# Novastep

- Location (FDA's records): Saint Gregoire, FR
- FDA decisions: 9 (2015–2026): 9 510(k) clearances
- Names in FDA's records: Novastep (8); Novastep SAS (1)
- Product codes: HRS (4), HWC (3), HTY (1), JDR (1)
- 510(k) review time since 2016: median 185 days, against 86 for FDA's reviews in the same codes and years (1 of 4 faster)
- Predicates its devices cite: 18 (3 its own); citations of its devices by later devices: 8 (3 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
- Memometal Technologies: 7 (https://510kreport.com/company/memometal-technologies)
- Wrightmedicaltechnologyinc: 3 (https://510kreport.com/company/wrightmedicaltechnologyinc)
- Stryker Trauma AG: 1 (https://510kreport.com/company/stryker-trauma)
- Paragon 28, Inc.: 1 (https://510kreport.com/company/paragon-28)
- Orthohelix Surgical Designs, Inc.: 1 (https://510kreport.com/company/orthohelix-surgical-designs)
- Small Bone Innovations, Inc.: 1 (https://510kreport.com/company/small-bone-innovations)
- Novatsep: 1 (https://510kreport.com/company/novatsep)

## Firms that cite its devices most
- Double Medical Technology, Inc.: 3 (https://510kreport.com/company/double-medical-technology)
- Nvision Biomedical Technologies, Inc.: 1 (https://510kreport.com/company/nvision-biomedical-technologies)
- GM Dos Reis Industria e Comercio Ltda.: 1 (https://510kreport.com/company/gm-dos-reis-industria-e-comercio)

## Its most-cited devices
- K143229: Nexis osteosynthesis compressive screws (2015), cited by 3
- K143523: Airlock osteosynthesis plate system (2015), cited by 2
- K143146: Nexis osteosynthesis snap-off screws (2015), cited by 1
- K192356: Airlock Centrolock Osteosynthesis Implant System (2019), cited by 1
- K151277: Airlock® osteosynthesis plate system (2015), cited by 1

## Recent decisions
- K260274: Airlock® Ankle Plating System (Mar 25, 2026)
- K230724: arcad® 2.0 Duo & Quadro osteosynthesis compressive staples (Dec 4, 2023)
- K223468: Nexis® compressive screws (Aug 30, 2023)
- K192356: Airlock Centrolock Osteosynthesis Implant System (Dec 14, 2019)
- K151277: Airlock® osteosynthesis plate system (Aug 13, 2015)
- K143523: Airlock osteosynthesis plate system (Apr 6, 2015)
- K143049: LYNC intramedullary implant (Feb 19, 2015)
- K143146: Nexis osteosynthesis snap-off screws (Feb 6, 2015)

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