# CarboFix Orthopedics, Ltd.

- Location (FDA's records): Herzeliya, IL
- FDA decisions: 32 (2011–2026): 32 510(k) clearances
- Product codes: NKB (12), HRS (7), HSB (6), NKG (2), MAX (1), PML (1), KWQ (1), OLO (1), MQP (1)
- 510(k) review time since 2016: median 62 days, against 72 for FDA's reviews in the same codes and years (19 of 24 faster)
- Predicates its devices cite: 189 (65 its own); citations of its devices by later devices: 76 (65 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- N.M.B. Medical Applications, Ltd.: 18 (https://510kreport.com/company/nmb-medical-applications)
- Synthes (Usa): 17 (https://510kreport.com/company/synthes-usa)
- Medtronic Sofamor Danek USA, Inc.: 10 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- K2m, Inc.: 8 (https://510kreport.com/company/k2m)
- Icotec AG: 8 (https://510kreport.com/company/icotec)
- Aesculap Implant System, Inc.: 8 (https://510kreport.com/company/aesculap-implant-system)
- Medos International SARL: 7 (https://510kreport.com/company/medos-international)
- Howmedica Osteonics Corp.: 7 (https://510kreport.com/company/howmedica-osteonics)

## Firms that cite its devices most
- Icotec AG: 5 (https://510kreport.com/company/icotec)
- Carbofix Orthpedics, Ltd.: 3 (https://510kreport.com/company/carbofix-orthpedics)
- Paragon 28, Inc.: 1 (https://510kreport.com/company/paragon-28)
- In2bones USA, LLC: 1 (https://510kreport.com/company/in2bones-usa)
- Sign Fracture Care International: 1 (https://510kreport.com/company/sign-fracture-care-international)

## Its most-cited devices
- K173487: CarboClear® Pedicle Screw System (2018), cited by 9
- K182377: CarboClear® Pedicle Screw System (2018), cited by 8
- K120409: Piccolo Composite Plate System (2012), cited by 6
- K130061: Piccolo Composite Plate System (2013), cited by 6
- K210716: CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments (2021), cited by 5
- K123810: Piccolo Composite Ankle Arthrodesis Nailing System (2013), cited by 4

## Recent decisions
- K254045: CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System (Mar 16, 2026)
- K243106: CarboClear® Hybrid Pedicle Screw System (Nov 5, 2024)
- K233793: CarboClear® X Pedicle Screw System (Aug 1, 2024)
- K240846: CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments; CarboClear® Hybrid Fenestrated Pedicle Screw System and High V+® Bone Cement; CarboClear® X Fenestrated Pedicle Screw System and High V+® Bone Cement (Apr 25, 2024)
- K233989: CarboClear® Posterior Cervical Screw System (Mar 27, 2024)
- K233944: CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments (Jan 10, 2024)
- K232341: CarboClear® Pedicle Screw System (Oct 10, 2023)
- K231280: CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X Fenestrated Pedicle Screw System with High V+® Bone Cement (Jul 3, 2023)

Source page: https://510kreport.com/company/carbofix-orthopedics