Atlas FDA

MALLORY/HEAD MODULAR CALCAR WITH AND WITHOUT HA

FDA 510(k) clearance K031693 · decided 2003-08-06

Clearance details

K-number
K031693
Device name
MALLORY/HEAD MODULAR CALCAR WITH AND WITHOUT HA
Applicant
Biomet, Inc.
Decision
Substantially Equivalent
Date received
2003-06-02
Decision date
2003-08-06
Days to decision
65 days
Clearance type
Traditional
Product code
LPH
Device class
2
Regulation number
888.3358
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
M/H MODULAR STEM, Item number 13-104756 - Product Usage: intended for use in limb salvage recall (Z-0622-2021)Biomet, Inc.2020-12-17
Mallory Head Calcar Provisional, 34 mm replacement stem, 11 mm x 220 mm left, Sterile, REF recall (Z-1665-2010)Biomet, Inc.2010-05-26
Mallory Head Calcar Provisional, 45 mm replacement stem, 13.0 x 220 mm left, Sterile, REF recall (Z-1666-2010)Biomet, Inc.2010-05-26
Mallory Head Calcar Femoral, 34 mm resection/porous coated, 9mm x 170 mm stem, Sterile, RE recall (Z-1667-2010)Biomet, Inc.2010-05-26
Mallory Head Calcar Femoral, 34 mm resection/porous coated, 13.0 x 170 mm,, Sterile, REF 1 recall (Z-1668-2010)Biomet, Inc.2010-05-26
Mallory Head Calcar Femoral, 34 mm resection/porous coated, 15.0 mm x 170 mm stem, Sterile recall (Z-1669-2010)Biomet, Inc.2010-05-26
Mallory Head Calcar Provisional, 55 mm resection/porous coated, 17.0 mm x 260 mm left, Ste recall (Z-1670-2010)Biomet, Inc.2010-05-26
Mallory Head Calcar Femoral, 34 mm resection/porous coated, 9.0 mm x 220 mm right stem, St recall (Z-1671-2010)Biomet, Inc.2010-05-26
Mallory Head Calcar Femoral, 34 mm resection/porous coated, 15.0 mm x 220 mm right stem, S recall (Z-1672-2010)Biomet, Inc.2010-05-26
Mallory Head Calcar Femoral, 34 mm resection/porous coated, 15.0 mm x 220 mm left stem, St recall (Z-1673-2010)Biomet, Inc.2010-05-26
Mallory Head Calcar Femoral, 55 mm resection/porous coated, 15.0 mm x 220 mm right stem, S recall (Z-1674-2010)Biomet, Inc.2010-05-26
Mallory Head Calcar Femoral 55 mm resection/porous coated 15.0 mm x 220 mm left stem, Ster recall (Z-1675-2010)Biomet, Inc.2010-05-26
17 mm Mallory Head Calcar 45 mm repl. fmrl. /100% porous 18.5 mm minimum ream dia x 260 mm recall (Z-1676-2010)Biomet, Inc.2010-05-26
17 mm Mallory Head Calcar 55 mm repl. femoral/100% porous 18.5 mm minimum ream dia. x 220 recall (Z-1677-2010)Biomet, Inc.2010-05-26
19 mm Mallory Head Calcar 45 mm repl. femoral/100% porous 20.5 mm minimum ream dia. x 260 recall (Z-1678-2010)Biomet, Inc.2010-05-26
19 mm Mallory Head Calcar 55 mm repl. femoral/100% porous 20.5 mm minimum ream dia. x 260 recall (Z-1679-2010)Biomet, Inc.2010-05-26

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