# S.M.A.I.O

- Location (FDA's records): Saint-Priest, FR
- FDA decisions: 13 (2020–2026): 13 510(k) clearances
- Product codes: NKB (10), LLZ (3)
- 510(k) review time since 2016: median 96 days, against 91 for FDA's reviews in the same codes and years (7 of 13 faster)
- Predicates its devices cite: 50 (29 its own); citations of its devices by later devices: 30 (29 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
- Medicrea International SA: 4 (https://510kreport.com/company/medicrea-international)
- SeaSpine Orthopedics Corporation: 4 (https://510kreport.com/company/seaspine-orthopedics)
- Medos International SARL: 4 (https://510kreport.com/company/medos-international)
- Nemaris, Inc.: 2 (https://510kreport.com/company/nemaris)
- Medtronic Sofamor Danek: 2 (https://510kreport.com/company/medtronic-sofamor-danek)
- Zimvie Spine (Zimmer Biomet Spine, Inc.): 2 (https://510kreport.com/company/zimvie-spine-zimmer-biomet-spine)
- Nu Vasive, Incorporated: 1 (https://510kreport.com/company/nu-vasive)
- Medtronic Sofamor Danek USA, Inc.: 1 (https://510kreport.com/company/medtronic-sofamor-danek-usa)

## Firms that cite its devices most
- Highridge Medical, LLC: 1 (https://510kreport.com/company/highridge-medical)

## Its most-cited devices
- K211981: KHEIRON® Spinal Fixation System (2022), cited by 7
- K232650: KHEIRON® Spinal Fixation System, including patient specific K-ROD (2023), cited by 6
- K251804: KHEIRON® Spinal Fixation System, including patient specific K-ROD (2025), cited by 4
- K201659: KHEIRON® Spinal Fixation System (2020), cited by 3
- K253990: KHEIRON® Spinal Fixation System, including patient specific K-ROD (2026), cited by 2
- K253721: KHEIRON® Spinal Fixation System, including patient specific K-ROD (2025), cited by 2

## Recent decisions
- K262828: KHEIRON® Spinal Fixation System, including patient specific K-ROD (Sep 4, 2026)
- K261500: KBA3D (v2.4.0) (Aug 17, 2026)
- K253802: KHEIRON® Spinal Fixation System, including patient specific K-ROD (Jul 1, 2026)
- K260786: KHEIRON® Spinal Fixation System, including patient specific K-ROD (Apr 3, 2026)
- K253990: KHEIRON® Spinal Fixation System, including patient specific K-ROD (Jan 7, 2026)
- K253721: KHEIRON® Spinal Fixation System, including patient specific K-ROD (Dec 17, 2025)
- K251804: KHEIRON® Spinal Fixation System, including patient specific K-ROD (Jul 8, 2025)
- K232650: KHEIRON® Spinal Fixation System, including patient specific K-ROD (Sep 29, 2023)

Source page: https://510kreport.com/company/smaio