MODULAR CATHCART FRACTURE SYSTEM— 510(k) K903084

Clearance details

Applicant

Depuy, Inc.

Product code

Code LZY

Device class

Class 2

Regulation

21 CFR 888.3360

Advisory panel

Orthopedic

Date received

1990-07-12

Decision date

1990-10-03

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Warsaw, IN, US

• K231448 — TANDEM Hip System2023-07-19
• K111145 — ENDO HEAD2011-08-16
• K974442 — PRE-POWDERED NITRILE EXAMINATION GLOVES1998-01-05
• K915528 — BHR BIPOLAR FEMORAL HEAD COMPONENT1993-06-29
• K915548 — IONGUARD TITANIUM MODULAR HEADS1992-03-10

• K043058 — PINNACLE CONSTRAINED ACETABULAR LINERS2005-03-14
• K042664 — LPS UPPER EXTREMITY2004-12-08
• K041085 — LPS (LIMB PRESERVATION SYSTEM) LOWER EXTREMITY DOVETAIL INTERCALARY2004-07-22
• K033959 — LPS2004-07-01
• K040544 — DURALOC OPTION ACETABULAR CUP SYSTEM, MODELS 1599-01-044 TO -066, 1599-11-044 TO -062 AND 1599-21-044 TO -0622004-05-28

Injury

431

Total

431

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-1375-2022 — MODULAR CATHCART FRACTURE HEAD HIP BALL, sizes 41mm to 60mm inclusive; metallic femoral head prosthesis, Product No. 136341000, 136342000, 136343000, 136344000, 136345000, 136346000, 136347000, 136348000, 136349000, 136350000, 136351000, 136352000, 136353000, 136354000, 136356000, 136358000, 136360000Class II·Ongoing·DePuy Orthopaedics, Inc.·20220518

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K903084.