# K112700: Frontier Sadl Interbody Fusion Device

- Pathway: 510(k) (Traditional)
- Applicant: Frontier Medical Devices, Inc.
- Decided: Nov 1, 2012 after 412 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: 11 generations back to K841189 (1984). 31 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081611: Nuvasive Coroent System, Nuvasive, Inc. (2008)
- K100175: Clydesdale Spinal System, Medtronic Sofamor Danek (2010) Summary page 1.

## Most influential descendants
- K143228: Ancora LLC Interbody Fusion Device (2015), 0 descendants of its own

## Indications for use
The Frontier LLC Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one level from L-2-L-5. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation (i.e. lateral plating or pedicle screw systems), which is in addition to the integrated locking plates provided in the system. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be use with autograft bone.

Source page: https://510kreport.com/device/K112700
Methodology: https://510kreport.com/methodology