INTER-OP METASUL ACETABULAR SYSTEM— 510(k) K974728

Name: FDA 510(k) clearance K974728
Creator: U.S. Food and Drug Administration
Published: 1999-08-03

Substantially Equivalent

Sulzer Orthopedics, Inc.

FDA 510(k) clearance K974728 for INTER-OP METASUL ACETABULAR SYSTEM, Substantially Equivalent on 1999-08-03. Applicant: Sulzer Orthopedics, Inc.. Device class: 3.

Clearance details

Applicant: Sulzer Orthopedics, Inc.
Product code: Code KWA
Device class: Class 3
Regulation: 21 CFR 888.3330
Advisory panel: Orthopedic
Date received: 1997-12-18
Decision date: 1999-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KWA

view all

K122778 — PROFEMUR Z REVISION HIP STEM2012-10-11
K121544 — DYNASTY BIOFOAM SHELL2012-07-30
K113271 — METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS2012-05-18
K113322 — CONSERVE THIN SHELL2012-02-03
K112080 — PRESERVE HIP STEM2011-12-28

More clearances from Sulzer Orthopedics, Inc.

view all

K022985 — ASCENDENT ACETABULAR SYSTEM2002-12-05
K021578 — NATURAL-KNEE II SYSTEM COCR TIBIAL BASEPLATE2002-08-09
K020713 — MS-30 LATERAL FEMORAL STEM2002-05-14
K013935 — ALLOFIT ACETABULAR SYSTEM 32MM ALPHA DURASUL INSERTS2001-12-13
K013031 — MOST OPTIONS SYSTEM2001-12-07

Adverse events under product code KWA

product code KWA

Death: 38
Injury: 10,439
Malfunction: 1,862
Total: 12,339

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 →

Recalls naming K974728

K-number listed on FDA's recall record

Z-1136-2015 — Metasul Femoral Head - indicated for total hip arthroplasty for treatment of patient conditions of non-inflammatory degenerative joint disease.Class II·Terminated·Zimmer Gmbh·20141217

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K974728.

Data sourced from openFDA. This site is unofficial and independent of the FDA.