aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM

K242260 · Carlsmed, Inc. · ODP · Nov 15, 2024 · Orthopedic

Device Facts

• Record ID: K242260
• Device Name: aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM
• Applicant: Carlsmed, Inc.
• Product Code: ODP · Orthopedic
• Decision Date: Nov 15, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

aprevo® Cervical ACDF Interbody The aprevo® Cervical ACDF Interbody System are interbody fusion devices indicated at one or more levels of the cervical spine (C2-T1) in patients with the following degenerative cervical conditions: cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as discogenic 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) weeks of non-operative treatment. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or cortico-cancellous bone. The aprevo® Cervical ACDF Interbody System must be used with supplemental fixation systems. For hyperlordotic corrections (≥20 lordosis), the system must be used with at least an anterior cervical plate as supplemental fixation. aprevo® Cervical ACDF-X Interbody (with and without CAM) The aprevo® Cervical ACDF-X Interbody System are interbody fusion devices indicated at one or more levels of the cervical spine (C2-T1) in patients with the following degenerative cervical conditions: cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as discogenic 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) weeks of non-operative treatment. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or cortico-cancellous bone. When used as a standalone system, the aprevo® Cervical ACDF-X Interbody implant with integrated screw fixation is intended for use at multiple contiguous levels, or up to two levels when used in trauma, deformity or failed previous fusions. Deformity procedures to correct coronal angulation or any use of hyperlordotic correction (>20°) must include supplemental fixation such as posterior cervical screw fixation or anterior plating.

Device Story

Personalized intervertebral body fusion devices designed to stabilize cervical spine and facilitate fusion; incorporates patient-specific features for deformity correction. Interbodies feature aperture for bone graft packing. Used by surgeons in clinical settings to treat degenerative cervical conditions. Devices are additively manufactured titanium alloy; accompanied by single-use sterile inserter instruments. Output is physical stabilization of spinal segments; clinical decision-making relies on surgeon assessment of patient-specific deformity needs. Benefits include tailored anatomical correction and spinal stabilization.

Clinical Evidence

Bench testing only. Performed static and dynamic axial compression, compression-shear, and torsion per ASTM F2077; subsidence testing per ASTM F2267; cervical screw pushout testing; and cadaveric validation labs.

Technological Characteristics

Interbodies: Ti-6Al-4V ELI titanium alloy (ASTM F3001). Screws: Ti alloy (ASTM F136). Additively manufactured. Single-use, sterile-packed. Standalone or supplemental fixation configurations.

Indications for Use

Indicated for skeletally mature patients with degenerative cervical conditions (C2-T1) including disc disease, instability, trauma, deformity (kyphosis, lordosis, scoliosis), myelopathy, stenosis, and failed fusion. Requires 6 weeks of prior non-operative treatment.

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

• IdentiTi Cervical Standalone (K222973)
• Modulus-C (K172676)
• TM-S Cervical Fusion Device (K111119)
• Latitude-CTM Cervical Interbody Spacer System (K151496)
• aprevo® ALIF System (K202034)
• IdentiTi™ Cervical Standalone Interbody System (K220782)
• Hive™ Standalone Cervical System (K223190)
• Fortilink Cervical Standalone (K201453)
• aprevo® ALIF-X System (K222009)
• Hexanium® ACIF (K221578)
• IdentiTi™-C Standalone Interbody System (K220782)

Submission Summary (Full Text)

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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. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 15, 2024

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

Re: K242260

Trade/Device Name: aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE, ODP Dated: October 11, 2024 Received: October 15, 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.

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2

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).

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.

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-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-regulatory

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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).

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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# Indications for Use

Submission Number (if known)

#### K242260

Device Name

aprevo® Cervical ACDF System; aprevo® Cervical ACDF-X System; aprevo® Cervical ACDF-X NO CAM System

ndications for Use (Describe)

aprevo® Cervical ACDF Interbody

The aprevo® Cervical ACDF Interbody System are interbody fusion devices indicated at one or more levels of the cervical spine (C2-T1) in patients with the following degenerative cervical conditions: cervical disc disease, instability, trauma including fractures, deformity defined as kvphosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as discogenic 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) weeks of non-operative treatment. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or cortico-cancellous bone. The aprevo® Cervical ACDF Interbody System must be used with supplemental fixation systems. For hyperlordotic corrections (≥20 lordosis), the system must be used with at least an anterior cervical plate as supplemental fixation.

aprevo® Cervical ACDF-X Interbody (with and without CAM)

The aprevo® Cervical ACDF-X Interbody System are interbody fusion devices indicated at one or more levels of the cervical spine (C2-T1) in patients with the following degenerative cervical conditions: cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as discogenic 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) weeks of non-operative treatment. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or cortico-cancellous bone. When used as a standalone system, the aprevo® Cervical ACDF-X Interbody implant with integrated screw fixation is intended for use at multiple contiguous levels, or up to two levels when used in trauma, deformity or failed previous fusions. Deformity procedures to correct coronal anqulation or any use of hyperlordotic correction (>20°) must include supplemental fixation such as posterior cervical screw fixation or anterior plating.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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| 510(k) Summary | |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Device Trade Name: | aprevo® Cervical ACDF System; aprevo® Cervical ACDF-X System |
| Manufacturer: | Carlsmed, Inc.<br>1800 Aston Ave. Suite 100<br>Carlsbad, CA 92008 |
| Contact: | Karen Liu<br>Vice President, Regulatory Affairs<br>1800 Aston Ave. Suite 100<br>Carlsbad, CA 92008<br>[e-mail] |
| Date Prepared: | November 13, 2024 |
| Classifications: | 21 CFR §882.3080 |
| Classification Name: | Intervertebral Body Fusion Devices |
| Class: | II |
| Product Codes: | OVE, ODP |

## Indications For Use:

## aprevo® Cervical ACDF Interbody

The aprevo® Cervical ACDF Interbody System are interbody fusion devices indicated at one or more levels of the cervical spine (C2-T1) in patients with the following degenerative cervical conditions: cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as discogenic 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) weeks of non-operative treatment. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or cortico-cancellous bone. The aprevo® Cervical ACDF Interbody System must be used with supplemental fixation systems. For hyperlordotic corrections (≥20 lordosis), the system must be used with at least an anterior cervical plate as supplemental fixation.

## aprevo® Cervical ACDF-X Interbody

The aprevo® Cervical ACDF-X Interbody System are interbody fusion devices indicated at one or more levels of the cervical spine (C2-T1) in patients with the following degenerative cervical conditions: cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as discogenic 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) weeks of non-operative treatment. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or cortico-cancellous bone. When used as a standalone system, the aprevo® Cervical ACDF-X Interbody implant with integrated screw fixation is intended for use at multiple contiguous levels, or up to two levels when used in trauma, deformity or failed previous fusions. Deformity procedures to correct coronal angulation or any use of hyperlordotic correction (>20°) must include supplemental fixation such as posterior cervical screw fixation or anterior plating.

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#### Device Description:

The aprevo® Cervical ACDF System, which includes the aprevo® Cervical ACDF Interbody, aprevo® Cervical ACDF-X Interbody, and the aprevo® Cervical ACDF-X (no cam) Interbody are designed to stabilize the cervical 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 for the packing of bone graft.

The aprevo® Cervical ACDF System interbodies are additively manufactured from Ti-6AI-4V ELI titanium alloy per F3001, while the screw are machined from Ti alloy per ASTM F136. The devices are accompanied by an inserter instrument which facilitates the placement of the interbodies. Both the interbody devices and the instrument are provided to the end-user as single use, sterile-packed products.

## Primary Predicate Device:

| Primary Predicate | Product Code | Trade Name | Manufacturer |
|-------------------|--------------|------------------------------|--------------|
| K222973 | OVE, ODP | IdentiTi Cervical Standalone | Alphatec |

#### Table 1. Additional Predicates for the aprevo® Cervical ACDF System

| 510(k) Number | Product<br>Code | Trade Name | Manufacturer |
|---------------|-----------------|--------------------------------------------------|---------------------|
| K172676 | ODP | Modulus-C | NuVasive, Inc. |
| K111119 | ODP | TM-S Cervical Fusion Device | Zimmer Spine, Inc. |
| K151496 | ODP | Latitude-CTM Cervical Interbody Spacer<br>System | Degen Medical, Inc. |
| K202034 | MAX | aprevo® ALIF System | Carlsmed, Inc. |

## Table 2. Additional Predicates for the aprevo® Cervical ACDF-X System

| 510(k) Number | Product Code | Trade Name | Manufacturer |
|---------------|--------------|---------------------------------------------------|------------------------|
| K220782 | OVE | IdentiTi™ Cervical Standalone<br>Interbody System | ATEC Spine, Inc |
| K223190 | OVE, ODP | Hive™ Standalone Cervical System | NanoHive Medical, Inc. |
| K201453 | OVE, ODP | Fortilink Cervical Standalone | Paradigm Spine |
| K222009 | OVD | aprevo® ALIF-X System | Carlsmed, Inc. |

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| 510(k) Number | Product<br>Code | Trade Name | Manufacturer |
|---------------|-----------------|--------------------------------------------|-------------------|
| K221578 | OVE | Hexanium® ACIF | SpineVision, Inc. |
| K220782 | OVE, OVD | IdentiTi™-C Standalone Interbody<br>System | ATEC Spine, Inc |
| K201453 | OVE, ODP | Fortilink Cervical Standalone | Paradigm Spine |
| K222009 | OVD | aprevo® ALIF-X System | Carlsmed, Inc. |

#### Table 3. Predicates for the aprevo® Cervical ACDF-X (no cam) System

#### Performance Testing Summary:

The following bench testing has been conducted on the aprevo® Cervical ACDF System:

- Static and Dynamic axial compression per ASTM F2077 ●
- Static and Dynamic compression-shear per ASTM F2077
- Static and Dynamic torsion per ASTM F2077 ●
- Subsidence per ASTM F2267
- Cervical Screw Pushout ●
- . Cadaveric Validation Labs

All testing demonstrated substantial equivalence between the subject and predicate devices.

## Substantial Equivalence/Conclusion:

The subject devices are substantially equivalent to the predicates cited in the table above with respect to indications, design, materials, function, operation, and performance. The nonclinical tests performed by Carlsmed demonstrate substantial equivalence to the predicate devices.