# K132907: Plif Lite and Tlif Lite

- Pathway: 510(k) (Traditional)
- Applicant: Sintea Plustek
- Decided: Jul 24, 2014 after 310 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: 6 generations back to K003155 (2001). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P950019: Ray Threaded Fusion Cage (TFC)(TM) with Instrumentation, Stryker Spine (1996) Summary page 1.
- P960025: Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws, Depuy Spine, Inc. (1999) Summary page 1.
- K042714: Fidji-Vertebral Body Replacement Type 1, 2, 3 and 4, Spine Next America Corporation (2004) Summary page 1.
- K092901: Epicage Interbody Fusion Device, R Tree Innovations (2010) Summary page 1.

## Indications for use
The PLIF Lite and TLIF Lite Lumbar Interbody Fusion Devices are indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The PLIF Lite and TLIF Lite Lumbar Interbody Fusion Devices are designed for use with autograft bone to facilitate fusion and are intended for use with supplemental fixation systems cleared for use in the lumbar spine.

Source page: https://510kreport.com/device/K132907
Methodology: https://510kreport.com/methodology