# K230607: SPICCA Cervical Fusion Cages

- Pathway: 510(k) (Traditional)
- Applicant: Southern Medical (Pty), Ltd.
- Decided: Aug 14, 2023 after 164 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, 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: 22 generations back to K841189 (1984). 386 ancestors in all.
No later device cites it as a predicate yet.
1 of 387 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210044: Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System, Ceres-C Spinal System, Omega XP Spinal System, Spinal Elements, Inc. (2021) Summary page 5.
- K200458: Tailored-C Cervical Interbody Fusion System, Bespoke Technologies (2020) Summary page 5.
- K172320: Neurostructures Cavetto® Cervical Cage System, Neurostructures, Inc. (2018) Summary page 5.
- K193359: SureMAX Family of Cervical Spacers, Additive Implants, Inc. (2020). Our reading of the summary gave K193369, FDA’s number for Xelis Dental 2.0 (Infinitt Healthcare Co., Ltd.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “SureMAX™ Family of Cervical Spacers”.

## Indications for use
SPICCA Cervical Fusion Cages are cervical 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 intended to be used in combination with an anterior cervical plating system.

Source page: https://510kreport.com/device/K230607
Methodology: https://510kreport.com/methodology