# K121658: Orthofix Acp (Anterior Cervical Plate System)

- Pathway: 510(k) (Traditional)
- Applicant: Orthofix, Inc.
- Decided: Jul 20, 2012 after 45 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: 8 generations back to K922087 (1992). 42 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050892: Hallmarktm Anterior Cervical Plate System, Blackstone Medical, Inc. (2005) Summary page 1.
- K100614: Hallmark Anterior Cervcial Plate System, Hallmark Five-Level Cervical Plates, Blackstone Medical, Inc. (2010) Summary page 1.
- K013877: Codman Slim-Loc System, Codman & Shurtleff, Inc. (2001) Summary page 1.
- K111528: Pioneer Aspect Anterior Cervical Plate Model 24-Series, Pioneer Surgical Technology, Inc. (2011) Summary page 1.

## Most influential descendants
- K191786: Cyclops™ Anterior Cervical Plate System (2019), 1 descendant of its own
- K130825: Azure Anterior Cervical Plate System (2013), 1 descendant of its own
- K213901: Cyclops™ Anterior Cervical Plate System (2022), 0 descendants of its own
- K143028: Azure Anterior Cervical Plate System (2015), 0 descendants of its own

## Indications for use
The Orthofix Anterior Cervical Plate System is a temporary implant intended for anterior fixation to the cervical spine from C2 to C7 and indicated for a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies); b) Spondylolisthesis; c) Trauma (i.e., fracture or dislocation); d) Spinal stenosis; e) Deformities (i.e., scoliosis, kyphosis, and/or lordosis); f) Tumor; g) Pseudoarthrosis; h) Revision of previous surgery

Source page: https://510kreport.com/device/K121658
Methodology: https://510kreport.com/methodology