(172 days)
No
The 510(k) summary describes a static and integrated interbody fusion device made of titanium alloy, with an optional surface treatment. There is no mention of any software, algorithms, image processing, or AI/ML capabilities in the intended use, device description, or performance studies. The device is a passive implant providing structural support.
Yes
The device is described as an interbody fusion device intended to provide structural stability and is used for conditions like degenerative disc disease and spondylolisthesis, which are medical conditions that require treatment.
No
The E3D™ -A Static Interbody Devices and E3D™ -A Integrated Interbody Devices are interbody fusion devices designed to provide structural stability during spinal fusion. They are used to facilitate spinal fusion and do not diagnose medical conditions.
No
The device description explicitly states that the device is an "interbody fusion device" and is "additively manufactured from titanium alloy powder." This indicates a physical hardware component, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The E3D™ -A Interbody Devices are described as implants designed to provide structural stability during spinal fusion surgery. They are physically placed within the patient's body.
- Lack of Specimen Analysis: There is no mention of this device analyzing any biological specimens or providing diagnostic information based on such analysis.
The device is a surgical implant used to treat specific spinal conditions by promoting fusion. This falls under the category of a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
E3D™ -A Static Interbody Devices are thoraco-lumbar interbody fusion devices indicated at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12- L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. Devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation.
E3D™ -A Integrated Interbody Devices are integrated lumbar interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with three screws or anchors which accompany the implants. When used with screws, these devices are stand-alone interbody fusion devices. When used with anchors, these devices are intended for use with supplemental fixation (e.g., facet screws or posterior fixation). Hyperlordotic implants (≥20° lordosis) are intended for use with supplemental fixation (e.g., facet screws or posterior fixation). When used without screws or anchors, these devices are intended for use with supplemental fixation (e.g., facet screws or posterior fixation).
When used for multilevel degenerative scoliosis or sagittal deformity, supplemental fixation that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems) must be used.
Product codes (comma separated list FDA assigned to the subject device)
OVD, MAX, PHM
Device Description
The E3D™ -A Interbody System provides interbody fusion devices designed to provide structural stability during spinal fusion. The E3D™-A Interbody System consists of interbodies offered in various sizes to accommodate surgical needs and anatomic requirements. The E3D-A Interbodies were designed to be placed via an anterior approach. All interbodies in the system are additively manufactured from titanium alloy powder, per ASTM F3001. The System offers both Static and Integrated Interbodies. The Integrated version is to be used in conjunction with three (3) screws that are subtractively manufactured from titanium alloy, per ASTM F136.
The E3D-A Interbody System's implants are available with and without HA®®º Surface®, a 20-40 nanometer thin hydroxyapatite (HA) surface treatment. The surface treatment presents nano-scale topography on the entirety of the implant surface.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic spine (T1-T12), thoracolumbar junction (T12- L1), or lumbosacral spine (L1-S1), lumbosacral spine (L2-S1)
Indicated Patient Age Range
skeletally mature
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)
Performance testing per ASTM F2077 for dynamic compression shear testing performed on the uncoated version of the subject device.
Performance testing of HAnano Surface was previously conducted per Promimic's protocols, as accepted by FDA for the clearance of the reference devices K201614 (TxTiHA IBF System, AxTiHA Stand-Alone ALIF System, Innovasis, Inc.), K222561 (Align Anterior Cages, Acuity Surgical Devices, and K220782 (IdentiTi™ NanoTec™ ALIF Standalone Interbody System, Alphatec Spine).
The results of these tests indicate that the E3D™-A Interbody System is substantially equivalent to the predicate and reference devices.
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.
EVOLUTION SPINE Interbody System (K223146), Align Anterior Cages from Acuity Surgical Devices (K222561), Alphatec Spine - IdentiTi™ NanoTec™ ALIF Standalone Interbody System (K220782), Innovasis® AxTiHA™ Stand-Alone ALIF System (K201614)
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.
K201614 (TxTiHA IBF System, AxTiHA Stand-Alone ALIF System, Innovasis, Inc.), K222561 (Align Anterior Cages, Acuity Surgical Devices), K220782 (IdentiTi™ NanoTec™ ALIF Standalone Interbody System, Alphatec Spine)
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
January 30, 2024
Image /page/0/Picture/1 description: The image shows 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 a blue square with the letters "FDA" in white. To the right of the square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
Evolution Spine Todd Wallenstein VP R&D, Quality, Regulatory 2300 N. Haskell Ave Dallas. Texas 75204
Re: K232432
Trade/Device Name: E3D™-A Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD, MAX, PHM Dated: January 2, 2024 Received: January 2, 2024
Dear Todd Wallenstein:
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.
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,
Katherine D. Kavlock -S
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
2
Indications for Use
Submission Number (if known)
Device Name
E3D™-A Interbody System
Indications for Use (Describe)
E3D™ -A Static Interbody Devices are thoraco-lumbar interbody fusion devices indicated at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12- L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. Devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation.
E3D™ -A Integrated Interbody Devices are integrated lumbar interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with three screws or anchors which accompany the implants. When used with screws, these devices are stand-alone interbody fusion devices. When used with anchors, these devices are intended for use with supplemental fixation (e.g., facet screws or
posterior fixation). Hyperlordotic implants (≥20° lordosis) are intended for use with supplemental fixation (e.g., facet screws or posterior fixation). When used without screws or anchors, these devices are intended for use with supplemental fixation (e.g., facet screws or posterior fixation).
When used for multilevel degenerative scoliosis or sagittal deformity, supplemental fixation that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems) must be used.
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.
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
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K232432 Page 1 of 3
510(k) Summary
In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR §807.92, the following summary of information is provided:
| Company: | Evolution Spine
2300 N Haskell Rd
Dallas, TX 75204 |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Todd Wallenstein
Evolution Spine
2300 N Haskell Ave
Dallas, TX 75204
Phone: (214) 682-8536
twallenstein@evolutionspine.com |
| Date Prepared: | November 16, 2023 |
| Device Trade Name: | E3D™-A Interbody System |
| Common Name: | Intervertebral Body Fusion Device |
| Classification: | 21 CFR §888.3080 |
| Class: | II |
| Product Code: | OVD, MAX, PHM |
| Primary Predicate: | EVOLUTION SPINE Interbody System (K223146) |
| Additional Predicates: | Align Anterior Cages from Acuity Surgical Devices (K222561)
Alphatec Spine - IdentiTi™ NanoTec™ ALIF Standalone Interbody
System (K220782)
Innovasis® AxTiHA™ Stand-Alone ALIF System (K201614) |
Device Description:
The E3D™ -A Interbody System provides interbody fusion devices designed to provide structural stability during spinal fusion. The E3D™-A Interbody System consists of interbodies offered in various sizes to accommodate surgical needs and anatomic requirements. The E3D-A Interbodies were designed to be placed via an anterior approach. All interbodies in the system are additively manufactured from titanium alloy powder, per ASTM F3001. The System offers both Static and Integrated Interbodies. The Integrated version is to be used in conjunction with three (3) screws that are subtractively manufactured from titanium alloy, per ASTM F136.
The E3D-A Interbody System's implants are available with and without HA®®º Surface®, a 20-40 nanometer thin hydroxyapatite (HA) surface treatment. The surface treatment presents nano-scale topography on the entirety of the implant surface.
4
Indications For Use:
E3D™-A Static Interbody Devices are thoraco-lumbar interbody fusion devices indicated at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12- L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. Devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation.
E3D™-A Integrated Interbody Devices are integrated lumbar interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with three screws or anchors which accompany the implants. When used with screws, these devices are stand-alone interbody fusion devices. When used with anchors, these devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). Hyperlordotic implants (200 lordosis) are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). When used without screws or anchors, these devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation).
When used for multilevel degenerative scoliosis or sagittal deformity, supplemental fixation that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems) must be used.
Technological Comparison To Predicates:
The technological design features of the subject E3D™-A Interbody System are identical to the predicate K223146, EVOLUTION SPINE Interbody System in intended use, indications for use, design, function, and technology, and it was demonstrated that they are substantially equivalent.
The subject E3D™-A Interbody System incorporates a nano-scale hydroxyapatite surface treatment, identical to that provided on devices cleared in K201614 (TxTiHA IBF System, AxTiHA Stand-Alone ALIF System, Innovasis, Inc.), K222561 (Align Anterior Cages, Acuity Surgical Devices, and K220782 (IdentiTi™ NanoTec™ ALIF Standalone Interbody System, Alphatec Spine).
5
Performance Data:
Performance testing per ASTM F2077 for dynamic compression shear testing performed on the uncoated version of the subject device.
Performance testing of HAnano Surface was previously conducted per Promimic's protocols, as accepted by FDA for the clearance of the reference devices K201614 (TxTiHA IBF System, AxTiHA Stand-Alone ALIF System, Innovasis, Inc.), K222561 (Align Anterior Cages, Acuity Surgical Devices, and K220782 (IdentiTi™ NanoTec™ ALIF Standalone Interbody System, Alphatec Spine).
The results of these tests indicate that the E3D™-A Interbody System is substantially equivalent to the predicate and reference devices.
Conclusion:
Based on the indications for use, technological characteristics, performance testing, and comparison to predicate devices, the subject E3D™-A Interbody System has been shown to be substantially equivalent to legally marketed predicate devices.