# K243281: LOCK-IN Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Lock-In USA Corp
- Decided: Dec 13, 2024 after 57 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- 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 K853033 (1985). 319 ancestors in all.
No later device cites it as a predicate yet.
1 of 320 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992333: Ebi Omega 21 System, Electro-Biology, Inc. (1999) Summary page 5.
- K102331: LDR Spine Usa Spinetune TL Spinal System, Ldr Spine USA (2010) Summary page 5.
- K124058: Creo Stabilization System, Globus Medical, Inc. (2013) Summary page 5.
- K151704: Diplomat® Spinal System, Signus Medizintechnik GmbH (2016) Summary page 5.
- K201457: Auxein Brand Vertaux 5.5 mm Pedicle Screw System, Auxein Medical Private Limited/71164 (2021) Summary page 5.
- K203507: Vitality® Spinal Fixation System, Zimmer Biomet Spine, Inc. (2021) Summary page 5.

## Indications for use
The LOCK-IN Spinal Fixation System is intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion. The LOCK-IN Spinal Fixation System is intended to be used with autograft and/or allograft.

Source page: https://510kreport.com/device/K243281
Methodology: https://510kreport.com/methodology