RINGLOC + HYBRID ACETABULAR SYSTEM— 510(k) K093235

Name: FDA 510(k) clearance K093235
Creator: U.S. Food and Drug Administration
Published: 2010-04-30

Substantially Equivalent

Biomet, Inc.

FDA 510(k) clearance K093235 for RINGLOC + HYBRID ACETABULAR SYSTEM, Substantially Equivalent on 2010-04-30. Applicant: Biomet, Inc.. Device class: 3.

Clearance details

Applicant: Biomet, Inc.
Product code: Code KWA
Device class: Class 3
Regulation: 21 CFR 888.3330
Advisory panel: Orthopedic
Date received: 2009-10-15
Decision date: 2010-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KWA

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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

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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 K093235

K-number listed on FDA's recall record

Z-0312-2018 — PPS RingLoc+ Acetabular Shell, RNGLC+ LTD HOLE SHELL SZ62 The Porous Plasma Spray (PPS) Ringloc¿+ Acetabular System is intended to replace the natural acetabulurn damaged by disease, trauma or revision of previous arthroplasty. The Porous Plasma Spray (PPS) Ringloc¿+ Acetabular System is intended for uncemented use only.Class II·Terminated·Zimmer Biomet, Inc.·20170629
Z-2483-2015 — Vision RingLoc Shell 50 mm Size 23. Hip joint replacement prosthesis.Class II·Terminated·Biomet, Inc.·20150728
Z-1123-2015 — Ringloc+ Acetabular Shell Finned 52 mm, PN 16-104152, hip prosthesis component.Class II·Terminated·Biomet, Inc.·20150109

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K093235.

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