# K202034: aprevo Intervertebral Body Fusion Device

- Pathway: 510(k) (Traditional)
- Applicant: Carlsmed, Inc.
- Decided: Dec 3, 2020 after 133 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: 22 generations back to K841189 (1984). 327 ancestors in all.
17 later devices descend from it; 5 cite it directly.
1 of 345 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191391: HEDRON Lumbar Spacers, Globus Medical, Inc. (2019) Summary page 5.
- K182158: UNiD Patient-matched PLIF cage, Medicrea International SA (2019) Summary page 5.
- K133455: Crossfuse II Coronal Taper, Crossfuse II Hyperlordotic, Pioneer Surgical Technology, Inc. (2014) Summary page 5.

## Most influential descendants
- K222009: aprevo® anterior lumbar interbody fusion device with interfixation (2022), 12 descendants of its own
- K210542: aprevo Transforaminal IBF (2021), 12 descendants of its own
- K222082: aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal lumbar interbody fusion devices (2022), 11 descendants of its own
- K241477: aprevo® anterior lumbar interbody fusion device with interfixation (2024), 6 descendants of its own
- K231140: aprevo® transforaminal lumbar interbody fusion device (2023), 6 descendants of its own

## Indications for use
The aprevo™ anterior lumbar interbody fusion and aprevo™ 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 lumbar interbody fusion and aprevo™ 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.

Source page: https://510kreport.com/device/K202034
Methodology: https://510kreport.com/methodology