METASUL TAPER LINERS, METASUL FEMORAL HEADS— 510(k) K091973

Clearance details

Applicant

Zimmer GmbH

Product code

Code KWA

Device class

Class 3

Regulation

21 CFR 888.3330

Advisory panel

Orthopedic

Date received

2009-07-01

Decision date

2009-11-17

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Warsaw, IN, US

• 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

• K211047 — CoCr Head2023-01-10
• K200814 — Affixus(R) Natural Nail(R) System Humeral Nail2020-04-28
• K200112 — Zimmer Hip Joint Replacement2020-04-10
• K193099 — Anatomical Shoulder System2020-01-29
• K193050 — Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset Femoral Stem2019-12-26

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 →

• Z-0334-2020 — Metasul Taper Liner, various sizes, Item Nos. 00877000528 00877000628 00877000732 00877000832 00877000936 00877001036 00877001140 00877001240 00877001340 00877001440 00877001540 00877001640 00877001740 00877001840 00877001940 00877002040 00877002140 00877002240 00877002340Class II·Terminated·Zimmer Biomet, Inc.·20191010
• Z-0335-2020 — Metasul Femoral Heads, various sizes, Item Nos. 00877004001 00877004002 00877004003 00877004004 00877004005Class II·Terminated·Zimmer Biomet, Inc.·20191010
• Z-0850-2016 — Metasul Head 40, 12/14, SZ M/0 total hip prosthesis - metal femoral heads Noninflammatory degenerative joint disease (NIDJD) including avascular necrosis, osteoarthritis, post-traumatic arthritis and congenital hip dysplasia and inflammatory joint disease (IJD) e.g. rheumatoid arthritis if bone quality is adequate. Failed previous surgery where pain, deformity, or dysfunction persists. Revision of previously failed hip arthroplasty. Total hip replacements may be considered for younger patients if any unequivocal indication outweighs the risks associated with the age of the patient and modified demands regarding activity and hip joint loading are assured. This includes severely handicapped patients with multiple joint involvement, for whom an immediate need of hip mobility leads to an expectation of significant improvement in the quality of their lives. The system is intended for use either with or without bone cement in total hip arthroplasty."Class II·Terminated·Zimmer Biomet, Inc.·20160111
• Z-0071-2014 — Metasul¿ Head. Intended for use either with or without bone cement in total hip arthroplasty.Class II·Terminated·Zimmer, Inc.·20130830

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K091973.