# Evolution Spine

- Location (FDA's records): Dallas, TX
- FDA decisions: 14 (2016–2026): 14 510(k) clearances
- Names in FDA's records: Evolution Spine (9); Evolution Spine, LLC (5)
- Product codes: KWQ (4), OVE (3), OVD (3), NKB (1), MAX (1), ODP (1), OLO (1)
- 510(k) review time since 2016: median 95 days, against 89 for FDA's reviews in the same codes and years (7 of 14 faster)
- Predicates its devices cite: 31 (11 its own); citations of its devices by later devices: 18 (11 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Globus Medical, Inc.: 5 (https://510kreport.com/company/globus-medical)
- Eminent Spine: 3 (https://510kreport.com/company/eminent-spine)
- Alphatec Spine, Inc.: 3 (https://510kreport.com/company/alphatec-spine)
- Omni Surgical, L.P.: 1 (https://510kreport.com/company/omni-surgical)
- Synthes (Usa): 1 (https://510kreport.com/company/synthes-usa)
- Genesys Spine: 1 (https://510kreport.com/company/genesys-spine)
- Atlas Spine, Inc.: 1 (https://510kreport.com/company/atlas-spine)
- Huvexel Co., Ltd.: 1 (https://510kreport.com/company/huvexel)

## Firms that cite its devices most
- Life Spine, Inc.: 1 (https://510kreport.com/company/life-spine)
- Altus Partners, LLC: 1 (https://510kreport.com/company/altus-partners)
- MiRus, LLC: 1 (https://510kreport.com/company/mirus)
- Medacta International S.A.: 1 (https://510kreport.com/company/medacta-international)
- Carlsmed, Inc.: 1 (https://510kreport.com/company/carlsmed)
- NanoHive Medical, LLC: 1 (https://510kreport.com/company/nanohive-medical)
- Medyssey Co, Ltd.: 1 (https://510kreport.com/company/medyssey)

## Its most-cited devices
- K241846: E3D™-C Interbody System (2024), cited by 5
- K223146: EVOLUTION SPINE Interbody System (2023), cited by 3
- K182478: Whistler Modular Pedicle Screw System (2019), cited by 2
- K232432: E3D™-A Interbody System (2024), cited by 2
- K180755: Vail ALIF Buttress Plate System (2018), cited by 1
- K173375: Anterior Cervical Plate System (2017), cited by 1

## Recent decisions
- K262094: E3D™-C Interbody System (Jul 22, 2026)
- K260038: E3D™-C Interbody System (Feb 4, 2026)
- K250167: Evolution Spine Navigation Instruments (Aug 18, 2025)
- K241846: E3D™-C Interbody System (Aug 12, 2024)
- K240368: E3D™-A Interbody System (May 15, 2024)
- K232432: E3D™-A Interbody System (Jan 30, 2024)
- K223146: EVOLUTION SPINE Interbody System (Feb 7, 2023)
- K220275: EMERGE Anterior Cervical Plate System (Mar 18, 2022)

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