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Panels › Orthopedic › Product code JDI · Class 2

Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Regulation 888.3350

3510(k)s in 12 months (565 all time)
0recalls in 12 months (255 all time)
161recalls that name a 510(k)
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Top companies in JDI

Company510(k)sRecalls
Zimmer Biomet192
Biomet, Inc.5118
Zimmer, Inc.2723
Depuy, Inc.450
Howmedica Corp.430
Stryker Howmedica Osteonics037
DePuy Orthopaedics, Inc.1220
Osteonics Corp.290
Howmedica Osteonics1711
Intermedics Orthopedics210
DateFirm and productCodeLinked 510(k)
Jul 2, 2019Zimmer Biomet, Inc.
Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151812
Terminated		 JDIK142814
Jul 2, 2019Zimmer Biomet, Inc.
Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151811
Terminated		 JDIK142814
Jul 2, 2019Zimmer Biomet, Inc.
Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151810
Terminated		 JDIK142814
Oct 24, 2018Zimmer Biomet, Inc.
Biomet 20mm Compress Device Short Anchor Plug With Drill Set / With Pin Inserter Ion Implant Item number: 178562 Product Usage: 1. Correction of revision of unsuccessful osteotomy, arthrodesis, or pr
Terminated		 JDIK062998
Jun 8, 2018Zimmer Biomet, Inc.
ARCOS Modular Revision Hip System, item number 11-300814 orthopedic hip prosthesis femoral stem.
Terminated		 JDIK090757
May 22, 2018Howmedica Osteonics Corp.
LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-236
Terminated		 JDIK022077
May 22, 2018Howmedica Osteonics Corp.
LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-336
Terminated		 JDIK022077
May 22, 2018Howmedica Osteonics Corp.
LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-144
Terminated		 JDIK022077
May 22, 2018Howmedica Osteonics Corp.
LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-140
Terminated		 JDIK022077
May 22, 2018Howmedica Osteonics Corp.
LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-136
Terminated		 JDIK022077
May 22, 2018Howmedica Osteonics Corp.
LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-044
Terminated		 JDIK022077
May 22, 2018Howmedica Osteonics Corp.
LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-040
Terminated		 JDIK022077
May 22, 2018Howmedica Osteonics Corp.
LFIT Anatomic CoCr Femoral Heads, 6260-9-036
Terminated		 JDIK022077
May 9, 2018Smith & Nephew, Inc.
smith&nephew ANTHOLOGY POROUS HIGH OFFSET STEM, 12/14 TAPER, 7H SIZE, 32 MM x 112 MM, REF 71356107 Hip prosthesis.
Terminated		 JDIK052792
Apr 2, 2018Zimmer Biomet, Inc.
Modular Head Component, Biomet Hip System; Item No. 163669, Hip Joint, metal/polymer semi-constrained cemented prosthesis The device is used in treatment of patients who need total hip arthroplasty,
Terminated		 JDIK911684
Nov 29, 2017Zimmer Biomet, Inc.
CPT 12/14 COCR SIZE 2 STD prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
Terminated		 JDIK960658
Nov 29, 2017Zimmer Biomet, Inc.
CPT 12/14 COCR SIZE 2 EXT prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
Terminated		 JDIK960658
Nov 29, 2017Zimmer Biomet, Inc.
CPT 12/14 COCR REVISION SIZE 2 180MM prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
Terminated		 JDIK960658
Sep 15, 2017Zimmer Biomet, Inc.
36MM COCR MODULAR HD -6MM
Terminated		 JDIK032396
Jun 5, 2017Zimmer Biomet, Inc.
OSS CEMENTED IM STEM 12X150, model # 150366
Terminated		 JDIK002757
Mar 27, 2017Zimmer Biomet, Inc.
various polyethylene implants Hips Active Articulation ArComXL Bearings Active Articulation E1 Bearings Arcos Taper Cap BIOLOX delta Option Head E1 RingLoc Bi-Polar Freedom Constrained Liner +5mm Hi
Terminated		 JDIK023357
K032396 +2
Nov 16, 2016Smith & Nephew, Inc.
REFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew, Inc,. Memphis, TN 38116
Terminated		 JDIK123598
Nov 7, 2016Exactech, Inc.
Novation Cemented Plus Femoral Stem, 12/14, Collared, Standard Offset, Matte, Cemented, Size 15.
Terminated		 JDIK083392
Aug 29, 2016Stryker Howmedica Osteonics Corp.
LFIT Anatomic V40 Femoral Head, Low Friction Ion Treatment, Sterile, 36 mm, REF 6260-9-236; Modular components designed to be locked onto a femoral hip stem trunnion during surgery for total hip repla
Terminated		 JDIK022077
Aug 11, 2016Stryker Howmedica Osteonics Corp.
Orthopedic manual surgical instrument Usage: Exeter Rasp Handle is a reusable instrument which is part of the Exeter femoral hip system. Exeter femoral rasps are assembled with the rasp handle and lo
Terminated		 JDIK110290
May 16, 2016Zimmer Manufacturing B.V.
Hgp ii acetabular cup bone screw selftap 6.5x15mm 00662406515 Hgp ii acetabular cup bone screw selftap 6.5x20mm 00662406520 Hgp ii acetabular cup bone screw selftap 6.5x25mm 00662406525 Hgp ii acetabu
Terminated		 JDIK840643
Apr 15, 2016Zimmer Trabecular Metal Technology, Inc.
REV. SHELL LINER 0D 28X48 00700504828 REV. SHELL LINER 10D 28X50 00701005028 REV. SHELL LINER 10D 28X52 00701005228 REV. SHELL LINER 10D 28X54 00701005428 REV. SHELL LINER 10D 28X56 00701005628
Terminated		 JDIK980486
K983128
Mar 12, 2016Zimmer Manufacturing B.V.
Product 72 consists of all product code: JDI and same usage: Item no: 805002202 ZIMTRON HEAD 12/14 0X22 MM For use in total or hemi hip arthroplasty
Terminated		 JDINone listed
Mar 12, 2016Zimmer Manufacturing B.V.
Product 71 consists of all product under product code: JDI and same usage: Item no: 783401000 VERSYS PRESS FIT LD/FX ST 783401100 VERSYS PRESS FIT LD/FX SZ 783401200 VERSYS PRESS FIT LD/FX SZ 7834013
Terminated		 JDIK955473
Mar 12, 2016Zimmer Manufacturing B.V.
Product 70 consists of all product under product code: JDI and same usage: Item no: 785701000 VERSYS HERITAGE FEM STEM 785701100 VERSYS HERITAGE FEM STEM 785701200 VERSYS HERITAGE FEM STEM 785701300
Terminated		 JDIK963109
Mar 12, 2016Zimmer Manufacturing B.V.
Product 69 consists of all product under product code: JDI and same usage: Item no: 785301701 VERSYS CEMENTED FEM STEM 785301521 VERSYS CEMENTED FEM STEM 15X140MM X-OFF 785301601 VERSYS CEMENTED FEM
Terminated		 JDIK950312
Mar 12, 2016Zimmer Manufacturing B.V.
Product 68 consists of all product under product code: JDI and same usage: Item no: 787101360 VERSYS CEM/REV/CALCAR 13X 787101361 VERSYS CEM/REV/CALCAR 13X 787101362 VERSYS CEM/REV/CALCAR 13X 7871013
Terminated		 JDIK913649
Mar 12, 2016Zimmer Manufacturing B.V.
Product 67 consists of all product under product code: JDI and same usage: Item no: 785001100 VERSYS ADVOCATE CEMENTED 785001200 VERSYS ADVOCATE CEMENTED 785001220 VERSYS ADVOCATE CEMENTED 785001300
Terminated		 JDIK955473
Mar 12, 2016Zimmer Manufacturing B.V.
Product 66 consists of all product under product code: JDI and same usage: Item no: 785001100 VERSYS ADVOCATE CEMENTED 785001200 VERSYS ADVOCATE CEMENTED 785001220 VERSYS ADVOCATE CEMENTED 785001300
Terminated		 JDIK950312
Mar 12, 2016Zimmer Manufacturing B.V.
Product 64 consists of all product under product code: JDI and same usage: Item no: 902605101 UNIPOLAR ENDO FEM HEAD 51MM For use in hemi hip arthroplasty
Terminated		 JDIK960278
Mar 12, 2016Zimmer Manufacturing B.V.
Product 57 consists of all product code: JDI and same usage: Item no: 763401000 PRESSFIT FEM ST FX 10 X 115 763401100 PRESSFIT FEM ST FX 11 X 1 763401200 PRESSFIT FEM ST FX 12 X 1 763401300 PRESSFIT
Terminated		 JDINone listed
Mar 12, 2016Zimmer Manufacturing B.V.
Product 39 consists of all product under product code: JDI and same usage: Item no: 32902605800 ION IMPLANTED FEM 22MM LO 32902604900 ION IMPLANTED FEM 26MM ME 32902603900 ION IMPLANTED FEM 26MM SH
Terminated		 JDIK840643
Mar 12, 2016Zimmer Manufacturing B.V.
Product 33 consists of all product under product code: JDI and same usage: Item no: 662406515 HGP II ACETABULAR CUP BON 662406520 HGP II ACETABULAR CUP BON 662406525 HGP II ACETABULAR CUP BON 662406
Terminated		 JDIK840643
Mar 12, 2016Zimmer Manufacturing B.V.
Product 28 consists of all product under product code: JDI and same usage: Item no: 32902605000 FEMORAL HD 28MM MEDIUM 32902604000 FEMORAL HD 28MM SHORT 32902604035 FEMORAL HD 28MM SHT+ 3.5M For use
Terminated		 JDIK840643
Mar 12, 2016Zimmer Manufacturing B.V.
Product 23 consists of all product code: JDI and same usage: Item no: 801100220 CPT 2 HIP STEM, X-OFFSET 801100320 CPT 3 HIP STEM, X-OFFSET 801100420 CPT 4 HIP STEM, X-OFFSET 801100005 CPT HIP STEM P
Terminated		 JDINone listed
Mar 12, 2016Zimmer Manufacturing B.V.
Product 22 consists of all product under product code: JDI and same usage: Item no: 811400218 CPT 12/14 COCR REVISION S 811400318 CPT 12/14 COCR REVISION S 811400420 CPT 12/14 COCR REVISION S 81140
Terminated		 JDIK030265
Mar 12, 2016Zimmer Manufacturing B.V.
Product 21 consists of all product under product code: JDI and same usage: Item no: 811400218 CPT 12/14 COCR REVISION S 811400318 CPT 12/14 COCR REVISION S 811400420 CPT 12/14 COCR REVISION S 811400
Terminated		 JDIK960658
Mar 12, 2016Zimmer Manufacturing B.V.
Product 19 consists of all product code: JDI and same usage: Item no: 765301101 CEM FEM ST 11X120 NOCOAT 765301201 CEM FEM ST 12X125 NOCOAT 765301301 CEM FEM ST 13X130 NOCOAT 765301401 CEM FEM ST 14X
Terminated		 JDINone listed
Mar 12, 2016Zimmer Manufacturing B.V.
Product 15 consists of all product code JDI , and same usage: Item no: 805002802 ASTEL FEM HEAD +0X28MM DI 805002805 ASTEL FEM HEAD +10.5X28MM 805002803 ASTEL FEM HEAD +3.5X28MM 805002804 ASTEL FEM H
Terminated		 JDINone listed
Mar 12, 2016Zimmer Manufacturing B.V.
Product 12 consists of all product under product code JDI , and same usage: Item no: 902602935 6 DEGREE COCR FEM HEAD 28 902602835 6 DEGREE COCR FEM HEAD 28 902603235 6 DEGREE COCR FEM HEAD 32 902603
Terminated		 JDIK840643
Mar 12, 2016Zimmer Manufacturing B.V.
Product 11 consists of all product under product code JDI , and same usage: Item no: 902602500 6 DEGREE COCR FEM HEAD 26 902602600 6 DEGREE COCR FEM HEAD 26 902602700 6 DEGREE COCR FEM HEAD 26 902602
Terminated		 JDIK960278
Mar 12, 2016Zimmer Manufacturing B.V.
Product 3 consists of all products under product code JDI, and same usage: Item no:781803800 12/14 UNIPOLAR FEMORAL HE 781804000 12/14 UNIPOLAR FEMORAL HE 781804100 12/14 UNIPOLAR FEMORAL HE 781804200
Terminated		 JDIK955473
Feb 22, 2016Zimmer Biomet, Inc.
CPT 12/14 COCR prosthesis, hip, semi-constrained, metal/polymer, porous uncemented various sizes "The CPT Hip System is indicated for cemented use in: Patients suffering from severe hip pain and dis
Terminated		 JDIK960658
Feb 22, 2016Zimmer Biomet, Inc.
CPT 12/14 COCR prosthesis, hip, semi-constrained, metal/polymer, porous uncemented various sizes The CPT Hip System is indicated for cemented use in: Patients suffering from severe hip pain and disa
Terminated		 JDIK030265
Nov 17, 2015Stryker Howmedica Osteonics Corp.
Stryker PCA 10 Degree Hooded Acetabular Insert ID 22mm, Part of the Howmedica PCA Total Hip System intended for use during total hip arthroplasty. The acetabular insert is used in conjunction with P
Terminated		 JDINone listed

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