(101 days)
No
The summary describes a mechanical spinal implant system (plates and interbody spacers) and its physical properties and testing. There is no mention of software, algorithms, image analysis, or any other component that would suggest the use of AI or ML.
Yes
The device is intended for various medical indications such as degenerative disc disease, trauma, tumors, deformity, pseudarthrosis, failed previous fusions, spondylolisthesis, and spinal stenosis, all of which aim to treat existing medical conditions for therapeutic purposes.
No
The device is a surgical implant designed for spinal fusion procedures, not for diagnosing medical conditions. It is used in conjunction with imaging studies (radiographs, CT, MRI) which are the diagnostic tools.
No
The device description explicitly details physical components made of titanium alloy and PEEK, intended for surgical implantation. It also mentions instrumentation for delivery. This is a hardware-based medical device, not software-only.
Based on the provided information, none of the described devices are IVDs (In Vitro Diagnostics).
Here's why:
-
Definition of IVD: An In Vitro Diagnostic (IVD) device is a medical device that is used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information for the diagnosis, monitoring, or treatment of a disease or condition. These tests are performed outside of the living body (in vitro).
-
Description of the Devices: The descriptions clearly state that these are implantable medical devices intended for surgical procedures to fix and fuse the cervical spine. They are physical implants (plates and interbody spacers) designed to be placed inside the patient's body.
-
Intended Use: The intended uses all describe surgical procedures for treating spinal conditions by providing structural support and promoting fusion. They do not involve testing biological samples.
-
Device Description: The device descriptions detail the materials and design of the implants and associated surgical instruments. They do not mention any components or functions related to laboratory testing or analysis of biological samples.
Therefore, these devices fall under the category of implantable surgical devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Segmental Plating System (SPS)
The Segmental Plating System (SPS) is intended for anterior screw fixation to the cervical spine (C2-T1) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (kyphosis or scoliosis), pseudarthrosis, failed previous fusions, spondylolisthesis, and spinal stenosis.
IdentiTi SPS Interbody System
The IdentiTi SPS 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, myelopathy, and/or pain at multiple contiguous levels from C2-T1. The IdentiTi SPS 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 SPS Interbody System
The IdentiTi SPS 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, and/or pain at multiple contiguous levels from C2-T1. The IdentiTi NanoTec SPS 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 SPS Interbody System
The Transcend SPS 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, and/ or pain at multiple contiguous levels from C2-T1. The Transcend SPS 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.
Transcend NanoTec SPS Interbody System
The Transcend SPS 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, and/or pain at multiple contiguous levels from C2-T1. The Transcend NanoTec SPS 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.
Product codes
KWQ, ODP
Device Description
The Segmental Plating System (SPS) is intended for anterior fixation to the cervical spine. The Segmental Plating System (SPS) consists of a variety of sizes of 2 - 4 holes plates and 3.5 mm and 4.0 mm screws that are manufactured from titanium alloy conforming to ASTM F136 and are offered non-sterile. The plate includes a screw anti-backout mechanism. The system will offer instrumentation for the delivery of the plate and screw construct. The instruments in this system are intended for use in surgical procedures. The plate system implants are provided non-sterile to be steam sterilized by the end user.
The IdentiTi and Transcend SPS 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, commercially pure titanium (CP Ti Grade 2) per ASTM F67, and an optional hydroxyapatite nano (HAMM) surface treatment. The subject system 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 subject IdentiTi and Transcend NanoTec SPS Interbody Systems interbody implant surfaces have been treated with a 20-40 nanometer thin hydroxyapatite (HA) surface treatment. The surface treatment presents a nano-scale topography on the entirety of the implant surface. in addition to macro-/micro-scale topography existing from prior to HA man treatment. The interbody spacers are provided individually packaged and sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
radiographs, CT, MRI
Anatomical Site
cervical spine (C2-T1)
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 non-clinical testing was performed and included, where appropriate for the design, or referenced in predicate 510(k) submissions to support clearance of Segmental Plating and Interbody Systems:
ASTM F2077:2018 Test Methods for Intervertebral Body Fusion Devices
- Static Compression
- Dynamic Compression
- Static Torsion
- Dynamic Torsion
ASTM F2267:2004/(R)2018 Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression - Subsidence
ASTM Draft Standard F 04.25.02.02 Static Push-out Test Method for Intervertebral Body Fusion Device - Expulsion
ASTM F1717:2021 Test Methods for Spinal Implant Constructs in a Vertebrectomy Model - Static Compression
- Dynamic Compression
- Static Torsion
The results demonstrate that the subject Segmental Plating and Interbody Systems are substantially equivalent to other predicate devices for nonclinical testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K213443, K211903, K072703, K222973
Reference Device(s)
K211805, K192938, K222028, K140417
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
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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.
February 22, 2024
Alphatec Spine Inc. Andrew Zhang Regulatory Affairs Specialist 1950 Camino Vida Roble Carlsbad, California 92008
Re: K233640
Trade/Device Name: Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS Interbody System: Transcend SPS Interbody System:Transcend NanoTec SPS Interbody System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ, ODP Dated: November 13, 2023 Received: January 24, 2024
Dear Andrew 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 (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"
1
(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).
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
Enclosure
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Segmental Plating System (SPS); ldentiTi SPS Interbody System; IdentiTi NanoTec SPS Interbody System; Transcend SPS Interbody System; Transcend NanoTec SPS Interbody System Indications for Use (Describe)
Segmental Plating System (SPS)
The Segmental Plating System (SPS) is intended for anterior screw fixation to the cervical spine (C2-T1) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (kyphosis or scoliosis), pseudarthrosis, failed previous fusions, spondylolisthesis, and spinal stenosis.
IdentiTi SPS Interbody System
The IdentiTi SPS 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, myelopathy, and/or pain at multiple contiguous levels from C2-T1. The IdentiTi SPS 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 SPS Interbody System
The IdentiTi SPS 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, and/or pain at multiple contiguous levels from C2-T1. The IdentiTi NanoTec SPS 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 SPS Interbody System
The Transcend SPS 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, and/ or pain at multiple contiguous levels from C2-T1. The Transcend SPS 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.
Transcend NanoTec SPS Interbody System
The Transcend SPS PEEK Interbody System with advanced NanoTec surface treatment is an anterior cervical interbody fusion system intended for use in skeletally mature patients with cervical
4
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 Transcend NanoTec SPS 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.
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)
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Image /page/5/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 next to the "c". 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) 494-6860
Fax: (760) 431-0289 |
|----|------------------------|----------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Andrew Zhang
Regulatory Affairs Specialist
Contact Phone: (760) 494-6860 |
| | Date Summary Prepared: | January 24, 2024 |
II. DEVICE
Trade or Proprietary Name:
| Segmental Plating System (SPS) | |
|---|---|
| IdentiTi™ SPS Interbody System | |
| IdentiTi™ NanoTec™ SPS Interbody System | |
| Transcend™ SPS Interbody System | |
| Transcend™ NanoTec™ SPS Interbody System | |
| Common Name: | Spinal Intervertebral Body Fixation Orthosis |
| Intervertebral body fusion device | |
| Classification Name: | Appliance, Fixation, Spinal Intervertebral Body |
| Intervertebral fusion device with bone graft, Cervical | |
| Regulation Number: | 21 CFR 888.3060 |
| 21 CFR 888.3080 | |
| Classification: | Class II |
| Product Code: | KWQ, ODP |
III. LEGALLY MARKETED PREDICATE DEVICES
| 510(k) | Product Name | Product Code | Clearance Date |
|---|---|---|---|
| K213443 | Insignia Anterior Cervical Plate System | KWQ | December 15, 2021 |
| 510(k) | Product Name | Product Code | Clearance Date |
|---|---|---|---|
| K211903 | Shoreline Threaded TruProfile Plate | KWQ | August 30, 2021 |
| K072703 | Pioneer SlimFuse Anterior Cervical Plate | ||
| System | KWQ | January 10, 2008 | |
| K222973 | IdentiTi and Transcend Interbody Systems | ODP, OVE | November 17, 2022 |
Additional Predicate Devices:
CONFIDENTIAL
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Image /page/6/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 trademark symbol to the right of the "c". A black line is underneath the word.
| Reference Devices: | |||
|---|---|---|---|
| 510(k) | Product Name | Product | |
| Code | Clearance Date | ||
| K211805 | IdentiTiTM Porous Ti Interbody System, | ||
| TranscendTM PEEK Interbody System, IdentiTiTM | |||
| NanoTecTM Interbody System, TranscendTM | |||
| NanoTecTM Interbody System | MAX, OVD, | ||
| ODP, PHM | August 26, 2021 | ||
| K192938 | InvictusTM Spinal Fixation System | NKB, KWP | December 12, 2019 |
| K222028 | IdentiTiTM Porous Ti Interbody System, IdentiTiTM | ||
| NanoTecTM Interbody System, TranscendTM PEEK | |||
| Interbody System, TranscendTM NanoTecTM | |||
| Interbody System, IdentiTiTM ALIF Standalone | |||
| Interbody System, IdentiTiTM NanoTecTM ALIF | |||
| Standalone Interbody System | MAX, OVD, | ||
| PHM | October 07, 2022 | ||
| K140417 | Divergence Mini-Plate Anterior Cervical Fusion | ||
| System | KWQ, ODP | July 09, 2014 |
IV. DEVICE DESCRIPTION
The Segmental Plating System (SPS) is intended for anterior fixation to the cervical spine. The Segmental Plating System (SPS) consists of a variety of sizes of 2 - 4 holes plates and 3.5 mm and 4.0 mm screws that are manufactured from titanium alloy conforming to ASTM F136 and are offered non-sterile. The plate includes a screw anti-backout mechanism. The system will offer instrumentation for the delivery of the plate and screw construct. The instruments in this system are intended for use in surgical procedures. The plate system implants are provided non-sterile to be steam sterilized by the end user.
The IdentiTi and Transcend SPS 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, commercially pure titanium (CP Ti Grade 2) per ASTM F67, and an optional hydroxyapatite nano (HAMM) surface treatment. The subject system 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 subject IdentiTi and Transcend NanoTec SPS Interbody Systems interbody implant surfaces have been treated with a 20-40 nanometer thin hydroxyapatite (HA) surface treatment. The surface treatment presents a nano-scale topography on the entirety of the implant surface. in addition to macro-/micro-scale topography existing from prior to HA man treatment. The interbody spacers are provided individually packaged and sterile.
V. INDICATIONS FOR USE
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Image /page/7/Picture/0 description: The image shows the logo for "atec". The "a" is green, and the "tec" is dark blue. There is a horizontal line below the logo.
Segmental Plating System (SPS)
The Segmental Plating System (SPS) is intended for anterior screw fixation to the cervical spine (C2-T1) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (kyphosis, lordosis or scoliosis), pseudarthrosis, failed previous fusions, spondylolisthesis, and spinal stenosis.
IdentiTi SPS Interbody System
The IdentiTi SPS 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, myelopathy, and/or pain at multiple contiguous levels from C2-T1. The IdentiTi SPS 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 SPS Interbody System
The IdentiTi SPS 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 SPS 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 SPS Interbody System
The Transcend SPS 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 SPS 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 NanoTec SPS Interbody System
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Image /page/8/Picture/0 description: The image shows the logo for "atec". The "a" is green, while the "tec" is dark blue. There is a trademark symbol to the right of the "c". There is a black line underneath the logo.
The Transcend SPS 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 SPS 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.
TECHNOLOGICAL COMPARISON TO PREDICATES VI.
The subject Segmental Plating System(SPS) is made with similar design, materials, and technological characteristics as those cleared in primary predicate Insignia Anterior Cervical Plate System (K213443) and additional predicates: Shoreline Threaded TruProfile Plate (K211903), and Pioneer SlimFuse Anterior Cervical Plate System (K072703).
The subject IdentiTi and Transcend SPS and IdentiTi and Transcend NanoTec SPS Interbody Systems' implants are a line extension to predicate IdentiTi and Transcend Interbody Systems (K222973). The subject interbody implants are similar in design and made of identical materials as the predicate IdentiTi and Transcend Cervical Interbody System (K222973) except the subject implants have scallop cuts on the anterior wall of the endplates.
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 Segmental Plating and Interbody Systems:
ASTM F2077:2018 Test Methods for Intervertebral Body Fusion Devices
- Static Compression ●
- Dynamic Compression ●
- Static Torsion ●
- Dynamic Torsion ●
ASTM F2267:2004/(R)2018 Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
- Subsidence ●
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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 to the right of the "c". There is a black line underneath the logo.
ASTM Draft Standard F 04.25.02.02 Static Push-out Test Method for Intervertebral Body Fusion Device
-
. Expulsion
ASTM F1717:2021 Test Methods for Spinal Implant Constructs in a Vertebrectomy Model -
Static Compression
-
Dynamic Compression
-
Static Torsion ●
The results demonstrate that the subject Segmental Plating and Interbody Systems are substantially equivalent to other predicate devices for nonclinical testing.
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.