# K151408: LOSPA IS Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Corentec Co., Ltd.
- Decided: Oct 2, 2015 after 129 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 K003155 (2001). 115 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 117 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073470: Avs PL Peek Spacers, Models 48351XXX and 48353XXX, Stryker Spine (2008) Summary page 7.
- K103111: Forza Spacer System, Orthofix, Inc. (2011) Summary page 7.
- K122639: Synthes Syncage Evolution Spacer, Synthes (USA) Products, LLC (2013) Summary page 7.
- K042714: Fidji-Vertebral Body Replacement Type 1, 2, 3 and 4, Spine Next America Corporation (2004) Summary page 7.
- K120275: Synthes Acis/Vertebral Spacer CR, Synthes (Usa), LLC (2012) Summary page 7.
- K083311: Aesculap Cespace Peek Intervertebral Body Fusion System, Aesculap Implant Systems, Inc. (2009) Summary page 7.

## Most influential descendants
- K170243: LOSPA IS TLIF & DLIF Cages (2017), 0 descendants of its own

## Indications for use
LOSPA IS PLIF&ALIF Cages are indicated for use with autogenous bone graft as intervertebral body fusion devices 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. LOSPA IS ACIF Cage is intended to be used as an adjunct to spinal fusion procedures at one level (C2-T1) in skeletally mature patients with degenerative disc disease (defined as neck pain with discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Patients should have received at least six weeks of non-operative treatment prior to treatment with the device. Devices are intended to be implanted via an open, anterior approach and used with autogenous bone and supplemental fixation.

Source page: https://510kreport.com/device/K151408
Methodology: https://510kreport.com/methodology