Medtronic 46501218 Instructions for Use

2021

Anteralign™ LS

Spinal System

DIRECTIONS FOR USE

MEDTRONIC-M333023W366 Rev B

2

3 System overview

4 Implant overview

5 Access

5 Trialing

6 Placement of bone graft

6 Implant placement

7 Intrinsic screw fixation

8 Closure

8 Fixation

9 Explantation

9 StealthStation™ Navigation

9 Set-Up

10 Workflow selections

12 Navigated Trial insertion

13 Navigated Implant placement

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System overview

The Anteralign™ LS spinal system is a streamlined Implant system intended to be used in two

different spinal approaches and four procedures: SynergyOLIF51™, SynergyALIF™,

OLIF51™, and ALIF.

The Anteralign™ LS Implant is intended to be used in spinal fusion procedures on skeletally

mature patients with symptomatic Degenerative Disc Disease (DDD) at one or two

contiguous levels from L2 to S1 whose condition requires the use of Interbody fusion. The

Anteralign™ spinal system with Titan nanoLOCK™ surface technology is intended for use

with supplemental internal fixation systems cleared for use in the lumbar spine.

Additionally, the Anteralign™ spinal system with Titan nanoLOCK™ surface technology can

be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis

and sagittal deformity. When used with all 3 screws, Anteralign™ LS is intended to be used as

a standalone device for 6- or 12-degree size offerings.

The Anteralign™ spinal system was designed to be used with navigation or fluoroscopy. For

details on the navigated workflow, please refer to page 10 of this Anteralign™ LS Surgical

Technique.

The Inserter can be used with all the Anteralign Trials and Implants. The foot of the Inserter

features a line to help with proper orientation of the Implant on the Inserter. The Anteralign™

LS Implant and Trials are marked with a circle for OLIF51™ and a triangle for ALIF

orientations.

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Implant overview

Implant dimensions

Three Footprints: Small (32mm X 25mm)

Medium (37mm X 29mm)

Large (42mm X 32mm)

Five Lordosis Options: 6°

12°

18°

24°

30°

Six Height Options: 10mm

12mm

14mm

16mm

18mm

20mm

Trial Options: 30 Corresponding Trial Sizes

Screw overview: Screw features Ti-on-Ti locking mechanism

Lengths: 20mm 30mm 40mm 50mm