# K141500: Optio-C Anterior Cervical System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Spine, Inc.
- Decided: Sep 23, 2014 after 109 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: 2 generations back to K926453 (1993). 7 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031276: Synthes Anterior Cervical Locking Plate (Aclp) System, Synthes (Usa) (2003) Summary page 5.
- K030866: Synthes Anterior CSLP System, Synthes (Usa) (2003) Summary page 5.
- K971883: Synthes Spine Small Stature Anterior Cervical Vertebrae Plate System, Synthes (Usa) (1997) Summary page 5.
- K012305: Modification to: Trinica Anterior Cervical Plate System, Sulzer Spine-Tech (2001) Summary page 5.

## Most influential descendants
- K230608: SPICCA Stand-Alone Cervical Fusion Cages (2023), 0 descendants of its own
- K152239: Zero-P Natural Plate System (2015), 0 descendants of its own

## Indications for use
When Optio-C Anterior Cervical Plate is used with structural allograft/autograft it is intended for one-level anterior screw fixation of the cervical spine (C2-T1). The implant has been designed for use with structural allograft/autograft to provide stabilization as an adjunct to cervical fusion. Indications for use of the Optio-C Anterior Plate with structural allograft/autograft include degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumor, pseudarthrosis or failed previous fusion. The Optio-C Anterior Cervical Plate is intended to be used with a structural allograft/autograft and with three Optio-C bone screws. When Optio-C Anterior Cervical Plate is used with an Optio-C PEEK IBF Spacer it becomes an Optio-C Anterior Cervical Intervertebral Body Fusion Device (IBFD), indicated for stand-alone anterior cervical interbody fusion procedures in skeletally mature patients with cervical degenerative disc disease at one level from C2 to T1. Degenerative disc disease (DDD) is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Optio-C IBFD is comprised of one Optio-C PEEK IBF Spacer, one Optio-C Anterior Cervical Plate and three Optio-C bone screws. The Optio-C IBFD is to be used with autograft and implanted via an open, anterior approach in patients who have had six weeks of non-operative treatment.

Source page: https://510kreport.com/device/K141500
Methodology: https://510kreport.com/methodology