The aprevo® anterior lumbar interbody fusion device with interfixation (ALIF-X) is intended for interbody fusion in skeletally mature patients and is to be used with supplemental fixation instrumentation cleared for use in the lumbar spine. The aprevo® anterior lumbar interbody fusion device with interfixation is indicated for use as an adjunct to fusion at one or more levels of the lumbar spine in patients having an ODI >40 and diagnosed with severe symptomatic adult spinal deformity (ASD) conditions. These patients should have had six months of non-operative treatment. The devices are intended to be used with autograft and/or allogenic bone graft comprised of cancellous bone and/or cortico-cancellous bone. These implanted via a variety of open or minimally invasive approaches. The aprevo® anterior lumbar interbody fusion device with interfixation is intended to be used with the screws that accompany each implant and with supplemental fixation.

The aprevo® anterior lumbar interbody fusion device with interfixation (ALIF-X) is indicated for use at one or more levels of the lumbosacral spine 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, aprevo® lumbar interbody fusion 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). These implants may be implanted via a variety of open or minimally invasive approaches. The aprevo® anterior lumbar interbody fusion device with interfixation is intended to be used with the screws that accompany each implant and with supplemental fixation.

aprevo anterior and lateral lumbar interbody fusion devices (ALIF and LLIF):

The aprevo® anterior and lateral lumbar interbody fusion devices are intended for interbody fusion in skeletally mature patients and are to be used with supplementation cleared for use in the lumbar spine. The aprevo® anterior and lateral lumbar interbody fusion devices are indicated for use as an adjunct to fusion at one or more levels of the lumbar spine in patients having an ODI>40 and diagnosed with severe symptomatic adult spinal deformity (ASD) conditions. These patients should have had six months of non-operative treatment. The devices are intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches may include anterior lumbar interbody fusion or lateral lumbar interbody fusion.

The aprevo® anterior and lateral lumbar interbody fusion devices are indicated for use at one or more levels of the lumbosacral spine 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. aprevo anterior and lateral lumbar interbody fusion 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). These implanted via a variety of open or minimally invasive approaches.

aprevo® transforaminal lumbar interbody fusion devices (TLIF):

The aprevo® transforaminal lumbar interbody fusion device is intended for interbody fusion in skeletally mature patients and is to be used with supplemental fixation instrumentation cleared for use in the lumbar spine. The aprevo® transforaminal lumbar interbody fusion device is indicated for use as an adjunct to fusion at one or more levels of the lumbar spine in patients having an ODI >40 and diagnosed with severe symptomatic adult spinal deformity (ASD) conditions. These patients should have had six months of non-operative treatment. The device is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft. These implants may be implanted via a variety of open or minimally invasive approaches.

The aprevo® transforaminal lumbar interbody fusion device is indicated for use at one or more levels of the lumbosacral spine 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. aprevo® transforaminal lumbar interbody fusion 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). These implanted via a variety of open or minimally invasive approaches.

Device Description

The aprevo® Intervertebral Body Fusion Devices include ALIF-X, ALIF, LLIF, TLIF-O, and TLIF-C interbodies. The aprevo® interbody fusion devices are designed to stabilize the lumbar spinal column and facilitate fusion. The personalized aprevo® devices incorporate patient specific features to allow the surgeon to tailor the deformity correction to the individual needs of the patient.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called "aprevo® anterior and lateral lumbar interbody fusion device". It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, particularly regarding changes in a manufacturing process (addition of a new heat treatment).

Based on the document, this is not a study of a device that uses Artificial Intelligence (AI) or machine learning (ML), nor does it involve a multi-reader multi-case (MRMC) comparative effectiveness study, human readers, or ground truth establishment in the context of diagnostic or prognostic AI/ML applications. The device in question is an implantable interbody fusion device, and the "performance" described relates to mechanical properties and material characteristics, not diagnostic accuracy or expert interpretation.

Therefore, many of the requested elements for describing acceptance criteria and study that proves a device meets them (especially those related to AI/ML, human readers, sample sizes for test/training sets, ground truth establishment for interpretative tasks, and effect sizes of AI assistance) are not applicable or extractable from this document.

The document primarily focuses on non-clinical testing/performance data to demonstrate substantial equivalence following a manufacturing change.

Here's a breakdown of the relevant and non-relevant information based on your request:

Acceptance Criteria and Study for aprevo® Interbody Fusion Device

Study Type: Non-clinical (mechanical and material performance) to demonstrate substantial equivalence for a manufacturing process change. This is not a clinical study or a study involving AI/ML performance.

Applicable Sections from Request:

1. A table of acceptance criteria and the reported device performance: This can be partially derived from the Discussion of Non-Clinical Testing/Performance Data section, as it outlines the tests performed to show equivalence.
2. Sample size used for the test set and the data provenance: For mechanical testing, this refers to the number of devices tested. Data provenance is not explicitly stated but is implied to be from internal testing by the manufacturer.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is not applicable in the context of an implantable device's performance, but if interpreted as device-only performance (without human input during its function), then yes, the mechanical tests are "standalone" in that sense.
7. The type of ground truth used: For mechanical properties, the "ground truth" would be established engineering standards (ASTM F2077-18, ASTM F3001-14) that define acceptable performance.

Non-Applicable Sections from Request (as per the provided document's content):

3. Number of experts used to establish the ground truth... and qualifications: Not applicable for mechanical tests of an implantable device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done... effect size: Not applicable. This is not an AI/ML diagnostic or image interpretation device.
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

Detailed Response:

1. Table of Acceptance Criteria and Reported Device Performance

The document details that the "subject device underwent mechanical performance testing to validate that the performance of the worst-case subject devices is substantially equivalent to the previously cleared predicate devices." The acceptance criteria implicitly involve meeting the performance requirements of the cited ASTM standards, and the reported performance is that substantial equivalence was demonstrated.

Acceptance Criteria Category	Specific Test Standard / Goal	Reported Device Performance (Summary)
Mechanical Performance	ASTM F2077-18: Methods for intervertebral body fusion devices	Demonstrated substantial equivalence to predicate devices.
	- Static/Dynamic Compression	The results "did not identify any new or increased risks".
	- Static/Dynamic Compression Shear
Material Performance	ASTM F3001-14: Standard specification for additively manufactured titanium-6 aluminum-4 vanadium alloys	Demonstrated substantial equivalence to predicate devices.
	- Tensile Testing	The results "did not identify any new or increased risks".
	- Microstructure Assessment per ASTM F3001
	- Chemical Composition Assessment per ASTM F3001
Overall Comparison	Substantial Equivalence to Predicate Devices (K222009, K222082, K231140) in Function and Performance	Concluded to be substantially equivalent in design, function, and performance.

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

Sample Size: The document does not explicitly state the number of devices (samples) used for each mechanical test. Standard practice for such tests under ASTM typically involves a minimum number of samples (e.g., n=5 or n=6 per condition) to achieve statistical significance. However, the exact sample sizes are not provided in this summary.
Data Provenance: The data provenance is implied to be from internal testing conducted by Carlsmed, Inc., as part of their premarket notification submission to the FDA. The country of origin for the data is not specified, but the company is based in Carlsbad, California, USA. The testing is prospective in the sense that it was conducted specifically to demonstrate equivalence for this submission, although the data itself is on device performance.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not Applicable. This is a mechanical/material performance study of an implantable medical device, not a study involving human interpretation of medical images or data. "Ground truth" for these tests refers to the objective physical measurements against established engineering standards.

4. Adjudication Method for the Test Set:

Not Applicable. No human adjudication process is involved as it's not an interpretive or diagnostic study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size:

No. This type of study is typically performed for diagnostic or AI-assisted diagnostic devices. This device is an implantable interbody fusion device, and its performance is assessed via mechanical and material properties, not human reader accuracy with or without AI assistance.

6. If a Standalone Performance Study was done:

Yes (in principle for mechanical device testing). The "Discussion of Non-Clinical Testing/Performance Data" describes tests performed on the device itself (e.g., static/dynamic compression, tensile testing) to evaluate its mechanical and material properties against established standards. These tests are performed on the device samples in a laboratory setting, independent of human clinical application for their evaluation of device performance in terms of strength, integrity, etc.

7. The Type of Ground Truth Used:

The "ground truth" for this study is established by validated engineering standards and specifications (ASTM F2077-18 for mechanical properties and ASTM F3001-14 for material properties). The performance of the devices is measured against the requirements outlined in these standards and compared to the performance of predicate devices.

8. The Sample Size for the Training Set:

Not Applicable. This is not an AI/ML device, so there is no training set in the context of machine learning.

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

Not Applicable. As there is no training set for an AI/ML model, this question does not apply.

Summary

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September 20, 2024

Image /page/0/Picture/1 description: The image shows 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

Carlsmed, Inc. Karen Liu VP Quality and Regulatory 1800 Aston Ave., Ste. 100 Carlsbad, California 92008

Re: K241332

Trade/Device Name: aprevo® anterior and lateral lumbar interbody fusion device: aprevo® anterior lumbar interbody fusion device with interfixation; aprevo® transforaminal lumbar interbody fusion device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX. OVD Dated: September 6, 2024 Received: September 9, 2024

Dear Karen Liu:

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"

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(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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about 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).

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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)

K241332

Device Name

aprevo® anterior and lateral lumbar interbody fusion device

aprevo® anterior lumbar interbody fusion device with interfixation

aprevo® transforaminal lumbar interbody fusion device

Indications for Use (Describe)

The aprevo® anterior lumbar interbody fusion device with interfixation (ALIF-X) is indicated for use at one or more levels of the lumbosacral spine 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. aprevo® lumbar interbody fusion 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). These implants may be implanted via a variety of open or minimally invasive approaches. The aprevo® anterior lumbar interbody fusion device with interfixation is intended to be used with the screws that accompany each implant and with supplemental fixation.

aprevo® anterior and lateral lumbar interbody fusion devices (ALIF and LLIF):

The aprevo® anterior and lateral lumbar interbody fusion devices are intended for interbody fusion in skeletally mature patients and are to be used with supplemental fixation instrumentation cleared for use in the lumbar spine. The aprevo® anterior and lateral lumbar interbody fusion devices are indicated for use as an adjunct to fusion at one or more levels of the lumbar spine in patients having an ODI >40 and diagnosed with severe symptomatic adult spinal deformity (ASD) conditions. These patients should have had six months of non-operative treatment. The devices are intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches may include anterior lumbar interbody fusion or lateral lumbar interbody fusion.

The aprevo® anterior and lateral lumbar interbody fusion devices are indicated for use at one or

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more levels of the lumbosacral spine 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. aprevo® anterior and lateral lumbar interbody fusion 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). These implants may be implanted via a variety of open or minimally invasive approaches.

aprevo® transforaminal lumbar interbody fusion devices (TLIF):

The aprevo® transforaminal lumbar interbody fusion device is indicated for use at one or more levels of the lumbosacral spine 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. aprevo® transforaminal lumbar interbody fusion 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). These implants may be implanted via a variety of open or minimally invasive approaches.

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)

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510(k) Summary

Submitter:	Carlsmed, Inc.1800 Aston Ave., Ste. 100Carlsbad, CA 92008
Official Correspondent:	Karen LiuVP Quality and RegulatoryCarlsmed, Inc.1800 Aston Ave., Ste. 100Carlsbad, CA 92008760-766-1926regulatory@carlsmed.com

Date Prepared: September 19, 2024

Trade Name:

aprevo® anterior lumbar interbody fusion devices with interfixation aprevo® anterior and lateral lumbar interbody fusion device aprevo® transforaminal lumbar interbody fusion device

Common Name:	Intervertebral fusion device with bone graft, lumbar
Classification:	Class II21 CFR §888.3080
Product Code:	MAX, OVD

Primary Predicate Device:

aprevo® anterior lumbar interbody fusion devices with interfixation (K222009)

Additional Predicate Devices:

aprevo® anterior and lateral lumbar interbody fusion devices (K222082) aprevo® transforaminal lumbar interbody fusion devices (K231140)

Device Description:

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Indications for Use:

aprevo anterior lumbar interbody fusion device with interfixation (ALIF-X):

aprevo anterior and lateral lumbar interbody fusion devices (ALIF and LLIF):

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and lateral lumbar interbody fusion 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). These implanted via a variety of open or minimally invasive approaches.

aprevo® transforaminal lumbar interbody fusion devices (TLIF):

The aprevo® transforaminal lumbar interbody fusion device is indicated for use at one or more levels of the lumbosacral spine 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. aprevo® transforaminal lumbar interbody fusion 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). These implanted via a variety of open or minimally invasive approaches.

Summarv of technological similarities and differences

The subject devices are identical to the predicate devices' intended use, indications for use, dimensions, mechanical properties, raw materials, sterilization method and packaging method.

The difference between the subject devices and the predicate devices is the addition of a new heat treatment process. Parts produced using the new process are equivalent to those of the predicate device.

Substantial Equivalence:

The subject device was demonstrated to be substantially equivalent to the predicates cited above with respect to indications, design, function, and performance. Additionally, the subject device is technologically equivalent to the predicate device.

Discussion of Non-Clinical Testing/Performance Data:

The subject device underwent mechanical performance testing to validate that the performance of the worst-case subject devices is substantially equivalent to the previously cleared predicate devices. A summarv of the tested performed in shown in the list below:

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Mechanical testing per ASTM F2077-18 ●
- Static/Dynamic Compression O
- Static/Dynamic Compression Shear o
Testing per ASTM F3001-14 ●
- Tensile Testing o
- Microstructure Assessment per ASTM F3001 O
- Chemical Composition Assessment per ASTM F3001 O

The performance testing demonstrated substantial equivalence between the subject and predicate devices. The results of the testing did not identify any new or increased risks associated with the new process.

Conclusion:

The aprevo® Interbody Fusion Devices are substantially equivalent to the previously cleared devices with respect to their indications for use, design, function, and performance.

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.