# K221447: Southern Anterior Screw Fixated Cage (SASCA)

- Pathway: 510(k) (Traditional)
- Applicant: Southern Medical (Pty), Ltd.
- Decided: Oct 14, 2022 after 149 days
- Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar)
- 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: 18 generations back to K841189 (1984). 223 ancestors in all.
No later device cites it as a predicate yet.
1 of 224 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173347: STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX, ACTILIF M FLX, ACTILIF L FLX and ACTILIF Lateral-Oblique FLX, Centinel Spine, Inc. (2018) Summary page 6.
- K183426: MectaLIF Anterior Stand Alone Extension, Medacta International S.A. (2019) Summary page 6.

## Indications for use
Southern Anterior Screw Fixated Cages are indicated for use as stand-alone anterior interbody fusion devices in the lumbar spine. The devices are designed to be used with the bone screws provided and the interior cavity must be filled with autograft. Supplementary spinal fixation is not required. The devices are indicated for use in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L1 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The devices may also be used in patients with pseudarthrosis / non-union from previous unsuccessful fusion surgery. Patients should have undergone at least six months of non-operative treatment.

Source page: https://510kreport.com/device/K221447
Methodology: https://510kreport.com/methodology