# K093669: Sec Ibf Cage

- Pathway: 510(k) (Traditional)
- Applicant: Innvotec Surgical, Inc.
- Decided: Mar 18, 2010 after 111 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
No predicates in its family tree.
744 later devices descend from it; 9 cite it directly.
1 of 745 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
- K110270: Acculif Cage (2011), 743 descendants of its own
- K113465: Acculif TL Cage (2011), 718 descendants of its own
- K121683: Acculif TL Cage (2012), 682 descendants of its own
- K123752: Acculif TL and PL Cage (2013), 676 descendants of its own
- K132505: Acculif TL and PL Cage (2013), 645 descendants of its own

## Indications for use
Intervertebral Body Fusion Device: The lnnvotec Surgical SEC IBF1 Cage is indicated for intervertebral body fusion with autogenous bone graft material in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to SI. ODD is defined as hack pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These ODD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment. The Innvotec Surgical SEC lEE Cage is to be used with supplemental fixation. Vertebral Body Replacement: When used as a vertebral body replacement, the lnnvotec Surgical SEC IBE Cage is intended for partial vertebral body replacement to aid in surgical correction and stabilization of the spine. The device is indicated for use in the thoracolumbar spine (TI to L-5) to replace or restore height a collapsed, damaged, diseased, or unstable portion of a vertebral body, excised as a result of tumor or trauma (i.e., fracture). It is indicated to achieve decompression of the spinal cord and neural tissues, and to restore the height of a collapsed or damaged vertebral body. The Innvotec Surgical SEC 113E Cage is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. The Innvotec Surgical SEC lEEF Cage is always to be used with supplemental internal spinal fixation. Additionally, the Innivotec Surgical SEC IBF Cage may be used with bone graft.

Source page: https://510kreport.com/device/K093669
Methodology: https://510kreport.com/methodology