# K151312: VerteLP Interbody Fusion Device

- Pathway: 510(k) (Traditional)
- Applicant: Vgi, LLC
- Decided: Jan 13, 2016 after 240 days
- Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K841189 (1984). 93 ancestors in all.
No later device cites it as a predicate yet.
0 of 94 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140479: Coroent XL-F System, Nu Vasive, Incorporated (2014) Summary page 5.
- K113285: LDR Spine Usa Avenue L Interbody Fusion, Ldr Spine USA, Inc. (2012) Summary page 5.
- K103382: Intercontinental Plate-Spacer, Globus Medical, Inc. (2011) Summary page 5.

## Recalls of this device
- Apr 9, 2018 · Class II · Z-2100-2018: IFU contained an automated cleaning process for the VerteLP Instrument Tray that was not validated

## Indications for use
The VerteLP is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-L5. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device is intended to be used with supplemental fixation in addition to the integrated fixation jaws, and must be used with autograft bone.

Source page: https://510kreport.com/device/K151312
Methodology: https://510kreport.com/methodology