# Icotec AG

- Location (FDA's records): 9450 Altstaetten (Sg), CH
- FDA decisions: 17 (2011–2025): 17 510(k) clearances
- Names in FDA's records: Icotec AG (16); Icotec (1)
- Product codes: NKB (5), PML (2), MQP (2), ODP (2), KWQ (2), MAX (2), OLO (1), NKG (1)
- 510(k) review time since 2016: median 163 days, against 87 for FDA's reviews in the same codes and years (0 of 16 faster)
- Predicates its devices cite: 56 (17 its own); citations of its devices by later devices: 31 (17 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- CarboFix Orthopedics, Ltd.: 5 (https://510kreport.com/company/carbofix-orthopedics)
- Corelink, LLC: 5 (https://510kreport.com/company/corelink)
- Blackstone Medical, Inc.: 3 (https://510kreport.com/company/blackstone-medical)
- Signus Medizintechnik GmbH: 3 (https://510kreport.com/company/signus-medizintechnik)
- Ulrich GmbH & Co. KG: 2 (https://510kreport.com/company/ulrich)
- Silony Medical GmbH: 1 (https://510kreport.com/company/silony-medical)
- G21, S.R.L.: 1 (https://510kreport.com/company/g21)
- Omnia Medical, LLC: 1 (https://510kreport.com/company/omnia-medical)

## Firms that cite its devices most
- CarboFix Orthopedics, Ltd.: 8 (https://510kreport.com/company/carbofix-orthopedics)
- Spineart: 1 (https://510kreport.com/company/spineart)
- Carbofix Orthpedics, Ltd.: 1 (https://510kreport.com/company/carbofix-orthpedics)
- Ulrich Medical USA: 1 (https://510kreport.com/company/ulrich-medical-usa)
- Precision Spine, Inc.: 1 (https://510kreport.com/company/precision-spine)
- Alphatec Spine, Inc.: 1 (https://510kreport.com/company/alphatec-spine)
- K7, LLC: 1 (https://510kreport.com/company/k7)

## Its most-cited devices
- K200596: G21 Cement, VADER® Pedicle System (2020), cited by 7
- K190545: VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0 (2019), cited by 4
- K172480: icotec Interbody Cage System (2018), cited by 4
- K151977: icotec Pedicle System (2016), cited by 4
- K193423: VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0 (2020), cited by 3
- K222789: VADER® Pedicle System, G21 Cement (2023), cited by 2

## Recent decisions
- K252327: CMORE® CT System; CMORE® CT System Navigated Instruments (Nov 12, 2025)
- K242900: VADER® Pedicle System and VADER®one Pedicle System (Feb 27, 2025)
- K233215: icotec Anterior Cervical Plate System (May 17, 2024)
- K232792: icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec ETurn™ TLIF Lumbar Cage) (Apr 5, 2024)
- K232790: KONG®-TL VBR System and KONG® C VBR System (Apr 4, 2024)
- K232628: VADER® Pedicle System (Feb 26, 2024)
- K230861: VADER® Pedicle System Navigated Instruments (Jun 27, 2023)
- K222789: VADER® Pedicle System, G21 Cement (Jan 9, 2023)

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