# K210182: PANAMA™ Anterior Cervical Plate (ACP) System

- Pathway: 510(k) (Traditional)
- Applicant: Flospine
- Decided: Apr 7, 2021 after 72 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: 3 generations back to K926453 (1993). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060442: Pyrenees Cervical Plate System, K2m, LLC (2006) Summary page 4.
- K022344: Trinica Select Anterior Cervical Plate System, Centerpulse Spine-Tech, Inc. (2002) Summary page 4.

## Indications for use
The FloSpine PANAMATM Anterior Cervical Plate System is intended for anterior cervical screw fixation of the cervical spine at levels C2-T1. The System is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and/or failed previous fusions.

Source page: https://510kreport.com/device/K210182
Methodology: https://510kreport.com/methodology