# K133286: Midline (TM)

- Pathway: 510(k) (Special)
- Applicant: Centinel Spine, Inc.
- Decided: Jan 9, 2014 after 76 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: 13 generations back to K841189 (1984). 55 ancestors in all.
460 later devices descend from it; 1 cites it directly.
1 of 516 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101301: Stalif Midline, Centinel Spine (2010) Summary page 1.
- K073109: Stalif TT Intervertebral Body Fusion System, Surgicraft, Ltd. (2008) Summary page 1.
- K101310: VU Apod Intervertebral Body Fusion Device, Theken Spine, LLC (2010) Summary page 2.

## Most influential descendants
- K141942: Midline II TI (2014), 459 descendants of its own
- 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

## Indications for use
The MIDLINETM 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 MIDLINETM is a stand-alone system intended to be used with the bone screws provided and requires no additional supplementary fixation systems. The MIDLINETM system must be used with bone grafting material (autograft only).

Source page: https://510kreport.com/device/K133286
Methodology: https://510kreport.com/methodology