Atlas FDA

RINGLOC + HYBRID ACETABULAR SYSTEM

FDA 510(k) clearance K093235 · decided 2010-04-30

Clearance details

K-number
K093235
Device name
RINGLOC + HYBRID ACETABULAR SYSTEM
Applicant
Biomet, Inc.
Decision
Substantially Equivalent
Date received
2009-10-15
Decision date
2010-04-30
Days to decision
197 days
Clearance type
Traditional
Product code
KWA
Device class
3
Regulation number
888.3330
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Warsaw, IN, US
Third-party review
No
Expedited review
No

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RecordFirmDate
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METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS (K113271)Biomet Manufacturing, Inc.2012-05-18
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Recalls involving this device

RecordFirmDate
Vision RingLoc Shell 50 mm Size 23. Hip joint replacement prosthesis. recall (Z-2483-2015)Biomet, Inc.2015-08-29
Ringloc+ Acetabular Shell Finned 52 mm, PN 16-104152, hip prosthesis component. recall (Z-1123-2015)Biomet, Inc.2015-02-17
Ringloc + Acetabular Shell limited hole finned 46 mm Size 22 porous coat, for uncemented u recall (Z-2421-2011)Biomet, Inc.2011-06-08
Ringloc + Acetabular Shell limited hole finned 48 mm Size 22 porous coat, for uncemented u recall (Z-2422-2011)Biomet, Inc.2011-06-08
Ringloc + Acetabular Shell limited hole finned 50 mm Size 23 porous coat, for uncemented u recall (Z-2423-2011)Biomet, Inc.2011-06-08
Ringloc + Acetabular Shell limited hole finned 52 mm Size 23 porous coat, for uncemented u recall (Z-2424-2011)Biomet, Inc.2011-06-08
Ringloc + Acetabular Shell limited hole finned 54 mm Size 24 porous coat, for uncemented u recall (Z-2425-2011)Biomet, Inc.2011-06-08
Ringloc + Acetabular Shell limited hole finned 56 mm Size 24 porous coat, for uncemented u recall (Z-2426-2011)Biomet, Inc.2011-06-08
Ringloc + Acetabular Shell limited hole finned 58 mm Size 25 porous coat, for uncemented u recall (Z-2427-2011)Biomet, Inc.2011-06-08
Ringloc + Acetabular Shell limited hole finned 60 mm Size 25 porous coat, for uncemented u recall (Z-2428-2011)Biomet, Inc.2011-06-08
Ringloc + Acetabular Shell limited hole finned 62 mm Size 26 porous coat, for uncemented u recall (Z-2429-2011)Biomet, Inc.2011-06-08
Ringloc + Acetabular Shell limited hole finned 64 mm Size 26 porous coat, for uncemented u recall (Z-2430-2011)Biomet, Inc.2011-06-08
Ringloc + Acetabular Shell limited hole finned 66 mm Size 27 porous coat, for uncemented u recall (Z-2431-2011)Biomet, Inc.2011-06-08
Ringloc + Acetabular Shell limited hole finned 70 mm Size 28 porous coat, for uncemented u recall (Z-2432-2011)Biomet, Inc.2011-06-08
Ringloc + Acetabular Shell limited hole, 46 mm Size 22 porous coat, for uncemented use, st recall (Z-2433-2011)Biomet, Inc.2011-06-08
Ringloc + Acetabular Shell limited hole, 48 mm Size 22, porous coat, for uncemented use, s recall (Z-2434-2011)Biomet, Inc.2011-06-08
Ringloc + Acetabular Shell limited hole, 50 mm Size 23, porous coat, for uncemented use, s recall (Z-2435-2011)Biomet, Inc.2011-06-08
Ringloc + Acetabular Shell limited hole, 52 mm Size 23, porous coat, for uncemented use, s recall (Z-2436-2011)Biomet, Inc.2011-06-08
Ringloc + Acetabular Shell limited hole, 54 mm Size 24, porous coat, for uncemented use, s recall (Z-2437-2011)Biomet, Inc.2011-06-08
Ringloc + Acetabular Shell limited hole, 56 mm Size 24, porous coat, for uncemented use, s recall (Z-2438-2011)Biomet, Inc.2011-06-08
Ringloc + Acetabular Shell limited hole, 58 mm Size 25, porous coat, for uncemented use, s recall (Z-2439-2011)Biomet, Inc.2011-06-08
Ringloc + Acetabular Shell limited hole, 60 mm Size 25, porous coat, for uncemented use, s recall (Z-2440-2011)Biomet, Inc.2011-06-08
Ringloc + Acetabular Shell limited hole, 62 mm Size 26, porous coat, for uncemented use, s recall (Z-2441-2011)Biomet, Inc.2011-06-08
Ringloc + Acetabular Shell limited hole, 64 mm Size 26, porous coat, for uncemented use, s recall (Z-2442-2011)Biomet, Inc.2011-06-08
Ringloc + Acetabular Shell limited hole, 66 mm Size 27, porous coat, for uncemented use, s recall (Z-2443-2011)Biomet, Inc.2011-06-08
Ringloc + Acetabular Shell limited hole, 68 mm Size 27, porous coat, for uncemented use, s recall (Z-2444-2011)Biomet, Inc.2011-06-08
Ringloc + Acetabular Shell limited hole, 70 mm Size 28, porous coat, for uncemented use, s recall (Z-2445-2011)Biomet, Inc.2011-06-08
Ringloc + Acetabular Shell limited hole, 72 mm Size 28, porous coat, for uncemented use, s recall (Z-2446-2011)Biomet, Inc.2011-06-08
Ringloc + Acetabular Shell limited hole, 76 mm Size 28, porous coat, for uncemented use, s recall (Z-2447-2011)Biomet, Inc.2011-06-08

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