IO FIX HAND, IO FIX FOOT, EXTREMITY MEDICAL SCREW SYSTEM
Device Facts
| Record ID | K101700 |
|---|---|
| Device Name | IO FIX HAND, IO FIX FOOT, EXTREMITY MEDICAL SCREW SYSTEM |
| Applicant | Extremity Medical, LLC |
| Product Code | HWC · Orthopedic |
| Decision Date | Oct 12, 2010 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3040 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Extremity Medical Screw and Washer System is intended for reduction and internal fixation of arthrodeses, osteotomies, intra- and extrarticular fractures and nonunions of the small bones and joints of the foot, ankle, hand, and wrist. The two-part construct is specifically intended for Talonavicular, Calcanealcuboid, Metatarso-Cunieform, Ankle, Capito-Lunate, and Triquetral-Hamate arthrodesis, as well as Metatarsal Osteotemies.
Device Story
System consists of lag screws (10-100mm) and mating washers (14-50mm) for bone fixation. Implants are titanium alloy. Used by surgeons for small bone/joint procedures in foot, ankle, hand, and wrist. Provides mechanical stability for arthrodesis, osteotomies, and fracture repair. Operates as a two-part construct to compress and stabilize bone segments. Clinical benefit includes facilitating bone healing through rigid internal fixation.
Clinical Evidence
No clinical testing was performed. Evidence consists of bench testing (pull-out strength, torque, bending) and cadaveric clinical simulations to verify surgical technique.
Technological Characteristics
Titanium alloy bone fixation fasteners. System includes lag screws (10-100mm) and mating washers (14-50mm). Mechanical fixation principle. Non-powered, manual surgical instrumentation.
Indications for Use
Indicated for reduction and internal fixation of arthrodeses, osteotomies, intra- and extrarticular fractures, and nonunions of small bones and joints in the foot, ankle, hand, and wrist, specifically including Talonavicular, Calcanealcuboid, Metatarso-Cunieform, Ankle, Capito-Lunate, and Triquetral-Hamate arthrodesis, and Metatarsal Osteotomies.
Regulatory Classification
Identification
A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.
Predicate Devices
- EXTREMITY MEDICAL Compression Screw System (K081934)
- 3.0 Cannulated Screw and Threaded Washer, Synthes (K962823)
- EXTREMITY MEDICAL Midfoot Screw System (K082934)
Submission Summary (Full Text)
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K101700
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# 510(k) Summary of Safety and Effectiveness:
## EXTREMITY MEDICAL Screw and Washer Implant System
| Submitter: | EXTREMITY MEDICAL<br>300 Interpace Parkway<br>Suite 410<br>Parsippany, NJ 07054 |
|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | OCT 12 2010 |
| Contact Person | Jamy Gannoe<br>President<br>Phone: (973) 588-8980<br>Email: jgannoe@extremitymedical.com |
| Date Prepared | September 15, 2010 |
| Trade Name | EXTREMITY MEDICAL Screw and Washer System |
| Classification Name<br>and Number | Smooth or threaded metallic bone fixation fastener<br>21 CFR 888.3040 |
| Product Code | HWC |
| Predicate Devices | 1. EXTREMITY MEDICAL Compression Screw System, EXTREMITY<br>MEDICAL K081934<br>2. 3.0 Cannulated Screw and Threaded Washer , Synthes K962823<br>3. EXTREMITY MEDICAL Midfoot Screw System, EXTREMITY<br>MEDICAL K082934 |
| Device Description | The EXTREMITY MEDICAL Screw and Washer System consists of a lag screw of five various diameters and lengths ranging from 10 to 100mm, as well as a mating washer component consisting of five various diameters and lengths ranging from 14 to 50mm. Both implant components are manufactured from Titanium alloy. |
| Indications for use | The EXTREMITY MEDICAL Screw and Washer System is intended for reduction and internal fixation of arthrodeses, osteotomies, intra- and extrarticular fractures and nonunions of the small bones and joints of the foot, ankle, hand, and wrist. The two-part construct is specifically intended for Talonavicular, Calcanealcuboid, Metatarso-Cunieform, Ankle, Capito-Lunate, and Triquetral-Hamate arthrodesis, as well as Metatarsal Osteotemies. |
| Statement of<br>Technological<br>Comparison | Mechanical Testing and calculations have been completed supporting substantial equivalence to the predicate devices listed. The implants in the EXTREMITY MEDICAL Screw and Washer system have a similar design; are made of similar materials, have the same indications for use, and have equivalent mechanical properties. |
| Non-clinical Testing | Bench testing, including pull-out strength, torque, and bending, was performed and compared to the predicate devices. Clinical simulations in cadavers were performed to verify the surgical technique. The results of the testing show the subject device, Extremity Medical Screw and Washer system, performed at least as well as the predicate devices. |
| Clinical Testing | No clinical testing was performed. |
| Conclusion | The EXTREMITY MEDICAL Screw and Washer System, subject of this submission, as supported by both mechanical testing and clinical simulation, constitutes a safe and effective medical device, meeting all the declared requirements of its intended use. The device presents no adverse health effects or safety risks to patients when used as intended. The EXTREMITY MEDICAL Screw and Washer System performed as well as the predicate devices. |
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### DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers inside of a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is written around the top half of the circle.
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#### Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
EXTREMITY MEDICAL % Jamy Gannoe President 300 Interpace Parkway, Suite 410 Parsippany, New Jersey 07054
DET 2 2010
Re: K101700
Trade/Device Name: EXTREMITY MEDICAL Screw and Washer System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II ್ಕ್ Product Code: HWC Dated: August 31, 2010 57
Received: September 16, 2010
Dear Jamy Gannoe:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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### Page 2 - Jamy Gannoe
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours
Oth. in
Del Dly
Mark N. Melkerso Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Indications for Use
1101700 510(k) Number (if known): Device Name: EXTREMITY MEDICAL Screw and Washer System Indications for Use:
The Extremity Medical Screw and Washer System is intended for reduction and internal fixation of arthrodeses, osteotomies, intra- and extrarticular fractures and nonunions of the small bones and joints of the foot, ankle, hand, and wrist. The two-part construct is specifically intended for Talonavicular, Calcanealcuboid, Metatarso-Cunieform, Ankle, Capito-Lunate, and Triquetral-Hamate arthrodesis, as well as Metatarsal Osteotemies.
Prescription Use X AND/OR Over-the-counter (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K101700
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