# K100243: Quintex Cervical Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap Implant Systems, LLC
- Decided: Sep 2, 2010 after 218 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K922087 (1992). 19 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050813: Abc 2 Screw, Aesculap, Inc. (2005)
- K040017: Abc Caudal and Cranial Extension Plate (E-Plate), Aesculap, Inc. (2004) Summary page 1.
- K000486: Abc Cervical Plating System, Aesculap, Inc. (2000)
- K974706: Aesculap Abc Cervical Plating System, Aesculap, Inc. (1998) Summary page 1.
- K953720: Aesculap Caspar Plate & Screw System for Anterior Cervical Fusion, Aesculap, Inc. (1995) Summary page 1.
- K936269: Caspar Titanium Alloy Bone Screws, Aesculap, Inc. (1994) Summary page 1.
- K913730: Aesculap Titanium Bone Plates, Aesculap, Inc. (1992) Summary page 1.
- K022997: Spectrum Cervical Spinal System, Spinal Innovations, LLC (2002) Summary page 1.
- K050804: Modification to: Spectrumtm Cervical Spinal System, Aesculap, Inc. (2005) Summary page 1.

## Most influential descendants
- K141993: Nakoma Acp (2014), 8 descendants of its own
- K231766: Skyway Anterior Cervical Plate System (2023), 3 descendants of its own
- K243015: Skyway Anterior Cervical Plate System (2024), 2 descendants of its own
- K173128: Alamo® C (2018), 2 descendants of its own
- K250486: Skyway Anterior Cervical Plate System (2025), 1 descendant of its own

## Recalls of this device
- Jan 24, 2012 · Not classified · Z-1455-2012: The firm has received complaints that the locking ring that sits in the head of the screw can come out of the screw head when engaged with the screwdriver if the screwdriver is improperly angled.

## Indications for use
The Quintex Cervical Plating System is intended for the immobilization and stabilization of the spine as an adjunct to fusion in patients with: o Degenerative disc disease (DDD) (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, Deformity (i.e., scoliosis, kyphosis, and/or lordosis), Tumors, Pseudoarthrosis as a result of failed spine surgery, Failed previous fusions, Symptomatic cervical spondylosis Instability following surgery for the above indications. Levels of anterior cervical intervertebral body screw fixation for this indication are from Co-Th. Warning: This device is not approved or intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Source page: https://510kreport.com/device/K100243
Methodology: https://510kreport.com/methodology