# K221182: Southern Transforaminal Lumbar Interbody Fusion (TLIF)

- Pathway: 510(k) (Traditional)
- Applicant: Southern Medical (Pty), Ltd.
- Decided: Dec 8, 2022 after 227 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, 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: 22 generations back to K841189 (1984). 333 ancestors in all.
No later device cites it as a predicate yet.
1 of 334 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150061: Lucent; Lucent Ti-Bond Systems, Spinal Elements, Inc. (2015) Summary page 5.
- K171657: ShurFit 2C Lumbar Interbody Fusion System, Precision Spine, Inc. (2017) Summary page 5.
- K092193: Spinal Usa Interbody Cages, Spinal USA (2009) Summary page 5.
- K172341: NuVasive® Modulus TLIF Interbody System, Nu Vasive, Incorporated (2017) Summary page 5.
- K113561: TM Ardis Interbody System TM Ardis Interbody System Instrumenation, Zimmer Trabecular Metal Technology (2012) Summary page 5.
- K133614: Aleutian Ibf System, K2m, Inc. (2014) Summary page 5.

## Indications for use
The Southern Transforaminal Lumbar Interbody Fusion (TLIF) family (PLIF Caliber Lordotic, TLIF Bullet, and TLIF Camber) are indicated for use as interbody fusion devices in the lumbar spine, auxiliary to supplementary lumbar spinal fixation systems, such as posterior pedicle screw and rod systems. The PLIF Caliber Lordotic devices are designed to be implanted bi-laterally following a posterior approach. The devices are intended to be used with autograft to facilitate fusion. 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/K221182
Methodology: https://510kreport.com/methodology