# K082262: LDR Spine Roi Interbody Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Ldr Spine USA
- Decided: Feb 2, 2009 after 178 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
No predicates in its family tree.
722 later devices descend from it; 8 cite it directly.
1 of 723 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K092901: Epicage Interbody Fusion Device (2010), 609 descendants of its own
- K130548: Epicage Interbody Fusion Device (2013), 602 descendants of its own
- K132601: Coroent Sterile Implants System (2013), 596 descendants of its own
- K140319: Coroent TI-C System (2014), 590 descendants of its own
- K141665: NuVasive CoRoent System (2015), 588 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
When used as an intervertebral body fusion device, the ROI 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 supplemental fixation and with autograft to facilitate fusion. When used as a vertebral body replacement device, the ROI System of implants 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 internal fixation. Supplemental internal fixation is required to properly utilize this system. These devices are intended to be used with autograft or allograft bone. The ROI-A implants are intended to be implanted singularly while the ROI-T implants may be implanted singularly or in pairs.

Source page: https://510kreport.com/device/K082262
Methodology: https://510kreport.com/methodology