# K172568: Cervage

- Pathway: 510(k) (Traditional)
- Applicant: Precifit Medical, Ltd.
- Decided: May 4, 2018 after 252 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: 14 generations back to K003155 (2001). 93 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 95 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133653: Anatomic Peek PTC Cervical Fusion System, Medtronic Sofamor Danek USA, Inc. (2014) Summary page 4.
- K112444: Anatomic Peek Cervical Fusion System, Medtronic Sofamor Danck USA, Inc. (2011) Summary page 4.

## Most influential descendants
- K173189: Lumfuse TP (2018), 0 descendants of its own

## Indications for use
The Cervage cage is indicated for cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. This device is to be used in patients who have had six weeks on non-operative treatment. The Cervage cage is to be used with supplemental fixation. The Cervage cage is also required to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and is to be implanted via an open, anterior approach.

Source page: https://510kreport.com/device/K172568
Methodology: https://510kreport.com/methodology