Initia T3 Acetabular Hemispherical Shell System— 510(k) K242045

Name: FDA 510(k) clearance K242045
Creator: U.S. Food and Drug Administration
Published: 2025-04-10

Substantially Equivalent

Kyocera Medical Technologies, Inc.

FDA 510(k) clearance K242045 for Initia T3 Acetabular Hemispherical Shell System, Substantially Equivalent on 2025-04-10. Applicant: Kyocera Medical Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Kyocera Medical Technologies, Inc.
Product code: Code LPH
Device class: Class 2
Regulation: 21 CFR 888.3358
Advisory panel: Orthopedic
Date received: 2024-07-12
Decision date: 2025-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redlands, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LPH

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K254043 — TRIVANCE Hip Stem2026-08-04
K261624 — Omnifit® 20° Series I Insert +11 more2026-07-10
K243192 — iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating2026-06-05
K251270 — Taperloc® Complete Hip Stem2026-05-19

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
K242928 — Tesera-k SC System2025-04-10
K242771 — Tesera-k PL System and Tesera-k XL System2025-03-20
K243295 — Initia Knee System2025-01-13
K243015 — Skyway Anterior Cervical Plate System2024-11-05

Adverse events under product code LPH

product code LPH

Death: 73
Injury: 31,640
Malfunction: 3,358
Other: 2
Total: 35,073

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.