Atlas FDA

VANGUARD PATELLA COMPONENTS

FDA 510(k) clearance K040770 · decided 2004-04-22

Clearance details

K-number
K040770
Device name
VANGUARD PATELLA COMPONENTS
Applicant
Biomet Manufacturing, Inc.
Decision
Substantially Equivalent
Date received
2004-03-25
Decision date
2004-04-22
Days to decision
28 days
Clearance type
Special
Product code
JWH
Device class
2
Regulation number
888.3560
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
various polyethylene implants Knees Revision Tibial Tray Systems Oxford Partial Knee Ortho recall (Z-1861-2017)Zimmer Biomet, Inc.2017-03-27
Biomet Series A Thin Patella size 25mm, three pegs, Part 184780, Sterile, Biomet Orthopedi recall (Z-0695-2012)Biomet, Inc.2012-01-11
Biomet Series A Standard Patella size 25mm, one peg, Part 184700, Sterile, Biomet Orthoped recall (Z-0696-2012)Biomet, Inc.2012-01-11
Biomet Series A Standard Patella size 28mm, one peg - 184702, Biomet Orthopedics, Warsaw, recall (Z-0697-2012)Biomet, Inc.2012-01-11
Biomet Series A Thin Patella size 25mm, one peg - 184720 Sterile, Biomet Orthopedics, Wars recall (Z-0698-2012)Biomet, Inc.2012-01-11
Biomet Series A Thin Patella size 25mm, one peg - 184720, Sterile, Biomet Orthopedics, War recall (Z-0699-2012)Biomet, Inc.2012-01-11
Biomet Series A Standard Patella size 25mm, three pegs - 184760, Sterile, Biomet Orthopedi recall (Z-0700-2012)Biomet, Inc.2012-01-11
Biomet Series A Standard Patella size 28mm, three pegs - 184762, Sterile, Biomet Orthopedi recall (Z-0701-2012)Biomet, Inc.2012-01-11
Biomet Series A Thin Patella size 28mm, three pegs - 184782, Sterile, Biomet Orthopedics, recall (Z-0702-2012)Biomet, Inc.2012-01-11
Biomet Series A Asymmetrical Patella size 25mm, three pegs - 184790, Sterile, Biomet Ortho recall (Z-0703-2012)Biomet, Inc.2012-01-11
Biomet Series A Asymmetrical Patella size 28mm, three pegs - 184791, Sterile, Biomet Ortho recall (Z-0704-2012)Biomet, Inc.2012-01-11