# K081888: Dynamik Intervertebral Body Fusion Device

- Pathway: 510(k) (Traditional)
- Applicant: Spineart
- Decided: Feb 6, 2009 after 219 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: 3 generations back to K010530 (2001). 7 ancestors in all.
282 later devices descend from it; 13 cite it directly.
0 of 290 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P960025: Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws, Depuy Spine, Inc. (1999) Summary page 1.
- K072253: Synfix-LR Spacer, Synthes Spine Co.Lp (2007) Summary page 1.
- K071724: Lucent, Spinal Elements, Inc. (2007) Summary page 1.

## Most influential descendants
- K101720: Juliet OL (2010), 259 descendants of its own
- K133557: Juliet LL Lateral Lumbar Cage (2014), 147 descendants of its own
- K141135: Juliet LL (2014), 146 descendants of its own
- K161888: JULIET® LL Lateral Lumbar Cage (2016), 145 descendants of its own
- K181644: EIT Cellular Titanium® Lumbar Cage LLIF (2018), 141 descendants of its own

## Indications for use
DYNAMIK Lumbar Interbody Device is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1, DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft. DYNAMIK Lumbar Interbody Device is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Source page: https://510kreport.com/device/K081888
Methodology: https://510kreport.com/methodology