# K201671: A-Link Z

- Pathway: 510(k) (Traditional)
- Applicant: Acuity Surgical Devices, LLC
- Decided: May 4, 2021 after 319 days
- Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, 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: 22 generations back to K841189 (1984). 383 ancestors in all.
25 later devices descend from it; 5 cite it directly.
1 of 409 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133827: A-Link Z, Osteo Vasive, LLC (2014) Summary page 5.
- K083475: Lucent Magnum, Spinal Elements, Inc. (2009) Summary page 5.
- K191391: HEDRON Lumbar Spacers, Globus Medical, Inc. (2019) Summary page 5.
- K162212: Divergence-L Anterior/Oblique Lumbar Fusion System, Medtronic Sofamor Danek USA, Inc. (2017) Summary page 5.
- K172816: TiGer Shark™ System, Choicespine, LP (2018) Summary page 6.

## Most influential descendants
- 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
- K241846: E3D™-C Interbody System (2024), 6 descendants of its own

## Indications for use
A-Link Z anterior cages are 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 systems are designed for use with allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and/or autograft to facilitate fusion. One device is used per intervertebral body space. A-Link Z anterior cages are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to Si, 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 2-screw anterior cages may be used as a stand alone device only when two (2) vertebral body bone screws are used. A-Link Z 4-screw anterior cages may be used as a stand alone device only when at least two (2) vertebral body bone screws are inserted in the two medial fixation holes with one inferior and one superior screw trajectory. If the physician chooses to use A-Link Z anterior cages with fewer than two (2) screws in the two medial fixation holes with one inferior and one superior screw trajectory, then an additional supplemental spinal fixation system cleared for use in the lumbosacral spine must be used. A-Link Z anterolateral cages are 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 systems are designed for use with allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and/or autograft to facilitate fusion. One device is used per intervertebral body space. A-Link Z anterolateral cages are 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 confinned by history and radiographic studies. A-Link Z anterolateral cages are intended to be used with supplemental spinal fixation system cleared for use in the lumbosacral spine. A-Link Z lateral cages are 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 systems are designed for use with allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and/or autograft to facilitate fusion. One device is used per intervertebral body space. A-Link Z lateral cages are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to Si, 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 lateral cages are intended to be used with supplemental spinal fixation system cleared for use in the lumbosacral spine.

Source page: https://510kreport.com/device/K201671
Methodology: https://510kreport.com/methodology