# K142456: GPS Spacers

- Pathway: 510(k) (Traditional)
- Applicant: G Surgical, LLC
- Decided: Apr 10, 2015 after 220 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, Cervical)
- 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: 3 generations back to P950002 (1996). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083798: Impix Alif Lumbar Ibf, Impix Alif-D Lumbar Ibf, Impix Tlif Lumbar Ibf, Medicrea Technologies (2010) Summary page 5.

## Most influential descendants
- K210890: GPS Cervical Spacers (2021), 0 descendants of its own

## Indications for use
When used as a cervical intervertebral fusion device, the GPS™ Cervical Spacers are indicated for use at one level in the cervical spine, from C2-T1, in skeletally mature patients who have had six weeks of non-operative treatment for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with autogenous bone graft and with supplemental fixation systems cleared for use in the cervical spine. When used as a lumbar intervertebral body fusion device, the GPS™ PLIF and TLIF Spacers are intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) at one or two contiguous spinal levels from L2-S1. These patients should have had six months of nonoperative treatment. These patients may have had a previous non-fusion spinal surgery and/or may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s). The device is to be used with autogenous bone graft and in combination with supplemental fixation indicated for lumbar spinal fusion procedures.

Source page: https://510kreport.com/device/K142456
Methodology: https://510kreport.com/methodology