# Newclip Technics

- Location (FDA's records): Haute-Goulaine, FR
- FDA decisions: 35 (2006–2026): 35 510(k) clearances
- Product codes: HRS (26), PBF (4), HWC (4), HTY (1)
- 510(k) review time since 2016: median 92 days, against 116 for FDA's reviews in the same codes and years (15 of 27 faster)
- Predicates its devices cite: 128 (35 its own); citations of its devices by later devices: 40 (35 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
- Synthes (Usa): 22 (https://510kreport.com/company/synthes-usa)
- Wrightmedicaltechnologyinc: 8 (https://510kreport.com/company/wrightmedicaltechnologyinc)
- Howmedica Osteonics Corp.: 6 (https://510kreport.com/company/howmedica-osteonics)
- Medartis AG: 6 (https://510kreport.com/company/medartis)
- Synthes (USA) Products, LLC: 4 (https://510kreport.com/company/synthes-usa-products)
- Arthrex, Inc.: 4 (https://510kreport.com/company/arthrex)
- Acumed, LLC: 4 (https://510kreport.com/company/acumed)
- TriMed, Inc.: 4 (https://510kreport.com/company/trimed)

## Firms that cite its devices most
- Neosteo: 2 (https://510kreport.com/company/neosteo)
- Avanti Orthopaedics, Inc.: 1 (https://510kreport.com/company/avanti-orthopaedics)
- TriMed, Inc.: 1 (https://510kreport.com/company/trimed)
- Z-Medical GmbH & Co. KG: 1 (https://510kreport.com/company/z-medical)

## Its most-cited devices
- K143061: Activ Ankle Locking Plating System (2015), cited by 5
- K100944: Clavicle Locking Plate System (2010), cited by 4
- K091118: Foot and Hand Motion System (2009), cited by 4
- K161448: Footmotion Plating System (2016), cited by 4
- K173641: Activ Ankle (2018), cited by 3
- K152289: Alians Elbow Locking Plating System (2016), cited by 3

## Recent decisions
- K262649: Alians Forearm (Sep 28, 2026)
- K261511: Xpert Ankle (Jul 28, 2026)
- K261191: Alians Elbow S (Jul 8, 2026)
- K261038: Xpert PFP (May 29, 2026)
- K253906: Xpert Hand (Mar 11, 2026)
- K250767: Newclip Patient-matched instrumentation non sterile PSI (Oct 1, 2025)
- K250155: Xpert Knee (Apr 23, 2025)
- K243912: Newclip Patient-matched instrumentation non sterile PSI (Feb 13, 2025)

Source page: https://510kreport.com/company/newclip-technics