Data / Medical devices / Ireland / Stryker Ireland Osteonics
Stryker Ireland Osteonics: FDA-registered device maker in County Cork, Ireland, 135 510(k) clearances and 1 PMA approval
Stryker Ireland Osteonics is registered with the FDA (registration 9616680) in County Cork, Ireland. It lists 43 device types. The FDA files 135 510(k) clearances and 1 PMA approval under its listings, the newest dated August 6, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9616680
- FEI number
- 3002459190
- Address
- Tullagreen Building, IDA Business & Technology Park Carrigtwohill, County Cork, Ireland, T45 HE42
- Owner or operator
- STRYKER CORP. (1811755)
- Roles
- Contract manufacturer, Manufacturer, Specification developer
- First device listed
- November 23, 1992
- Registered through
- 2027
- Brand names listed
- ., 10mm SUBFIX TRIAL, 11.5mm SUBFIX TRIAL, 135 mm Reusable Slat, SE Retr, 10 Pack, 155 mm Reusable Slat, SE Retr, 10 Pack, 175mm Reusable Slat, SE Retr, 10 Pack, 206-716 w/2 small sculps/pkg, 234-112-100 VersiQuad Halo Retractor 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 135.
| 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 |
| July 10, 2026 | K261624 | Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar Component | LPH | 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 |
| July 25, 2025 | K250989 | Stryker and Serf hip devices | LPH | Substantially Equivalent | Howmedica Osteonics Corp (Dba Stryker Orthopaedics) | accessdata.fda.gov |
| February 6, 2025 | K243817 | Scorpio 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 Insert | JWH | Substantially Equivalent | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | accessdata.fda.gov |
| February 6, 2025 | K243784 | Stryker Orthopaedics Hip Devices Labeling Update | LPH | 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 |
| April 24, 2024 | K234025 | 22.2mm BIOLOX® delta Ceramic V40 Femoral Heads | LZO | 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 |
| January 20, 2023 | K223528 | Triathlon® Hinge Knee System | KRO | Substantially Equivalent | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | accessdata.fda.gov |
| August 11, 2022 | K220731 | Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem | MEH | Substantially Equivalent | Stryker | accessdata.fda.gov |
| May 20, 2022 | K220838 | Artisan Bone Plug, Universal Cement Restrictor | LZN | Substantially Equivalent | Howmedica Osteonics, Dba Stryker Orthopaedics | accessdata.fda.gov |
| March 1, 2022 | K212187 | Restoration® Modular Hip System | LPH | Substantially Equivalent | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | accessdata.fda.gov |
| December 21, 2021 | K213129 | Restoration Modular 115mm Conical Distal Stem | LZO | Substantially Equivalent | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | accessdata.fda.gov |
| August 16, 2021 | K211703 | Insignia Hip Stem | MEH | Substantially Equivalent | Stryker Orthopaedics | accessdata.fda.gov |
| October 16, 2020 | K202016 | Dall-Miles® Cable System | JDQ | 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 27, 2020 | K193233 | Restoration® Modular Hip System | LPH | Substantially Equivalent | Howmedica Osteonics Corp. (Aka Stryker Orthopaedics) | accessdata.fda.gov |
| October 24, 2019 | K191358 | Trident II Acetabular System | LPH | Substantially Equivalent | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | accessdata.fda.gov |
| August 15, 2019 | K190991 | Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment | MBH | Substantially Equivalent | Howmedica Osteonics Corp. (Aka Stryker Orthopaedics) | accessdata.fda.gov |
| March 19, 2019 | K182468 | Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System | LPH | Substantially Equivalent | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | 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 |
| October 30, 2017 | K172326 | Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System | JWH | Substantially Equivalent | Stryker Orthopaedics | accessdata.fda.gov |
| October 2, 2017 | K171768 | Trident® II Acetabular System | LPH | Substantially Equivalent | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | accessdata.fda.gov |
| October 14, 2016 | K161569 | Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws | LPH | Substantially Equivalent | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | accessdata.fda.gov |
| May 25, 2016 | K153345 | Stryker Orthopaedics Hip Systems Labeling Update | LPH | Substantially Equivalent | Stryker Orthopaedics | accessdata.fda.gov |
| February 9, 2015 | K143085 | Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use with the Direct Superior Approach | LPH | Substantially Equivalent | Stryker Orthopaedics | accessdata.fda.gov |
| January 13, 2015 | K143393 | Triathlon Tritanium Cone Augments | MBH | Substantially Equivalent | Stryker Orthopaedics | accessdata.fda.gov |
| August 5, 2014 | K141056 | TRIATHLON KNEE SYSTEM POSTERIOR STABILIZED COMPONENTS | MBH | Substantially Equivalent | Stryker Orthopaedics | accessdata.fda.gov |
| November 26, 2013 | K132624 | TRIATHLON TRITANIUM METAL-BACKED PATELLA | MBH | Substantially Equivalent | Stryker Orthopaedics | accessdata.fda.gov |
| August 16, 2013 | K123604 | ABG III MONOLITHIC HIP STEM | MAY | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| May 3, 2013 | K123486 | TRIATHLON TRITANIUM TIBIAL BASEPLATE | MBH | Substantially Equivalent | Stryker | 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 |
| July 30, 2012 | K121308 | HIP SYSTEMS | LPH | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| March 29, 2012 | K120578 | ACCOLADE II HIP STEM | JDI | Substantially Equivalent | Howmedica Osteonics | 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 |
| September 27, 2011 | K110290 | EXETER HIP STEM | JDI | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| May 25, 2011 | K110807 | ABG II MONOLITHIC HIP STEM | MAY | Substantially Equivalent | Stryker Corp. | accessdata.fda.gov |
| March 10, 2011 | K103479 | NOVEL TAPERED HIP STEM | MEH | Substantially Equivalent | Stryker 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 |
| July 22, 2008 | K081171 | TRITANIUM ACETABULAR SHELL SYSTEM | LPH | 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 |
| October 18, 2007 | K072020 | RESTORATION ADM SYSTEM | MEH | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| May 16, 2007 | K070885 | UNIVERSAL TAPER DELTA FEMORAL HEAD | LZO | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| March 2, 2007 | K070170 | DALL-MILES SYSTEM | HRS | Substantially Equivalent | Stryker Orthopaedics | accessdata.fda.gov |
| January 13, 2006 | K053528 | SHORT CITATION FEMORAL STEM | MEH | Substantially Equivalent | Stryker Orthopaedics | accessdata.fda.gov |
| December 27, 2005 | K052917 | STRYKER COMPARTMENTAL KNEE SYSTEM | NPJ | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| October 27, 2005 | K052718 | V40 BIOLOX DELTA CERAMIC FEMORAL HEADS | LZO | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| July 12, 2005 | K051588 | BIOLOX DELTA CERAMIC FEMORAL HEADS | LZO | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| June 23, 2005 | K051363 | RESTORATION MODULAR SYSTEM | JDI | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| March 21, 2005 | K050138 | MODIFICATION TO: RESTORATION MODULAR SYSTEM | JDI | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| February 11, 2005 | K041940 | HOWMEDICA OSTEONICS ZIRCONIA-TOUGHENED-ALUMINA (BIOLOX DELTA) CERAMIC FEMORAL HEADS | LZO | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| February 10, 2005 | K033716 | TRIDENT ACETABULAR SYSTEM | LPH | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| February 9, 2005 | K042343 | SCORPIO NRG KNEE SYSTEM | JWH | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| September 23, 2004 | K041591 | SCORPIO-FLEX POSTERIOR STABILIZED TIBIAL INSERT COMPONENTS | JWH | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| August 25, 2004 | K040734 | MODIFICATION TO RESTORATION MODULAR SYSTEM | LZO | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| May 28, 2004 | K040964 | SCORPIO TOTAL KNEE SYSTEM - POSTERIOR STABILIZED TIBIAL INSERTS | JWH | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| April 12, 2004 | K033972 | SCORPIO TOTAL KNEE SYSTEM | MBH | 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 |
| November 20, 2003 | K030978 | SCORPIO NRG KNEE SYSTEM | JWH | 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 |
| August 29, 2003 | K031730 | 36MM ORTHINOX V40 FEMORAL HEAD COMPONENTS | JDI | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| January 28, 2003 | K023901 | ALUMINA V40 FEMORAL HEADS | LZO | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| October 9, 2002 | K023102 | ACCOLADE TMZF PLUS HA 127 SIZE 0 HIP STEM | MEH | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| September 23, 2002 | K022549 | RESTORATION MODULAR SYSTEM | LZO | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| April 3, 2002 | K013106 | 2 PIECE MODULAR HIP STEM | LZO | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| March 4, 2002 | K020572 | ACCOLADE TMZF HA 132 DEGREE SIZE 0 HIP STEM | MEH | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| December 5, 2001 | K013676 | TRIDENT HEMISPHERICAL ACETABULAR SHELLS | MEH | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| October 10, 2001 | K012172 | DURACON PS LIPPED TIBIAL INSERT | JWH | Substantially Equivalent | Howmedica Osteonics | accessdata.fda.gov |
| June 28, 2001 | K011643 | SCORPIO CR SUPERFLEX TIBIAL INSERT | JWH | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| June 15, 2001 | K011623 | EXETER HIP SYSTEM WITH V40 TAPER | JDI | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| April 11, 2001 | K010757 | LFIT V40 FEMORAL HEAD COMPONENTS | JDI | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| November 28, 2000 | K003391 | OSTEONICS ALUMINA C-TAPER HEAD | LZO | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| March 16, 2000 | K994366 | TMZF PRESS FIT HA STEM AND TMZF PRESS FIT PLUS HA STEM | MEH | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| March 10, 2000 | K000091 | DURACON SYMMETRIC METAL-BACKED PATELLAR COMPONENT | JWH | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| March 6, 2000 | K994128 | SCORPIO TOTAL STABLIZER (TS) TOTAL KNEE SYSTEM | JWH | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| January 21, 2000 | K993768 | CITATION TMZF HA STEM | MEH | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| December 2, 1999 | K993692 | DURACON INSET PATELLA, 25MM | JWH | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| November 19, 1999 | K993352 | CROSSFIRE SYSTEM 12 ACETABULAR INSERTS | LPH | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| November 16, 1999 | K993601 | HOWMEDICA OSTEONICS FEMORAL HEADS | LWJ | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| September 1, 1999 | K992570 | UNITRAX C-TAPER NECK ADJUSTMENT SLEEVE | KWL | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| June 29, 1999 | K991952 | OSTEONICS ALUMINA C-TAPER HEAD, OSTEONICS TRIDENT POLYETHYLENE INSERTS | LZO | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| December 16, 1998 | K983502 | OSTEONICS SECUR-FIT AD GENERATION II ACETABULAR COMPONENT SYSTEM | LPH | Substantially Equivalent | Osteonics Corp. | accessdata.fda.gov |
| December 11, 1998 | K983382 | OSTEONICS HA GENERATION II ACETABULAR COMPONENT SYSTEM | MEH | Substantially Equivalent | Osteonics Corp. | accessdata.fda.gov |
| September 22, 1998 | K974685 | OSTEONICS POLYETHYLENE ACETABULAR COMPONENTS | JDI | Substantially Equivalent | Osteonics Corp. | accessdata.fda.gov |
| July 9, 1998 | K982032 | OSTEONICS OMNIFIT HA HIP STEM SERIES, OSTEONICS SECUR-FIT HA HIP STEM SERIES, OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS | MEH | Substantially Equivalent | Osteonics Corp. | 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 |
| December 5, 1997 | K972228 | MERIDIAN TITANIUM FEMORAL STEMS | LZO | Substantially Equivalent for Some Indications | 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 |
| November 3, 1997 | K972928 | KERBOULL CROSS | JDI | Substantially Equivalent for Some Indications | Howmedica, Inc. | accessdata.fda.gov |
| October 29, 1997 | K972863 | DURATION STABILIZED UHMWPE KNEE COMPONENTS | JWH | Substantially Equivalent | Howmedica Corp. | accessdata.fda.gov |
| July 16, 1997 | K971741 | DALL-MILES HOMOGENEOUS STAINLESS STEEL CABLE AND BEADED CABLE | JDQ | Substantially Equivalent | Howmedica Corp. | accessdata.fda.gov |
| July 9, 1997 | K971409 | OSTEONICS ALUMINA C-TAPER HEAD | LZO | Substantially Equivalent | Osteonics Corp. | accessdata.fda.gov |
| April 9, 1997 | K970200 | RELIANCE PF FEMORAL STEMS | LZO | Substantially Equivalent | Howmedica Corp. | accessdata.fda.gov |
| February 13, 1997 | K963940 | EXETER MESH | JDJ | Substantially Equivalent | Howmedica, Inc. | accessdata.fda.gov |
| February 6, 1997 | K964655 | UHMWPE HIP AND KNEE COMPONENTS - PACKAGING CHANGE | JDI | Substantially Equivalent | Howmedica Corp. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| February 3, 2003 | P000013 | TRIDENT SYSTEM | MRA | 26 | September 17, 2025 | accessdata.fda.gov |
Compare with other makers
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- All makers of Cerclage, Fixation
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.