# K130461: Stalif X

- Pathway: 510(k) (Traditional)
- Applicant: Centinel Spine, Inc.
- Decided: Aug 28, 2013 after 187 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: 12 generations back to K841189 (1984). 61 ancestors in all.
13 later devices descend from it; 1 cites it directly.
0 of 75 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073109: Stalif TT Intervertebral Body Fusion System, Surgicraft, Ltd. (2008) Summary page 2.
- K101301: Stalif Midline, Centinel Spine (2010) Summary page 2.
- K112986: Lateral Fusion Device, Integra Spine (Integra Lifesciences) (2012)
- K121733: Infill Intervertebral Body Fusion Device, Pinnacle Spine Group, LLC (2012)
- K103729: Infill Intervertebral Body Fusion Device, Pinnacle Spine Group, LLC (2011) Summary page 2.

## Most influential descendants
- 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 (2018), 12 descendants of its own
- K201453: Fortilink Cages with TiPlus Technology (2020), 4 descendants of its own
- K242260: aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM (2024), 3 descendants of its own
- K200458: Tailored-C Cervical Interbody Fusion System (2020), 3 descendants of its own
- K250827: aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion device with interfixation; aprevo® transforaminal lumbar interbody fusion device; aprevo® TLIF-CA Articulating System; aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X No Cams (2025), 2 descendants of its own

## Indications for use
The STALIF XTM is indicated for use with autogenous bone graft in patients with degenerative disc disease (ODD) at one or two contiguous levels from L2 to L5. These ODD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. DDID is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated. These implants may be implanted via a laparoscopic or an open lateral approach. The STALIF XTM is required to be used with supplementary fixation systems (e.g., pedicle screws) that have been cleared for use in the lumbar spine. The STALIF XTM system should be used with bone grafting material (autograft only).

Source page: https://510kreport.com/device/K130461
Methodology: https://510kreport.com/methodology