# K132894: Optio-C Anterior Cervical System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Spine, Inc.
- Decided: Jan 16, 2014 after 122 days
- Product code: OVE (Intervertebral Fusion Device With Integrated Fixation, Cervical)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K003155 (2001). 92 ancestors in all.
24 later devices descend from it; 3 cite it directly.
0 of 117 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103033: Trabecular Metal Fusion Device Model 06-101-Xxxxx, 06-102-Xxxxx and 08-100-Xxxxx, Zimmer Trabecular Metal Technology (2011) Summary page 2.
- K111119: Trabecular Metal (TM) Fusion Device, Zimmer Spine, Inc. (2011) Summary page 2.
- K073351: Crystal, Spinal Elements, Inc. (2008) Summary page 2.
- K112388: Lanx Cervical SA, Lanx, Inc. (2011) Summary page 2.
- K120345: Honour Spacer System, Nexxt Spine, LLC (2012) Summary page 2.
- (no number) PEEK PREVAIL Cervical Interbody: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K091898: Blood Glucose Monitoring System, Model Fora G90/TD-4234, Taidoc Technology Corporation (2009). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K173077: Cavetto-SA Cervical Cage System (2018), 21 descendants of its own
- K200115: Cavetto-SA Cervical Cage System (2020), 19 descendants of its own
- K212853: Cervical Stand-Alone System (2021), 18 descendants of its own
- K223105: Tesera-K SC System (2022), 5 descendants of its own
- K223190: Hive™ Standalone Cervical System (2022), 5 descendants of its own

## Indications for use
The Optio-C Anterior Cervical Intervertebral Body Fusion Device (IBFD) is 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/K132894
Methodology: https://510kreport.com/methodology