# K260810: Anteralign LS coverplate

- Pathway: 510(k) (Traditional)
- Applicant: Tyber Medical, LLC
- Decided: Jun 10, 2026 after 90 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: 30 generations back to K841189 (1984). 838 ancestors in all.
No later device cites it as a predicate yet.
1 of 839 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K214010: Anteralign Spinal System with Titan nanoLOCK Surface Technology, Medtronic Sofamor Danek USA (2022) Summary page 5.
- K222465: Tyber Medical Anatomical Plating System, Tyber Medical, LLC (2023) Summary page 5.

## Indications for use
When used with Anteralign™ LS Spinal System, the Anteralign™ LS coverplate and cage is only intended to be used according to the indications of Medtronic’s Anteralign™ LS Spinal System. Anteralign™ LS Spinal System Indications for Use The Anteralign™ LS Spinal System is intended to be used in spinal fusion procedures on skeletally mature patients with symptomatic Degenerative Disc Disease (DDD, defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies), degenerative spondylolisthesis, and/or spinal stenosis, at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion. These patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. These patients should have had six months of nonoperative treatment prior to treatment with this device. Additionally, the Anteralign™ LS Spinal System and optional Anteralign™ LS Coverplate can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. The Anteralign™ LS interbody cage may be used as a stand-alone device or in conjunction with supplemental fixation. The Anteralign LS™ interbody fusion Device e may be inserted via minimally invasive or open anterior or oblique approach at one or two contiguous levels from L2 to S1. These approaches include anterior and oblique. When used as a stand-alone device, the Anteralign™ LS cage must be used with 3 screws with devices that have standard lordosis (<16°). If the physician chooses to use less than 3 screws or none of the provided screws, additional supplemental fixation in the lumbar spine must be used to augment stability. When used in patients as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity conditions, additional supplemental fixation (e.g. posterior fixation) must be used. Additionally, cages with lordosis angles 16° or greater are intended to be used with supplemental fixation (e.g. facet screws or posterior fixation).

Source page: https://510kreport.com/device/K260810
Methodology: https://510kreport.com/methodology