# K130274: Biolign Acif Systems, Biolign Stacc Acif System, Biolign Tlif System

- Pathway: 510(k) (Traditional)
- Applicant: Elite Surgical Supplies (Pty), Ltd.
- Decided: Oct 29, 2013 after 267 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: 10 generations back to K841189 (1984). 31 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090887: Orio-C Cervical, Orio-TL Tlif, Orio-PL Plif, Orio-AL Alif Intervedrtebral Body Fusion Cages, SpineCraft (2009) Summary page 2.
- K080401: Shell Cage, Wave Cage, Loop Cage, Advanced Medical Technologies AG (2008) Summary page 3.
- K072415: Stalif (TM) C, Surgicraft, Ltd. (2008) Summary page 4.

## Most influential descendants
- K153629: ArcadiusXP C Spinal System (2016), 7 descendants of its own
- K231763: Stable-C Interbody System (2023), 6 descendants of its own
- K232530: Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System (2023), 5 descendants of its own
- K240416: Tranquil-C Interbody System (2024), 3 descendants of its own
- K241467: Stable-C Interbody System (2024), 2 descendants of its own

## Indications for use
The Biolign® ACIF System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease at one level from C3-C7. Cervical disc disease is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. Patients should have six (6) weeks of non-operative treatment. The Bioligne ACIF System is to be used with autograft bone graft and is implanted via an open anterior approach. The Biolign® ACIF System is intended to be used with supplemental fixation systems such as Anterior Cervical plating systems. The Biolign® TLIF Intervertebral Body Fusion Devices are indicated for use with autograft bone graft in skeletally mature patients with degenerative disc disease (DDD) at one level or two contiguous levels of the lumbar spine (L-2 - SI). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six (6) months of non-operative therapy. The Biolign® TLIF Intervertebral Body Fusion Devices are used to facilitate fusion in the lumbar spine and are implanted via a postero-lateral approach. The Biolign® Intervertebral Body Fusion Devices are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine, for example posterior pedicle screw and rod systems. The Biolign® STACC ACIF System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease at one level from C3-C7. Cervical disc disease is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. Patients should have six (6) weeks of non-operative treatment. The Biolign® STACC ACIF System is to be used with autograft bone graft and is implanted via an open anterior approach. The Biolign® STACC ACIF system is intended to be used as a stand-alone system using the bone screws provided for fixation. It may also be used with supplemental fixation systems that have been cleared for use in the cervical spine, such as cervical plating systems.

Source page: https://510kreport.com/device/K130274
Methodology: https://510kreport.com/methodology