# K143228: Ancora LLC Interbody Fusion Device

- Pathway: 510(k) (Traditional)
- Applicant: Frontier Medical Devices, Inc.
- Decided: Feb 26, 2015 after 108 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). 94 ancestors in all.
No later device cites it as a predicate yet.
0 of 95 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112700: Frontier Sadl Interbody Fusion Device, Frontier Medical Devices, Inc. (2012) Summary page 4.
- K140479: Coroent XL-F System, Nu Vasive, Incorporated (2014) Summary page 4.
- P950002: Bak Interbody Fusion System, Zimmer Spine, Inc. (1996) Summary page 4.

## Indications for use
The Ancora LLC Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD). DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. 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. When used with the integrated locking plates, it is indicated to be used at one level from L2-L5. When used without the integrated locking plates, it is indicated to be used at one or two contiguous levels, from L2-S1. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone.

Source page: https://510kreport.com/device/K143228
Methodology: https://510kreport.com/methodology