# K140303: Alamo T

- Pathway: 510(k) (Special)
- Applicant: Alliance Partners, LLC
- Decided: Apr 21, 2014 after 74 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: 12 generations back to K841189 (1984). 57 ancestors in all.
No later device cites it as a predicate yet.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120401: Alamo T, Alliance Partners, LLC (2012) Summary page 1.
- K111569: Plateau Spacer System, Life Spine (2011) Summary page 1.
- K072791: Oracle Spacer, Opal Spacer, Synthes Spine (2007) Summary page 1.
- K130274: Biolign Acif Systems, Biolign Stacc Acif System, Biolign Tlif System, Elite Surgical Supplies (Pty), Ltd. (2013) Summary page 1.

## Indications for use
The Alamo T device is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as back pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is to be implanted via a transforaminal approach.

Source page: https://510kreport.com/device/K140303
Methodology: https://510kreport.com/methodology