# K163265: Kepler II

- Pathway: 510(k) (Traditional)
- Applicant: Orbbo Surgical, LLC
- Decided: Apr 7, 2017 after 137 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: 5 generations back to K091531 (2009). 14 ancestors in all.
No later device cites it as a predicate yet.
1 of 15 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112801: Ayers Rock Cervical Cage, Qualgenix (2012) Summary page 5.
- K161407: Ascential IBD PEEKc Spacer, Stryker Spine (2016) Summary page 5.

## Indications for use
The Kepler II is indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history of radiographic studies. These patients should have had 6 weeks of non-operative treatment. The Kepler II implants are to be used with autogenous bone graft and implanted via an open, anterior approach. The Kepler II Cervical Cage is to be used with supplemental fixation.

Source page: https://510kreport.com/device/K163265
Methodology: https://510kreport.com/methodology