# K101301: Stalif Midline

- Pathway: 510(k) (Special)
- Applicant: Centinel Spine
- Decided: Sep 24, 2010 after 137 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: 11 generations back to K841189 (1984). 39 ancestors in all.
474 later devices descend from it; 9 cite it directly.
1 of 514 devices in its family (counting itself) has 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 1.

## Most influential descendants
- K133286: Midline (TM) (2014), 460 descendants of its own
- 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

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

Source page: https://510kreport.com/device/K101301
Methodology: https://510kreport.com/methodology