# K210542: aprevo Transforaminal IBF

- Pathway: 510(k) (Traditional)
- Applicant: Carlsmed, Inc.
- Decided: Jun 30, 2021 after 126 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- 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: 23 generations back to K841189 (1984). 329 ancestors in all.
12 later devices descend from it; 2 cite it directly.
1 of 342 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190092: UNiD Patient specific 3D printed TLIF cage, Medicrea International SA (2019) Summary page 5.
- K182158: UNiD Patient-matched PLIF cage, Medicrea International SA (2019) Summary page 5.
- K202034: aprevo Intervertebral Body Fusion Device, Carlsmed, Inc. (2020) Summary page 5.

## Most influential descendants
- K222082: aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal lumbar interbody fusion devices (2022), 11 descendants of its own
- K231140: aprevo® transforaminal lumbar interbody fusion device (2023), 6 descendants of its own
- K241332: aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion devices with interfixation; aprevo® transforaminal lumbar interbody fusion device (2024), 5 descendants of its own
- K241019: aprevo® TLIF-C Articulating System (2024), 4 descendants of its own
- K243802: aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar interbody fusion device with interfixation (2025), 3 descendants of its own

## Indications for use
The aprevo™ Transforaminal interbody 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™ Personalized Interbody 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.

Source page: https://510kreport.com/device/K210542
Methodology: https://510kreport.com/methodology