# K153665: Prow Fusion-L

- Pathway: 510(k) (Traditional)
- Applicant: Nlt Spine, Ltd.
- Decided: Sep 15, 2016 after 269 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: 17 generations back to K841189 (1984). 224 ancestors in all.
No later device cites it as a predicate yet.
1 of 225 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133717: Longbow Spacer System, Life Spine (2014) Summary page 4.
- K112359: Prow Fusion, Nlt Spine, Ltd. (2011) Summary page 4.
- K130254: Prow Fusion, Nlt Spine, Ltd. (2013) Summary page 4.
- K151654: Prow Fusion, Nlt Spine, Ltd. (2015) Summary page 4.
- K153786: Prow Fusion-V, Nlt Spine, Ltd. (2016). Cleared while this submission was under review Summary page 4.
- K143297: Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody Fusion System, InFix Anterior Lumbar System, TraXis Vertebral Body Replacement (Ti and VUE), Zimmer Spine, Inc. (2015) Summary page 4.
- K132897: Clydesdale Spinal System, Medtronic Sofamor Danek, Inc. (2013) Summary page 4.
- K143163: AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer, AVS® Navigator PEEK Spacer, AVS® ARIA PEEK Spacer, AccuLIF TL and PL Cage, AVS® Anchor-L Spacer, Aero-AL Lumbar Cage System, Stryker Corporation (2015) Summary page 4.
- K123231: Caliber Spacers, Globus Medical, Inc. (2013) Summary page 4.
- K100210: TRANS1 Lateral Intervertebral Fusion Device, T, Trans1 Incorporated (2010) Summary page 4.

## Indications for use
The PROW FUSION-L is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 through S1. 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). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the PROW FUSION-L device. The device is intended to be used with autogenous bone graft and a supplemental spinal fixation system that have been cleared for use in the lumbosacral spine (e.g. posterior pedicle screw and rod systems).

Source page: https://510kreport.com/device/K153665
Methodology: https://510kreport.com/methodology