FDA.reportPublic FDA data

STRYKER IRELAND OSTEONICS

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96166803002459190STRYKER IRELAND OSTEONICS1N2026-01-01Tullagreen Building, IDA Business & Technology Park Carrigtwohill Cork Munster IE T45 HE42

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
37721129472013P000013TRIDENT SYSTEMMRA2003-02-03
37721535137228K994366TMZF PRESS FIT HA STEM AND TMZF PRESS FIT PLUS HA STEMMEH2000-03-16
37721829655602K994128SCORPIO TOTAL STABLIZER (TS) TOTAL KNEE SYSTEMJWH2000-03-06
37721335517647K993889EXETER CERAMIC FEMORAL HEADSLZO2000-02-11
37721815678626K993768CITATION TMZF HA STEMMEH2000-01-21
37721153333237K993692DURACON INSET PATELLA, 25MMJWH1999-12-02
37721402061443K993601HOWMEDICA OSTEONICS FEMORAL HEADSLWJ1999-11-16
37721725463265K993352CROSSFIRE SYSTEM 12 ACETABULAR INSERTSLPH1999-11-19
37721525418046K992570UNITRAX C-TAPER NECK ADJUSTMENT SLEEVEKWL1999-09-01
37721922328749K991952OSTEONICS ALUMINA C-TAPER HEAD, OSTEONICS TRIDENT POLYETHYLENE INSERTSLZO1999-06-29
37721041188150K991461OSTEONICS SCORPIO TOTAL KNEE RELAXED BACK P/S TIBIAL BEARING INSERTJWH1999-05-17
37721386603108K984432DALL-MILES CABLE GRIP (A-GRIP)JDQ1999-02-24
37721297045706K983502OSTEONICS SECUR-FIT AD GENERATION II ACETABULAR COMPONENT SYSTEMLPH1998-12-16
37721076012146K983382OSTEONICS HA GENERATION II ACETABULAR COMPONENT SYSTEMMEH1998-12-11
37721433275177K982032OSTEONICS OMNIFIT HA HIP STEM SERIES, OSTEONICS SECUR-FIT HA HIP STEM SERIES, OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMSMEH1998-07-09
37721002212539K974685OSTEONICS POLYETHYLENE ACETABULAR COMPONENTSJDI1998-09-22
37721042392260K974556OSTEONICS SCORPIO POSTERIOR CRUCIATE RETAINING TOTAL KNEE SYSTEMJWH1998-02-27
37721234386758K974054DISTAL CENTRALIZER, EXETER II HIP SYSTEMJDI1997-12-23
37721959008495K973164HOWMEDICA TOTAL STABILIZER KNEE COMPONENTSJWH1997-11-20
37721915111166K972928KERBOULL CROSSJDI1997-11-03
37721689367784K972863DURATION STABILIZED UHMWPE KNEE COMPONENTSJWH1997-10-29
37721018686114K972752DURACON CONVERSION METAL BACKED PATELLAJWH1997-10-21
37721392722002K972361V40 ZIRCONIA FEMORAL HEADSLZO1997-09-23
37721253917674K972228MERIDIAN TITANIUM FEMORAL STEMSLZO1997-12-05
37721623383886K971741DALL-MILES HOMOGENEOUS STAINLESS STEEL CABLE AND BEADED CABLEJDQ1997-07-16
37721635217146K971409OSTEONICS ALUMINA C-TAPER HEADLZO1997-07-09
37721682863876K971206MERIDIAN ST FEMORAL STEM AND VITALOCK SOLID BACK SHELL W/ PERI-APATITE COATINGLPH1998-02-11
37721887519275K970200RELIANCE PF FEMORAL STEMSLZO1997-04-09
37721995123136K964655UHMWPE HIP AND KNEE COMPONENTS - PACKAGING CHANGEJDI1997-02-06
37721639742131K963940EXETER MESHJDJ1997-02-13
37721983305438K963612DURATION STABILIZED UHMWPEJDI1997-06-11
37721651580217K962152OSTEONICS SCORPIO POSTERIORLY STABILIZED TOTAL KNEE SYSTEMJWH1996-08-14
37721532052263K961483DURACON ALL POLYETHYLENE PATELLA IIJWH1996-07-09
37722070930018K961283DALL-MILES HOMOGENOUS VITALLIUM CABLEJDQ1996-05-22
37721427078181K955871HOWMEDICA ASYMMETRIC STEM FEMORAL COMPONENTLPH1996-03-22
37721155847947K955305PCA +15MM MODULAR FEMORAL HEADMEH1996-01-18
37721387297284K954077UNITRAX V40 MODULAR ADAPTORKWL1995-11-15
37721418537383K953818DALL-MILES SUTURE/BEADED CABLEJDQ1995-10-12
37721682181101K953067HIP FRACTURE STEM FENESTRATION PLUGJDG1995-08-21
37721945228515K951860HOWMEDICE BONE PLUGLZN1995-05-16
37721735852722K951655DURACON RECESSED PATELLAJWH1995-07-11
37721536017252K945691OSTEONICS(R) THREADED HA ACETABULAR SHELLSMEH1995-03-17
37721315439263K945294DALL MILES SYSTEM HOMOGENEOUS VITALLIUM CABLEJDQ1995-03-07
37721359291310K9442136.2 VITALLIUM ALLOY CANCELLOUS BONE SCREWHWC1994-12-09
37721632642650K943054OSTEONICS SECURE-FIT AD ACETABULAR COMPONENT SYSTEMLPH1994-10-04
37721915656396K942900OSTEONICS SECURE-FIT AD-HA ACETABULAR COMPONENT SYSTEMMEH1995-03-15
37721806372096K940861PCA(R) MODULAR TOTAL KNEE TIB INSERT DUROCON BASEPLATEJWH1995-09-18
37721317537273K940307HOWMEDICA STRAIGHT STEM FEMORAL COMPONENTJDI1995-01-19
37721776440426K936292PACKAGING AND MANUFACTURING METHODS CHANGE/KNEE COMPONENTSLPH1995-08-18
37721271045623K936127HOWMEDICA PREMIUM FEMORAL COMPONENTJDI1994-10-26
37721353699340K936126HOWMEDICS DRG FEMORAL COMPONENTJDI1994-10-20
37721386487714K936008DURACON BASEPLATESJWH1995-08-09
37721919074172K934060HOWMEDICA(R) ACETABULAR COMP PACK/MANUF METH CHANGELPH1995-08-18
37721442713325K934059DALL MILES SYSTEM GROOVED BUTTONJDQ1994-08-01
37721437154322K934058DALL MILES SYSTEM MINICLEATJDQ1994-02-23
37721851847996K933102HOWMEDICA ACETABULAR SHELL W/SCREW HOLESLPH1994-05-16
37721852113202K923011OSTEONICS UNIX UNICOMPARTMENTALHRY1993-11-30
37721555430938K922525DALL MILES BROAD BONE PLATEHRS1992-09-22
37721766090287K922048DURACON ALL PLASTIC TIBIAL COMPONENTJWH1992-09-08
37721987568042K920231OMNIFIT M-HA HIP STEM SERIESKWL1992-06-08
37721677018308K915512DURACON TOTAL KNEE SYSTEM TIBIAL COMPONENTSJWH1992-08-18
37721645179591K915184HOWMEDICA ALUMINA FEMORAL HEADLZO1992-01-31
37721702764978K914565OSTEONICS 7000 POSTERIOR STAB. TOTAL KNEE FEM. COMJWH1992-05-15
37721929236159K912395HOWMEDICA PRECIS OSTEOLOCK FEM COMP W/HYDRO COATMEH1991-07-24
37721164119556K911585OMNIFIT II EPF HIP STEM SERIESMEH1991-07-01
37721393809054K910235PCA MTK II TOTAL KNEE SYSTEMJWH1991-06-21
37721204780630K903362OSTEOLOCK(TM) ACETABULAR CUPJDI1990-10-22
37721443863804K902365MODULAR UNIPOLAR SYSTEMKWL1991-01-11
37721813768573K900926TROCHANTER CABLE GRIP SYSTEM (ADD'L INDICATIONS)LRN1990-04-23
37721116457733K894403PCA MODULAR KNEE CONSTRAINED TIBIAL INSERTJWH1990-02-02
37721529967738K894149MOD. FEMORAL COM. & CLUSTER PATTER OUTER SHELLJDI1989-09-14
37721629449261K891454EXETER II TOTAL HIP SYSTEMJDI1989-06-07
37721104923385K890326HIP FRACTURE STEM SYSTEM - FENESTRATION PLUGLZN1989-02-03
37722009799999K885102OMNIFIT CERAMIC MORSE TAPER HEAD (1002 SERIES)LZO1989-06-22
37721144590553K884398OMNIFIT TOTAL KNEE SERIES II TIBIAL INSERTSJWH1989-01-17
37721794343320K883179HIP FRACTURE STEM SYSTEMKWL1988-09-22
37722047139238K872224MODIFIED TROCHANTER CABLE GRIP SYSTEMKTT1987-08-17
37721295418170K870235OMNIFIT II HIP PROSTHESES: CEMENT FIXATIONJDI1987-05-29
37721592390756K864633VITALLIUM HEX-DRIVE BONE SCREW SYSTEMHWC1986-12-18
37721937770742K863668OMNIFIT (TM) TOTAL KNEE PROSTHESIS SYSTEMJWH1986-12-19
37722042173697K853886P.C.A. UNIVERSAL ACETABULAR COMPONENT SYSTEMJDI1985-11-25
37721036061234K852449HOWMEDICA HIP SYS DISTAL CENTRALIZING SPACERLZN1985-08-12
37721998581625K851404OMNIFIT THREADED ACETABULAR COMPONENTS 2005 SERIESKWA1985-06-18
37721263019942K831373P.C.A. HIP SYSTEMJDI1983-08-26
37721345220014K803192HCL ACETABULAR COMPONENTSKWZ1981-01-23
37721172731438K252898Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge BumperKRO2025-12-15
37721970384553K243817Scorpio Universal Dome Patella; Scorpio Total Stabilizer Insert; Scorpio-Flex Posterior Stabilized Tibial Insert; Scorpio-Flex Cruciate Retaining Tibial Insert; Scorpio NRG Tibial Bearing Insert – Cruciate Retaining Insert; Scorpio NRG Tibial Bearing Insert – Posteriorly Stabilized InsertJWH2025-02-06
37722003852970K243784Stryker Orthopaedics Hip Devices Labeling UpdateLPH2025-02-06
37722031208299K242831Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon Tritanium Tibial Baseplate; Triathlon Low Profile Tibial Tray; Triathlon Metal Backed Patella; Triathlon Partial Knee System; Avon Patello-femoral Joint Prosthesis; Restoris Multi-Compartmental Knee SystemJWH2024-12-04
37721399450021K240418Stryker Orthopaedics Hip Systems Labeling UpdateJDI2024-04-12
37721954289554K23402522.2mm BIOLOX® delta Ceramic V40™ Femoral HeadsLZO2024-04-24
37721320880728K233498Stryker Orthopaedics Hip Systems Labeling UpdateLPH2023-12-21
37721174904923K223528Triathlon® Hinge Knee SystemKRO2023-01-20
37721666280155K220838Artisan Bone Plug, Universal Cement RestrictorLZN2022-05-20
37722013294100K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemMEH2022-08-11
37721545537642K213129Restoration Modular 115mm Conical Distal StemLZO2021-12-21
37721939712902K212187Restoration® Modular Hip SystemLPH2022-03-01
37721364270313K211703Insignia Hip StemMEH2021-08-16
37721102612265K202016Dall-Miles® Cable SystemJDQ2020-10-16
37721359335629K193429Exeter V40 Femoral Stem, Exeter X3 RimFit CupJDI2020-08-13
37721474369621K193233Restoration® Modular Hip SystemLPH2020-05-27
37721802663404K191358Trident II Acetabular SystemLPH2019-10-24
37721818580734K190991Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal AugmentMBH2019-08-15
37721484330970K182468Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip SystemLPH2019-03-19
37721480408198K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsJDG2018-03-19
37721446842265K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemJWH2017-10-30
37722027853980K171768Trident® II Acetabular SystemLPH2017-10-02
37721513026100K161569Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex ScrewsLPH2016-10-14
37721524831326K153345Stryker Orthopaedics Hip Systems Labeling UpdateLPH2016-05-25
37721960376261K143393Triathlon Tritanium Cone AugmentsMBH2015-01-13
37721793272114K143085Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use with the Direct Superior ApproachLPH2015-02-09
37721785532598K141056TRIATHLON KNEE SYSTEM POSTERIOR STABILIZED COMPONENTSMBH2014-08-05
37721538035326K132624TRIATHLON TRITANIUM METAL-BACKED PATELLAMBH2013-11-26
37722034310131K123604ABG III MONOLITHIC HIP STEMMAY2013-08-16
37721795317216K123486TRIATHLON TRITANIUM TIBIAL BASEPLATEMBH2013-05-03
37721888327358K123166TRIATHLON ALL-POLYETHYLENE CONDYLAR STABILIZING (CS) TIBIAL IMPLANTS TRIATHLON ALL-POLYETHYLENE POSTERIOR STABILIZING (PJWH2013-02-14
37721542908865K122015DISTAL FEMORAL GROWING PROSTHESIS, TIBIAL ROTATING COMPONENTS, BEARING, AXIS, CIRCLIP, WEDGEKRO2013-02-22
37721428210540K121308HIP SYSTEMSLPH2012-07-30
37721268998000K120578ACCOLADE II HIP STEMJDI2012-03-29

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JWH322025-02-06
LZO262024-04-24
JDI262024-04-12
MEH232022-08-11
LPH222025-02-06
MBH102019-08-15
JDQ82020-10-16
KWL51999-09-01
LZN42022-05-20
KRO32025-12-15
JDG22018-03-19
MAY22013-08-16
HRS22007-03-02
HWC21994-12-09
NPJ12005-12-27
JDR12003-04-28
MRA12003-02-03
LWJ11999-11-16
JDJ11997-02-13
HRY11993-11-30
LRN11990-04-23
KTT11987-08-17
KWA11985-06-18
KWZ11981-01-23