aprevo® posterior/transforaminal lumbar interbody fusion device

K250987 · Carlsmed, Inc. · MAX · Jun 30, 2025 · Orthopedic

Device Facts

• Record ID: K250987
• Device Name: aprevo® posterior/transforaminal lumbar interbody fusion device
• Applicant: Carlsmed, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: Jun 30, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The aprevo® posterior/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® posterior/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, cortical, and/or corticocancellous bone. The device may be implanted via an open or minimally invasive approach. The aprevo® posterior/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 months of non-operative treatment. The aprevo® transforaminal lumbar interbody fusion device is to be filled with autograft bone and/or allogenic bone graft comprised of cancellous, cortical, and/or corticocancellous bone. The device is 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). The device may be implanted via an open or minimally invasive approach.

Device Story

Patient-specific interbody fusion device; stabilizes lumbar spinal column; facilitates fusion. Input: patient radiological images used to develop individualized surgical correction plan and device configuration. Additively manufactured titanium alloy; includes aperture for bone graft packing. Used in OR by surgeons; implanted via open or minimally invasive approach. Requires supplemental fixation (e.g., pedicle screws/rods). Benefits patient by providing personalized anatomical fit for spinal correction.

Clinical Evidence

No clinical data. Substantial equivalence based on bench testing (ASTM F2077, ASTM F2267) and cadaveric validation.

Technological Characteristics

Material: Titanium alloy (Ti-6Al-4V ELI) per ASTM F3001. Additively manufactured. Includes aperture for bone graft. Provided sterile. Used with stainless steel instruments (ASTM A564).

Indications for Use

Indicated for skeletally mature patients requiring interbody fusion at one or more lumbar/lumbosacral levels. Conditions include severe symptomatic adult spinal deformity (ODI >40, 6 months non-operative treatment), degenerative disc disease, disc herniation, spondylolisthesis, deformity (scoliosis/kyphosis), spinal stenosis, and pseudarthrosis. Requires 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® transforaminal lumbar interbody fusion device (K241332)
• aprevo® TLIF-C Articulating System (K241019)
• WaveForm TO Interbody System (K241466)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

June 30, 2025

Carlsmed Inc.
Jesse Albright
Sr. Manager, Regulatory Affairs
1800 Aston Ave, Ste 100
Carlsbad, California 92008

Re: K250987
Trade/Device Name: aprevo® posterior/transforaminal lumbar interbody fusion device
Regulation Number: 21 CFR 888.3080
Regulation Name: Intervertebral Body Fusion Device
Regulatory Class: Class II
Product Code: MAX
Dated: May 30, 2025
Received: June 2, 2025

Dear Jesse Albright:

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"

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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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 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 (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-reporting-combination-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 Rule"). 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-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).

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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

Enclosure

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aprevo® posterior/transforaminal lumbar interbody fusion device
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| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K250987 | ? |
| Please provide the device trade name(s). | | ? |
| aprevo® posterior/transforaminal lumbar interbody fusion device | | |
| Please provide your Indications for Use below. | | ? |
| The aprevo® posterior/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® posterior/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, cortical, and/or corticocancellous bone. The device may be implanted via an open or minimally invasive approach. The aprevo® posterior/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 months of non-operative treatment. The aprevo® transforaminal lumbar interbody fusion device is to be filled with autograft bone and/or allogenic bone graft comprised of cancellous, cortical, and/or corticocancellous bone. The device is 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). The device may be implanted via an open or minimally invasive approach. | | |
| Please select the types of uses (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

## Contact Details

Applicant: Carlsmed, Inc.
Address: 1800 Aston Ave Ste 100
Carlsbad, CA 92008
Phone number: [phone]

Contact person: Jesse Albright
Sr. Manager, Regulatory Affairs
[e-mail]

Date prepared: March 31, 2025

## Device Name

Trade name: aprevo® posterior/transforaminal lumbar interbody fusion device
Common name: Intervertebral Body Fusion Device
Classification name: Intervertebral Fusion Device with Bone Graft, Lumbar (21 CFR 888.3080)
Class: 2
Product code: MAX

## Legally Marketed Predicate Devices

| 510(k) Number | Product Code | Trade Name | Manufacturer |
| --- | --- | --- | --- |
| Primary Predicate Device | | | |
| K241332 | MAX | aprevo® transforaminal lumbar interbody fusion device | Carlsmed, Inc. |
| Additional Predicate Device(s) | | | |
| K241019 | MAX | aprevo® TLIF-C Articulating System | Carlsmed, Inc. |
| K241466 | MAX | WaveForm TO Interbody System | SeaSpine Orthopedics Corporation |

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# Device Description

The aprevo® posterior/transforaminal intervertebral body fusion device is designed to stabilize the lumbar spinal column and facilitate fusion. The personalized aprevo® device incorporates patient specific features and includes an aperture intended for the packing of bone graft. The individualized surgical correction plan and device configurations are developed using patient radiological images.

The aprevo® posterior/transforaminal lumbar interbody fusion device is additively manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F3001 and provided sterile. The associated instruments, which facilitate the placement, adjustment, and removal, if necessary, of the interbody device, are manufactured from stainless steel per ASTM A564 and provided sterile packaged for single use.

# Indications for Use

The aprevo® posterior/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® posterior/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, cortical, and/or corticocancellous bone. The device may be implanted via an open or minimally invasive approach.

The aprevo® posterior/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 months of non-operative treatment. The aprevo® transforaminal lumbar interbody fusion device is to be filled with autograft bone and/or allogenic bone graft comprised of cancellous, cortical, and/or corticocancellous bone. The device is 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). The device may be implanted via an open or minimally invasive approach.

# Summary of Technological Characteristics

The aprevo® posterior/transforaminal lumbar interbody fusion device technological characteristics are substantially equivalent to the cited predicate devices. The equivalence determination was based on comparison of intended use/indications for use, operating principle,

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design, components, materials, biocompatibility, manufacturing, packaging, labeling, sterility, and non-clinical testing.

## Non-Clinical Testing

The aprevo® posterior/transforaminal lumbar interbody fusion device demonstrated substantially equivalent mechanical performance to the predicate devices through static and dynamic axial compression and compression-shear (ASTM F2077) and engineering analysis of subsidence (ASTM F2267). A cadaveric validation also demonstrated that the subject device performs as intended.

## Clinical Testing

Not applicable. The determination of substantial equivalence is not based on an assessment of clinical performance data.

## Conclusion

The submitted data demonstrates that the subject aprevo® posterior/transforaminal lumbar interbody fusion device is substantially equivalent to the cited legally marketed predicates.