FDA.report

HOWMEDICA OSTEONICS CORP

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
22496973003070421HOWMEDICA OSTEONICS CORP1Y2026-01-01325 CORPORATE DR. MAHWAH NJ US 07430

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
37731313645990P960047OSTEONICS CONSTRAINED ACETABULAR INSERTKWZ 1997-06-13
37731129472013P000013TRIDENT SYSTEMMRA2003-02-03
37731829655602K994128SCORPIO TOTAL STABLIZER (TS) TOTAL KNEE SYSTEMJWH2000-03-06
37731649197830K993603WICHITA FUSION NAIL FULLY THREADED SELF-TAPPING SCREWHSB1999-11-19
37731402061443K993601HOWMEDICA OSTEONICS FEMORAL HEADSLWJ1999-11-16
37731725463265K993352CROSSFIRE SYSTEM 12 ACETABULAR INSERTSLPH1999-11-19
37731964658362K993077HOWMEDICA OSTEONICS RESTORATION HA HIP STEMMEH1999-10-08
37731525418046K992570UNITRAX C-TAPER NECK ADJUSTMENT SLEEVEKWL1999-09-01
37731774782370K992462OSTEONICS UNIVERSAL DISTAL CEMENT PLUGLZN1999-08-13
37731214606680K992287FIRST STEP UNICOMPARTMENTAL KNEE SYSTEMHSX1999-11-16
37731994455887K992025PRECISION OSTEOLOCK FEMORAL STEMS WITH PURE-FIX HA COATINGMEH1999-08-13
37731922328749K991952OSTEONICS ALUMINA C-TAPER HEAD, OSTEONICS TRIDENT POLYETHYLENE INSERTSLZO1999-06-29
37731041188150K991461OSTEONICS SCORPIO TOTAL KNEE RELAXED BACK P/S TIBIAL BEARING INSERTJWH1999-05-17
37731508040494K990712OSTEONICS SOLAR SHOULDER BIPOLAR SYSTEMMJT1999-07-20
37731974174416K990598OSTEONICS SOLAR SHOULDER HUMERAL BEARING HEADKWS1999-03-15
37731912336285K990203OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMSMEH1999-02-18
37731037136516K984202HOWMEDICA HUMERAL INTERCALARY SYSTEMHSD1999-02-05
37731846925109K983870OSTEONICS RESTORATION HA HIP STEMSMEH1998-12-02
37731000764335K983657OSTEONICS SERIES 7000 AD TIBIAL TRAYHRY2000-04-06
37731297045706K983502OSTEONICS SECUR-FIT AD GENERATION II ACETABULAR COMPONENT SYSTEMLPH1998-12-16
37731076012146K983382OSTEONICS HA GENERATION II ACETABULAR COMPONENT SYSTEMMEH1998-12-11
37731617175489K983226OSTEONICS X CEMENTED HIP STEM SERIESJDI1998-12-04
37731482084919K982936OSTEONICS EXTENDED FEMORAL BEARING HEADLWJ1998-10-21
37731942692799K982248HOWMEDICA ASYMMETRIC STEM VITALOCK CLUSTER & SPIKED SHELLS, AND ACETABULAR SHELLS WITH MESH INGROWTH SURFACE WITH PERI-ALPH1998-08-31
37731433275177K982032OSTEONICS OMNIFIT HA HIP STEM SERIES, OSTEONICS SECUR-FIT HA HIP STEM SERIES, OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMSMEH1998-07-09
37731024967890K981201OSTEOLOCK ACETABULAR CUPLZO1998-05-29
37731966616371K980774OSTEONICS GAP-II RESTORATION ACETABULAR SHELLSLZO1998-04-29
37731800646713K980713FEMORAL AND TIBIAL PLUGS OF INTERAX TOTAL KNEE SYSTEMJWH1998-05-22
37731601151953K980502OSTEONICS TOTAL ELBOW SYSTEMJDC1998-05-05
37731805083867K974807OSTEO AUSTIN MOORE ENDOPROSTHESIS SYSTEMKWL1998-03-16
37731002212539K974685OSTEONICS POLYETHYLENE ACETABULAR COMPONENTSJDI1998-09-22
37731042392260K974556OSTEONICS SCORPIO POSTERIOR CRUCIATE RETAINING TOTAL KNEE SYSTEMJWH1998-02-27
37731188517629K974434OSTEONICS SERIES 7000 TOTAL KNEE ANTERIOR FEMORAL BLOCKSHRY1998-01-12
37731234386758K974054DISTAL CENTRALIZER, EXETER II HIP SYSTEMJDI1997-12-23
37731959008495K973164HOWMEDICA TOTAL STABILIZER KNEE COMPONENTSJWH1997-11-20
37731569451695K973163ACETABULAR SHELLS WITH MESH INGROWTH SURFACELPH1997-11-21
37731841204853K973121INTERAX TOTAL KNEE SYSTEMJWH1997-11-18
37731695446568K972967OSTEONICS SCORPIO TOTAL KNEE UNIVERSAL DOME PATELLAR COMPONENT;OSTEONICS SCORPIO TOTAL KNEE RECESSED PATELLAR COMPONENTJWH1998-01-16
37731915111166K972928KERBOULL CROSSJDI1997-11-03
37731689367784K972863DURATION STABILIZED UHMWPE KNEE COMPONENTSJWH1997-10-29
37731535142923K972792DURATION STABILIZED UHMWPE ACETABULAR COMPONENTSJDI1997-10-16
37731873268944K972460OSTEONICS OMNIFIT-C CEMENTED HIP STEM (LINE EXTENSION)JDI1997-09-25
37731392722002K972361V40 ZIRCONIA FEMORAL HEADSLZO1997-09-23
37731489417467K971854OSTEOLOCK ACETABULAR SHELL SYSTEMLPH1997-07-30
37731635217146K971409OSTEONICS ALUMINA C-TAPER HEADLZO1997-07-09
37731800259918K970957OSTEONICS RESTORATION ACETABULAR RINGJDJ1997-06-03
37731686800074K970779OSTEONICS TIBIAL TRAY SCREW HOLE PLUGSLZN1997-05-09
37731687753054K970394OSTEONICS NORMALIZED AD-HA ACETABULAR COMPONENT SYSTEMMEH1997-04-22
37731239063337K965173DURATION STABILIZED UHMWPE KNEE COMPONENTSJWH1997-06-11
37732031762791K965164HOWMEDICA MODULAR REPLACEMENT SYSTEM-PROXIMAL FEMURLPH1997-03-13
37731196195955K965056OSTEONICS SCREW HOLE PLUGSJDK1997-02-28
37731995123136K964655UHMWPE HIP AND KNEE COMPONENTS - PACKAGING CHANGEJDI1997-02-06
37731821419940K963959OSTEONICS MODULAR ACETABULAR CUP (HA-COATED VERSION)MEH1996-12-19
37731454933699K963946OSTEONICS MODULAR ACETABULAR CUP (MICROSTRUCTURED VERSION)LPH1997-01-27
37731582974816K963796KINEMAX PLUS MODULAR STABILIZER FEMORAL COMPONENT AND FEMORAL SPACERSJWH1996-12-09
37731358365002K963671OSTEONICS FLANGED POLYETHYLENE ACETABULAR CUPJDI1997-02-03
37731983305438K963612DURATION STABILIZED UHMWPEJDI1997-06-11
37731651580217K962152OSTEONICS SCORPIO POSTERIORLY STABILIZED TOTAL KNEE SYSTEMJWH1996-08-14
37731715167437K962082OSTEONICS ALL POLYETHYLENE GLENOID SHOULDER COMPONENTKWS1996-08-13
37731532052263K961483DURACON ALL POLYETHYLENE PATELLA IIJWH1996-07-09
37731201355709K961482DURACON INSET PATELLA WITH CENTRAL PEGJWH1996-07-05
37731458897023K960976KINEMATIC II REPLACEMENT TIBIAL INSERTSJWH1996-08-07
37731952478423K955731OSTEONICS SHOULDER HUMERAL COMPONENTSKWS1996-03-05
37731081505858K954598OSTEONICS OFFSET HIP STEMSJDI1996-04-04
37731820971537K954559HOWMEDICCA MODULAR PROXIMAL HUMERUS REPLACEMENT SYSTEMHSD1996-07-12
37731769074157K954138DURACON MONOLITHIC STABILIZER FEMORAL COMPONENTJWH1995-11-21
37731455080784K954023OSTEONICS SECUR-FIT HA PSL EXTRA ACETABULAR COMPONENT SYSTEMMEH1995-11-22
37731787850892K953664VITALOCK SPIKED ACETABULAR SHELLLPH1995-10-23
37731247679056K952923INTRAMEDULLARY COMPRESSION ARTHRODESIS (ICA) NAILHSB1995-09-29
37731512572115K952397VITALOCK SOLID BACKED ACETABULAR SHELLLPH1995-07-21
37731911426005K951956OSTEONICS SERIES 7000 TOTAL KNEE FULL TIBIAL BONE AUGEMENTATION BLOCKS & WEDGESJWH1995-08-11
37731746095352K951932OSTEONICS RESTORATION MONOLITHIC II HIP STEM SERIESMEH1995-09-01
37732053969711K951671OSTEONICS RESTORATION MONOLITHIC II SLOTTED HIP STEM SERIESMEH1995-09-06
37731491642347K951517OSTEONICS SECUR-FIT HA PLUS HIP STEM SERIESMEH1996-01-17
37731488980993K951115HOWMEDICA VITALOCK 22MM ACERTABULAR SHELL AND SYSTEM 12 INSERTSLPH1995-06-16
37731187004250K951114SYSTEM 12 P1 26MM ACETABULAR INSERTLPH1995-06-16
37731843205503K950541HOWMEDICA V40 22MM FEMORAL HEADLWJ1995-03-21
37731487279733K950521OSTEONICS ALL POLYETHYLENE GLENOID SHOULDER COMPONENTKWS1995-06-16
37732029687810K946234OSTEONICS(R) RESTORATION MONOLITHIC II HIP STEM SERIESMEH1995-04-10
37731875355191K945639SPETZLER PINHTY1995-04-14
37731410185854K945613DURACON(TM) UNICOMPARTMENTAL FEMORAL COMPONENTHSX1995-03-06
37731517015672K945574OSTEONICS(R) CCR HIP STEM SERIESJDI1995-05-30
37731315439263K945294DALL MILES SYSTEM HOMOGENEOUS VITALLIUM CABLEJDQ1995-03-07
37731044897272K945096CDH HIP STEMLZO1995-01-19
37731346654484K945095APC FEMORAL COMPONENTLZO1995-01-19
37731077192607K945094HNR-PC HIPLZO1995-01-19
37731211635938K945093P.C.A. E-SERIES HIP- CEMENTLESS USELZO1995-01-19
37731933829504K945092P.C.A.PRIMARY HIP- CEMENTLESS USELZO1995-01-19
37731458146832K945091HOWMEDICA ALUMINA FEMORAL HEADLZO1995-01-18
37731014933627K945089SENTRY TOTAL HIPLZO1995-01-19
37731826830011K944836OSTEONICS RESTORATION MONOLITHIC II HIP STEM SERIESMEH1995-04-10
37731618886610K944592PRECISION OSTEOLOCK FEMORAL COMPONENTLPH1995-05-17
37731421835554K944285OSTEONICS SERIES 7000 TOTAL KNEE FEMORAL COMPONENTSJWH1994-12-19
37731545492341K943957RESTORATION HA ACETABULAR CUP SERIESMEH1995-03-06
37731500363617K943778OSTEONICS RESTORATION CEMENTED HIP STEM SERIESKWL1995-08-14
37731888635786K943774OSTEONICS RESTORATION MONOLITHIC HIP STEMLZO1995-03-06
37731491562990K943549RESTORATION ACETABULAR CUPJDI1994-12-19
37731632642650K943054OSTEONICS SECURE-FIT AD ACETABULAR COMPONENT SYSTEMLPH1994-10-04
37731915656396K942900OSTEONICS SECURE-FIT AD-HA ACETABULAR COMPONENT SYSTEMMEH1995-03-15
37731221420060K942809ACETABULAR DOME HOLE PLUGSJDL1994-09-20
37731694100996K941366OSTEONICS OMNIFIT AD-HA HIP STEM SERIESMEH1995-06-06
37731693517803K941141PRECISION OSTELOCK SP FEMORAL COMPONENTLPH1994-09-28
37731150014425K941128OSTEONICS SERIES 7000 BASIC FEMORAL COMPONENTSJWH1994-12-08
37731468715465K940813OSTEONICS(R) SERIES 7000 TOTAL KNEEJWH1995-01-30
37731592961103K940736HAIG NAILJDS1994-09-12
37731393030779K940715OSTEONICS OMNIFIT AD HIP STEM SERIESLPH1995-06-07
37731576784064K940713PCA MODULAR PRIMARY/REVISION PATELLAJWH1994-11-10
37731445466640K936132EXETER ALL PLASTIC ACETABULAR COMPONENTJDI1994-06-14
37731353699340K936126HOWMEDICS DRG FEMORAL COMPONENTJDI1994-10-20
37731082950174K935950FX-CABLELOK CABLE/PLATE SYSTEMJDQ1994-03-09
37731527384765K935913HOWMEDICA SENTRY S TOTAL HIP SYSTEMLZO1994-12-15
37731309435765K935875OSTEONICS SCREWLESS ACETABULAR COMPONENTSLPH1994-07-29
37731338066140K935593ANATOMIC PROPORTIONAL SHOULDER APS (HEMI-SHOULDER) SYSTEMHSD1994-10-14
37731195241951K933882OSTEONICS PS HEMI-HIP STEM SERIESLPH1995-08-14
37731742194038K933875PREMISE CEMENTED FEMORAL STEM, ADDITION STYLEJDI1994-03-01
37731932942415K933561OSTEONICS OMNIFIT FORGED HIP STEM SERIESJDI1994-03-09
37731619117562K933359OSTEONICS 22MM, +10 NECK BEARING HEADSLWJ1994-03-07
37731851847996K933102HOWMEDICA ACETABULAR SHELL W/SCREW HOLESLPH1994-05-16
37731185626753K932519OSTEONICS(R) OMNIFIT(R) NORMALIZED HIP STEMLZO1994-03-10
37731203875268K932070DURACON STABILIZER FEMORAL COMPONENT AND INSERTJWH1995-03-22

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
JWH792025-02-06
JDI692024-08-02
LPH512025-07-25
LZO402024-04-24
MEH342022-08-11
MBH172026-02-18
KWL112022-10-21
HSX102022-06-02
HSD92007-05-04
KRO82025-12-15
KWS72010-11-22
JDK71997-02-28
LZN62022-05-20
JDQ62020-10-16
HRY62015-03-20
KWZ62007-03-08
LWJ51999-11-16
HWC51994-03-01
JDG42018-03-19
JDL41994-09-20
LOD32007-01-08
KWY31994-03-01
NPJ22015-03-10
MQV22006-03-01
JDR22003-04-28
HSB21999-11-19
JDC21998-05-05
JDJ21997-06-03
KWA21988-01-14
KRR12021-06-04
MAY12013-08-16
KKY12010-10-26
MBB12007-02-26
MRA12003-02-03
KWI12001-06-19
MJT11999-07-20
KWZ 11997-06-13
HTY11995-04-14
JDS11994-09-12
LRN11990-04-23

PMA

Trident Acetabular System: Trident Alumina Inserts

2022-04-01

HOWMEDICA OSTEONICS CORP.325 Corporate Drivemahwah, NJ 07430 PMA NumberP000013 Supplement NumberS020 Date Received03/03/2022 Decision Date04/01/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Typespecial (immediate Track) Supplement Reason L...

Trident(R) Acetabular System

2022-03-01

HOWMEDICA OSTEONICS CORP.325 Corporate Drivemahwah, NJ 07430 PMA NumberP000013 Supplement NumberS019 Date Received02/03/2022 Decision Date03/01/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Chang...

TRIDENT

2015-11-05

HOWMEDICA OSTEONICS CORP.

PMN

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GUDID

200 records. Showing 1-40. Next