# K242260: aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM

- Pathway: 510(k) (Traditional)
- Applicant: Carlsmed, Inc.
- Decided: Nov 15, 2024 after 107 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, Cervical)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 31 generations back to K841189 (1984). 1,158 ancestors in all.
3 later devices descend from it; 1 cites it directly.
2 of 1,162 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222973: IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System, IdentiTi NanoTec Cervical Interbody System, Transcend Cervical PEEK Interbody System, Transcend NanoTec Cervical Interbody System, IdentiTi Cervical Standalone Interbody System, IdentiTi NanoTec Cervical Standalone Interbody Sytem, Alphatec Spine, Inc. (2022) Summary page 7.
- K172676: NuVasive® Modulus-C Interbody System, Nu Vasive, Incorporated (2017) Summary page 7.
- K111119: Trabecular Metal (TM) Fusion Device, Zimmer Spine, Inc. (2011) Summary page 7.
- K151496: Latitude-C Cervical Interbody Spacer System, Degen Medical (2015) Summary page 7.
- K202034: aprevo Intervertebral Body Fusion Device, Carlsmed, Inc. (2020) Summary page 7.
- K220782: IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ PEEK Interbody System, Transcend™ NanoTec™ Interbody System, IdentiTi™ ALIF Standalone Interbody System, IdentiTi™ NanoTec™ ALIF Standalone Interbody System, IdentiTi™ Cervical Standalone Interbody System, IdentiTi™ NanoTec™ Cervical Standalone Interbody System, Alphatec Spine, Inc. (2022) Summary page 7.
- K223190: Hive™ Standalone Cervical System, NanoHive Medical, LLC (2022) Summary page 7.
- K201453: Fortilink Cages with TiPlus Technology, Paradigm Spine GmbH (2020) Summary page 7.
- K222009: aprevo® anterior lumbar interbody fusion device with interfixation, Carlsmed, Inc. (2022) Summary page 7.
- K221578: Hexanium ACIF, Spinevision, S.A.S. (2022) Summary page 8.

## Most influential descendants
- K250827: aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion device with interfixation; aprevo® transforaminal lumbar interbody fusion device; aprevo® TLIF-CA Articulating System; aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X No Cams (2025), 2 descendants of its own
- K252894: aprevo® cervical interbody system (2026), 1 descendant of its own
- K260385: aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra™ cervical plating system (2026), 0 descendants of its own

## Indications for use
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, 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. 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. 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.

Source page: https://510kreport.com/device/K242260
Methodology: https://510kreport.com/methodology