# K080058: Turbo Prime Ibd System

- Pathway: 510(k) (Traditional)
- Applicant: Spineselect, LLC
- Decided: Apr 16, 2008 after 98 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: 1 generation back to P950002 (1996). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P970015: Inter Fix Threaded Fusion Device, Sofamor Danek (1999) Summary page 1.
- P950019: Ray Threaded Fusion Cage (TFC)(TM) with Instrumentation, Stryker Spine (1996) Summary page 1.
- P950002: Bak Interbody Fusion System, Zimmer Spine, Inc. (1996) Summary page 1.

## Most influential descendants
- K171656: Genesys Spine Apache Interbody Fusion System (2017), 0 descendants of its own

## Indications for use
The Turbo Prime IBD (Interbody Device) System is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-SI. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies who have had at least six months of non-operative care for their DDD. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone.

Source page: https://510kreport.com/device/K080058
Methodology: https://510kreport.com/methodology