# K170243: LOSPA IS TLIF & DLIF Cages

- Pathway: 510(k) (Special)
- Applicant: Corentec Co., Ltd.
- Decided: Mar 31, 2017 after 64 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 K003155 (2001). 157 ancestors in all.
No later device cites it as a predicate yet.
1 of 158 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151408: LOSPA IS Spinal System, Corentec Co., Ltd. (2015) Summary page 6.
- K110650: Zyston Arc Interbody Spacer, Biomet Spine (Aka Ebi, LLC) (2011) Summary page 6.
- K133126: K7 Lumbar Spacers, K7, LLC (2013) Summary page 6.
- K100175: Clydesdale Spinal System, Medtronic Sofamor Danek (2010) Summary page 6.
- K072791: Oracle Spacer, Opal Spacer, Synthes Spine (2007) Summary page 6.

## Indications for use
LOSPA IS PLIF/T-PLIF & ALIF & TLIF & DLIF Cages are indicated for use with autogenous bone graft as an intervertebral body fusion device at one or two contiguous levels in the lumbosacral region (L2-S1) in the treatment of degenerative disc disease (DDD) With up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients with previous non-fusion spinal surgery at involved level may be treated with the device. Patients should be skeletally mature and have had six months of non-operative treatment. Devices are intended to be implanted via an open, posterior or anterior approach and used with autogenous bone and supplemental fixation.

Source page: https://510kreport.com/device/K170243
Methodology: https://510kreport.com/methodology