# K073177: Pioneer Intervertebral Fusion Device System

- Pathway: 510(k) (Abbreviated)
- Applicant: Pioneer Surgical Technology
- Decided: May 13, 2008 after 182 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: 9 generations back to K841189 (1984). 32 ancestors in all.
775 later devices descend from it; 12 cite it directly.
1 of 808 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061151: Pioneer Vertebral Spacer (Vertebral Spacer), Pioneer Surgical Technology (2006) Summary page 1.
- K072226: Impix Spacer, Medicrea Technologies (2007). Cleared while this submission was under review Summary page 1.
- K072120: Paramount Intervertebral Body Fusion Device, Innovative Spinal Technologies, Inc. (2007) Summary page 1.
- K072253: Synfix-LR Spacer, Synthes Spine Co.Lp (2007) Summary page 1.
- P980048: Bak/Cervical (Bak/C) Interbody Fusion System, Sulzer Spine-Tech (2001) Summary page 1.

## Most influential descendants
- K112496: Pioneer Crossfuse II Ibf/VBR System (2011), 604 descendants of its own
- 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

## Recalls of this device
- Oct 7, 2013 · Class II · Z-0627-2014: As the result of a recent internal review of regulatory documents, we have determined that the 10 mm x 12 mm Webless C-Plus implants were incorrectly documented as meeting the requirement for labeling

## Indications for use
The Pioneer IBF device systems are indicated for intervertebral body fusion of the spine in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used with supplemental spinal fixation cleared for the implanted level, such as the Quantum, LowTop or SlimFuse systems. The Cervical IBF device is intended for use at one level in the cervical spine, from C3 to Ti, for the treatment of cervical disc disease (defined at 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. The Lumbar IBF device system is also intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S 1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who have had six months of non-operative treatment.

Source page: https://510kreport.com/device/K073177
Methodology: https://510kreport.com/methodology