# Restor3D

- Location (FDA's records): Durham, NC
- FDA decisions: 20 (2020–2026): 20 510(k) clearances
- Names in FDA's records: Restor3D (13); Restor3D, Inc. (6); restor3d, inc. (1)
- Product codes: HSN (5), PHX (4), MAX (2), OYK (1), PLF (1), SAI (1), LPH (1), HTY (1), KWD (1), HWC (1), MBH (1), JDR (1)
- 510(k) review time since 2016: median 94 days, against 114 for FDA's reviews in the same codes and years (7 of 16 faster)
- Predicates its devices cite: 36 (6 its own); citations of its devices by later devices: 10 (6 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
- 4Web, Inc.: 4 (https://510kreport.com/company/4web)
- Conformis, Inc.: 3 (https://510kreport.com/company/conformis)
- Corelink, LLC: 3 (https://510kreport.com/company/corelink)
- Kinos Medical: 2 (https://510kreport.com/company/kinos-medical)
- Wrightmedicaltechnologyinc: 2 (https://510kreport.com/company/wrightmedicaltechnologyinc)
- Zimmer, Inc.: 2 (https://510kreport.com/company/zimmer)
- SeaSpine Orthopedics Corporation: 2 (https://510kreport.com/company/seaspine-orthopedics)
- Biomet, Inc.: 1 (https://510kreport.com/company/biomet)

## Firms that cite its devices most
- Nvision Biomedical Technologies, Inc.: 1 (https://510kreport.com/company/nvision-biomedical-technologies)
- MiRus, LLC: 1 (https://510kreport.com/company/mirus)
- Sinaptic Surgical: 1 (https://510kreport.com/company/sinaptic-surgical)
- Auxano Medical, LLC: 1 (https://510kreport.com/company/auxano-medical)

## Its most-cited devices
- K201314: Restor3d Utility Wedge (2021), cited by 4
- K220523: restor3d TiDAL Lumbar Interbody Fusion Device (2022), cited by 2
- K243643: restor3d Reverse Total Shoulder Arthroplasty System (2025), cited by 1
- K232595: Kinos Axiom Total Ankle System (2023), cited by 1
- K241482: Kinos Total Ankle System (2024), cited by 1
- K242868: Kinos Total Ankle System (2024), cited by 1

## Recent decisions
- K263421: Veritas Shoulder System (Oct 22, 2026)
- K260556: Veritas Shoulder System (Jul 1, 2026)
- K253992: Veritas Reverse Total Shoulder System (May 7, 2026)
- K252067: Velora Acetabular System (Dec 5, 2025)
- K252454: Kinos Total Ankle System (Sep 3, 2025)
- K243643: restor3d Reverse Total Shoulder Arthroplasty System (May 19, 2025)
- K243768: iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System (Mar 27, 2025)
- K242356: TIDAL Fusion Cage System (Mar 24, 2025)

Source page: https://510kreport.com/company/restor3d