# K060025: Slimplicity Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Spinal USA
- Decided: Apr 18, 2006 after 104 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 K993513 (2000). 3 ancestors in all.
11 later devices descend from it; 5 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993513: Deltaloc Anterior Cervical Plate System, Alphatec Mfg., Inc. (2000) Summary page 2.
- K030866: Synthes Anterior CSLP System, Synthes (Usa) (2003) Summary page 2.
- K031702: Reflex Anterior Cervical Plate System, Howmedica Osteonics (2003) Summary page 2.

## Most influential descendants
- K231766: Skyway Anterior Cervical Plate System (2023), 3 descendants of its own
- K160702: ZION Anterior Cervical Fixation System (2016), 3 descendants of its own
- K243015: Skyway Anterior Cervical Plate System (2024), 2 descendants of its own
- K250486: Skyway Anterior Cervical Plate System (2025), 1 descendant of its own
- K261451: ZSAlign Cervical Interbody System (2026), 0 descendants of its own

## Indications for use
The Slimplicity Anterior Cervical Plate System is indicated for use in the temporary stabilization of the anterior spine from C2 to TI during the development of cervical spinal fusions in patients with: degenerative disc disease (DDD) (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies); spondylolisthesis; trauma (including fractures or dislocations); spinal tumors; spinal stenosis; pseudarthrosis; and failed previous fusions. WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Source page: https://510kreport.com/device/K060025
Methodology: https://510kreport.com/methodology