# K171538: Cure™ Lumbar Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Meditech Spine, LLC
- Decided: Jun 16, 2017 after 21 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: 1 generation back to K022791 (2002). 1 ancestor in all.
19 later devices descend from it; 6 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022791: Synthes Anterior Tension Band (Atb) System, Synthes (Usa) (2002) Summary page 4.

## Most influential descendants
- K200885: Meridian Anterior Plate System, Regatta Lateral Plate System (2020), 12 descendants of its own
- K220711: SeaSpine Meridian System, SeaSpine Meridian Anterior Plate System (2022), 10 descendants of its own
- K222732: WaveForm A Interbody System (2022), 9 descendants of its own
- K233694: Meridian Interbody System; WaveForm A Interbody System (2024), 8 descendants of its own
- K241466: Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System; Reef L Interbody System; Reef TO/TA System; Meridian Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; WaveForm A Interbody System (2024), 3 descendants of its own

## Indications for use
The Cure™ Lumbar Plate System is intended 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/K171538
Methodology: https://510kreport.com/methodology