# Additive Implants, Inc.

- Location (FDA's records): Phoenix, AZ
- FDA decisions: 3 (2019–2021): 3 510(k) clearances
- Names in FDA's records: Additive Implants, Inc. (2); Additive Implants, LLC (1)
- Product codes: ODP (2), OVE (1)
- 510(k) review time since 2016: median 93 days, against 92 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 11 (1 its own); citations of its devices by later devices: 9 (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
- K2m, Inc.: 3 (https://510kreport.com/company/k2m)
- Astura Medical: 1 (https://510kreport.com/company/astura-medical)
- Alphatec Spine, Inc.: 1 (https://510kreport.com/company/alphatec-spine)
- Ldr Spine USA: 1 (https://510kreport.com/company/ldr-spine-usa)
- Sulzer Spine-Tech: 1 (https://510kreport.com/company/sulzer-spine-tech)
- Synthes (Usa): 1 (https://510kreport.com/company/synthes-usa)
- Globus Medical, Inc.: 1 (https://510kreport.com/company/globus-medical)
- Spinevision S.A.: 1 (https://510kreport.com/company/spinevision)

## Firms that cite its devices most
- Orthofix, Inc.: 3 (https://510kreport.com/company/orthofix)
- Southern Medical (Pty), Ltd.: 2 (https://510kreport.com/company/southern-medical)
- Kyocera Medical Technologies, Inc.: 1 (https://510kreport.com/company/kyocera-medical-technologies)
- Bespoke Technologies, LLC: 1 (https://510kreport.com/company/bespoke-technologies)
- Flospine: 1 (https://510kreport.com/company/flospine)

## Its most-cited devices
- K193359: SureMAX Family of Cervical Spacers (2020), cited by 5
- K211111: SureMAX-SA Cervical Standalone System (2021), cited by 3
- K182477: Cervical Spacer (2019), cited by 1

## Recent decisions
- K211111: SureMAX-SA Cervical Standalone System (Jul 16, 2021)
- K193359: SureMAX Family of Cervical Spacers (Jan 3, 2020)
- K182477: Cervical Spacer (Jan 28, 2019)

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