# K161809: ShurFit CpTi-HA ACIF Interbody Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Precision Spine, Inc.
- Decided: Dec 6, 2016 after 158 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, Cervical)
- 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: 16 generations back to K841189 (1984). 179 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 185 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083118: Spinal Usa Anterior Cervical Interbody Fusion Device, Spinal USA (2009) Summary page 4.
- K142269: Reliance Cervical IBF System, Reliance Medical Systems, LLC (2015) Summary page 5.
- K142026: Spinefrontier Arena-C HA Peek Cervical Intervertebral Body Fusion Device, Spinefrontier, Inc. (2014) Summary page 5.
- K112036: Calix PC Spinal Implant System, X-Spine Systems, Inc. (2011) Summary page 5.
- K123909: Aesculap Cespace XP, Aesculap Implant System, Inc. (2013) Summary page 5.

## Most influential descendants
- K171657: ShurFit 2C Lumbar Interbody Fusion System (2017), 4 descendants of its own
- 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 CpTi-HA Coated Anterior Cervical Interbody Fusion System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. ShurFit Anterior Cervical Interbody Fusion System implants are used to facilitate fusion in the cervical spine and are placed via an anterior approach at the C-3 to C-7 disc levels using autograft bone. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral fusion device. The device should be used with supplemental fixation.

Source page: https://510kreport.com/device/K161809
Methodology: https://510kreport.com/methodology