KMTI S141 Lumbar Interbody Fusion System— 510(k) K212070

Clearance details

Applicant

Kyocera Medical Technologies, Inc.

Product code

Code MAX

Device class

Class 2

Regulation

21 CFR 888.3080

Advisory panel

Orthopedic

Date received

2021-07-02

Decision date

2021-08-30

Decision

Substantially Equivalent

Clearance type

Special

Location

Redlands, CA, US

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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
• K243295 — Initia Knee System2025-01-13

Death

13

Injury

1,305

Malfunction

2,885

Total

4,203

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 →