Initia Knee System— 510(k) K243295

Name: FDA 510(k) clearance K243295
Creator: U.S. Food and Drug Administration
Published: 2025-01-13

Substantially Equivalent

Kyocera Medical Technologies, Inc.

FDA 510(k) clearance K243295 for Initia Knee System, Substantially Equivalent on 2025-01-13. Applicant: Kyocera Medical Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Kyocera Medical Technologies, Inc.
Product code: Code JWH
Device class: Class 2
Regulation: 21 CFR 888.3560
Advisory panel: Orthopedic
Date received: 2024-10-18
Decision date: 2025-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redlands, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JWH

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K260063 — GSPE Spacer2026-09-11
K262293 — EVOLUTION MPX Total Knee System2026-09-10
K262341 — b-ONE® Mobio Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions2026-09-08
K262130 — ATTUNE Revision Knee System2026-09-04
K253961 — SK Knee System2026-09-01

More clearances from Kyocera Medical Technologies, Inc.

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K261353 — Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System2026-07-15
K242045 — Initia T3 Acetabular Hemispherical Shell System2025-04-10
K242928 — Tesera-k SC System2025-04-10
K242771 — Tesera-k PL System and Tesera-k XL System2025-03-20
K243015 — Skyway Anterior Cervical Plate System2024-11-05

Adverse events under product code JWH

product code JWH

Death: 26
Injury: 51,564
Malfunction: 9,725
Other: 9
Total: 61,324

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.