# K102265: LDR Spine Usa C-Plate, TL Anterior Cervical Plate System

- Pathway: 510(k) (Special)
- Applicant: Ldr Spine USA
- Decided: Sep 29, 2010 after 50 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: 2 generations back to K994239 (2000). 3 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061002: Maxima Anterior Cervical Plate System, U&I Corp. (2006) Summary page 1.

## Most influential descendants
- K153526: Pyrenees Cervical Plate System (2016), 6 descendants of its own
- K162664: Pyrenees Cervical Plate System (2016), 5 descendants of its own
- K182473: PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate System, CAYMAN Thoracolumbar and Buttress Plate Systems (2018), 4 descendants of its own
- K242361: OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System; MESA® Spinal System; MESA® Small Stature Spinal System; CASPIAN® Spinal System; DENALI® Spinal System; DENALI® MI Spinal System; YUKON OCT Spinal System; Xia® 3 Spinal System; K2M Patient Specific; CASCADIA™ Interbody System; CAYMAN® Plate System; CAYMAN® Plate System-MI (2024), 1 descendant of its own
- K221728: Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior Cervical Plating (ACP) System, Reflex™ Hybrid ACP System, UniVise™ Spinous Process Fixation Plate (2022), 1 descendant of its own

## Indications for use
The C-Plate Tm Anterior Cervical Plate System is intended for anterior cervical fixation for the following indications: * Degenerative disc disease (DOD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) * Spondylolisthesis * Trauma (i.e., fracture or dislocation) * Spinal stenosis * Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) * Tumor * Pseudloarthrosis * Failed previous fusion

Source page: https://510kreport.com/device/K102265
Methodology: https://510kreport.com/methodology