# K123207: Primalif TM Llif Unitary Peek Lateral Lumbar Interbody Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Osteomed LP
- Decided: Nov 29, 2012 after 48 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: 8 generations back to K841189 (1984). 31 ancestors in all.
16 later devices descend from it; 2 cite it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103666: Lanx Lateral, Lanx, Inc. (2011) Summary page 3.
- P960025: Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws, Depuy Spine, Inc. (1999) Summary page 1.
- K072791: Oracle Spacer, Opal Spacer, Synthes Spine (2007) Summary page 1.

## Most influential descendants
- K160976: Altus Spine Interbody Fusion System (2017), 8 descendants of its own
- K170512: Altus Spine Titanium Interbody Fusion System (2017), 6 descendants of its own
- K131540: Interfuse L Intervertebral Body Fusion Device (2013), 6 descendants of its own
- K160074: Rampart D Lumbar Interbody Fusion Device (2016), 5 descendants of its own
- K171660: Duo Lumbar Interbody Fusion Device (2017), 4 descendants of its own

## Indications for use
The PrimaLIFrm LLIF Unitary PEEK Lateral Lumbar Interbody Fusion System (PrimaLIF Tm LLIF) is indicated for intervertebral body fusion of the lumbar spine to be used with autogenous bone graft, 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) and these patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc, confirmed by history and radiographic studies. The device is intended for use with supplemental fixation systems such as PrimaLOKTM SP and PrimaLOKTM FE which have been cleared for use in the lumbar spine. The PrimaLIPrm LLIF implants are intended for single use only.

Source page: https://510kreport.com/device/K123207
Methodology: https://510kreport.com/methodology