curvafix.comCurvaFix IM System
CurvaFix, Inc.
CURVAFIX, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3016537375 | 3016537375 | CURVAFIX, INC. | 1 | N | 2026-01-01 | 10220 Points Dr NE Suite 300 Kirkland WA US 98033 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 10850070500682 | Redirect Handle - Custom reusable handle that connects to Redirect Shaft and actuates the shaft’s pull wire to deflect the shaft. Cannulated to allow passage of any CurvaFix single use wire. | 4252768800 | support@curvafix.com |
| 10850070500699 | Flexible Disposable Redirect Shaft - Fits over Steerable Guidewire or Drill Wire and is actuated by Redirect Handle to alter the trajectory of the wire from outside the body. Supplied in a single sterile barrier package placed in a shelf carton. Flexible version with both distal and main shaft flexibility. | 4252768800 | support@curvafix.com |
| 10850070500705 | Standard Disposable Redirect Shaft - Fits over Steerable Guidewire or Drill Wire and is actuated by Redirect Handle to alter the trajectory of the wire from outside the body. Supplied in a single sterile barrier package placed in a shelf carton. Standard version with only distal flexibility. | 4252768800 | support@curvafix.com |
| 10850070500712 | CurvaFix Redirect System Instrument Set - A reusable instrument set consisting of the Redirect Handle, housed in a sterilizable storage container, that is used during a surgical procedure for the CurvaFix Low Profilie Implant. Provided non-sterile; ready for cleaning and steam sterilization at healthcare facility before use; reprocessed after each use. See below for kit item descriptions. | 4252768800 | support@curvafix.com |
| 10855068008485 | Countersink - A T-handled instrument used to manually enlarge the diameter of the proximal portion of bone canal in preparation for insertion of the CurvaFix Implant. | 425-276-8800 | support@curvafix.com |
| 10855068008867 | Bead Extractor, 8.0 mm - A hand-held surgical instrument with a cannulated stainless steel shaft and an aluminum handle used over a wire to grab and extract a loose 9.5mm CurvaFix Implant Main Body Bead using sharp flutes on the inside of the head of the instrument. | 425-276-8800 | support@curvafix.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 288866 | 1356893642 | K252019 | CurvaFix Low Profile System | HWC | 2025-08-29 |
| 288866 | 1050509301 | K222505 | CurvaFix IM System | HWC | 2022-10-27 |
| 288866 | 1255192286 | K180050 | CurvaFix Intramedullary Rodscrew System | HWC | 2019-03-01 |
| 288866 | 1939458761 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| HWC | 3 | 2025-08-29 |
PMN#
CurvaFix Intramedullary Rodscrew System
CurvaFix, Inc.
GUDID#
Redirect Handle - Custom reusable handle that connects to Redirect Shaft and actuates the shaft’s pull wire to deflect the shaft. Cannulated to allow passage of any CurvaFix single use wire.
2026-04-14
Flexible Disposable Redirect Shaft - Fits over Steerable Guidewire or Drill Wire and is actuated by Redirect Handle to alter the trajectory of the wire from outside the body. Supplied in a single sterile barrier package placed in a shelf carton. Flexible version with both distal and main shaft flexibility.
2026-04-14
Standard Disposable Redirect Shaft - Fits over Steerable Guidewire or Drill Wire and is actuated by Redirect Handle to alter the trajectory of the wire from outside the body. Supplied in a single sterile barrier package placed in a shelf carton. Standard version with only distal flexibility.
2026-04-14
CurvaFix Redirect System Instrument Set - A reusable instrument set consisting of the Redirect Handle, housed in a sterilizable storage container, that is used during a surgical procedure for the CurvaFix Low Profilie Implant. Provided non-sterile; ready for cleaning and steam sterilization at healthcare facility before use; reprocessed after each use. See below for kit item descriptions.
2026-04-14
Redirect System Sterilization Tray - Off the shelf tray for storage, transportation (within the hospital), and steam sterilization of the Redirect Handle.
2026-04-14
Bead Extractor, 8.0 mm - A hand-held surgical instrument with a cannulated stainless steel shaft and an aluminum handle used over a wire to grab and extract a loose 9.5mm CurvaFix Implant Main Body Bead using sharp flutes on the inside of the head of the instrument.
2023-09-26
Bead Extractor, 6.8 mm - A hand-held surgical instrument with a cannulated stainless steel shaft and an aluminum handle used over a wire to grab and extract a loose 7.5mm CurvaFix Implant Main Body Bead using sharp flutes on the inside of the head of the instrument.
2023-09-26
Countersink - A T-handled instrument used to manually enlarge the diameter of the proximal portion of bone canal in preparation for insertion of the CurvaFix Implant.
2022-06-20
Instrument Set (Case and Reusable Instruments) - A custom engineered set of reusable surgical instruments, housed in a sterilizable storage container, that are used during a CurvaFix surgical procedure.
2022-06-20
Implant Selection Device - Reusable surgical measurement instrument used when determining the size of the CurvaFix IM Implant to be used in a pelvic fixation procedure.
2021-12-02
Sterilization Case, Implant Selection Device - Reusable, stainless steel instrument storage case that is used to contain the implant selection device during sterilization processing in preparation for pelvic fixation procedure.
2021-12-02
Implant Selection Device Set - A custom engineered set consisting of reusable implant selection device, housed in a sterilizable storage container, that is used during a surgical procedure for the CurvaFix IM Implant.
2021-12-02
Handled Cannula - A hand-held stainless steel tube used during a CurvaFix Implant implantation procedure to maintain direct access to the surgical site, protect the patient soft tissue, and facilitate the acceptance of orthopaedic instrumentation into the surgical site.
2021-08-11
Guide Pin Sleeve - A hand-held tubular surgical device designed to be used during an CurvaFix Implant implantation procedure to facilitate the acceptance of a Guide Pin through it.
2021-08-11
10.2 mm Sleeve - A hand-held tubular surgical device designed to be used during an CurvaFix Implant implantation procedure to facilitate the acceptance of a Step Drill through it.
2021-08-11
Countersink - A manual rotary tool used to enlarge the diameter of the proximal portion of bone canal in preparation for insertion of the CurvaFix Implant.
2021-08-11
Steerable Guide Sleeve - A hand-held tubular surgical device designed to be used during an CurvaFix Implant implantation procedure to facilitate the acceptance of a Steerable Guide through it.
2021-08-11
Inserter/Extractor - Reusable surgical instrument used to engage the proximal end of the flexible CurvaFix® IM Implant in preparation for insertion into the intramedullary canal for implantation. If needed, device can also be used to engage the implant during a removal procedure.
2021-08-11
Quick Disconnect - An instrument that enables connection of the torque limiting handle to the Inserter during implantation of the CurvaFix IM Implant.
2021-08-11
Instrument Sterilization Case - Reusable instrument storage case that is used to contain the reusable instruments during sterilization processing in preparation for pelvic fixation procedure.
2021-08-11
Lock Activator - Reusable surgical instrument used during pelvic fixation procedure to convert a flexible intramedullary implant to a rigid state in order to stabilize and repair a bone fracture.
2021-08-11
Instrument Set - A custom engineered set of reusable surgical instruments, housed in a sterilizable storage container, that are used during a surgical procedure for the CurvaFix IM Implant.
2021-08-11
6.0mm Disposable Cannulated Flexible Drill - A surgical drilling instrument (6.0mm diameter) intended to fit over the Steerable Guide or Drill Wire and creates a canal in the intramedullary space of the pelvic bones for Implant implantation. All sizes have front cutting features. Supplied in a single sterile barrier package placed in shelf carton
2025-10-23
6.5mm Disposable Cannulated Flexible Drill - A surgical drilling instrument (6.5mm diameter) intended to fit over the Steerable Guide or Drill Wire and creates a canal in the intramedullary space of the pelvic bones for Implant implantation. All sizes have front cutting features. Supplied in a single sterile barrier package placed in shelf carton
2025-10-23
7.0mm Disposable Cannulated Flexible Drill - A surgical drilling instrument (7.0mm diameter) intended to fit over the Steerable Guide or Drill Wire and creates a canal in the intramedullary space of the pelvic bones for Implant implantation. All sizes have front cutting features. Supplied in a single sterile barrier package placed in shelf carton
2025-10-23
7.5mm Disposable Cannulated Flexible Drill - A surgical drilling instrument (7.5mm diameter) intended to fit over the Steerable Guide or Drill Wire and creates a canal in the intramedullary space of the pelvic bones for Implant implantation. All sizes have front cutting features. Supplied in a single sterile barrier package placed in shelf carton
2025-10-23
8.0mm Disposable Cannulated Flexible Drill - A surgical drilling instrument (8.0mm diameter) intended to fit over the Steerable Guide or Drill Wire and creates a canal in the intramedullary space of the pelvic bones for Implant implantation. All sizes have front cutting features. Supplied in a single sterile barrier package placed in shelf carton.
2025-10-23
8.5mm Disposable Cannulated Flexible Drill - A surgical drilling instrument (8.5mm diameter) intended to fit over the Steerable Guide or Drill Wire and creates a canal in the intramedullary space of the pelvic bones for Implant implantation. All sizes have front cutting features. Supplied in a single sterile barrier package placed in shelf carton
2025-10-23
Short 2.8mm Guide Pin - A thin wire with a sharp, smooth tip. Provides a starting location for the Step Drill. Fits within the Spiked Start Sleeve. L=255 mm. Supplied in a single sterile barrier package placed in shelf carton
2025-10-23
Long Smooth 2.8mm Guide Pin - A thin wire with a sharp, smooth tip. Provides a starting location for the Step Drill. Fits within the Spiked Start Sleeve. L=455 mm. Supplied in a single sterile barrier package placed in shelf carton.
2025-10-23
Long Threaded 2.8mm Guide Pin - A thin wire with a sharp, treaded tip. Provides a starting location for the Step Drill. Fits within the Spiked Start Sleeve. L=455 mm. Supplied in a single sterile barrier package placed in shelf carton
2025-10-23
Low Profile Guidewire Kit - A single use kit, composed of a sterile packaged Steerable Guide, Driving Guidewire and Exchange Tube, that is used during a surgical procedure for the placement of the CurvaFix Low Profile Implant. Supplied in a single sterile barrier package placed in shelf carton.
2025-10-23
CurvaFix® Low Profile Implant - The CurvaFix® Low Profile Implant is an implantable intramedullary device for the fixation of pelvic fractures. It has a threaded, self-tapping distal end, and a proximal end feature for driving torque, and a lock feature that changes the IM Implant from a flexible to rigid state during implantation. If explantation is required, the Implant can be unlocked into a flexible state before removal. Supplied individually on a backer card in sterile barrier package placed in shelf carton. The device is manufactured from Stainless Steel.
2025-10-22
CurvaFix® Low Profile Implant - The CurvaFix® Low Profile Implant is an implantable intramedullary device for the fixation of pelvic fractures. It has a threaded, self-tapping distal end, and a proximal end feature for driving torque, and a lock feature that changes the IM Implant from a flexible to rigid state during implantation. If explantation is required, the Implant can be unlocked into a flexible state before removal. Supplied individually on a backer card in sterile barrier package placed in shelf carton. The device is manufactured from Stainless Steel.
2025-10-22
CurvaFix® Low Profile Implant - The CurvaFix® Low Profile Implant is an implantable intramedullary device for the fixation of pelvic fractures. It has a threaded, self-tapping distal end, and a proximal end feature for driving torque, and a lock feature that changes the IM Implant from a flexible to rigid state during implantation. If explantation is required, the Implant can be unlocked into a flexible state before removal. Supplied individually on a backer card in sterile barrier package placed in shelf carton. The device is manufactured from Stainless Steel.
2025-10-22
CurvaFix® Low Profile Implant - The CurvaFix® Low Profile Implant is an implantable intramedullary device for the fixation of pelvic fractures. It has a threaded, self-tapping distal end, and a proximal end feature for driving torque, and a lock feature that changes the IM Implant from a flexible to rigid state during implantation. If explantation is required, the Implant can be unlocked into a flexible state before removal. Supplied individually on a backer card in sterile barrier package placed in shelf carton. The device is manufactured from Stainless Steel.
2025-10-22
CurvaFix® Low Profile Implant - The CurvaFix® Low Profile Implant is an implantable intramedullary device for the fixation of pelvic fractures. It has a threaded, self-tapping distal end, and a proximal end feature for driving torque, and a lock feature that changes the IM Implant from a flexible to rigid state during implantation. If explantation is required, the Implant can be unlocked into a flexible state before removal. Supplied individually on a backer card in sterile barrier package placed in shelf carton. The device is manufactured from Stainless Steel.
2025-10-22
CurvaFix® Low Profile Implant - The CurvaFix® Low Profile Implant is an implantable intramedullary device for the fixation of pelvic fractures. It has a threaded, self-tapping distal end, and a proximal end feature for driving torque, and a lock feature that changes the IM Implant from a flexible to rigid state during implantation. If explantation is required, the Implant can be unlocked into a flexible state before removal. Supplied individually on a backer card in sterile barrier package placed in shelf carton. The device is manufactured from Stainless Steel.
2025-10-22
CurvaFix® Low Profile Implant - The CurvaFix® Low Profile Implant is an implantable intramedullary device for the fixation of pelvic fractures. It has a threaded, self-tapping distal end, and a proximal end feature for driving torque, and a lock feature that changes the IM Implant from a flexible to rigid state during implantation. If explantation is required, the Implant can be unlocked into a flexible state before removal. Supplied individually on a backer card in sterile barrier package placed in shelf carton. The device is manufactured from Stainless Steel.
2025-10-22
CurvaFix® Low Profile Implant - The CurvaFix® Low Profile Implant is an implantable intramedullary device for the fixation of pelvic fractures. It has a threaded, self-tapping distal end, and a proximal end feature for driving torque, and a lock feature that changes the IM Implant from a flexible to rigid state during implantation. If explantation is required, the Implant can be unlocked into a flexible state before removal. Supplied individually on a backer card in sterile barrier package placed in shelf carton. The device is manufactured from Stainless Steel.
2025-10-22