# K212075: ShurFit Lumbar Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Precision Spine, Inc.
- Decided: Dec 8, 2021 after 159 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). 393 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 395 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171657: ShurFit 2C Lumbar Interbody Fusion System, Precision Spine, Inc. (2017) Summary page 5.
- K092193: Spinal Usa Interbody Cages, Spinal USA (2009) Summary page 5.
- K081196: Spinal Usa VBR System, Spinal USA (2008) Summary page 5.
- K080314: Spinal Usa Interbody Fusion Device, Spinal USA (2008) Summary page 5.
- K172341: NuVasive® Modulus TLIF Interbody System, Nu Vasive, Incorporated (2017) Summary page 5.
- K181589: Curiteva Lumbar Interbody Fusion System, Curiteva, LLC (2018) Summary page 5.
- K162496: Foundation 3D Interbody, Corelink, LLC (2017) Summary page 5.
- K180963: Roccia Alif, Roccia Tlif, Silony Medical GmbH (2018) Summary page 5.
- K201024: Expandable Titanium PLIF/TLIF System, Spectrum Spine, LLC (2021) Summary page 5.

## Most influential descendants
- K221172: FOCUS Interbody System (2022), 0 descendants of its own

## Indications for use
The ShurFit Lumbar Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space for the ALIF, LLIF, TLIF and T-PLIF system. Two devices are used per intervertebral space for the PLIF system. The ShurFit Lumbar Interbody System (ALIF, LLIF, TLIF, T-PLIF and PLIF Systems) is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used with supplemental fixation and autogenous autograft. Patients should have at least six months of non-operative treatment prior to treatment with a lumbar intervertebral fusion device.

Source page: https://510kreport.com/device/K212075
Methodology: https://510kreport.com/methodology