# K092017: Pivotec Lumbar Interbody Fusion Device (Lifd)

- Pathway: 510(k) (Traditional)
- Applicant: Captiva Spine, Inc.
- Decided: Dec 1, 2009 after 148 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: 5 generations back to K010530 (2001). 9 ancestors in all.
24 later devices descend from it; 4 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P960025: Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws, Depuy Spine, Inc. (1999) Summary page 1.
- P950019: Ray Threaded Fusion Cage (TFC)(TM) with Instrumentation, Stryker Spine (1996) Summary page 1.
- K083661: Avs TL Peek Spacers, Stryker Corp. (2009) Summary page 1.

## Most influential descendants
- K170297: Tranquil Interbody System (2017), 15 descendants of its own
- K181702: Tranquil-L Interbody System (2018), 8 descendants of its own
- K212498: Stable-L Standalone Lumbar Interbody System (2022), 7 descendants of its own
- K181621: Stable-C Interbody System (2018), 7 descendants of its own
- K231763: Stable-C Interbody System (2023), 6 descendants of its own

## Indications for use
The Pivotec LIFD implant is an intervertebral body fusion deviceindicated for interertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to SI in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The Pivotec LIFD Implant is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine.

Source page: https://510kreport.com/device/K092017
Methodology: https://510kreport.com/methodology