# Kyocera Medical Technologies, Inc.

- Location (FDA's records): Redlands, CA
- FDA decisions: 16 (2020–2026): 16 510(k) clearances
- Product codes: OVD (4), OQG (3), OVE (2), MAX (2), HSX (1), KWQ (1), LPH (1), KWY (1), JWH (1)
- 510(k) review time since 2016: median 85 days, against 99 for FDA's reviews in the same codes and years (7 of 12 faster)
- Predicates its devices cite: 45 (6 its own); citations of its devices by later devices: 8 (6 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
- Renovis Surgical Technologies, LLC: 20 (https://510kreport.com/company/renovis-surgical-technologies)
- Choicespine, LP: 2 (https://510kreport.com/company/choicespine)
- Eminent Spine: 1 (https://510kreport.com/company/eminent-spine)
- Additive Implants, Inc.: 1 (https://510kreport.com/company/additive-implants)
- Neurostructures, Inc.: 1 (https://510kreport.com/company/neurostructures)
- Smith & Nephew, Inc.: 1 (https://510kreport.com/company/smith-nephew)
- K2m, Inc.: 1 (https://510kreport.com/company/k2m)
- Nu Vasive, Incorporated: 1 (https://510kreport.com/company/nu-vasive)

## Firms that cite its devices most
- Kyocera Medical Technologies Inc. (KMTI): 2 (https://510kreport.com/company/kyocera-medical-technologies-kmti)

## Its most-cited devices
- K223105: Tesera-K SC System (2022), cited by 2
- K212980: Tesera-k ALIF System (2022), cited by 2
- K242771: Tesera-k PL System and Tesera-k XL System (2025), cited by 1
- K193320: KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System (2020), cited by 1
- K243015: Skyway Anterior Cervical Plate System (2024), cited by 1
- K200328: Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System (2020), cited by 1

## Recent decisions
- K261353: Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System (Jul 15, 2026)
- K242928: Tesera-k SC System (Apr 10, 2025)
- K242045: Initia T3 Acetabular Hemispherical Shell System (Apr 10, 2025)
- K242771: Tesera-k PL System and Tesera-k XL System (Mar 20, 2025)
- K243295: Initia Knee System (Jan 13, 2025)
- K243015: Skyway Anterior Cervical Plate System (Nov 5, 2024)
- K232114: TRIBRID® Unicompartmental Knee System (Apr 4, 2024)
- K230808: PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System (Apr 21, 2023)

Source page: https://510kreport.com/company/kyocera-medical-technologies