# In2bones USA, LLC

- Location (FDA's records): Memphis, TN
- FDA decisions: 27 (2016–2026): 27 510(k) clearances
- Names in FDA's records: In2bones USA, LLC (25); In2bones USA (1); In2Bones USA, LLC (1)
- Product codes: HRS (16), HWC (3), KWH (2), KWI (2), JDR (1), HTY (1), MBI (1), HTN (1)
- 510(k) review time since 2016: median 90 days, against 96 for FDA's reviews in the same codes and years (14 of 23 faster)
- Predicates its devices cite: 96 (48 its own); citations of its devices by later devices: 56 (48 its own)
- Recalls linked to its devices: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Wrightmedicaltechnologyinc: 10 (https://510kreport.com/company/wrightmedicaltechnologyinc)
- In2bones Sas: 8 (https://510kreport.com/company/in2bones)
- Arthrex, Inc.: 3 (https://510kreport.com/company/arthrex)
- Crossroads Extremity Systems, LLC: 2 (https://510kreport.com/company/crossroads-extremity-systems)
- Vilex, LLC: 2 (https://510kreport.com/company/vilex)
- New Deal, S.A.: 2 (https://510kreport.com/company/new-deal)
- Nexa Orthopedics, Inc.: 2 (https://510kreport.com/company/nexa-orthopedics)
- Syntec Scientific Corp.: 2 (https://510kreport.com/company/syntec-scientific)

## Firms that cite its devices most
- Brm Extremities: 1 (https://510kreport.com/company/brm-extremities)
- Maxxion Medical, LLC / Baumer SA: 1 (https://510kreport.com/company/maxxion-medical-baumer)
- Nvision Biomedical Technologies, Inc.: 1 (https://510kreport.com/company/nvision-biomedical-technologies)
- Tdm Co., Ltd.: 1 (https://510kreport.com/company/tdm)
- Gramercy Extremity Orthopedics, LLC: 1 (https://510kreport.com/company/gramercy-extremity-orthopedics)
- Electro-Spec, Inc.: 1 (https://510kreport.com/company/electro-spec)
- Theramicro: 1 (https://510kreport.com/company/theramicro)
- Steps Ortho: 1 (https://510kreport.com/company/steps-ortho)

## Its most-cited devices
- K163293: Colink™ Plating System (2017), cited by 14
- K181113: CoLink™ Afx Plating System (2018), cited by 9
- K170518: In2Bones Fracture and Correction System (2017), cited by 6
- K180377: Fracture and Correction System (2018), cited by 5
- K172300: CoLink View Plating System (2017), cited by 5
- K161426: NeoSpan Compression Staple Impant w/instruments (2016), cited by 2

## Recent decisions
- K261154: CoLink® & CoLag® Non-Sterile Screws (May 30, 2026)
- K241387: CoLink NeoFuse MIS Plating System (see attached parts list) (Aug 13, 2024)
- K233089: NeoSpan® Compression Implant System (May 24, 2024)
- K231236: IBS-B MIS Beveled Screw System (Jul 27, 2023)
- K213698: CoLink PCR Plating System (May 27, 2022)
- K220260: Hercules Syndesmosis Implant System (Mar 31, 2022)
- K212872: Avenger Radial Head System (Dec 17, 2021)
- K213069: CoLink NeoFuse Plating System (Dec 13, 2021)

Source page: https://510kreport.com/company/in2bones-usa