# K162211: AccuFit Lateral Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Precision Spine, Inc.
- Decided: Nov 28, 2016 after 112 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K922543 (1993). 18 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133194: Diamond Rattlesnake System, Eminent Spine (2014) Summary page 6.
- K070922: Modification to Spinal Usa VBR System, Spinal USA (2007) Summary page 6.
- K020244: Synthes Thoracolumbar Spine Locking Plate (TSLP), Synthes Spine (2002) Summary page 6.

## Most influential descendants
- K220324: AccuFit Lateral 2-Hole Plate (2022), 3 descendants of its own
- K241468: Vertiwedge® Intraosseous System (2024), 1 descendant of its own
- K261810: Vertiwedge® Intraosseous System (2026), 0 descendants of its own
- K232256: Alcantara Thoracolumbar Plate System (2024), 0 descendants of its own

## Indications for use
The AccuFit Lateral Plate System is indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery. The device is intended as a temporary fixation device until fusion is achieved.

Source page: https://510kreport.com/device/K162211
Methodology: https://510kreport.com/methodology