# K112496: Pioneer Crossfuse II Ibf/VBR System

- Pathway: 510(k) (Special)
- Applicant: Pioneer Surgical Technology, Inc.
- Decided: Sep 28, 2011 after 30 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). 33 ancestors in all.
604 later devices descend from it; 6 cite it directly.
1 of 638 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043206: Pioneer Vertebral Body Replacement Device (Pioneer Vertebral Spacer), Pioneer Surgical Technology (2005) Summary page 2.
- K061151: Pioneer Vertebral Spacer (Vertebral Spacer), Pioneer Surgical Technology (2006) Summary page 2.
- K073177: Pioneer Intervertebral Fusion Device System, Pioneer Surgical Technology (2008) Summary page 2.

## Most influential descendants
- K133623: C-PLUS (2014), 598 descendants of its own
- K133455: Crossfuse II Coronal Taper, Crossfuse II Hyperlordotic (2014), 596 descendants of its own
- K141665: NuVasive CoRoent System (2015), 588 descendants of its own
- K151472: NuVasive CoRoent Lumbar System (2015), 479 descendants of its own
- K150994: NuVasive CoRoent Thoracolumbar Implants (2015), 402 descendants of its own

## Indications for use
The Pioneer IBFIVBR System, when used as an IBF implant, is indicated for intervertebral body fuision of the spine in skeletally mature patients. Pioneer IBFs are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. Pioneer lBFs are intended to be used with supplemental spinal fixation cleared for the implanted level, such as the Quantum, Streamline, Contact ALP or SlimFuse systems. The Cervical IBF device in intended for use at one level in the cervical spine, from C3 to T I, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment Lumbar IB~s are also intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to SI1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. ODD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Lumbar lBFs are to be used in patients who have had six months of non-operative treatment. The Pioneer IRFIVBR System, when used as a VBR implant, is intended for use in the thoracolumbar spine (TI - L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. Pioneer VBRs are also indicated for treating fractures of the thoracic and lumbar spine. Pioneer VBRs are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period of time. The system must be used with the Pioneer®R Quantum Spinal Fixation System or supplemental internal fixation systems cleared for the conditions listed above (i.e., tumor or trauma of TI -L5). Additionally, the Pioneer Vertebral Spacer implant is intended to be used with bone graft.

Source page: https://510kreport.com/device/K112496
Methodology: https://510kreport.com/methodology