# Genesys Spine

- Location (FDA's records): Austin, TX
- FDA decisions: 31 (2010–2025): 31 510(k) clearances
- Product codes: MAX (8), NKB (6), OVE (6), KWQ (6), ODP (2), OUR (2), OLO (1)
- 510(k) review time since 2016: median 89 days, against 97 for FDA's reviews in the same codes and years (11 of 21 faster)
- Predicates its devices cite: 124 (49 its own); citations of its devices by later devices: 80 (49 its own)
- Recalls linked to its devices: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ldr Spine USA: 8 (https://510kreport.com/company/ldr-spine-usa)
- Depuy Spine, Inc.: 5 (https://510kreport.com/company/depuy-spine)
- Medtronic Sofamor Danek: 5 (https://510kreport.com/company/medtronic-sofamor-danek)
- SI-BONE, Inc.: 4 (https://510kreport.com/company/si-bone)
- Synthes (Usa): 4 (https://510kreport.com/company/synthes-usa)
- Medtronic Sofamor Danek USA, Inc.: 4 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Eminent Spine: 3 (https://510kreport.com/company/eminent-spine)
- X-Spine Systems, Inc.: 3 (https://510kreport.com/company/x-spine-systems)

## Firms that cite its devices most
- Nvision Biomedical Technologies, Inc.: 3 (https://510kreport.com/company/nvision-biomedical-technologies)
- Biogennix, LLC: 2 (https://510kreport.com/company/biogennix)
- Bm Korea Co., Ltd.: 2 (https://510kreport.com/company/bm-korea)
- Curiteva, Inc.: 2 (https://510kreport.com/company/curiteva)
- L&K BIOMED Co., Ltd.: 2 (https://510kreport.com/company/l-k-biomed)
- Nexus Spine, LLC: 2 (https://510kreport.com/company/nexus-spine)
- Exactech, Inc.: 2 (https://510kreport.com/company/exactech)
- Promethean Restorative, LLC: 1 (https://510kreport.com/company/promethean-restorative)

## Its most-cited devices
- K103034: Genesys Spine Interbody Fusion System (2010), cited by 22
- K191748: Genesys Spine Sacroiliac Joint Fusion System (2019), cited by 6
- K100757: Tilock Pedicle Screw System (2010), cited by 5
- K181295: Genesys Spine AIS-C Cervical Stand-Alone System (2018), cited by 5
- K103671: Genesys Spine Tilock System (2011), cited by 4
- K173885: Genesys Spine Binary Lumbar Plate System (2018), cited by 4

## Recent decisions
- K252322: SIros-X System (Oct 22, 2025)
- K242483: Genesys Spine AIS-C II Cervical Interbody Fusion System (Feb 7, 2025)
- K233595: Genesys Spine Sacroiliac Joint Fusion System with Navigation (Mar 29, 2024)
- K233594: Genesys Spine 3DP AIS-C II Cervical Interbody System (Dec 13, 2023)
- K220096: Genesys Spine 3DP Lumbar Interbody System (Mar 9, 2022)
- K191489: Genesys Spine 3DP Cervical Interbody System (Jan 8, 2020)
- K182987: Genesys Spine 3DP Lumbar Interbody System (Dec 12, 2019)
- K192678: Genesys Spine Binary® Lumbar Plate System (Oct 24, 2019)

Source page: https://510kreport.com/company/genesys-spine