EMPHASYS Dual Mobility System— 510(k) K231522

Clearance details

Applicant

Depuy Ireland UC

Product code

Code LPH

Device class

Class 2

Regulation

21 CFR 888.3358

Advisory panel

Orthopedic

Date received

2023-05-26

Decision date

2024-02-15

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Cork Munster, IE

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

• K260480 — VELYS Robotic-Assisted Solution2026-06-25
• K261458 — ATTUNE Total Knee System; ATTUNE Cementless Knee System2026-06-25
• K260536 — Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement2026-05-15
• K253624 — INHANCE Reverse Shoulder System2026-03-11
• K253551 — VELYS Hip Navigation2026-03-06

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 →