# K113285: LDR Spine Usa Avenue L Interbody Fusion

- Pathway: 510(k) (Traditional)
- Applicant: Ldr Spine USA, Inc.
- Decided: Jul 26, 2012 after 262 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: 11 generations back to K841189 (1984). 24 ancestors in all.
199 later devices descend from it; 5 cite it directly.
0 of 224 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082262: LDR Spine Roi Interbody Fusion System, Ldr Spine USA (2009) Summary page 1.
- K090507: Modification to LDR Spine Roi Interbody Fusion System; Roi-a Implant System, Ldr Spine USA (2009) Summary page 1.
- K110327: LDR Spine Roi-a Interbody Fusion System, Ldr Spine USA (2011)
- K103382: Intercontinental Plate-Spacer, Globus Medical, Inc. (2011) Summary page 1.

## Most influential descendants
- K142645: Avenue T TLIF Cage (2015), 191 descendants of its own
- K153495: Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant System (2016), 189 descendants of its own
- 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

## Indications for use
The Avenue® L Interbody Fusion 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 to facilitate fusion.

Source page: https://510kreport.com/device/K113285
Methodology: https://510kreport.com/methodology