# K123045: Brigade Standalone System

- Pathway: 510(k) (Special)
- Applicant: Nuvasive, Inc.
- Decided: Apr 16, 2013 after 197 days
- Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, 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: 13 generations back to K841189 (1984). 66 ancestors in all.
696 later devices descend from it; 17 cite it directly.
1 of 763 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100043: Coroent XLR Standalone System, Nuvasive, Inc. (2010) Summary page 1.
- K073109: Stalif TT Intervertebral Body Fusion System, Surgicraft, Ltd. (2008). Our reading of the summary gave K071309, FDA’s number for Blue Max Balloon Dilatation Catheter (Boston Scientific Corp). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Surgicraft Limited STALIF TmTT Intervertebral Body Fusion System”.
- K071795: Nuvasive Coroent System, Nuvasive, Inc. (2007) Summary page 1.

## Most influential descendants
- K141665: NuVasive CoRoent System (2015), 588 descendants of its own
- K151472: NuVasive CoRoent Lumbar System (2015), 479 descendants of its own
- K140479: Coroent XL-F System (2014), 465 descendants of its own
- K141942: Midline II TI (2014), 459 descendants of its own
- K150994: NuVasive CoRoent Thoracolumbar Implants (2015), 402 descendants of its own

## Indications for use
The Brigade Hyperlordotic System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2 to S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved level(s). The Brigade Hyperlordotic System is intended for use with autograft. The Brigade Hyperlordotic System must be used with supplemental internal spinal fixation systems (i.e. posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the Brigade Hyperlordotic System.

Source page: https://510kreport.com/device/K123045
Methodology: https://510kreport.com/methodology