# Additive Orthopaedics, LLC

- Location (FDA's records): Little Silver, NJ
- FDA decisions: 7 (2016–2022): 7 510(k) clearances
- Names in FDA's records: Additive Orthopaedics, LLC (6); Additive Orthopaedics (1)
- Product codes: HRS (5), HTY (1), PBF (1)
- 510(k) review time since 2016: median 120 days, against 116 for FDA's reviews in the same codes and years (3 of 7 faster)
- Predicates its devices cite: 14 (1 its own); citations of its devices by later devices: 4 (1 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
- Nextremity Solutions, Inc.: 2 (https://510kreport.com/company/nextremity-solutions)
- Paragon 28, Inc.: 1 (https://510kreport.com/company/paragon-28)
- Ascension Orthopedic: 1 (https://510kreport.com/company/ascension-orthopedic)
- 4-Web, Inc.: 1 (https://510kreport.com/company/4-web)
- Biopro, Inc.: 1 (https://510kreport.com/company/biopro)
- Arthrex, Inc.: 1 (https://510kreport.com/company/arthrex)
- MedShape, Inc.: 1 (https://510kreport.com/company/medshape)
- Synchro Medical: 1 (https://510kreport.com/company/synchro-medical)

## Firms that cite its devices most
- Bodycad Laboratories, Inc.: 1 (https://510kreport.com/company/bodycad-laboratories)
- Sky Surgical, LLC: 1 (https://510kreport.com/company/sky-surgical)
- 4Web, Inc.: 1 (https://510kreport.com/company/4web)

## Its most-cited devices
- K170214: Additive Orthopaedics Locking Lattice Plate (2017), cited by 2
- K183011: Additive Orthopaedics Patient Specific 3D Locking Lattice Plates (2019), cited by 1
- K160264: Additive Orthopaedics Hammertoe Correction System (2016), cited by 1

## Recent decisions
- K211076: Patient Specific Marking Guides (Jun 28, 2022)
- K183011: Additive Orthopaedics Patient Specific 3D Locking Lattice Plates (Jan 10, 2019)
- K180239: Additive Orthopaedics Patient Specific 3D Printed Bone Segments (May 16, 2018)
- K163593: Additive Orthopaedics Bunion System (Jun 20, 2017)
- K170214: Additive Orthopaedics Locking Lattice Plate (Apr 13, 2017)
- K153207: Additive Orthopaedics Bone Wedge System (Sep 7, 2016)
- K160264: Additive Orthopaedics Hammertoe Correction System (Jun 1, 2016)

Source page: https://510kreport.com/company/additive-orthopaedics