# K151654: Prow Fusion

- Pathway: 510(k) (Special)
- Applicant: Nlt Spine, Ltd.
- Decided: Jul 17, 2015 after 29 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: 10 generations back to K841189 (1984). 27 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130254: Prow Fusion, Nlt Spine, Ltd. (2013) Summary page 4.

## Most influential descendants
- K153665: Prow Fusion-L (2016), 0 descendants of its own

## Indications for use
The PROW FUSION Intervertebral body fusion device is indicated for spinal fusion procedures at one or two contiguous levels from L2 through S1 in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by the history and radiographic studies. DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. The patient may have had a previous non-fusion spinal surgery at the involved spinal level(s). The device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (e.g. posterior pedicle screw and rod systems). The device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the PROW FUSION device. The PROW FUSION intervertebral body fusion device must be inserted using a transforaminal approach.

Source page: https://510kreport.com/device/K151654
Methodology: https://510kreport.com/methodology