# K150643: Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti

- Pathway: 510(k) (Traditional)
- Applicant: Centinel Spine, Inc.
- Decided: Jun 8, 2015 after 88 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: 16 generations back to K841189 (1984). 97 ancestors in all.
368 later devices descend from it; 11 cite it directly.
1 of 466 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141942: Midline II TI, Centinel Spine, Inc. (2014) Summary page 4.
- K101301: Stalif Midline, Centinel Spine (2010) Summary page 4.
- K073109: Stalif TT Intervertebral Body Fusion System, Surgicraft, Ltd. (2008) Summary page 4.

## Most influential descendants
- K152475: FORZA PTC Spacer System (2016), 236 descendants of its own
- K153495: Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant System (2016), 189 descendants of its own
- K162103: Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine Interbody Fusion System (Harrier™), Choice Spine Vertebral Body Replacement System (Hawkeye™) (2016), 161 descendants of its own
- K161379: ELSA Spacers (2016), 155 descendants of its own
- K171686: Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System (2017), 116 descendants of its own

## Indications for use
The STALIF TT™, STALIF MIDLINE®, MIDLINE II™, and MIDLINE II-Ti™ is indicated for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft) in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. DDD 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 anterior approach. The STALIF TT™, STALIF MIDLINE®, MIDLINE II™, and MIDLINE II-Ti™ is a stand-alone system intended to be used with the bone screws provided and requires no additional supplementary fixation systems. The STALIF TT™, STALIF MIDLINE®, MIDLINE II™, and MIDLINE II-Ti™ system must be used with autograft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft.

Source page: https://510kreport.com/device/K150643
Methodology: https://510kreport.com/methodology