Atlas FDA

VANGUARD XP KNEE SYSTEM

FDA 510(k) clearance K132873 · decided 2013-12-11

Clearance details

K-number
K132873
Device name
VANGUARD XP KNEE SYSTEM
Applicant
Biomet, Inc.
Decision
Substantially Equivalent
Date received
2013-09-13
Decision date
2013-12-11
Days to decision
89 days
Clearance type
Traditional
Product code
MBH
Device class
2
Regulation number
888.3565
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
Zimmer® Persona® Personalized Knee System (K251840)Zimmer, Inc.2026-05-28
Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs) (K253189)Zimmer, Inc.2026-03-09
GMK 3D Metal Tibial Tray Extension (K253328)Medacta International S.A.2026-02-26
Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert (K253637)Howmedica Osteonics Corp., Dba Stryker Orthopaedics2026-02-18
Active-V Total Knee System; World Total Knee System (K253239)Signature Orthopaedics Pty, Ltd.2025-12-23
Balanced Knee System TriMax Porous Femoral Components (K253161)Ortho Development Corp.2025-12-19
Freedom Metaphyseal Cone Implants (Metaphyseal Cones) (K252777)Maxx Orthopedics, Inc.2025-10-31
Triathlon® Total Knee System - Triathlon® Gold Femoral Components (K252044)Howmedica Osteonics Corp., Dba Stryker Orthopaedics2025-10-24
U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella (K243656)United Orthopedic Corporation2025-07-31
Physica System (Physica CR Porous Femoral components) (K250980)Lima Corporate S.P.A.2025-05-22
iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System (K243768)Restor3D, Inc.2025-03-27
Freedom® Total Knee System - Porous Tibial Base Plate (K241597)Maxx Orthopedics, Inc.2025-02-13

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