Atlas FDA

INTRAMEDULLARY NAIL SYSTEM

FDA 510(k) clearance K965098 · decided 1997-02-28

Clearance details

K-number
K965098
Device name
INTRAMEDULLARY NAIL SYSTEM
Applicant
Zimmer, Inc.
Decision
Substantially Equivalent
Date received
1996-12-20
Decision date
1997-02-28
Days to decision
70 days
Clearance type
Traditional
Product code
HSB
Device class
2
Regulation number
888.3020
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Warsaw, IN, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

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

RecordFirmDate
Pangea Femur Reconstruction System (K261481)Stryker GmbH2026-06-29
Precice™ Max System and Precice™ Ankle Salvage System (K261651)NuVasive Specialized Orthopedics2026-06-18
AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02) (K253080)Suzhou and Science & Technology Development Corp.2026-06-18
Fule Metallic Lockable Intramedullary Nail Systems (K253155)Beijing Fule Science & Technology Development Co., Ltd.2026-06-17
HERA Interlocking Intramedullary Nailing System (K253046)ZheJiang Decans Medical Devices Co., Ltd.2026-06-16
FITBONE® TRANSPORT AND LENGTHENING SYSTEM (K260146)Orthofix Srl2026-05-19
Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA (K253991)Orthofix Srl2026-05-08
AUTOBAHN™ Nailing System (K261043)Globus Medical, Inc.2026-04-24
Arthrex Humeral Nails (K252016)Arthrex, Inc.2026-03-20
Fusion FibFix Nail (K252961)Fusion Orthopedics USA, LLC2026-03-18
Affixus Retrograde Femoral Nailing System (K253566)Zimmer, Inc.2026-03-12
Reselute Tibial Nail (K253517)Reselute, Inc.2026-03-10

Recalls involving this device

RecordFirmDate
Por fullct fem st 20x200mm, Sterile, Rod, fixation, intramedullary and accessories- Specif recall (Z-2549-2017)Zimmer Biomet, Inc.2017-03-20
Fem IM Nail 16mmdx38cm, Sterile, Rod, fixation, intramedullary and accessories- Specific K recall (Z-2550-2017)Zimmer Biomet, Inc.2017-03-20
Fem IM Nail 16mmdx40cm, Sterile, Rod, fixation, intramedullary and accessories- Specific K recall (Z-2551-2017)Zimmer Biomet, Inc.2017-03-20
Fem IM Nail 16mmdx42cm, Sterile, Rod, fixation, intramedullary and accessories- Specific K recall (Z-2552-2017)Zimmer Biomet, Inc.2017-03-20
Fem IM Nail 15mmdx44cm, Sterile, Rod, fixation, intramedullary and accessories- Specific K recall (Z-2553-2017)Zimmer Biomet, Inc.2017-03-20
Fem IM Nail 16mmdx44cm, Sterile, Rod, fixation, intramedullary and accessories- Specific K recall (Z-2554-2017)Zimmer Biomet, Inc.2017-03-20
Fem IM Nail 15mmdx46cm, Sterile, Rod, fixation, intramedullary and accessories- Specific K recall (Z-2555-2017)Zimmer Biomet, Inc.2017-03-20
Fem IM Nail 16mmdx46cm, Sterile, Rod, fixation, intramedullary and accessories- Specific K recall (Z-2556-2017)Zimmer Biomet, Inc.2017-03-20
Fem IM Nail 15mmdx48cm, Sterile, Rod, fixation, intramedullary and accessories- Specific K recall (Z-2557-2017)Zimmer Biomet, Inc.2017-03-20
Fem IM Nail 16mmdx48cm, Sterile, Rod, fixation, intramedullary and accessories- Specific K recall (Z-2558-2017)Zimmer Biomet, Inc.2017-03-20
Fem IM Nail 15mmdx50cm, Sterile, Rod, fixation, intramedullary and accessories- Specific K recall (Z-2559-2017)Zimmer Biomet, Inc.2017-03-20
Fem IM Nail 16mmdx50cm, Sterile, Rod, fixation, intramedullary and accessories- Specific K recall (Z-2560-2017)Zimmer Biomet, Inc.2017-03-20
Tibial IM Nail 15mmdx44cm, Sterile, Rod, fixation, intramedullary and accessories- Specifi recall (Z-2561-2017)Zimmer Biomet, Inc.2017-03-20
Segmental malefemale taper, 220mm, Sterile, Knee joint femorotibial meta/polymer constrain recall (Z-2567-2017)Zimmer Biomet, Inc.2017-03-20
Segmental fluted stem, 17x190mm str, Sterile, Knee joint femorotibial meta/polymer constra recall (Z-2568-2017)Zimmer Biomet, Inc.2017-03-20
Segmental fluted stem, 18x190mm str, Sterile, Knee joint femorotibial meta/polymer constra recall (Z-2569-2017)Zimmer Biomet, Inc.2017-03-20
Segmental fluted stem, 19x190mm str, Sterile, Knee joint femorotibial meta/polymer constra recall (Z-2570-2017)Zimmer Biomet, Inc.2017-03-20
Segmental fluted stem, 15x250mm bwd, Sterile, Knee joint femorotibial meta/polymer constra recall (Z-2571-2017)Zimmer Biomet, Inc.2017-03-20
Segmental fluted stem, 16x250mm bwd, Sterile, Knee joint femorotibial meta/polymer constra recall (Z-2572-2017)Zimmer Biomet, Inc.2017-03-20
Segmental fluted stem, 17x250mm bwd, Sterile, Knee joint femorotibial meta/polymer constra recall (Z-2573-2017)Zimmer Biomet, Inc.2017-03-20
Product 37 consists of all product under product code: HSB and same usage: Item no: 225302 recall (Z-1135-2016)Zimmer Manufacturing B.V.2016-03-12
Product 42 consists of all product under product code: HSB and same usage: Item no: 225224 recall (Z-1140-2016)Zimmer Manufacturing B.V.2016-03-12
Product 60 consists of all product under product code: HSB and same usage: Item no: 225207 recall (Z-1158-2016)Zimmer Manufacturing B.V.2016-03-12
RECON SCREW LG 5.5MM DIA and M/DN FEM IM NAIL 8MM DIA to 16 MM DIA. Item codes starting wi recall (Z-1008-2014)Zimmer, Inc.2014-02-20
INTERLOCKING IM SCREW SML, MED and LRG; M/DN TIBIAL I/M NAIL 6 MM to 15 MM. Some items sta recall (Z-1009-2014)Zimmer, Inc.2014-02-20
M/DN HUMERAL I/M NAIL. Sizes from 6 MM to 13 MM. Codes starting with 0022541, 002542 and 0 recall (Z-1011-2014)Zimmer, Inc.2014-02-20
M/DN Intramedullary Fixation Humeral Nail recall (Z-1004-04)Zimmer Inc.2004-07-20

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