ACS® LD FB Knee System— 510(k) K234044

Clearance details

Applicant

Implantcast GmbH

Product code

Code JWH

Device class

Class 2

Regulation

21 CFR 888.3560

Advisory panel

Orthopedic

Date received

2023-12-21

Decision date

2024-09-06

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Buxtehude, DE

• K260063 — GSPE Spacer2026-09-11
• K262293 — EVOLUTION MPX Total Knee System2026-09-10
• K262341 — b-ONE® Mobio Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions2026-09-08
• K262130 — ATTUNE Revision Knee System2026-09-04
• K253961 — SK Knee System2026-09-01

• K252451 — EPORE® XO cup system2026-04-24
• K260037 — implantcast Packaging System Update2026-03-30
• K252401 — implaFit® short stems2026-03-12
• K241944 — AGILON® XO Shoulder Replacement System2025-03-10
• K240391 — MUTARS® femoral stem cemented 160 mm and 200 mm2024-10-24

Death

26

Injury

51,564

Malfunction

9,725

Other

9

Total

61,324

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 →