# K191791: TranS1 Interbody Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Trans1
- Decided: Sep 25, 2019 after 84 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) TranS1 Interbody Fusion Devices: named in the summary without a submission number
- (no number) Life Spine Altitude Spacer System: named in the summary without a submission number
- (no number) Amendia Interbody Fusion Device: named in the summary without a submission number
- (no number) Choice Spine Lumbar Spacer System: named in the summary without a submission number
- (no number) LDR CASCADIA Interbody System: named in the summary without a submission number

## Indications for use
The TranS1 Interbody Fusion System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The TranS1 Interbody Fusion System can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. These patients should have had six months of non-operative treatment. The TranS1 Interbody Fusion System is designed to be used with autograft and/or allograft comprised of cancellous and/or coritcocancellous bone graft, and a supplemental spinal fixation system that is cleared for use in the lumbar spine.

Source page: https://510kreport.com/device/K191791
Methodology: https://510kreport.com/methodology