Atlas FDA

COLLARLESS POLISHED TAPER HIP PROSTHESIS

FDA 510(k) clearance K960658 · decided 1996-07-16

Clearance details

K-number
K960658
Device name
COLLARLESS POLISHED TAPER HIP PROSTHESIS
Applicant
Zimmer, Inc.
Decision
Substantially Equivalent
Date received
1996-02-16
Decision date
1996-07-16
Days to decision
151 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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OSSTM Orthopedic Salvage System (K253434)Biomet, Inc.2026-07-01
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Recalls involving this device

RecordFirmDate
CPT Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis, used in Hip Arthroplasty recall (Z-2450-2024)Zimmer, Inc.2024-07-30
Product 21 consists of all product under product code: JDI and same usage: Item no: 811400 recall (Z-1119-2016)Zimmer Manufacturing B.V.2016-03-12
CPT 12/14 COCR prosthesis, hip, semi-constrained, metal/polymer, porous uncemented various recall (Z-0844-2016)Zimmer Biomet, Inc.2016-02-22
CPT 12/14 COCR (various sizes) recall (Z-1032-2014)Zimmer, Inc.2014-02-20
CPT DEGREE TAPER (various sizes) and FEMORAL HD (various sizes) recall (Z-1036-2014)Zimmer, Inc.2014-02-20
CPT Hip System, Parts 00-8114-002-10 and 00-8011-004-00 Hip joint metal/polymer semi-const recall (Z-0608-2014)Zimmer, Inc.2013-12-30
Versys Build-Up Block The VerSys CRC Hip System is indicated for total hip arthroplasty in recall (Z-0610-2014)Zimmer, Inc.2013-12-30
CPT Femoral Stem (CPT 12/14 STEM SIZE 0 COCR; CPT 12/14 SIZE 0 COCR EXT; CPT 12/14 STEM SI recall (Z-0069-2014)Zimmer, Inc.2013-10-25
CPT Femoral Stem 12/14 Neck Taper Extended Offset,(item 00-8114-001-10. CPT stems are prim recall (Z-0062-2013)Zimmer, Inc.2012-10-15

PMA approvals by this applicant

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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