# K253401: SCRIPT™ Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Apr 29, 2026 after 211 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: 32 generations back to K841189 (1984). 1,416 ancestors in all.
No later device cites it as a predicate yet.
4 of 1,417 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222270: HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS Instruments, Globus Medical, Inc. (2022) Summary page 5.
- K221894: Lumbar Expandable lnterbody Spacers -Additional Indications/Implants, Globus Medical, Inc. (2023) Summary page 5.
- K222082: aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal lumbar interbody fusion devices, Carlsmed, Inc. (2022) Summary page 5.
- K243635: aprevo® anterior lumbar interbody fusion device with interfixation, Carlsmed, Inc. (2024) Summary page 5.
- K203714: NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System, NuVasive CoRoent XL Interfixated System, Brigade System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, NuVasive Cohere Thoracolumbar Interbody System, NuVasive Modulus XLIF Interbody System, NuVasive Modulus TLIF Interbody System, NuVasive Modulus ALIF System, NuVasive Attrax Putty, Nu Vasive, Incorporated (2021) Summary page 5.
- K220478: NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody System, Nu Vasive, Incorporated (2022) Summary page 5.

## Indications for use
SCRIPT™ Lumbar Spacers, including SCRIPT ALIF™, SCRIPT XLIF™, SCRIPT XLIF EX™, SCRIPT TLIF™, SCRIPT TLIF EX™, and SCRIPT TLIF-A™, are lumbar interbody fusion devices indicated at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L.1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. SCRIPT™ Lumbar Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone or a bone void filler as cleared by the FDA for use in intervertebral body fusion to facilitate fusion. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (=20° lordosis) must be used with at least anterior supplemental fixation. SCRIPT ALIF IA™ Lumbar Spacers are integrated lumbar interbody fusion devices indicated for use at one or more levels of the lumbosacral spine (L1-S1), as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). 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 at least six (6) months of non-operative treatment. These devices are intended to be used with or without three screws and/or anchors which accompany the implants. These devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). In addition, these devices are intended for stand-alone use in patients with DDD at one or two levels only when <20° lordotic implants are used with three screws per implant. SCRIPT™ ALIF IA Lumbar Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone or a bone void filler as cleared by the FDA for use in intervertebral body fusion to facilitate fusion.

Source page: https://510kreport.com/device/K253401
Methodology: https://510kreport.com/methodology