Panels › Orthopedic › Product code HWC · Class 2
Screw, Fixation, Bone
Regulation 888.3040
22510(k)s in 12 months (1,070 all time)
7recalls in 12 months (389 all time)
359recalls that name a 510(k)
Top companies in HWC
| Company | 510(k)s | Recalls |
|---|---|---|
| Zimmer, Inc. | 12 | 50 |
| Biomet, Inc. | 24 | 27 |
| Arthrex, Inc. | 47 | 1 |
| Acumed, LLC | 5 | 35 |
| Depuy Mitek, A Johnson & Johnson Co. | 13 | 21 |
| Synthes (Usa) | 31 | 3 |
| Smith & Nephew, Inc. | 27 | 6 |
| Smith & Nephew Inc., Endoscopy Division | 1 | 30 |
| Wrightmedicaltechnologyinc | 31 | 0 |
| Stryker Howmedica Osteonics Corp. | 0 | 30 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 9, 2011 | Biomet, Inc. STA-Flex SUBTALAR SCREW, 9 mm x 15 mm, REF 982363, Sterile, Biomet Sports Medicine, 56 East Bell Drive, Warsaw, IN.
Used to reduce excessive rearfoot pronation by blocking forward and downward displa Terminated |
HWC | K071498 |
| Mar 9, 2011 | Biomet, Inc. STA-Flex SUBTALAR SCREW, 8 mm x 14 mm, REF 982362, Sterile, Biomet Sports Medicine, 56 East Bell Drive, Warsaw, IN.
Used to reduce excessive rearfoot pronation by blocking forward and downward displa Terminated |
HWC | K071498 |
| Mar 9, 2011 | Biomet, Inc. STA-Flex SUBTALAR SCREW, 7 mm x 13 mm, REF 982361, Sterile, Biomet Sports Medicine, 56 East Bell Drive, Warsaw, IN.
Used to reduce excessive rearfoot pronation by blocking forward and downward displa Terminated |
HWC | K071498 |
| Dec 14, 2010 | Stryker Endoscopy Stryker Titanium Intraline Anchor, Model Numbers 3910400050, 3910400055, 3910400060, 3910400065, Soft Eyelet Anchor, manufactured by Stryker Endoscopy, Puerto Rico Terminated |
HWC | K071157 |
| Jun 10, 2010 | Orthohelix Surgical Designs Inc Modular Foot System 3.5mm x 22mm Locking Screw M/N: MFT-021-35-22. OrthoHelix Surgical Designs, Inc. Medina, OH 44256.
Intended as a guide to normal healing and are not intended to replace normal b Terminated |
HWC | K073624 |
| May 14, 2010 | Acumed LLC Polarus(R) Humeral Fixation System, size: 3.5mm x 25.0mm Cortical Screw, QTY 1, Ref: HCO3250-S Acumed, LLC Hillsboro, OR
Intended use: Acumed intramedullary rods and screws are designed to provide Terminated |
HWC | K942340 |
| May 7, 2010 | Stryker Craniomaxillofacial Division Inion 1.5 x 6mm CPS(R) Baby Screw, 1.5mm Inion CPS(R) Baby 5+E, REF SCR 1221, 5/pack, STERILE/R Stryker Craniomaxillofacial, Portage, MI.
The INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM is a cra Terminated |
HWC | K010352 K020266 |
| Apr 26, 2010 | Trilliant Surgical LTD 2.0/2.4 Cannulated Screw Driver Bit, part #210-24-003 Terminated |
HWC | K081510 |
| Apr 7, 2010 | Integra LifeSciences Corporation Qwix 4.3mm Stabilization Screws - 34mm Terminated |
HWC | K050346 |
| Apr 7, 2010 | Integra LifeSciences Corporation Qwix 4.3mm Stabilization Screws - 32mm Terminated |
HWC | K050346 |
| Apr 6, 2010 | Orthohelix Surgical Designs Inc MaxTorque Cannulated Screw Model # MSD-010-55-060S Terminated |
HWC | K060428 |
| Feb 2, 2010 | Biomet, Inc. Biomet bone mulch screw, 10.5mm x 20 mm, TI-6AL-4V alloy, sterile, Biomet Sports Medicine, Warsaw, IN; REF 907320. Terminated |
HWC | K941941 |
| Jan 13, 2010 | Biomet, Inc. Biomet 2.9 Micromax L-15 suture anchor, flexible long shaft, #2 blue/white maxbraid, PLLA/PGA L-15, sterile, Biomet Sports Medicine, Warsaw, IN; REF 905456.
Intended for use in soft tissue reattachme Terminated |
HWC | K040475 |
| Jan 4, 2010 | Biomet Microfixation, Inc. LACTOSORB SYSTEM 1.5MM ADJUSTABLE SELF-DRILLING TAP FOR POWER DRIVER, REF: 915-2185, NON-STERILE PRODUCT,
BIOMET MICROFIXATION,K INC. 1520 TRA DEPORT DRIVE JACKSONVILLE, FL 32218 USA. www.biometmic Terminated |
HWC | None listed |
| Jan 4, 2010 | Biomet Microfixation, Inc. LACTOSORB SYSTEM 2.0MM ADJUSTABLE SELF-DRILLING TAP, REF: 915-2075, NON-STERILE PRODUCT,
BIOMET MICROFIXATION,K INC. 1520 TRA DEPORT DRIVE JACKSONVILLE, FL 32218 USA. www.biometmicrofixation.com.
Terminated |
HWC | None listed |
| Nov 12, 2009 | Biomet, Inc. Biomet 5.5 mm peek Allthread PEEK Knotless Anchor, knotless, sterile, Biomet sports Medicine, Inc., Ontario, CA; REF 904842P.
Intended to be implanted for fixation of bone fractures and for bone reco Terminated |
HWC | K070389 |
| Oct 23, 2009 | Acumed LLC Biotrak PLLA Pin, Resorbable Fixation System, Biotrak 20 mm Pin; sterile pin packaged in sterile bag, enclosed within a box labeled Biotrak Resorbable Fixation System Biotrak 20 mm Pin REF 30170320- Terminated |
HWC | K061763 |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Cancellous Bone Screw;
Dia 6.5 mm; Lnth: 55 mm; Sterile:
Made in the USA;
Stryker Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430.
The bone screws are optional fixtures that Terminated |
HWC | K013106 |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Cancellous Bone Screw;
Dia 6.5 mm; Lnth: 35 mm; Sterile:
Made in the USA;
Stryker Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430.
The bone screws are optional fixtures that Terminated |
HWC | K873251 |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Bone Screw;
Dia 6.5 mm; Lnth: 30 mm; Sterile:
Made in the USA;
Stryker Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430.
The bone screws are optional fixtures that may be use Terminated |
HWC | K873251 |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Bone Screw;
Dia 6.5 mm; Lnth: 25 mm; Sterile:
Made in the USA;
Stryker Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430.
The bone screws are optional fixtures that may be use Terminated |
HWC | K873251 |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Cancellous Bone Screw;
Dia 5.5 mm; Lnth: 50 mm; Sterile:
Made in the USA;
Stryker Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430.
The bone screws are optional fixtures that Terminated |
HWC | K873251 |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Cancellous Bone Screw;
Dia 5.5 mm; Lnth: 40 mm; Sterile:
Made in the USA;
Stryker Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430.
The bone screws are optional fixtures that Terminated |
HWC | K873251 |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Cancellous Bone Screw;
Dia 5.5 mm; Lnth: 35 mm; Sterile:
Made in the USA;
Stryker Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430.
The bone screws are optional fixtures that Terminated |
HWC | K873251 |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Cancellous Bone Screw;
Dia 5.5 mm; Lnth: 30 mm; Sterile:
Made in the USA;
Stryker Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430.
The bone screws are optional fixtures that Terminated |
HWC | K873251 |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Cancellous Bone Screw;
Dia 5.5 mm; Lnth: 25 mm; Sterile:
Made in the USA;
Stryker Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430.
The bone screws are optional fixtures that Terminated |
HWC | K873251 |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Cancellous Bone Screw;
Dia 5.5 mm; Lnth: 20 mm; Sterile:
Made in the USA;
Stryker Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430.
The bone screws are optional fixtures that Terminated |
HWC | K873251 |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Cancellous Bone Screw;
Dia 5.5 mm; Lnth: 15 mm; Sterile:
Made in the USA;
Stryker Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430.
The bone screws are optional fixtures that Terminated |
HWC | K873251 |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Cancellous Bone Screw;
Dia 6.5 mm; Lnth: 60 mm; Sterile:
Made in the USA;
Stryker Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430.
The bone screws are optional fixtures that Terminated |
HWC | K873251 |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Cancellous Bone Screw;
Dia 6.5 mm; Lnth: 50 mm; Sterile:
Made in the USA;
Stryker Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430.
The bone screws are optional fixtures that Terminated |
HWC | K873251 |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Cancellous Bone Screw;
Dia 6.5 mm; Lnth: 45 mm; Sterile:
Made in the USA;
Stryker Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430.
The bone screws are optional fixtures that Terminated |
HWC | K873251 |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Cancellous Bone Screw;
Dia 6.5 mm; Lnth: 40 mm; Sterile:
Made in the USA;
Stryker Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430.
The bone screws are optional fixtures that Terminated |
HWC | K873251 |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Cancellous Bone Screw;
Dia 6.5 mm; Lnth: 30 mm; Sterile;
Made in the USA;
Stryker Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430.
The bone screws are optional fixtures that Terminated |
HWC | K873251 |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Cancellous Bone Screw;
Dia 6.5 mm; Lnth: 25 mm; Sterile;
Made in the USA;
Stryker Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430.
The bone screws are optional fixtures that Terminated |
HWC | K873251 |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Cancellous Bone Screw;
Dia 6.5 mm; Lnth: 20 mm; Sterile
Made in the USA;
Stryker Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430.
The bone screws are optional fixtures that Terminated |
HWC | K873251 |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Cancellous Bone Screw;
Dia 6.5 mm; Lnth: 16 mm; Sterile:
Made in the USA;
Stryker Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430.
The bone screws are optional fixtures that Terminated |
HWC | K873251 |
| Jan 26, 2009 | Zimmer Inc. Zimmer TIV Self Tap Screw, 42 mm. Manufactured by Zimmer Manufacturing B.V., A Subsidiary of Zimmer, Inc., Warsaw, IN; Item No. 48231904200. NOTE: This product is not sold in the United States.
Th Terminated |
HWC | None listed |
| Jan 26, 2009 | Zimmer Inc. Zimmer TIV Self Tap Screw, 40 mm. Manufactured by Zimmer Manufacturing B.V., A Subsidiary of Zimmer, Inc., Warsaw, IN; Item No. 48231904000. NOTE: This product is not sold in the United States.
Th Terminated |
HWC | None listed |
| Sep 22, 2008 | Stryker Howmedica Osteonics Corp. 6.5 Cancellous Bone Screw 25 mm; Responsible Firm on Label: Manufacturer, Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 USA, A Subsidiary of Stryker Corp., Made in USA; Catalog Numb Terminated |
HWC | K873251 K894124 |
| Sep 20, 2008 | Acumed LLC Locking Clavicle Plate, 9 Holes, J-Plate Right. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Locking Clavicle Plate, 9 Holes, J-Plate Right... REF PL Terminated |
HWC | K012655 |
| Sep 20, 2008 | Acumed LLC Locking Clavicle Plate, 9 Holes, J-Plate Left. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Locking Clavicle Plate, 9 Holes, J-Plate Left... REF PL-C Terminated |
HWC | K012655 |
| Sep 20, 2008 | Acumed LLC Locking Clavicle Plate, 8 Holes Small Right. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Locking Clavicle Plate, 8 Holes Small Right ... REF PL-CL8S Terminated |
HWC | K012655 |
| Sep 20, 2008 | Acumed LLC Locking Clavicle Plate, 8 Holes Medium Right. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Locking Clavicle Plate, 8 Holes Medium Right ... REF PL-CL Terminated |
HWC | K012655 |
| Sep 20, 2008 | Acumed LLC Locking Clavicle Plate, 8 Holes Medium Left. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Locking Clavicle Plate, 8 Holes Medium Left ... REF PL-CL8M Terminated |
HWC | K012655 |
| Sep 20, 2008 | Acumed LLC Locking Clavicle Plate, 8 Holes Large Right. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Locking Clavicle Plate, 8 Holes Large Right ... REF PL-CL8L Terminated |
HWC | K012655 |
| Sep 20, 2008 | Acumed LLC Locking Clavicle Plate, 8 Holes Large Left. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Locking Clavicle Plate, 8 Holes Large Left ... REF PL-CL8LL- Terminated |
HWC | K012655 |
| Sep 20, 2008 | Acumed LLC Locking Clavicle Plate, 8 Holes, J-Plate Right. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Locking Clavicle Plate, 8 Holes, J-Plate Right... REF PL Terminated |
HWC | K012655 |
| Sep 20, 2008 | Acumed LLC Locking Clavicle Plate, 8 Holes, J-Plate Left. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Locking Clavicle Plate, 8 Holes, J-Plate Left... REF PL-C Terminated |
HWC | K012655 |
| Sep 20, 2008 | Acumed LLC Locking Clavicle Plate, 6 Holes Small Right. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Locking Clavicle Plate, 6 Holes Small Right ... REF PL-CL6S Terminated |
HWC | K012655 |
| Sep 20, 2008 | Acumed LLC Locking Clavicle Plate, 6 Holes Small Left. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Locking Clavicle Plate, 6 Holes Small Left ... REF PL-CL6SL- Terminated |
HWC | K012655 |
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