corticocancellous bone graft, demineralized allograft with bone marrow aspirate, or a combination thereof.
The IdentiTi Cervical Interbody System with advanced NanoTec surface treatment is an anterior cervical interbody fusion system intended for spinal fusion procedures in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/ or pain at multiple contiguous levels from C2-T1. The IdentiTi NanoTec Cervical Interbody System is intended for use with supplemental fixation systems. The system is designed for use with autograft comprised of cortical, cancellous, and/or corticocancellous bone graft, demineralized allograft with bone marrow aspirate, or a combination thereof.
The Transcend Cervical PEEK Interbody System is an anterior cervical interbody fusion system intended for use in skeletally mature patients with cervical disc degeneration and/or cervical instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at multiple contiguous levels from C2-T1. The Transcend Cervical PEEK Interbody System is intended for use with supplemental fixation systems. The system is designed for use with autograft, allograft comprised of cortical, cancellous bone graft, demineralized allograft with bone marrow aspirate, or a combination thereof.
The Transcend Cervical PEEK Interbody System with advanced NanoTec surface treatment is an anterior cervical interbody fusion system intended for use in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2-T1. The Transcend NanoTec Cervical Interbody System is intended for use with supplemental fixation systems. The system is designed for use with autograft comprised of cortical, cancellous and/or corticocancellous bone graft, demineralized allograft with bone marrow aspirate, or a combination thereof.
The IdentiTi Cervical Standalone Interbody System is a stand-alone anterior cervical interbody fusion system intended for use in skeletally mature patients for the treatment of cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at multiple contiguous levels from C2-T1. The IdentiTi Cervical Standalone Interbody System is intended to be used with autograft, allograft comprised of cortical, cancellous, and/or cortico-cancellous bone graft, demineralized allograft with bone marrow aspirate, or a combination thereof.
The IdentiTi Cervical Standalone Interbody System with advanced NanoTec surface treatment is a stand-alone anterior cervical interbody fusion system intended for use in skeletally mature patients for the treatment of cervical degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radioulopathy, myelopathy, and/or pain at multiple contiguous levels from C2-T1. The IdentiTi NanoTec Cervical Standalone Interbody System is intended to be used with autograft, allograft comprised of cortical, cancellous, and/or cortico-cancellous bone graft, demineralized allograft with bone marrow aspirate, or a combination thereof.
Product codes (comma separated list FDA assigned to the subject device)
ODP, OVE
Device Description
The IdentiTi and Transcend Interbody Systems are cervical intervertebral body fusion systems designed to be inserted through anterior surgical approaches. The interbody spacers are manufactured from PEEK (polyetheretherketone) Optima LT1 per ASTM F2026, tantalum per ASTM F560, titanium alloy (Ti-6A1-4V ELI), and commercially pure titanium (CPTi Grade 2) per ASTM F67. The interbody spacers are available in the following material options: (1) PEEK (polyetheretherketone) with tantalum and titanium alloy markers, or (2) commercially pure porous titanium (PTi), or (3) a combination of commercially pure porous titanium (CPTi Grade 2) per ASTM F67 and titanium alloy (Ti-6Al-4V ELI) per ASTM F136.
The subject IdentiTi and Transcend Interbody Systems implants consist of various lengths, widths, heights and lordotic options to accommodate individual patient anatomy. To mitigate risk of expulsion, the interbody endplates feature teeth. All interbody spacers feature an internal graft aperture for placement of graft material to promote fusion through the cage. Additionally, the IdentiTi implants are offered with a microstructure due to the layering of material that forms the porous architecture. This porous geometry extends to the superior and inferior surfaces of the device for implant fixation.
The IdentiTi and Transcend NanoTec Interbody Systems implant surfaces have been treated with a 20-40 nanometer thin hydroxyapatite (HA) 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
radiographs, CT, MRI
Anatomical Site
cervical (C2-T1)
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Prescription Use
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 non-clinical testing was performed and included, where appropriate for the design, or referenced in predicate 510(k) submissions to support clearance of IdentiTi™ and Transcend™ Interbody Systems.
- ASTM F2077 static and dynamic axial compression and torsion
- ASTM F2267 static subsidence
- Static push-out
- F1714 gravimetric analysis
- F1877 particulate analysis
- Screw push-out
Since the technological characteristics of the subject IdentiTi and Transcend systems are substantially equivalent to the predicate systems, no further clinical or non-clinical testing is required to support the expanded indications for use of the subject systems.
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.
K172676, K192582, K211258, K211805, K220782
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
§ 888.3080 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
Image /page/0/Picture/0 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 17, 2022
Alphatec Spine Inc. Andrew Zhang Regulatory Affairs Associate 1950 Camino Vida Roble Carlsbad, California 92008
Re: K222973
Trade/Device Name: IdentiTi™ and Transcend™ Interbody Systems: IndentiTi™ Cervical Porous Ti Interbody System, IdentiTiTM NanoTec™ Cervical Interbody System, Transcend™ Cervical PEEK Interbody System, Transcend™ NanoTecTM Cervical Interbody System, IdentiTiTM Cervical Standalone Interbody System, IdentiTiTM NanoTecTM Cervical Standalone Interbody Sytem Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP, OVE Dated: September 27, 2022 Received: September 28, 2022
Dear Mr. Zhang:
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 mav, 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
1
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 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,
Brent Showalter -S
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known) K22973
Device Name IdentiTi Cervical Porous Ti Interbody System
Indications for Use (Describe)
The IdentiTi Cervical Porous Ti Interbody System is an anterior cervical interbody fusion system intended for spinal fusion procedures in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at multiple contiguous levels from C2-T1. The IdentiTi Cervical Porous Ti Interbody System is intended for use with supplemental fixation systems. The system is designed for use with autograft comprised of cortical, cancellous, and/or corticocancellous bone graft, demineralized allograft with bone marrow aspirate, or a combination thereof.
| 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
3
510(k) Number (if known) K222973
Device Name
IdentiTiTM NanoTec™ Cervical Interbody System
Indications for Use (Describe)
The IdentiTi Cervical Interbody System with advanced NanoTec surface treatment is an anterior cervical interbody fusion system intended for spinal fusion procedures in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/ or pain at multiple contiguous levels from C2-T1. The IdentiTi NanoTec Cervical Interbody System is intended for use with supplemental fixation systems. The system is designed for use with autograft comprised of cortical, cancellous, and/or corticocancellous bone graft, demineralized allograft with bone marrow aspirate, or a combination thereof.
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
4
510(k) Number (if known) K222973
Device Name Transcend Cervical PEEK Interbody System
Indications for Use (Describe)
The Transcend Cervical PEEK Interbody System is an anterior cervical interbody fusion system intended for use in skeletally mature patients with cervical disc degeneration and/or cervical instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at multiple contiguous levels from C2-T1. The Transcend Cervical PEEK Interbody System is intended for use with supplemental fixation systems. The system is designed for use with autograft, allograft comprised of cortical, cancellous bone graft, demineralized allograft with bone marrow aspirate, or a combination thereof.
| 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
5
510(k) Number (if known) K222973
Device Name
Transcend NanoTec Cervical Interbody System
Indications for Use (Describe)
The Transcend Cervical PEEK Interbody System with advanced NanoTec surface treatment is an anterior cervical interbody fusion system intended for use in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/ or pain at multiple contiguous levels from C2-T1. The Transcend NanoTec Cervical Interbody System is intended for use with supplemental fixation systems. The system is designed for use with autograft comprised of cortical, cancellous and/or corticocancellous bone graft, demineralized allograft with bone marrow aspirate, or a combination thereof.
| 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
6
510(k) Number (if known) K222973
Device Name IdentiTi Cervical Standalone Interbody System
Indications for Use (Describe)
The IdentiTi Cervical Standalone Interbody System is a stand-alone anterior cervical interbody fusion system intended for use in skeletally mature patients for the treatment of cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at multiple contiguous levels from C2-T1. The IdentiTi Cervical Standalone Interbody System is intended to be used with autograft, allograft comprised of cortical, cancellous, and/or cortico-cancellous bone graft, demineralized allograft with bone marrow aspirate, or a combination thereof.
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
7
510(k) Number (if known) K222973
Device Name
IdentiTi NanoTec Cervical Standalone Interbody System
Indications for Use (Describe)
The IdentiTi Cervical Standalone Interbody System with advanced NanoTec surface treatment is a stand-alone anterior cervical interbody fusion system intended for use in skeletally mature patients for the treatment of cervical degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radioulopathy, myelopathy, and/or pain at multiple contiguous levels from C2-T1. The IdentiTi NanoTec Cervical Standalone Interbody System is intended to be used with autograft, allograft comprised of cortical, cancellous, and/or cortico-cancellous bone graft, demineralized allograft with bone marrow aspirate, or a combination thereof.
| 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
8
Image /page/8/Picture/0 description: The image shows the logo for Atec. The logo is a stylized lowercase "a" in green, followed by "tec" in dark blue. There is a black line underneath 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) 431-9286
Fax: (760) 431-0289 |
|-----|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Andrew Zhang
Regulatory Affairs Associate
Contact Phone: (760) 494-6806 |
| | Date Summary Prepared: | September 27, 2022 |
| II. | DEVICE | |
| | Name of Device: | IdentiTi™ and Transcend™ Interbody Systems:
IdentiTi™ Cervical Porous Ti Interbody System
IdentiTi™ NanoTec™ Cervical Interbody System
Transcend™ Cervical PEEK Interbody System
Transcend™ NanoTec™ Cervical Interbody System
IdentiTi™ Cervical Standalone Interbody System
IdentiTi™ NanoTec™
Cervical Standalone
Interbody System |
| | Common or Usual Name: | Intervertebral body fusion device |
| | Classification Name: | Intervertebral fusion device with bone graft, Cervical
Intervertebral fusion device with integrated fixation,
Cervical |
| | Regulatory Class: | Class II |
| | Product Code: | ODP, OVE |
III. LEGALLY MARKETED PREDICATE DEVICES
| 510(k) | Product
Code | Trade Name | Manufacturer |
|-------------------------------------|-----------------|-----------------------------------------------|--------------|
| Primary Predicate Device | | | |
| K172676 | ODP | NuVasive® Modulus-C Interbody System | NuVasive |
| Additional Predicate Devices | | | |
| K192582 | OVE | NuVasive® CoRoent® Small Interlock™
System | NuVasive |
K222973 510(k) Summary Page 1 of 5
9
Image /page/9/Picture/0 description: The image shows the logo for "atec". The "a" is green and the "tec" is dark blue. There is a trademark symbol in the upper right corner of the logo. There is a black line underneath the logo.
| 510(k) | Product
Code | Trade Name | Manufact
urer |
|---------|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| K211258 | MAX, ODP,
OVD, OVE | Endoskeleton TC Interbody System,
Endoskeleton TCS Interbody System,
Endoskeleton TA Interbody System,
Endoskeleton TAS & TAS Hyp Interbody
System, Endoskeleton TL Interbody System,
Endoskeleton TL Hyp. Interbody
System, Endoskeleton TO Interbody System,
Endoskeleton TT Interbody System | Medtronic |
| K211805 | MAX, ODP,
OVD, PHM | IdentiTi™ Porous Ti Interbody System,
Transcend™ PEEK Interbody System,
IdentiTi™ NanoTec™ Interbody System,
Transcend™ NanoTec™ Interbody
System | Alphatec
Spine |
| K220782 | MAX,
OVD, PHM,
OVE | IdentiTi™ Porous Ti Interbody System,
IdentiTi™ NanoTec™ Interbody System,
Transcend™ PEEK Interbody System,
Transcend™ NanoTec™ Interbody System,
IdentiTi™ ALIF Standalone Interbody System,
IdentiTi™ NanoTec™ ALIF Standalone
Interbody System | Alphatec
Spine |
IV. DEVICE DESCRIPTION
The IdentiTi and Transcend Interbody Systems are cervical intervertebral body fusion systems designed to be inserted through anterior surgical approaches. The interbody spacers are manufactured from PEEK (polyetheretherketone) Optima LT1 per ASTM F2026, tantalum per ASTM F560, titanium alloy (Ti-6A1-4V ELI), and commercially pure titanium (CPTi Grade 2) per ASTM F67. The interbody spacers are available in the following material options: (1) PEEK (polyetheretherketone) with tantalum and titanium alloy markers, or (2) commercially pure porous titanium (PTi), or (3) a combination of commercially pure porous titanium (CPTi Grade 2) per ASTM F67 and titanium alloy (Ti-6Al-4V ELI) per ASTM F136.
The subject IdentiTi and Transcend Interbody Systems implants consist of various lengths, widths, heights and lordotic options to accommodate individual patient anatomy. To mitigate risk of expulsion, the interbody endplates feature teeth. All interbody spacers feature an internal graft aperture for placement of graft material to promote fusion through the cage. Additionally, the IdentiTi implants are offered with a microstructure due to the layering of material that forms the porous architecture. This porous geometry extends to the superior and inferior surfaces of the device for implant fixation.
K222973 510(k) Summary Page 2 of 5
10
Image /page/10/Picture/0 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 horizontal line underneath the word. The letters are connected to each other.
The IdentiTi and Transcend NanoTec Interbody Systems implant surfaces have been treated with a 20-40 nanometer thin hydroxyapatite (HA) 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.
The purpose of this Traditional 510(k) is to receive clearance for expanded indications for cervical spinal instability and use at multiple contiguous levels, and use of allograft consisting of cortical bone, as well as demineralized allograft with bone marrow aspirate.
INDICATIONS FOR USE V.
IdentiTi Cervical Porous Ti Interbody System
The IdentiTi Cervical Porous Ti Interbody System is an anterior cervical interbody fusion system intended for spinal fusion procedures in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at multiple contiguous levels from C2-T1. The IdentiTi Cervical Porous Ti Interbody System is intended for use with supplemental fixation systems. The system is designed for use with autograft, allograft comprised of cortical, cancellous, and/or corticocancellous bone graft, demineralized allograft with bone marrow aspirate, or a combination thereof.
IdentiTi NanoTec Cervical Interbody System
The IdentiTi Cervical Interbody System with advanced NanoTec surface treatment is an anterior cervical interbody fusion system intended for spinal fusion procedures in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2-T1. The IdentiTi NanoTec Cervical Interbody System is intended for use with supplemental fixation systems. The system is designed for use with autograft, allograft comprised of cortical, cancellous, and/or corticocancellous bone graft, demineralized allograft with bone marrow aspirate, or a combination thereof.
Transcend Cervical PEEK Interbody System
The Transcend PEEK Cervical Interbody System is an anterior cervical interbody fusion system intended for use in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2-T1. The Transcend PEEK Cervical Interbody System is intended for use with supplemental fixation systems. The system is designed for use with autograft, allograft comprised of cortical, cancellous and/or corticocancellous bone graft, demineralized allograft with bone marrow aspirate, or a combination thereof.
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Transcend NanoTec Cervical Interbody System
The Transcend Cervical PEEK Interbody System with advanced NanoTec surface treatment is an anterior cervical interbody fusion system intended for use in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2-T1. The Transcend NanoTec Cervical Interbody System is intended for use with supplemental fixation systems. The system is designed for use with autograft, allograft comprised of cortical, cancellous and/or corticocancellous bone graft, demineralized allograft with bone marrow aspirate, or a combination thereof.
IdentiTi Cervical Standalone Interbody System
The IdentiTi Cervical Standalone Interbody System is a stand-alone anterior cervical interbody fusion system intended for use in skeletally mature patients for the treatment of cervical degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at multiple contiguous levels from C2-T1. The IdentiTi Cervical Standalone Interbody System is intended to be used with autograft, allograft comprised of cortical, cancellous, and/or cortico-cancellous bone graft, demineralized allograft with bone marrow aspirate, or a combination thereof.
IdentiTi NanoTec Cervical Standalone Interbody System
The IdentiTi Cervical Standalone Interbody System with advanced NanoTec surface treatment is a stand-alone anterior cervical interbody fusion system intended for use in skeletally mature patients for the treatment of cervical degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2-T1. The IdentiTi NanoTec Cervical Standalone Interbody System is intended to be used with autograft, allograft comprised of cortical, cancellous, and/or cortico-cancellous bone graft, demineralized allograft with bone marrow aspirate, or a combination thereof.
VI. TECHNOLOGICAL COMPARISON TO PREDICATES
The technological design features of the subject IdentiTi and Transcend Interbody Systems are substantially equivalent to the primary predicate NuVasive® Modulus-C Interbody System (K172676), and additional predicates: NuVasive® CoRoent® Small InterlockTM System (K192582), Endoskeleton™ Interbody System (K211258), IdentiTi™ and Transcend™ Interbody Systems (K211805), IdentiTiTM and Transcend™ Interbody Systems (K220782).
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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
The following non-clinical testing was performed and included, where appropriate for the design, or referenced in predicate 510(k) submissions to support clearance of IdentiTi™ and Transcend™ Interbody Systems.
- ASTM F2077 static and dynamic axial compression and torsion ●
- ASTM F2267 static subsidence ●
- Static push-out ●
- F1714 gravimetric analysis ●
- F1877 particulate analysis
- Screw push-out ●
Since the technological characteristics of the subject IdentiTi and Transcend systems are substantially equivalent to the predicate systems, no further clinical or non-clinical testing is required to support the expanded indications for use of the subject systems.
Clinical Information
Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data.
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.