# K171657: ShurFit 2C Lumbar Interbody Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Precision Spine, Inc.
- Decided: Aug 11, 2017 after 67 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). 208 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 213 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092193: Spinal Usa Interbody Cages, Spinal USA (2009) Summary page 4.
- K161809: ShurFit CpTi-HA ACIF Interbody Fusion System, Precision Spine, Inc. (2016) Summary page 5.
- K150061: Lucent; Lucent Ti-Bond Systems, Spinal Elements, Inc. (2015) Summary page 5.
- K133967: Interbody Cage System, Aurora Spine (2014) Summary page 5.
- K150321: EVOS Lumbar Interbody System, Cutting Edge Spine, LLC (2015) Summary page 5.

## Most influential descendants
- K212075: ShurFit Lumbar Interbody System (2021), 1 descendant of its own
- K221182: Southern Transforaminal Lumbar Interbody Fusion (TLIF) (2022), 0 descendants of its own
- K221172: FOCUS Interbody System (2022), 0 descendants of its own
- K212070: KMTI S141 Lumbar Interbody Fusion System (2021), 0 descendants of its own

## Indications for use
The ShurFit 2C Interbody Fusion Devices (LLIF and TLIF) are indicated for intervertebral body fusion of the spine in skeletally mature patients. The device is designed to be used with autograft to facilitate fusion. One device is used per intervertebral space for the LLIF and TLIF. The ShurFit 2C Interbody Fusion Devices (LLIF and TLIF) are intended for use at either one level or two contiguous levels in the lumbar spine, for 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/K171657
Methodology: https://510kreport.com/methodology