Atlas FDA

HARRIS-GALANTE POROUS TOTAL HIP SYS

FDA 510(k) clearance K840643 · decided 1984-04-17

Clearance details

K-number
K840643
Device name
HARRIS-GALANTE POROUS TOTAL HIP SYS
Applicant
Zimmer, Inc.
Decision
Substantially Equivalent
Date received
1984-02-15
Decision date
1984-04-17
Days to decision
62 days
Clearance type
Traditional
Product code
JDI
Device class
2
Regulation number
888.3350
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Warsaw, IN, US
Third-party review
No
Expedited review
No

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

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Recalls involving this device

RecordFirmDate
Hgp ii acetabular cup bone screw selftap 6.5x15mm 00662406515 Hgp ii acetabular cup bone s recall (Z-1683-2016)Zimmer Manufacturing B.V.2016-05-16
Product 12 consists of all product under product code JDI , and same usage: Item no: 90260 recall (Z-1110-2016)Zimmer Manufacturing B.V.2016-03-12
Product 28 consists of all product under product code: JDI and same usage: Item no: 329026 recall (Z-1126-2016)Zimmer Manufacturing B.V.2016-03-12
Product 33 consists of all product under product code: JDI and same usage: Item no: 662406 recall (Z-1131-2016)Zimmer Manufacturing B.V.2016-03-12
Product 39 consists of all product under product code: JDI and same usage: Item no: 329026 recall (Z-1137-2016)Zimmer Manufacturing B.V.2016-03-12
HGP II ACETABULAR CUP BON recall (Z-1025-2014)Zimmer, Inc.2014-02-20
6 DEGREE COCR FEM HEAD (various sizes) and 6 DEG UNIPOLAR FEMORAL HE recall (Z-1033-2014)Zimmer, Inc.2014-02-20
CPT DEGREE TAPER (various sizes) and FEMORAL HD (various sizes) recall (Z-1036-2014)Zimmer, Inc.2014-02-20

PMA approvals by this applicant

RecordFirmDate
NexGen© LPSFlex/ LPS Mobile Bearing Knee System (P060037/S095)Zimmer, Inc.2025-08-18
NexGen© LPSFlex/LPS Mobile Bearing Knee System (P060037/S093)Zimmer, Inc.2025-04-09
NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM (P060037/S094)Zimmer, Inc.2025-04-01
NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM (P060037/S092)Zimmer, Inc.2024-12-12
NexGen® LPS-Flex LPS-Mobile Bearing Knee (P060037/S091)Zimmer, Inc.2024-07-05
NexGen® LPS-Flex / LPS Mobile Bearing Knee System (P060037/S090)Zimmer, Inc.2024-05-17
NexGen LPS-Flex/LPS Mobile Bearing Knee System (P060037/S089)Zimmer, Inc.2024-04-04
NexGen® LPS-Flex/LPS Mobile Bearing Knee System (P060037/S088)Zimmer, Inc.2024-02-13