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AGC TOTAL KNEE SYSTEM KNEE, ASCENT TOTAL KNEE SYSTEM, MAXIM COMPLETE KNEE SYSTEM, MAXIM ACCEL KNEE SYSTEM ALSO KNOWN

FDA 510(k) clearance K033489 · decided 2004-06-02

Clearance details

K-number
K033489
Device name
AGC TOTAL KNEE SYSTEM KNEE, ASCENT TOTAL KNEE SYSTEM, MAXIM COMPLETE KNEE SYSTEM, MAXIM ACCEL KNEE SYSTEM ALSO KNOWN
Applicant
Biomet, Inc.
Decision
Substantially Equivalent
Date received
2003-11-04
Decision date
2004-06-02
Days to decision
211 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
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Balanced Knee System TriMax Porous Femoral Components (K253161)Ortho Development Corp.2025-12-19
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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