# K163180: Hubble II

- Pathway: 510(k) (Traditional)
- Applicant: Orbbo Surgical, LLC
- Decided: Dec 29, 2016 after 45 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: 14 generations back to K841189 (1984). 64 ancestors in all.
No later device cites it as a predicate yet.
1 of 65 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152355: Twin Peaks Lumbar Interbody Fusion System, Spineway (2015) Summary page 5.

## Indications for use
The Hubble II Lumbar Interbody Fusion System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Hubble II System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six months of non-operative treatment. The Hubble II System must be used with supplemental fixation cleared by FDA for use in the lumbar spine.

Source page: https://510kreport.com/device/K163180
Methodology: https://510kreport.com/methodology