# K141942: Midline II TI

- Pathway: 510(k) (Traditional)
- Applicant: Centinel Spine, Inc.
- Decided: Nov 7, 2014 after 113 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: 15 generations back to K841189 (1984). 96 ancestors in all.
459 later devices descend from it; 4 cite it directly.
1 of 556 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133286: Midline (TM), Centinel Spine, Inc. (2014) Summary page 4.
- K101301: Stalif Midline, Centinel Spine (2010) Summary page 4.
- K111122: Aesculap Sibd XP Spinal System, Aesculap Implant Systems, Inc. (2011) Summary page 4.
- K102090: Spinesmith Cynch Spinal System - Visualif Interbody Fusion Implant System, Spine Smith Partners L.P. (2010) Summary page 4.
- K123045: Brigade Standalone System, Nuvasive, Inc. (2013) Summary page 4.
- K101310: VU Apod Intervertebral Body Fusion Device, Theken Spine, LLC (2010) Summary page 4.

## Most influential descendants
- K150643: Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti (2015), 368 descendants of its own
- K152475: FORZA PTC Spacer System (2016), 236 descendants of its own
- K151214: ALIF Interfixated System (2015), 220 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
- K152943: NuVasive Foundation-LL System (2015), 187 descendants of its own

## Indications for use
The MIDLINE II™ / MIDLINE II -Ti™ is indicated for use with autogenous 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 MIDLINE II™ / 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 MIDLINE II™ / MIDLINE II -Ti™ system must be used with bone grafting material (autograft only).

Source page: https://510kreport.com/device/K141942
Methodology: https://510kreport.com/methodology