# K133827: A-Link Z

- Pathway: 510(k) (Traditional)
- Applicant: Osteo Vasive, LLC
- Decided: Nov 17, 2014 after 335 days
- Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K841189 (1984). 90 ancestors in all.
26 later devices descend from it; 1 cites it directly.
0 of 117 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102090: Spinesmith Cynch Spinal System - Visualif Interbody Fusion Implant System, Spine Smith Partners L.P. (2010) Summary page 6.
- K071922: Interplate Interbody Fusion Device, Models C, CGC, L and LGC, Rsb Spine, LLC (2007) Summary page 6.
- K110327: LDR Spine Roi-a Interbody Fusion System, Ldr Spine USA (2011) Summary page 6.
- K080314: Spinal Usa Interbody Fusion Device, Spinal USA (2008) Summary page 6.
- K123767: Lanx Fusion System- SA, Lanx, Inc. (2013) Summary page 6.
- K120345: Honour Spacer System, Nexxt Spine, LLC (2012) Summary page 6.
- K073109: Stalif TT Intervertebral Body Fusion System, Surgicraft, Ltd. (2008) Summary page 6.
- K091301: Life Spine Stand-Alone Spacer System, Life Spine (2009) Summary page 6.
- K111626: Endoskeleton (R) Tas, Titan Spine, LLC (2011) Summary page 6.

## Most influential descendants
- K201671: A-Link Z (2021), 25 descendants of its own
- K222561: Align (2022), 14 descendants of its own
- K232432: E3D™-A Interbody System (2024), 8 descendants of its own
- K233694: Meridian Interbody System; WaveForm A Interbody System (2024), 8 descendants of its own
- K240368: E3D™-A Interbody System (2024), 7 descendants of its own

## Recalls of this device
- Jan 7, 2019 · Class II · Z-2354-2020: Due to a manufacturing process issue, it allowed vertebral body bone screws to not seat properly within the spinal device/cage.
- Jan 7, 2019 · Class II · Z-2355-2020: Due to a manufacturing process issue, it allowed vertebral body bone screws to not seat properly within the spinal device/cage.

## Indications for use
A-Link Z is indicated for intervertebral body fusion of the spine in skeletally mature patients who have had at least six months of non-operative treatment. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral body space. A-Link Z is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. A-Link Z may be used as a stand alone device when all four (4) vertebral body bone screws are used. If the physician chooses to use fewer than the four (4) screws, then an additional supplemental spinal fixation system cleared for use in the lumbosacral spine must be used.

Source page: https://510kreport.com/device/K133827
Methodology: https://510kreport.com/methodology