# K100215: Archimed Remedy Cervical Plate

- Pathway: 510(k) (Traditional)
- Applicant: Archimed, Inc.
- Decided: Apr 7, 2010 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 K953730 (1995). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021461: Atlantis Vision Anterior Cervical Plate System, Medtronic Sofamor Danek (2002) Summary page 1.
- K042922: Venture Anterior Cervical Plating System, Medtronic Sofamor Danek, Inc. (2004) Summary page 1.
- K992110: Premier Anterior Cervical Plate System, Sofamor Danek USA (1999) Summary page 1.
- K030327: Zephir Anterior Cervical System, Medtronic Sofamor Danek (2003) Summary page 1.
- K042544: Uniplate Anterior Cervical Plate System, Depuy Spine, Inc. (2004) Summary page 1.
- K040655: Swift Anterior Cervical Plate System, Depuy Spine, Inc. (2004) Summary page 1.
- K040261: Reflex Hybrid Anterior Cervical Plate System, Stryker Spine (2004) Summary page 1.
- K070775: Modification to: Providence Anterior Cervical Plate System, Globus Medical, Inc. (2007) Summary page 1.
- K030866: Synthes Anterior CSLP System, Synthes (Usa) (2003) Summary page 1.
- K000536: Synthes Anterior CSLP System, Synthes Spine (2000) Summary page 1.
- K071329: Nuvasive Helix Acp System, Nuvasive, Inc. (2007) Summary page 1.
- K053581: Nuvasive Smartplate Gradient Plus System, Nuvasive, Inc. (2006) Summary page 1.
- (no number) Skyline: named in the summary without a submission number
- (no number) Trinica Select: named in the summary without a submission number

## Indications for use
The REMEDY™ Cervical Plate System is intended for anterior interbody screw/plate fixation from C2 to 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: 1) Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) Trauma (including fractures), 3) Tumors, 4) Deformity (defined as kyphosis, lordosis, or scoliosis), 5) Pseudarthrosis, and/or 6) Failed previous fusions. Warning: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

Source page: https://510kreport.com/device/K100215
Methodology: https://510kreport.com/methodology