# K120091: R&D Innovation Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: R&D Innovation, LLC
- Decided: May 18, 2012 after 128 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K955348 (1996). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071824: Acme Talon Pedicle Screw, Acme Spine, LLC (2007) Summary page 1.
- K103490: Expedium Spine System, Moss Miami Spine System, Johnson & Johnson (2011) Summary page 1.
- K955348: Titanium Moss Miami Spinal System, Depuy, Inc. (1996) Summary page 2.

## Most influential descendants
- K180655: Viking Lumbar Polyaxial Screw System (2018), 0 descendants of its own

## Indications for use
When used as a pedicle screw fixation system in the non-cervical posterior spine (Ti-Si) in skeletally mature patients, the R&D Innovation Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), (5) spinal stenosis, (6) curvatures (i.e., scoliosis, kyphosis, and/or lordosis, (7) tumor, (8) failed previous fusion (i.e. pseudarthrosis).

Source page: https://510kreport.com/device/K120091
Methodology: https://510kreport.com/methodology