# K153495: Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Ldr Spine USA
- Decided: Mar 31, 2016 after 115 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 18 generations back to K841189 (1984). 166 ancestors in all.
189 later devices descend from it; 5 cite it directly.
1 of 356 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113285: LDR Spine Usa Avenue L Interbody Fusion, Ldr Spine USA, Inc. (2012) Summary page 10.
- K142645: Avenue T TLIF Cage, Ldr Spine USA, Inc. (2015) Summary page 10.
- K110327: LDR Spine Roi-a Interbody Fusion System, Ldr Spine USA (2011) Summary page 10.
- K082262: LDR Spine Roi Interbody Fusion System, Ldr Spine USA (2009) Summary page 10.
- K152475: FORZA PTC Spacer System, Orthofix, Inc. (2016). Cleared while this submission was under review Summary page 10.
- K150643: Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti, Centinel Spine, Inc. (2015) Summary page 10.
- K090507: Modification to LDR Spine Roi Interbody Fusion System; Roi-a Implant System, Ldr Spine USA (2009) Summary page 10.

## Most influential descendants
- K162103: Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine Interbody Fusion System (Harrier™), Choice Spine Vertebral Body Replacement System (Hawkeye™) (2016), 161 descendants of its own
- K171686: Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System (2017), 116 descendants of its own
- K183557: Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TO Interbody Fusion Device, Endoskeleton® TT Interbody Fusion Device, Endoskeleton® TC Interbody Fusion Device, Endoskeleton® TCS Interbody Fusion Device, Endoskeleton® TL Interbody Fusion Device, Endoskeleton® TA Vertebral Body Replacement (VBR) Device (2019), 104 descendants of its own
- K192018: Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic Interbody Fusion Device, Endoskeleton TO Interbody Fusion Device, Endoskeleton TT Interbody Fusion Device, Endoskeleton TC Interbody Fusion Device, Endoskeleton TCS Interbody Fusion Device, Endoskeleton TL Interbody Fusion Device (2019), 102 descendants of its own
- K191581: Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion Device (2020), 81 descendants of its own

## Recalls of this device
- Aug 29, 2016 · Class II · Z-0045-2017: The ROI-A Anterior Delivery Device T-Handle, part number SI-ROIA-0023 has experienced binding of the rotation of the t-handle. There have been no reports of patient injury

## Indications for use
The Avenue® L Lateral Lumbar Cage system is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels 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. The device system is designed for use with or without integrated fixation and must be used in conjunction with posterior supplemental fixation (e.g. pedicle screws). The device system is intended to be used with autograft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft to facilitate fusion. The Avenue® T TLIF Cage System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Avenue T TLIF Cage is designed for use with or without integrated fixation and must be used in conjunction with supplemental fixation cleared by FDA for use in the lumbar spine. The device is implanted via a transforaminal approach and intended for use with autograft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft to facilitate fusion. The ROI-A® ALIF Cage System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one or two contiguous levels 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. The device system is designed for use with supplemental fixation and with autograft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft to facilitate fusion. The ROI-T® Implant System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one or two contiguous levels 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. The device system is designed for use with supplemental fixation and with autograft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft to facilitate fusion. When used as a vertebral body replacement device, the ROI-T® Implant System is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a partial vertebral body replacement in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental fixation. Supplemental internal fixation is required to properly utilize the system. These devices are intended to be used with autograft or allograft bone.

Source page: https://510kreport.com/device/K153495
Methodology: https://510kreport.com/methodology