# K072120: Paramount Intervertebral Body Fusion Device

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Spinal Technologies, Inc.
- Decided: Oct 11, 2007 after 71 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). 23 ancestors in all.
1,405 later devices descend from it; 8 cite it directly.
1 of 1,429 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062759: Paramount VBR System, Innovative Spinal Technologies, Inc. (2007) Summary page 1.
- P950002: Bak Interbody Fusion System, Zimmer Spine, Inc. (1996) Summary page 1.

## Most influential descendants
- K073291: Capstone Spinal System (2008), 1,103 descendants of its own
- K100175: Clydesdale Spinal System (2010), 1,008 descendants of its own
- K080083: Intrepid Spinal System (2008), 932 descendants of its own
- K073109: Stalif TT Intervertebral Body Fusion System (2008), 907 descendants of its own
- K080401: Shell Cage, Wave Cage, Loop Cage (2008), 840 descendants of its own

## Indications for use
The Paramount TM IBF device, when used with autogenous bone graft, is indicated for use in patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. ParamountTM IBF devices are to be implanted via a direct posterior or transforaminal approach. The ParamountTM IBF device may be used singly or in pairs in the lumbosacral spine with or without supplemental fixation, such as the ParamountTM Pedicle Screw System.

Source page: https://510kreport.com/device/K072120
Methodology: https://510kreport.com/methodology