Company ยท US
Howmedica Osteonics Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1999 to 2020. Name variants (Inc, Corp, punctuation) are merged.
301510(k) clearances (0 in 12 months)
251recalls (20 in 12 months)
224recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 93 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 47 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 39 |
| LTF | Stimulator, Salivary System | 35 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | 29 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 28 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 26 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | 22 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 20 |
| JDB | Prosthesis, Elbow, Semi-Constrained, Cemented | 18 |
| KWI | Prosthesis, Elbow, Hemi-, Radial, Polymer | 18 |
| HRS | Plate, Fixation, Bone | 16 |
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | 10 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 10 |
| LXH | Orthopedic Manual Surgical Instrument | 10 |
| LXT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | 9 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 9 |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | 7 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 7 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | 6 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 13, 2020 | K193429 | Exeter V40 Femoral Stem, Exeter X3 RimFit Cup Howmedica Osteonics Corp. | JDI |
| May 13, 2020 | K200782 | Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon Cruciate Retaining Femoral Compon Howmedica Osteonics Corp. | MBH |
| Dec 27, 2013 | K130895 | REUNION RSA SHOULDER SYSTEM Howmedica Osteonics Corp. | PHX |
| Aug 16, 2013 | K123604 | ABG III MONOLITHIC HIP STEM Howmedica Osteonics Corp. | MAY |
| Feb 22, 2013 | K122015 | DISTAL FEMORAL GROWING PROSTHESIS, TIBIAL ROTATING COMPONENTS, BEARING, AXIS, CIRCLIP, WEDGE Howmedica Osteonics Corp. | KRO |
| Feb 14, 2013 | K123166 | TRIATHLON ALL-POLYETHYLENE CONDYLAR STABILIZING (CS) TIBIAL IMPLANTS TRIATHLON ALL-POLYETHYLENE POSTERIOR STABILIZING (P Howmedica Osteonics Corp. | JWH |
| Feb 1, 2013 | K122853 | NOVEL FIT AND FILL STEM Howmedica Osteonics Corp. | MEH |
| Nov 1, 2012 | K121315 | STRYKER CMF MEDPOR CUSTOMIZED IMPLANT Howmedica Osteonics Corp. | FWP |
| Jul 30, 2012 | K121308 | HIP SYSTEMS Howmedica Osteonics Corp. | LPH |
| Mar 29, 2012 | K120578 | ACCOLADE II HIP STEM Howmedica Osteonics | JDI |
| Feb 15, 2012 | K113409 | S2 FEMORAL A/R NAIL S2 FEMORAL COMRESSION NAIL S2 TIBIAL NAIL S2 TIBIAL COMPRESSION NAIL Howmedica Osteonics Corp. | HSB |
| Sep 28, 2011 | K112556 | ADM AND ADM/MDM DURATION INSERTS, ADM AND ADM/MDM X3 INSERTS Howmedica Osteonics Corp. | MEH |
| Sep 27, 2011 | K110290 | EXETER HIP STEM Howmedica Osteonics Corp. | JDI |
| May 5, 2011 | K103835 | REUNION TSA SYSTEM-HUMERAL PRESS-FIT & CEMENTED STEMS MODEL 5569-YY-20XX (YY=P,C; XX=07-17,06L-12L) REUNION TSA SYSTEM N Howmedica Osteonics Corp. | KWS |
| Apr 11, 2011 | K101072 | TRITANIUM PERI-APATITIE ACETABULAR SOLID-BACKED SHELL, TRITANIUM PERI-APATITE Howmedica Osteonics Corp. | LPH |
| Mar 3, 2011 | K102019 | RESTORATION ACETABULAR WEDGE AUGMENTS Howmedica Osteonics | LPH |
| Feb 3, 2011 | K103233 | MODULAR DUAL MOBILITY LINER, X3 ACETABULAR INSERT Howmedica Osteonics Corp. | LZO |
| Dec 22, 2010 | K102992 | T2 RECON NAIL, R1500, LEFT/RIGHT 125 DEGREES / 120 DEGREES / 130 DEGREES Howmedica Osteonics Corp. | HSB |
| Nov 22, 2010 | K103104 | SPECIAL ORTHOPAEDIC SOLUTIONS GLENOID SHOULDER COMPONENT Howmedica Osteonics Corp. | KWS |
| Jun 25, 2010 | K100884 | STRYKER KNIFELIGHT Howmedica Osteonics Corp. | FTD |
| Jun 17, 2010 | K101438 | T2 GREATER TROCHANTER NAIL Howmedica Osteonics Corp. | HSB |
| May 14, 2010 | K100271 | VARI AX DISTAL RADIUS LINE EXTENSIONS OF XXL PLATES Howmedica Osteonics Corp. | HRS |
| May 13, 2010 | K101056 | VARIAX ELBOW SYSTEM Howmedica Osteonics Corp. | HRS |
| Apr 30, 2010 | K100475 | AXSOS LOCKED PLATING SYSTEM LINE EXTENSION OF 5MM LOCKING INSERTS Howmedica Osteonics Corp. | HRS |
| Apr 2, 2010 | K091955 | STRYKER SONICPIN SYSTEM Howmedica Osteonics Corp. | HTY |
| Jan 28, 2010 | K093433 | VARIAX ELBOW SYSTEM PLATE LINE EXTENSION Howmedica Osteonics Corp. | HRS |
| Dec 18, 2009 | K093644 | RESTORATION ADM SYSTEM X3 ACETABULAR Howmedica Osteonics Corp. | MEH |
| Nov 20, 2009 | K092178 | AXSOS STRYKER LOCKED PLATING SYSTEM LINE EXTENSION OF CABLE PLUGS Howmedica Osteonics Corp. | HRS |
| Nov 4, 2009 | K092406 | ABG II MODULAR HIP STEM Howmedica Osteonics Corp. | MEH |
| Oct 23, 2009 | K090897 | TRITANIUM NON-MODULAR SHELL & X3 ALL-POLY INSERT Howmedica Osteonics Corp. | LPH |
| Oct 20, 2009 | K092561 | REJUVENATE MODULAR STEM Howmedica Osteonics Corp. | MEH |
| Oct 8, 2009 | K092834 | HOFFMAN XPRESS LINE EXTENSION Howmedica Osteonics Corp. | KTT |
| Sep 23, 2009 | K092671 | VARIAX ELBOW SYSTEM LINE EXTENSION Howmedica Osteonics Corp. | HRS |
| Sep 1, 2009 | K092419 | AXSOS LOCKED PLATING SYSTEM LINE EXTENSION OF 3MM LOCKING INSERTS Howmedica Osteonics Corp. | HRS |
| Jun 16, 2009 | K091161 | REJUVENATE MONOLITHIC SIZE 4 HIP STEM Howmedica Osteonics Corp. | MEH |
| Dec 29, 2008 | K082892 | REJUVENATE MONOLITHIC HIP SYSTEM Howmedica Osteonics Corp. | MEH |
| Dec 18, 2008 | K083437 | MODIFICATION TO T2 RECON NAIL SYSTEM Howmedica Osteonics Corp. | HSB |
| Oct 10, 2008 | K082018 | T2 FLEXIBLE NAIL Howmedica Osteonics Corp. | HSB |
| Oct 3, 2008 | K082567 | STRYKER COMPARTMENTAL KNEE SYSTEM LINE EXTENSION Howmedica Osteonics Corp. | HRY |
| Jul 22, 2008 | K081171 | TRITANIUM ACETABULAR SHELL SYSTEM Howmedica Osteonics Corp. | LPH |
| Jul 18, 2008 | K081284 | VARIAX DISTAL FIBULA PLATE Howmedica Osteonics Corp. | KTT |
| Jun 10, 2008 | K081152 | T2 FEMORAL NAIL Howmedica Osteonics Corp. | HSB |
| Jun 3, 2008 | K081044 | REJUVENATE MODULAR HIP SYSTEM Howmedica Osteonics Corp. | MEH |
| May 29, 2008 | K081278 | OMEGA 3 TROCHANTERIC STABILIZING PLATE Howmedica Osteonics Corp. | KTT |
| Mar 19, 2008 | K080667 | VARIAX DISTAL RADIUS TORX SCREWS Howmedica Osteonics Corp. | HRS |
| Feb 15, 2008 | K073076 | HOFFMANN LIGHT SYSTEM Howmedica Osteonics Corp. | KTT |
| Feb 14, 2008 | K073527 | VARIAX ELBOW SYSTEM Howmedica Osteonics Corp. | KTT |
| Oct 18, 2007 | K072020 | RESTORATION ADM SYSTEM Howmedica Osteonics Corp. | MEH |
| Oct 15, 2007 | K072221 | MODIFICATION TO TRIATHLON TS KNEE SYSTEM Howmedica Osteonics Corp. | JWH |
| Oct 9, 2007 | K071881 | TRIATHLON PKR SYSTEM Howmedica Osteonics Corp. | HRY |
Newest 50 of 301.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 15, 2026 | Howmedica Osteonics Corp. TS Misc. Instruments Tray, Triathlon. Catalog Number: 6543-6-519. Open, Classified |
FSM | None listed |
| Oct 15, 2026 | Howmedica Osteonics Corp. Triathlon Hinge Femoral Prep Tray. Catalog Number: 6543-6-514. Open, Classified |
FSM | None listed |
| Oct 15, 2026 | Howmedica Osteonics Corp. TS Femoral Prep Tray, Triathlon. Catalog Number: 6543-6-507. Open, Classified |
FSM | None listed |
| Oct 15, 2026 | Howmedica Osteonics Corp. TS Universal Baseplate Finishing Tray, Triathlon. Catalog Number: 6543-6-506. Open, Classified |
FSM | None listed |
| Sep 16, 2026 | Howmedica Osteonics Corp. SCORPIO C-DOME PATELLA
73-2710
73-2910
SCORPIO U-DOME PATELLA
73-3110
73-3508
73-3708
73-3710
73-3910
Orthopaedic implant components manufactured from UHMWPE (polyethylene) Open, Classified |
NPJ | K051948 K052917 +2 |
| Sep 16, 2026 | Howmedica Osteonics Corp. SCORPIO + MOBILE BEARING PCS
78-5-0910
SYSTEM ONE BIPOLAR 40MM
6074-4022
SYSTEM ONE BIPOLAR 43MM
6074-4322
SYSTEM ONE BIPOLAR 44MM
6074-4422
Orthopaedic implant components manufacture Open, Classified |
N/A | None listed |
| Sep 16, 2026 | Howmedica Osteonics Corp. TRIDENT 0 POLY INSERT 28mm ID
620-00-28D
Orthopaedic implant components manufactured from UHMWPE (polyethylene) Open, Classified |
MEH | K983502 |
| Sep 16, 2026 | Howmedica Osteonics Corp. SCORPIO RECESSED METAL BACKED PATELLA
3045-0026
3045-0028
3045-0030
3045-0032
Orthopaedic implant components manufactured from UHMWPE (polyethylene) Open, Classified |
MBH | K033972 |
| Sep 16, 2026 | Howmedica Osteonics Corp. BEARING AND AXLE BUSHING ASSY STD ELBOW
C-M113-1-301
KRH REV TIB INS 16mm THK .640 DIA STEM
C-M113-5-600
SELF-PRESSURIZING GLENOID SIZE 9
C-M063-5-800
Orthopaedic implant components manufa Open, Classified |
LGE | None listed |
| Sep 16, 2026 | Howmedica Osteonics Corp. ACETABULAR CUP UHMWPE
61-3258
ALL POLY CONSTRAINED INSERT 44MM
69-2244
ALL POLY CONSTRAINED INSERT 46MM
69-2246
ALL POLY CONSTRAINED INSERT 48MM
69-2248
ALL POLY CONSTRAINED INSERT 50M Open, Classified |
KWZ | K261624 |
| Sep 16, 2026 | Howmedica Osteonics Corp. DURACON XL ANGLED TIB INS 11/14MM
C-M064-1-300
SELF-PRESSURIZING GLENOID SIZE 8
C-M062-6-800
C-M062-7-500
C-M063-2-600
SELF-PRESSURIZING GLENOID SIZE 9
C-M063-5-000
SHOULDER - GLENOID # Open, Classified |
KWS | K962082 |
| Sep 16, 2026 | Howmedica Osteonics Corp. ABG I ACETABULAR INSERT HOODED 28mm ID X 48mm
C-M079-2-801
ARC2F ACETABULAR INSERT 48/50/52mm OD x 28mm ID
C-M071-6-700
ARC2F ACETABULAR INSERT 50mm OD x 28mm ID 10DEGREE HOOD
C-M071-8- Open, Classified |
KWL | K261624 |
| Sep 16, 2026 | Howmedica Osteonics Corp. TRIATHLON HINGE INSERT SIZE 4 11MM
5612-P-411
TRIATHLON HINGE INSERT SIZE 4 13MM
5612-P-413
Orthopaedic implant components manufactured from UHMWPE (polyethylene) Open, Classified |
KRO | K223528 |
| Sep 16, 2026 | Howmedica Osteonics Corp. ALL POLY CONSTRAINED INSERT 54MM
69-2854
NRG KNEE CR
82-2-0512
82-2-0518
82-2-0912
NRG KNEE P/S
82-3-0318
SCORPIO + MOBILE BEARING PCS
78-5-0910
SCORPIO C-DOME PATELLA
73-2710
SC Open, Classified |
JWH | K243817 |
| Sep 16, 2026 | Howmedica Osteonics Corp. OMNIFIT SERIES I ACET. INSERT 10 22mm ID
Catalog No. 2001-2246
Orthopaedic implant components manufactured from UHMWPE (polyethylene) Open, Classified |
JDL | K850352 K900438 |
| Sep 16, 2026 | Howmedica Osteonics Corp. AXLE PIN ASSY LARGE ELBOW COBALT CHROME
Catalog No. C-M112-2-500
Orthopaedic implant components manufactured from UHMWPE (polyethylene) Open, Classified |
JDC | K980502 |
| Jun 17, 2026 | Howmedica Osteonics Corp. TRI TS BASEPLATE SIZE 4. Part Number: 5521-B-400. Open, Classified |
MBH | K123486 |
| Jun 17, 2026 | Howmedica Osteonics Corp. TRI TS BASEPLATE SIZE 3. Part Number: 5521-B-300. Open, Classified |
MBH | K123486 |
| Mar 18, 2026 | Howmedica Osteonics Corp. MICS3 Angled Sagittal Saw Attachment;
Part Number: 210490 Open, Classified |
OLO | K220459 K241011 |
| Dec 19, 2025 | Howmedica Osteonics Corp. The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) with 31 infrared (IR) light-emitting diodes (LEDs) as well as an electronics control unit fo Open, Classified |
HAW | K212194 |
| Sep 26, 2025 | Howmedica Osteonics Corp. 1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442;
2. EXETER V40 STEM 37.5MM NO 0, Model/Catalog Number: 0580-1-352; Open, Classified |
JDI | K193429 |
| Oct 9, 2024 | Howmedica Osteonics Corp. MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063 Open, Classified |
OLO | K093425 |
| Oct 7, 2024 | Howmedica Osteonics Corp. Triathlon Universal TS Baseplate Size 2 - A single use sterile implantable device intended for cemented applications during primary and revision Total Knee Arthroplasty (TKA) when the Triathlon Knee S Open, Classified |
JWH | K141056 |
| Aug 26, 2024 | Howmedica Osteonics Corp. Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00; Open, Classified |
JDI | K023087 K222056 |
| Jul 16, 2024 | Howmedica Osteonics Corp. UNITRAX Endoprosthesis Head Component - 38mm. Implantable component used in partial hip arthroplasty.
Catalog Number: 6942-5-038 Open, Classified |
KWL | K014226 |
| Jul 16, 2024 | Howmedica Osteonics Corp. UNITRAX Endoprosthesis Head Component - 42mm. Implantable component used in partial hip arthroplasty.
Catalog Number: 6942-5-042 Open, Classified |
KWL | K014226 |
| Jul 16, 2024 | Howmedica Osteonics Corp. UNITRAX Endoprosthesis Head Component - 43mm. Implantable component used in partial hip arthroplasty.
Catalog Number: 6942-5-043 Open, Classified |
KWL | K014226 |
| Jun 18, 2024 | Howmedica Osteonics Corp. Gray Revision Instrument System Accessory Tray/Case, Catalog/Part Number: 6210-9-910 Open, Classified |
LXH | None listed |
| Jun 18, 2024 | Howmedica Osteonics Corp. HRIS Storage & Sterilization Case and Tray, Catalog/Part Number: 6210-9-900 Open, Classified |
LXH | None listed |
| Apr 25, 2024 | Howmedica Osteonics Corp. TRIDENTII PSL CLUSTER64H- Indicated for use in primary and revision patients at high risk of hip dislocation
Catalog Number: 742-11-64H Open, Classified |
LPH | K171768 |
| Apr 25, 2024 | Howmedica Osteonics Corp. TRIDENTII PSL CLUSTER58F-Indicated for use in primary and revision patients at high risk of hip dislocation
Catalog Number: 742-11-58F Open, Classified |
LPH | K171768 |
| Apr 25, 2024 | Howmedica Osteonics Corp. TRIDENTII PSL CLUSTER52E- Indicated for use in primary and revision patients at high risk of hip dislocation
Catalog Number: 742-11-52E Open, Classified |
LPH | K171768 |
| Apr 25, 2024 | Howmedica Osteonics Corp. TRIDENTII PSL CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation
Catalog Number: 742-11-50D Open, Classified |
LPH | K171768 |
| Apr 25, 2024 | Howmedica Osteonics Corp. TRIDENTII PSL CLUSTER48D- Indicated for use in primary and revision patients at high risk of hip dislocation
Catalog Number: 742-11-48D Open, Classified |
LPH | K171768 |
| Apr 25, 2024 | Howmedica Osteonics Corp. TRIDENTII HEMI CLUSTER66H- Indicated for use in primary and revision patients at high risk of hip dislocation
Catalog Number: 702-11-66H Open, Classified |
LPJ | K171768 |
| Apr 25, 2024 | Howmedica Osteonics Corp. TRIDENTII HEMI CLUSTER58F- Indicated for use in primary and revision patients at high risk of hip dislocation
Catalog Number: 702-11-58F Open, Classified |
LPH | K171768 |
| Apr 25, 2024 | Howmedica Osteonics Corp. TRIDENTII HEMI CLUSTER54E- Indicated for use in primary and revision patients at high risk of hip dislocation
Catalog Number: 702-11-54E Open, Classified |
LPH | K171768 |
| Apr 25, 2024 | Howmedica Osteonics Corp. TRIDENTII HEMI CLUSTER52E-Indicated for use in primary and revision patients at high risk of hip dislocation
Catalog Number: 702-11-52E Open, Classified |
LPH | K171768 |
| Apr 25, 2024 | Howmedica Osteonics Corp. TRIDENTII HEMI CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation
Catalog Number: 702-11-50D Open, Classified |
LPH | K171768 |
| Apr 25, 2024 | Howmedica Osteonics Corp. TRIDENTII HEMI CLUSTER48D-indicated for use in primary and revision patients at high risk of hip dislocation
Catalog Number: 702-11-48D Open, Classified |
LPH | K171768 |
| Apr 25, 2024 | Howmedica Osteonics Corp. TRIDENTII HEMI CLUSTER44B- Indicated for use in primary and revision patients at high risk of hip dislocation
Catalog Number: 702-11-44B Open, Classified |
LPH | K171768 |
| Mar 6, 2024 | Howmedica Osteonics Corp. NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM Open, Classified |
MBH | K172634 |
| Mar 6, 2024 | Howmedica Osteonics Corp. NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM Open, Classified |
MBH | K172634 |
| Mar 6, 2024 | Howmedica Osteonics Corp. NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM Open, Classified |
MBH | K172634 |
| Mar 6, 2024 | Howmedica Osteonics Corp. NO 3 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM Open, Classified |
MBH | K172634 |
| Mar 6, 2024 | Howmedica Osteonics Corp. X3 TRIATHLON CS INSERT NO 7 9 MM Open, Classified |
MBH | K172634 |
| Mar 6, 2024 | Howmedica Osteonics Corp. X3 TRIATHLON CS INSERT NO 6 11 MM Open, Classified |
MBH | K172634 |
| Mar 6, 2024 | Howmedica Osteonics Corp. X3 TRIATHLON CS INSERT NO 6 10 MM Open, Classified |
MBH | K173849 |
| Mar 6, 2024 | Howmedica Osteonics Corp. X3 TRIATHLON CS INSERT NO 3 10 MM Open, Classified |
MBH | K173849 |
| Feb 6, 2024 | Howmedica Osteonics Corp. HRIS ACET CUP CUT TIP 32X140
Part Number: 6210-5-200rker.
single-use, sterile surgical instruments used during hip arthroplasty Open, Classified |
LXH | None listed |
Newest 50 of 251.