# K073669: Oria Natura Spacer

- Pathway: 510(k) (Traditional)
- Applicant: Choicespine, LP
- Decided: Feb 13, 2008 after 49 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
No predicates in its family tree.
508 later devices descend from it; 5 cite it directly.
0 of 509 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K111792: Mobis, Moval, Semial, Tetrismodel Peek and Titanium, Kimba Model Standard and Mini (2012), 470 descendants of its own
- K131372: Mobis II (2013), 462 descendants of its own
- K141405: Mobis II ST Spinal Implant (2014), 461 descendants of its own
- K150481: Cascadia Interbody System (2015), 459 descendants of its own
- K160125: Cascadia Interbody System (2016), 315 descendants of its own

## Indications for use
When used as an intervertebral body fusion device, the ORIA Natura Spacer is indicated for intervertebral body fusion of the lumbar spine, from L2 to SI, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation (e.g., ORIA Claris, ORIA Spinal Clip System, etc.) and with autograft to facilitate fusion. When used as a vertebral body replacement device, the ORIA Natura Spacer is intended for use in the thoracic and lumbar spine, from TI to L5, for the replacement of a collapsed or unstable vertebral body resulting from a tumor or traumatic injury. The device system is designed for use with supplemental fixation (e.g., ORIA Claris, ORIA Spinal Clip System, etc.) and with autograft to facilitate fusion.

Source page: https://510kreport.com/device/K073669
Methodology: https://510kreport.com/methodology