KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System— 510(k) K201660

Clearance details

Applicant

Kyocera Medical Technologies, Inc.

Product code

Code OQG

Device class

Class 2

Regulation

21 CFR 888.3358

Advisory panel

Orthopedic

Date received

2020-06-18

Decision date

2020-07-16

Decision

Substantially Equivalent

Clearance type

Special

Location

Redlands, CA, US

• K202705 — Prime and DYNASTY® Additive Manufacturing Shells2021-08-20
• K203472 — KMTI Hip Replacement System2021-04-02
• K200328 — Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System2020-03-11
• K172651 — FMP Extended Liners2017-12-13
• K171543 — Renovis Surgical Hip Replacement System2017-11-16

• 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
• K243295 — Initia Knee System2025-01-13

Injury

249

Total

249

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 →