Data / Medical devices / Ireland / Howmedica International S. De R.L.
Howmedica International S. De R.L.: FDA-registered device maker in LIMERICK Munster, Ireland, 101 510(k) clearances
Howmedica International S. De R.L. is registered with the FDA (registration 9610726) in LIMERICK Munster, Ireland. It lists 39 device types. The FDA files 101 510(k) clearances under its listings, the newest dated August 6, 2026. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 9610726
- FEI number
- 3002807172
- Address
- Raheen Business Park, LIMERICK Munster, Ireland, V94 X6T4
- Owner or operator
- STRYKER CORP. (1811755)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- June 9, 2000
- Registered through
- 2027
- Brand names listed
- 10mm SUBFIX TRIAL, 11.5mm SUBFIX TRIAL, 206-716 w/2 small sculps/pkg, 3MM DBL SLEEVE 80MM TROC/ASSY, 3mm PREDRILL ASSEMBLY LONG, 3mm PREDRILL ASSEMBLY SHORT, 4MM DBL SLVE 180MM TROC/ASSY, 4mm DBL SLEEVE 150mm TROC/ASSY and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 101.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 6, 2026 | K261898 | Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System | KRO | Substantially Equivalent | Howmedica Osteonics Corp. dba Stryker Orthopaedics | accessdata.fda.gov |
| December 15, 2025 | K252898 | Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge Bumper | KRO | Substantially Equivalent | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | accessdata.fda.gov |
| October 24, 2025 | K252044 | Triathlon® Total Knee System - Triathlon® Gold Femoral Components | MBH | Substantially Equivalent | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | accessdata.fda.gov |
| July 25, 2025 | K251665 | Triathlon® Hinge Knee System | KRO | Substantially Equivalent | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | accessdata.fda.gov |
| December 4, 2024 | K242831 | Triathlon 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 System | JWH | Substantially Equivalent | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | accessdata.fda.gov |
| August 2, 2024 | K241716 | Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component | JDI | Substantially Equivalent | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | accessdata.fda.gov |
| April 12, 2024 | K240418 | Stryker Orthopaedics Hip Systems Labeling Update | JDI | Substantially Equivalent | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | accessdata.fda.gov |
| December 21, 2023 | K233498 | Stryker Orthopaedics Hip Systems Labeling Update | LPH | Substantially Equivalent | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | accessdata.fda.gov |
| December 8, 2023 | K233261 | Global Modular Replacement System | JDI | Substantially Equivalent | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | accessdata.fda.gov |
| May 19, 2023 | K230416 | Triathlon® Hinge Knee System; Triathlon® Revision Insert X3® | KRO | Substantially Equivalent | Stryker | accessdata.fda.gov |
| April 21, 2023 | K223069 | Modular Rotating Hinge Knee Systems and Compatible Components | KRO | Substantially Equivalent | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | accessdata.fda.gov |
| January 26, 2023 | K222056 | Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee | JDI | Substantially Equivalent | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | accessdata.fda.gov |
| January 20, 2023 | K223528 | Triathlon® Hinge Knee System | KRO | Substantially Equivalent | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | accessdata.fda.gov |
| June 25, 2021 | K211238 | SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone Cement | NDN | Substantially Equivalent | Stryker Instruments | accessdata.fda.gov |
| June 4, 2021 | K211303 | Avon Patello-femoral Joint Prosthesis | KRR | Substantially Equivalent | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | accessdata.fda.gov |
| August 13, 2020 | K193429 | Exeter V40 Femoral Stem, Exeter X3 RimFit Cup | JDI | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| May 13, 2020 | K200782 | Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon Cruciate Retaining Femoral Component - beaded with Peri-Apatite | MBH | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| March 31, 2020 | K192818 | Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal System | PML | Substantially Equivalent | Stryker Corporation | accessdata.fda.gov |
| August 28, 2019 | K191414 | EXETER Centralizer, EXETER 2.5mm Plug | JDI | Substantially Equivalent | Stryker Orthopaedics | accessdata.fda.gov |
| August 22, 2019 | K190402 | Triathlon Total Knee System-Additional Components | JWH | Substantially Equivalent | Stryker Orthopaedics (Aka Howmedica Osteonics Corp.) | accessdata.fda.gov |
| March 19, 2018 | K173499 | Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads | JDG | Substantially Equivalent | Stryker Orthopaedics | accessdata.fda.gov |
| February 2, 2018 | K173849 | Triathlon Total Knee System | MBH | Substantially Equivalent | Stryker Orthopaedics | accessdata.fda.gov |
| November 16, 2017 | K172634 | Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components | MBH | Substantially Equivalent | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | accessdata.fda.gov |
| October 30, 2017 | K172326 | Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System | JWH | Substantially Equivalent | Stryker Orthopaedics | accessdata.fda.gov |
| May 25, 2016 | K153345 | Stryker Orthopaedics Hip Systems Labeling Update | LPH | Substantially Equivalent | Stryker Orthopaedics | accessdata.fda.gov |
| September 2, 2015 | K143661 | DirectInject | GXP | Substantially Equivalent | Stryker | accessdata.fda.gov |
| June 12, 2015 | K150582 | Vertaplex® High Viscosity (HV) Radiopaque Bone Cement | NDN | Substantially Equivalent | Stryker Corporation | accessdata.fda.gov |
| August 5, 2014 | K141056 | TRIATHLON KNEE SYSTEM POSTERIOR STABILIZED COMPONENTS | MBH | Substantially Equivalent | Stryker Orthopaedics | accessdata.fda.gov |
| May 3, 2013 | K123486 | TRIATHLON TRITANIUM TIBIAL BASEPLATE | MBH | Substantially Equivalent | Stryker | accessdata.fda.gov |
| March 15, 2013 | K123225 | BONOS R 1X20, BONOS R 2X20, BONOS R 1X40, BONOS R 2X40, BONOS R 1X60 | LOD | Substantially Equivalent | Aap Biomaterials GmbH & Co. KG | accessdata.fda.gov |
| March 7, 2013 | K123081 | BONOS R GENTA 1X20 MODEL 01-0228; BONOS R GENTA 2X20 MODEL 01-0229; BONOS R GENTA 1X40 MODEL 01-0217; BONOS R GENTA 2X40 | LOD | Substantially Equivalent | Aap Biomaterials GmbH & Co. KG | accessdata.fda.gov |
| February 22, 2013 | K122015 | DISTAL FEMORAL GROWING PROSTHESIS, TIBIAL ROTATING COMPONENTS, BEARING, AXIS, CIRCLIP, WEDGE | KRO | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| February 14, 2013 | K123166 | TRIATHLON ALL-POLYETHYLENE CONDYLAR STABILIZING (CS) TIBIAL IMPLANTS TRIATHLON ALL-POLYETHYLENE POSTERIOR STABILIZING (P | JWH | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| October 5, 2011 | K111848 | EXETER X3 RIMFIT ACETABULAR CUP | JDI | Substantially Equivalent | Stryker Corp. | accessdata.fda.gov |
| September 28, 2011 | K112556 | ADM AND ADM/MDM DURATION INSERTS, ADM AND ADM/MDM X3 INSERTS | MEH | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| February 3, 2011 | K103233 | MODULAR DUAL MOBILITY LINER, X3 ACETABULAR INSERT | LZO | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| December 18, 2009 | K093644 | RESTORATION ADM SYSTEM X3 ACETABULAR | MEH | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| January 7, 2008 | K072575 | TRIATHLON SCREW-FIXATION TIBIAL BASEPLATE | MBH | Substantially Equivalent | Stryker Orthopaedics | accessdata.fda.gov |
| May 11, 2007 | K070883 | DURACON X3 CS TIBIAL INSERT | MBH | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| February 26, 2007 | K063857 | SIMPLEX P SPEEDSET WITH TOBRAMYCIN BONE CEMENT | MBB | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| January 22, 2007 | K063423 | TRIATHLON CS (CONDYLAR STABILIZING) LIPPED INSERT | JWH | Substantially Equivalent | Howmedica Osteonics | accessdata.fda.gov |
| January 8, 2007 | K062553 | SIMPLEX P BONE CEMENT | LOD | Substantially Equivalent | Stryker Orthopaedics | accessdata.fda.gov |
| August 11, 2006 | K061521 | TRIATHLON METAL BACKED PATELLA | MBH | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| August 3, 2006 | K062037 | TRIATHLON LOW PROFILE TIBIAL TRAY | JWH | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| March 15, 2006 | K060360 | HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE WITH OFFSET ADAPTERS | KRO | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| January 26, 2006 | K053198 | SIMPLEX P SPEEDSET BONE CEMENT | LOD | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| December 27, 2005 | K052917 | STRYKER COMPARTMENTAL KNEE SYSTEM | NPJ | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| October 21, 2005 | K051948 | AVON PATELLO-FEMORAL JOINT PROSTHESIS | KRR | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| August 30, 2005 | K051380 | TRIATHLON PRESS-FIT TOTAL KNEE SYSTEM | MBH | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| July 13, 2005 | K051146 | TRIATHLON KNEE SYSTEM | JWH | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| March 29, 2005 | K050539 | SIZE 1 TRIATHLON POSTERIOR STABILIZED (PS) TIBIAL INSERT | JWH | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| February 10, 2005 | K033716 | TRIDENT ACETABULAR SYSTEM | LPH | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| January 12, 2005 | K042993 | TRIATHLON POSTERIORLY STABILIZED (PS) FEMORAL COMPONENT | JWH | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| November 23, 2004 | K042883 | SIZE 1 TRIATHLON CRUCIATE RETAINING (CR) TIBIAL INSERT | JWH | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| June 17, 2004 | K040749 | MODULAR REPLACEMENT SYSTEM CEMENTED STEMS | KRO | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| May 27, 2004 | K041160 | AVON EXTRA-SMALL PATELLO-FEMORAL REPLACEMENT | KRR | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| May 25, 2004 | K032945 | SIMPLEX X | LOD | Substantially Equivalent | Stryker Corp. | accessdata.fda.gov |
| May 5, 2004 | K040267 | TRIATHLON CRUCIATE RETAINING (CR) TOTAL KNEE | JWH | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| March 26, 2004 | K040128 | MODIFICATION TO MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEMS | HSD | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| January 15, 2004 | K033342 | SCORPIO KNEE SYSTEM - TIBIAL INSERTS | JWH | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| October 9, 2003 | K032581 | GLOBAL MODULAR REPLACEMENT SYSTEM ANTEVERTED PROMIMAL FEMORAL COMPONENT | LPH | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| September 12, 2003 | K032163 | DURACON TOTAL KNEE SYSTEM | MBH | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| September 11, 2003 | K032418 | DURACON TOTAL KNEE SYSTEM WITH PERI-APATITE COATING | MBH | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| September 2, 2003 | K031729 | TRIATHLON POSTERIORLY STABILIZED (PS) TOTAL KNEE SYSTEM | JWH | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| August 8, 2003 | K032264 | MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEM | HSD | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| July 31, 2003 | K031480 | GLOBAL MODULAR REPLACEMENT SYSTEM PEDIATRIC TIBIAL BEARING COMPONENT | KRO | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| May 6, 2003 | K014199 | SURGICAL SIMPLEX P WITH TOBRAMYCIN | LOD | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| February 3, 2003 | K023724 | DURACON CS LIPPED EXTRA SMALL TIBIAL INSERT | JWH | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| December 16, 2002 | K023087 | GLOBAL MODULAR REPLACEMENT SYSTEM (GMRS) | KRO | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| October 18, 2002 | K021451 | DURACON CS TIBIAL INSERT | JWH | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| October 17, 2002 | K022403 | GMRS PRESS FIT STEMS WITH PUREFIX HA | LZO | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| April 11, 2002 | K020841 | AVON PATELLAR COMPONENT | KRR | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| November 13, 2000 | K002552 | HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE | KRO | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| July 27, 2000 | K001385 | HOWMEDICA OSTEONICS RADIAL HEAD PROTHESIS | KWI | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| July 25, 2000 | K001957 | MODULAR ROTATING HINGE KNEE TIBIAL ROTATING COMPONENT | KRO | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| June 7, 2000 | K001548 | MODULAR ROTATING HINGE KNEE CROSSOVER TIBIAL BEARING COMPONENTS | KRO | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| March 13, 2000 | K994207 | HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE | KRO | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| August 12, 1999 | K992346 | KINEMATIC II ROTATING HINGE KNEE | LGE | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| February 5, 1999 | K984202 | HOWMEDICA HUMERAL INTERCALARY SYSTEM | HSD | Substantially Equivalent | Howmedica, Inc. | accessdata.fda.gov |
| June 2, 1998 | K980843 | EXETER INTRAMEDULLARY BONE PLUG | JDI | Substantially Equivalent | Howmedica, Inc. | accessdata.fda.gov |
| February 27, 1998 | K974556 | OSTEONICS SCORPIO POSTERIOR CRUCIATE RETAINING TOTAL KNEE SYSTEM | JWH | Substantially Equivalent | Osteonics Corp. | accessdata.fda.gov |
| December 23, 1997 | K974054 | DISTAL CENTRALIZER, EXETER II HIP SYSTEM | JDI | Substantially Equivalent | Howmedica, Inc. | accessdata.fda.gov |
| November 20, 1997 | K973164 | HOWMEDICA TOTAL STABILIZER KNEE COMPONENTS | JWH | Substantially Equivalent for Some Indications | Howmedica Corp. | accessdata.fda.gov |
| October 29, 1997 | K972864 | DURATION STABILIZED UHMWPE KNEE COMP., WEAR CLAIMS | JWH | Substantially Equivalent | Howmedica Corp. | accessdata.fda.gov |
| October 29, 1997 | K972863 | DURATION STABILIZED UHMWPE KNEE COMPONENTS | JWH | Substantially Equivalent | Howmedica Corp. | accessdata.fda.gov |
| March 13, 1997 | K965164 | HOWMEDICA MODULAR REPLACEMENT SYSTEM-PROXIMAL FEMUR | LPH | Substantially Equivalent | Howmedica Corp. | accessdata.fda.gov |
| February 24, 1997 | K964951 | KINEMAX PLUS TIBIAL SPACERS | JWH | Substantially Equivalent for Some Indications | Howmedica Corp. | accessdata.fda.gov |
| February 6, 1997 | K964655 | UHMWPE HIP AND KNEE COMPONENTS - PACKAGING CHANGE | JDI | Substantially Equivalent | Howmedica Corp. | accessdata.fda.gov |
| August 14, 1996 | K962152 | OSTEONICS SCORPIO POSTERIORLY STABILIZED TOTAL KNEE SYSTEM | JWH | Substantially Equivalent for Some Indications | Osteonics Corp. | accessdata.fda.gov |
| July 12, 1996 | K954559 | HOWMEDICCA MODULAR PROXIMAL HUMERUS REPLACEMENT SYSTEM | HSD | Substantially Equivalent | Howmedica Corp. | accessdata.fda.gov |
| January 17, 1996 | K952970 | HOWMEDICA FEMORAL & PROXIMAL TIBIAL MODULAR REPLACEMENT SYTESM | JDI | Substantially Equivalent | Howmedica Corp. | accessdata.fda.gov |
| August 18, 1995 | K936292 | PACKAGING AND MANUFACTURING METHODS CHANGE/KNEE COMPONENTS | LPH | Substantially Equivalent | Howmedica Corp. | accessdata.fda.gov |
| February 22, 1994 | K924482 | HOWMEDICAL TOTAL KNEE STEM EXTENDER | JWH | Substantially Equivalent | Howmedica Corp. | accessdata.fda.gov |
| September 8, 1992 | K921640 | KINEMAX PLUS ALL PLASTIC TIBIAL COMPONENT | JWH | Substantially Equivalent | Howmedica Corp. | accessdata.fda.gov |
| August 18, 1992 | K915512 | DURACON TOTAL KNEE SYSTEM TIBIAL COMPONENTS | JWH | Substantially Equivalent for Some Indications | Pfizer Hospital Products Group, Inc. | accessdata.fda.gov |
| June 21, 1991 | K910235 | PCA MTK II TOTAL KNEE SYSTEM | JWH | Substantially Equivalent for Some Indications | Howmedica Corp. | accessdata.fda.gov |
| May 6, 1991 | K910500 | HOWMEDICA KINEMAX PLUS TOTAL KNEE SYSTEM | JWH | Substantially Equivalent for Some Indications | Howmedica Corp. | accessdata.fda.gov |
| April 1, 1991 | K904208 | KINEMAX SUPERSTABILIZER TOTAL KNEE SYSTEM | JWH | Substantially Equivalent | Howmedica Corp. | accessdata.fda.gov |
| January 4, 1990 | K896452 | KINEMAX TIBIAL STEM EXTENSION | JWH | Substantially Equivalent | Howmedica Corp. | accessdata.fda.gov |
| July 1, 1981 | K811630 | KINEMATIC ROTATING HINGE TOTAL KNEE PR. | LGE | Substantially Equivalent | Howmedica Corp. | accessdata.fda.gov |
Compare with other makers
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- All makers of Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- All makers of Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- All makers of Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- All makers of Cement, Bone, Vertebroplasty
Updated August 6, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.