Atlas FDA

RINGLOC BI-POLAR ACETABULAR COMPONENT

FDA 510(k) clearance K051569 · decided 2005-09-29

Clearance details

K-number
K051569
Device name
RINGLOC BI-POLAR ACETABULAR COMPONENT
Applicant
Biomet, Inc.
Decision
Substantially Equivalent
Date received
2005-06-14
Decision date
2005-09-29
Days to decision
107 days
Clearance type
Traditional
Product code
JDI
Device class
2
Regulation number
888.3350
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Warsaw, IN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
RingLoc Bi-Polar Hip System Acetabular Cup, 41 mm Outer Diameter - Used in hip hemi-arthro recall (Z-2179-2024)Biomet, Inc.2024-06-25
RINGLOC BIPOLAR Hip System Bi Polar Locking Ring, Item number 11-165304 - Product Usage: P recall (Z-0628-2021)Biomet, Inc.2020-12-17
(1) RingLoc Bi-Polar Hip System Acetabular Cup ArCom: Acetabular Bi-Polar Cup, E1 Antioxid recall (Z-0097-2021)Biomet, Inc.2020-10-09
various polyethylene implants Hips Active Articulation ArComXL Bearings Active Articulatio recall (Z-1860-2017)Zimmer Biomet, Inc.2017-03-27

PMA approvals by this applicant

RecordFirmDate
C2A-TAPER ACETABULAR HIP SYSTEM (P050009/S009)Biomet, Inc.2011-02-11
C2A-TAPER ACETABULAR SYSTEM (P050009/S004)Biomet, Inc.2009-04-17
C2A TAPER ACETABULAR SYSTEM (P050009/S007)Biomet, Inc.2009-03-13
C2-A TAPER ACETABULAR SYSTEM (P050009/S005)Biomet, Inc.2007-11-30
C2A-TAPER ACETABULAR SYSTEM (P050009/S002)Biomet, Inc.2006-06-16
C2A-TAPER ACETABULAR SYSTEM (P050009/S001)Biomet, Inc.2006-02-01
C2 A-TAPER ACETABULAR SYSTEM (P050009)Biomet, Inc.2005-12-16