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), spondvlolisthesis, 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.

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; or three (3) Anchors that are additively manufactured from titanium alloy per ASTM F3001.

The E3D™-A Interbody System's implants are available with and without HAnano Surface®, a 20-40 nanometer thin hydroxyapatite (HA) surface treatment. The surface treatment presents nano-scale topography on the entirety of the implant surface.

The purpose of this submission is to add larger footprints and Anchors.

AI/ML Overview

This document is a 510(k) summary for the E3D™-A Interbody System, a medical device used for spinal fusion. The information provided heavily focuses on regulatory aspects and comparisons to predicate devices, rather than a detailed study proving the device meets specific acceptance criteria based on clinical performance. Therefore, I cannot provide a table of acceptance criteria and reported device performance directly from this text, as specific quantitative performance metrics and acceptance thresholds for clinical efficacy are not detailed.

However, I can extract information related to performance testing that supports the device's substantial equivalence.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, the document does not contain a typical table of clinical acceptance criteria (e.g., sensitivity, specificity, accuracy) and reported device performance. It instead describes mechanical performance testing against predicate devices and standards.

Acceptance Criteria Type	Acceptance Standard/Predicate Performance	Reported Device Performance
Mechanical Testing	Performed equal to or better than predicate devices in static and dynamic testing per ASTM F2077.	"The worst-case implants for the E3D™-A Interbody System were tested and performed equal to or better than the predicate devices in static and dynamic testing per ASTM F2077."
HAnano Surface® Performance	Previously conducted per Promimic's protocols, as accepted by FDA for clearance of reference device K232432.	Performance tested as accepted for K232432.
Substantial Equivalence	Demonstrated through comparison of design, intended use, material composition, function, and range of sizes against predicate devices.	The E3D™-A Interbody System was shown to have "substantially equivalent technological characteristics" and "substantially equivalent to legally marketed predicate devices."

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "worst-case implants" for mechanical testing, but does not specify the sample size (number of implants tested) for the test set. It does not mention clinical data or studies with human subjects, so there is no information on data provenance (country of origin, retrospective/prospective). This submission is for substantial equivalence based on technological characteristics and mechanical testing, not clinical performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The document does not describe a clinical study or expert review for establishing ground truth, as the submission focuses on mechanical and design equivalence.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of adjudication, as no clinical ground truth assessment or expert review is described.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a physical intervertebral body fusion device, not an AI or software-based diagnostic tool, so an MRMC study is not relevant.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical implant, not an algorithm.

7. The type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the mechanical testing, the "ground truth" would be the established performance standards of ASTM F2077 and the performance of the predicate devices. For the HAnano Surface®, the "ground truth" was established by Promimic's protocols accepted by FDA (reference K232432).

8. The Sample Size for the Training Set

Not applicable. This document describes a physical medical device and its regulatory submission, not a machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable. As there is no training set mentioned, this question is not relevant.

Summary

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Image /page/0/Picture/0 description: The image shows the date May 15, 2024. The text is written in a clear, sans-serif font. The date is formatted with the month first, followed by the day and year. The text is black against a white background.

Evolution Spine Todd Wallenstein

VP R&D, Quality, Regulatory 2300 N. Haskell Ave Dallas, Texas 75204

Re: K240368

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: April 12, 2024 Received: April 12, 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).

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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

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Indications for Use

Submission Number (if known)

K240238

Device Name

E3D™-A Interbody System

Indications for Use (Describe)

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.

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Image /page/4/Picture/0 description: The image shows the logo for Evolution Spine. The word "EVOLUTION" is written in large, bold, sans-serif font. Below the "TION" portion of the word, the word "SPINE" is written in a smaller, sans-serif font. The logo is simple and modern.

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 Spine2300 N Haskell RdDallas, TX 75204
Contact:	Todd WallensteinEvolution Spine2300 N Haskell AveDallas, TX 75204Phone: (214) 682-8536twallenstein@evolutionspine.com
Date Prepared:	February 6, 2024
Device Trade Name:Common Name:Classification:Class:Product Code:	E3DTM-A Interbody SystemIntervertebral Body Fusion Device21 CFR §888.3080IIOVD, MAX, PHM
Primary Predicate:Additional Predicates:	EVOLUTION SPINE Interbody System (K223146)E3DTM-A Interbody System (K232432)Globus Hedron IA (K191391)Alphatec Spine - IdentiTiTM NanoTecTM ALIF Standalone InterbodySystem (K222028)

Device Description:

The purpose of this submission is to add larger footprints and Anchors.

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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 (DD), 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).

Technological Comparison To Predicates:

The subject E3D™-A Interbody System is substantially equivalent to the predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to have substantially equivalent technological characteristics to the predicate devices through comparison of design, intended use, material composition, function, and range of sizes.

Performance Data:

The worst-case implants for the E3D™-A Interbody System were tested and performed equal to or better than the predicate devices in static and dynamic testing per ASTM F2077. The proposed implants do not represent a new worst case for mechanical testing.

Performance testing of HAnano Surface was previously conducted per Promimic's protocols, as accepted by FDA for the clearance of the reference device K232432 (Evolution Spine's E3D™-A Interbody System).

Conclusion:

Based on the indications for use, technological characteristics, performance testing, and comparison to predicate devices, composition, material, and function the subject E3D™-A Interbody System has been shown to be substantially equivalent to legally marketed predicate devices.

Regulation Number and Section

§ 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.