(75 days)
No
The summary describes a mechanical implant system (screws and washers) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is an orthopedic implant (screw and washer system) designed for internal fixation of bones and joints, which falls under the category of surgical implants rather than active therapeutic devices that deliver energy or substances for treatment.
No
Explanation: The device is an orthopedic implant (screw and washer system) used for reduction and internal fixation in surgeries, not for diagnosing medical conditions. Its intended use describes surgical applications for fixation, not diagnostic procedures.
No
The device description explicitly states it consists of a "Screw and a Washer," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for internal fixation of bones and joints. This is a therapeutic and structural device, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description of a screw and washer system for providing stability and compression aligns with a surgical implant, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other elements typically associated with in vitro diagnostics.
Therefore, this device falls under the category of a surgical implant or orthopedic device, not an IVD.
N/A
Intended Use / 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, Calcaneocuboid, Metatarsocuneiform, Ankle, Capito-Lunate, and Triquetral-Hamate arthrodesis, as well as Metatarsal Osteotomies."
Product codes
HWC
Device Description
The EXTREMITY MEDICAL Screw and Washer System consists of two pieces, a Screw and a Washer, which couple together to provide stability and compression across an intended area of fusion.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small bones and joints of the foot, ankle, hand, and wrist. Specifically for Talonavicular, Calcaneocuboid, Metatarsocuneiform, Ankle, Capito-Lunate, and Triquetral-Hamate arthrodesis, as well as Metatarsal Osteotomies.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Bench testing, including pull-out, torque and bending was performed and compared to the predicate devices. Clinical simulations in cadavers were performed to verify the surgical technique.
No clinical testing was performed.
Key Metrics
Not Found
Predicate Device(s)
EXTREMITY MEDICAL Screw and Washer System, Extremity Medical (K101700)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
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.(b)
Classification. Class II.
0
JUL 1882012
Special 510(k) Summary of Safety and Effectiveness:
EXTREMITY MEDICAL Screw and Washer System
| Submitter: | EXTREMITY MEDICAL LLC
300 Interpace Parkway
Suite 410
Parsippany, NJ 07054 |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Jamy Gannoe
President
Phone: (973) 588-8980
Email: jgannoe@extremitymedical.com |
| Date Prepared | June 11, 2012 |
| Trade Name | EXTREMITY MEDICAL Screw and Washer System |
| Classification Name
and Number | Smooth or threaded metallic bone fixation fastener
21 CFR 888.3040 |
| Product Code | HWC |
| Predicate Devices | EXTREMITY MEDICAL Screw and Washer System, Extremity Medical (K101700) |
| Reason for Submission | Additional screw and washer options have been added to the system to allow for
intraoperative flexibility for the surgeon. |
| Device Description | The EXTREMITY MEDICAL Screw and Washer System consists of two
pieces, a Screw and a Washer, which couple together to provide stability and
compression across an intended area of fusion. |
| 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, Calcaneocuboid,
Metatarsocuneiform, Ankle, Capito-Lunate, and Triquetral-Hamate arthrodesis,
as well as Metatarsal Osteotomies." |
| Statement of
Technological
Comparison | The EXTREMITY MEDICAL Screw and Washer System and its predicate
devices have the same indications for use; have a similar design; are made of
similar materials, and have equivalent mechanical properties. |
| Non-clinical Testing | Bench testing, including pull-out, torque and bending was performed and
compared to the predicate devices. Clinical simulations in cadavers were
performed to verify the surgical technique. |
| Clinical Testing | No clinical testing was performed. |
| Conclusion | The EXTREMITY MEDICAL Screw and Washer System is substantially
equivalent to its predicate devices. This conclusion is based upon indications for
use, materials, design, test data and principles of operation. |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three swooping lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Extremity Medical, LLC % Jamy Gannoe President 300 Interpace Parkway, Suite 410 Parsippany, New Jersey 07054
JUL 18 2012
Re: K121349
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 Product Code: HWC Dated: June 15, 2012 Received: June 18, 2012
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, listing 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
2
Page 2 - Jamy Gannoe
CFR Part 807): labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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/CDRH/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 vours.
Eunel Keith
o-Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
EXTREMITY MEDICAL Screw System
. .
Special 510(k) Premarket Notification
Indications for Use
| 510(k) Number (if known): | K121349 |
|---|---|
| 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 extraricular 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 Calcaneocuboid, Metatarsocuneiform, Ankle, Capito-Lunate, and Triquetral-Hamate arthrodesis, as well as Metatarsal Osteotomies.
Over-the-counter Prescription Use X AND/OR (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ar
(Division Sign-Off) (Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K121349