aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo® Transforaminal Lumbar Interbody Fusion device (TLIF); aprevo® Anterior Lumbar Interbody Fusion device with Interfixation (ALIF-X)

K241328 · Carlsmed, Inc. · MAX · Aug 12, 2024 · Orthopedic

Device Facts

• Record ID: K241328
• Device Name: aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo® Transforaminal Lumbar Interbody Fusion device (TLIF); aprevo® Anterior Lumbar Interbody Fusion device with Interfixation (ALIF-X)
• Applicant: Carlsmed, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: Aug 12, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

aprevo® ALIF and LLIF: The aprevo® anterior and lateral lumbar interbody fusion devices are 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 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® 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 (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 implants may be implanted via a variety of open or minimally invasive approaches. aprevo® ALIF-X: 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.

Device Story

Personalized interbody fusion devices (ALIF, LLIF, TLIF, ALIF-X) designed to stabilize lumbar spine; facilitate fusion. Device configurations/surgical plans developed from patient CT scans; incorporate patient-specific features for deformity correction. Implants feature aperture/cavity for bone graft packing. Used by surgeons in open or minimally invasive procedures. ALIF-X includes integrated screws. Benefits: tailored deformity correction to individual patient needs.

Clinical Evidence

Bench testing only. No clinical data presented. Performance supported by mechanical testing per ASTM F2077, manufacturing sensitivity analyses, and manufacturing validation.

Technological Characteristics

Materials: Titanium alloy (Ti-6Al-4V) per ASTM F3001 and ASTM F136. Form factor: Patient-specific interbody fusion implants with bone graft cavity. Sterilization: Provided sterile. Connectivity: N/A.

Indications for Use

Indicated for skeletally mature patients requiring lumbar interbody fusion. Conditions: severe symptomatic adult spinal deformity (ODI >40), degenerative disc disease, disc herniation, spondylolisthesis, deformity (scoliosis/kyphosis), spinal stenosis, pseudarthrosis. Requires 6 months non-operative treatment. Used with supplemental fixation.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• aprevo® anterior and lateral lumbar interbody fusion device (ALIF/LLIF) (K222082)
• aprevo® transforaminal lumbar interbody fusion device (TLIF) (K222082)
• aprevo® anterior lumbar interbody fusion device with fixation (ALIF-X) (K222009)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 12, 2024

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

#### Re: K241328

Trade/Device Name: aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF): aprevo® Transforaminal Lumbar Interbody Fusion device (TLIF); aprevo® Anterior Lumbar Interbody Fusion device with Interfixation (ALIF-X) Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, OVD Dated: July 17, 2024 Received: July 17, 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" (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 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 ([e-mail]) or phone [phone] 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}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Submission Number (if known)

#### K241328

#### Device Name

aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF);

aprevo® Transforaminal Lumbar Interbody Fusion device (TLIF);

aprevo® Anterior Lumbar Interbody Fusion device with Interfixation (ALIF-X)

Indications for Use (Describe)

aprevo® ALIF and LLIF:

The aprevo® anterior and lateral lumbar interbody fusion devices are 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 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® 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 (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

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

{3}------------------------------------------------

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.

# aprevo® ALIF-X:

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.

#### Type of Use (Select one or both, as applicable)

× Prescription Use (Part 21 CFR 801 Subpart D)

ver-The-Counter Use (21 CFR 801 Subpart C)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

# 510(k) Summary

| Submitter: | Carlsmed, Inc.<br>1800 Aston Ave., Ste. 100<br>Carlsbad, CA 92008 |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Correspondent: | Aly Alvarez<br>Director, Regulatory Affairs<br>Carlsmed, Inc.<br>1800 Aston Ave., Ste. 100<br>Carlsbad, CA 92008<br>[e-mail] |
| Date Prepared: | May 10, 2024 |
| Trade Name: | aprevo® anterior and lateral lumbar interbody fusion device<br>aprevo® transforaminal lumbar interbody fusion device<br>aprevo® anterior lumbar interbody fusion device with<br>interfixation |
| Common Name: | Intervertebral Fusion Device with Bone Graft, Lumbar<br>Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Classification: | Class II<br>21 CFR §888.3080 |
| Product Code: | MAX, OVD |
| Primary Predicate Device: | aprevo® anterior and lateral lumbar interbody fusion device (ALIF/LLIF) (K222082) |
| Additional Predicate Device: | aprevo® transforaminal lumbar interbody fusion device<br>(TLIF) (K222082) |
| Additional Predicate Device: | aprevo® anterior lumbar interbody fusion device with<br>fixation (ALIF-X) (K222009) |

### Device Description:

The aprevo® anterior, lateral and transforaminal lumbar 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 and include an aperture intended for the packing of bone graft. The individualized surgical correction plan and device configurations are developed using patient CT scans. The aprevo® devices are manufactured from titanium alloy (Ti-6Al-4V) per ASTM F3001 and are provided sterile.

{5}------------------------------------------------

The aprevo® anterior lumbar interbody fusion device with interfixation, (ALIF-X), is 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. The individualized surgical correction plan and device configurations are developed using patient CT scans. The aprevo® devices are manufactured from Titanium Alloy (Ti-6Al-4V) per ASTM F3001 and ASTM F136. The aprevo® ALIF-X device has a cavity intended for the packing of bone graft.

#### Indications for Use:

#### aprevo® anterior and lateral lumbar interbody fusion devices

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 nonoperative 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 implants may be implanted via a variety of open or minimally invasive approaches.

#### aprevo® transforaminal lumbar interbody fusion device

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 implanted via a variety of open or minimally invasive approaches.

{6}------------------------------------------------

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 implants may be implanted via a variety of open or minimally invasive approaches.

#### aprevo® anterior lumbar interbody fusion device with interfixation

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 nonoperative 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 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.

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.

#### Substantial Equivalence:

The subject devices were demonstrated to be substantially equivalent to the predicates cited above with respect to indications, design, function, and performance.

{7}------------------------------------------------

# Performance Testing:

The following testing have been conducted in order to support substantial equivalence:

- Manufacturing Sensitivity Analyses ●
- Manufacturing Validation Activities .
- Mechanical Testing per ASTM F2077 ●

# Conclusion:

The aprevo® anterior and lateral lumbar interbody fusion device (ALIF/LLIF), transforaminal lumbar interbody fusion device (TLIF), and anterior lumbar interbody fusion device with interfixation (ALIF-X) are substantially equivalent to the previously cleared devices with respect to their indications for use, design, function, and performance.