# K111512: Bonebac T-Plif Intervertebral Body Fusion Device System

- Pathway: 510(k) (Traditional)
- Applicant: Thompson Mis, Inc.
- Decided: Oct 26, 2011 after 147 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: 8 generations back to K841189 (1984). 33 ancestors in all.
762 later devices descend from it; 1 cites it directly.
1 of 796 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100042: Difusion Technologies Xiphos Interbody Fusion System, Difusion Technologies (2010) Summary page 1.
- K071724: Lucent, Spinal Elements, Inc. (2007) Summary page 1.
- K072791: Oracle Spacer, Opal Spacer, Synthes Spine (2007) Summary page 1.
- K071795: Nuvasive Coroent System, Nuvasive, Inc. (2007) Summary page 1.
- K080537: L-Varlock, Kiscomedica S.A. (2008) Summary page 1.

## Most influential descendants
- K120368: Capstone Control Spinal System (2012), 761 descendants of its own
- K121760: Capstone Spinal System (2012), 723 descendants of its own
- K123027: Capstone (R) Spinal System (2013), 709 descendants of its own
- K141896: Coroent System (2014), 480 descendants of its own
- K151472: NuVasive CoRoent Lumbar System (2015), 479 descendants of its own

## Indications for use
The BoneBac M T-PLIF Intervertebral Body Fusion Device System is indicated for use in skeletally mature patients who have had six months of non-operative treatment. The device is intended for the treatment of degenerative disc disease (ODD) at one or two contiguous spinal levels from L2-S1. These DOD patients may also have up to Grade I spondylolisthesis or retrolithesis at the involved level(s). The BoneBacTM T-PLIF Intervertebral Body Fusion Device System is intended to be used with supplemental spinal fixation system(s) cleared for use in the lumbar spine and autogenous bone graft to facilitate fusion. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history or radiographic studies.

Source page: https://510kreport.com/device/K111512
Methodology: https://510kreport.com/methodology