Atlas FDA

HERITAGE HIP SYSTEM

FDA 510(k) clearance K963109 · decided 1997-01-09

Clearance details

K-number
K963109
Device name
HERITAGE HIP SYSTEM
Applicant
Zimmer, Inc.
Decision
Substantially Equivalent
Date received
1996-08-12
Decision date
1997-01-09
Days to decision
150 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.

RecordFirmDate
OSSTM Orthopedic Salvage System (K253434)Biomet, Inc.2026-07-01
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Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component (K241716)Howmedica Osteonics Corp., Dba Stryker Orthopaedics2024-08-02
Stryker Orthopaedics Hip Systems Labeling Update (K240418)Howmedica Osteonics Corp., Dba Stryker Orthopaedics2024-04-12
Global Modular Replacement System (K233261)Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics2023-12-08
Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee (K222056)Howmedica Osteonics Corp., Dba Stryker Orthopaedics2023-01-26
C-Stem AMT LE Prosthesis (K220216)Depuy Ireland UC2022-07-22
Exeter® X3® RimFit® Cup (K213701)Howmedica Osteonics Corp., Dba Stryker Orthopaedics2022-02-01
MPO Hip Instruments (K213816)Microport Orthopedics, Inc.2022-01-05
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Recalls involving this device

RecordFirmDate
Product 70 consists of all product under product code: JDI and same usage: Item no: 785701 recall (Z-1168-2016)Zimmer Manufacturing B.V.2016-03-12
12/14 UNIPOLAR FEMORAL HE VERSYS CEM LD/FX SZ 11X12 VERSYS CEM LD/FX SZ 12X12 VERSYS CEM L recall (Z-1029-2014)Zimmer, Inc.2014-02-20
VerSys Cemented Revision Calcar (CRC) Hip System Femoral Stems VerSys Heritage Hip System recall (Z-0277-2014)Zimmer, Inc.2013-11-14

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