# K230608: SPICCA Stand-Alone Cervical Fusion Cages

- Pathway: 510(k) (Traditional)
- Applicant: Southern Medical (Pty), Ltd.
- Decided: Aug 14, 2023 after 164 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: 24 generations back to K841189 (1984). 424 ancestors in all.
No later device cites it as a predicate yet.
1 of 425 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153352: Vertu® & Vertu® Ti-Bond and Crystal® & Crystal® Ti-Bond Cervical Interbody System, Spinal Elements, Inc. (2016) Summary page 5.
- K211111: SureMAX-SA Cervical Standalone System, Additive Implants, Inc. (2021) Summary page 5.
- K212853: Cervical Stand-Alone System, Eminent Spine, LLC (2021) Summary page 5.
- K141500: Optio-C Anterior Cervical System, Zimmer Spine, Inc. (2014) Summary page 5.

## Indications for use
The SPICCA Stand-Alone Cervical Fusion Cages are stand-alone interbody fusion devices intended for spinal fusion procedures at one or two levels from the C2/C3 disc space to the C7/T1 disc space in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients must have undergone a regimen of at least six (6) weeks non-operative treatment prior to being treated with these devices. The implant is designed to accommodate two screws. Two screws should be used to ensure adequate fixation of the implant.

Source page: https://510kreport.com/device/K230608
Methodology: https://510kreport.com/methodology