# K123388: K7C Spacer

- Pathway: 510(k) (Traditional)
- Applicant: K7, LLC
- Decided: Jan 4, 2013 after 63 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: 12 generations back to K841189 (1984). 62 ancestors in all.
No later device cites it as a predicate yet.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090064: Eminent Spine Interbody Fusion System, Eminent Spine (2009) Summary page 1.
- P980048: Bak/Cervical (Bak/C) Interbody Fusion System, Sulzer Spine-Tech (2001) Summary page 1.
- K043479: MC+ Partial VBR, Ldr Spine USA (2005) Summary page 1.
- K091088: LDR Spine Cervical Interbody Fusion System, Ldr Spine USA (2009) Summary page 1.
- K082698: Aleutian Ibf System, K2m, Inc. (2009) Summary page 1.
- K101302: Aleutian Ibf System, K2m, Inc. (2010) Summary page 1.
- K103169: Aleuttian, K2m, Inc. (2011) Summary page 1.

## Indications for use
When used as a cervical intervertebral fusion device, the K7CTM spacers are indicated for use at one level in the cervical spine, from C2-T1, in skeletally mature patients who have had six weeks of non-operative treatment for the treatment of degenerative disc disease (DOD) with up to Grade 1 spondylolisthesis. ODD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with autogenous bone graft and with supplemental fixation systems cleared for use in the cervical spine.

Source page: https://510kreport.com/device/K123388
Methodology: https://510kreport.com/methodology