Bencox M Stem Lateralized & Bencox Mirabo Cup System— 510(k) K162127

Clearance details

Applicant

Corentec Co., Ltd.

Product code

Code LPH

Device class

Class 2

Regulation

21 CFR 888.3358

Advisory panel

Orthopedic

Date received

2016-08-01

Decision date

2016-12-05

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Cheonan, KR

• K253630 — Mpact 3D Metal Foam2026-08-28
• 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

• K250889 — EXULT Knee Replacement System2025-04-17
• K242401 — EXULT Knee Replacement System2024-09-12
• K242046 — EXULT Knee Replacement System2024-08-01
• K223828 — BENCOX Delta Option Heads2023-03-16
• K223223 — BENCOX Mirabo Z Cup Cortinium2023-02-27

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 →

• Z-1454-2017 — Bencox Mirabo PE Liner 36/44 Model Number: H1.L61.3644, UDI: 8806373852343Class II·Terminated·CORENTEC CO., LTD·20170227

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K162127.