Atlas FDA

COCR BI-ANGULAR HUMERAL COMPONENT

FDA 510(k) clearance K961571 · decided 1996-08-05

Clearance details

K-number
K961571
Device name
COCR BI-ANGULAR HUMERAL COMPONENT
Applicant
Biomet, Inc.
Decision
Substantially Equivalent
Date received
1996-04-23
Decision date
1996-08-05
Days to decision
104 days
Clearance type
Traditional
Product code
KWT
Device class
2
Regulation number
888.3650
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Warsaw, IN, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants (K250713)Exactech, Inc.2025-12-01
Tornier Humeral Reconstruction System Max (Tornier HRS Max) (K251686)Tornier, Inc.2025-10-30
AGILON® XO Shoulder Replacement System (K241944)Implantcast GmbH2025-03-10
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AGILON® XO Shoulder Replacement System (K231657)Implantcast GmbH2024-02-16
Comprehensive Segmental Revision System(SRS) (K223631)Biomet Orthopedics2023-07-12
AGILON XO Shoulder System (K222482)Implantcast GmbH2022-09-28
LINK Embrace Shoulder System- Anatomical Configuration (K210899)Waldemar Link GmbH & Co. KG2021-06-21
TiN Coated Humeral Head (K191698)Fx Shoulder USA, Inc.2020-07-16
Shoulder Innovations Total Shoulder System (K192365)Shoulder Innovations, Inc.2019-11-29
Catalyst OrthoScience CSR Shoulder System (K191811)Catalyst Orthoscience, Inc.2019-09-11
Signature ONE System (K190595)Orthosoft Inc (D/B/A Zimmer Cas)2019-06-05

Recalls involving this device

No recalls on record reference this clearance.

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