# K151756: Sterispine LC Cage

- Pathway: 510(k) (Traditional)
- Applicant: Safe Orthopaedics
- Decided: Aug 21, 2015 after 53 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: 15 generations back to K841189 (1984). 75 ancestors in all.
No later device cites it as a predicate yet.
0 of 76 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133893: Sterispine LC Cage, Safe Orthopaedics (2014) Summary page 4.
- K122021: Sterispine LC Cage, Safe Orthopaedics (2012) Summary page 4.

## Indications for use
The SteriSpine™LC device is indicated for intervertebral body fusion procedures at one or two contiguous levels from L2 to S1 in skeletally mature patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage. This device is to be used with autogenous bone graft to facilitate fusion and is intended for use with SteriSpine™ PS, a supplemental fixation system cleared by the FDA for use in the lumbar spine.

Source page: https://510kreport.com/device/K151756
Methodology: https://510kreport.com/methodology