(212 days)
Not Found
No
The device description focuses on the mechanical properties and design of a surgical screw, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes
The device is intended for fixation of fractures and non-unions, and for arthrodesis and osteotomies, which are therapeutic interventions.
No
The device description indicates it is a headless compression screw intended for fixation of fractures and non-unions, functioning as an implanted medical device for treatment rather than diagnosis.
No
The device description clearly states it is a physical screw made of titanium alloy, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The AREX SCRU2 is a surgical implant (a screw) used for fixing bones. It is physically inserted into the body.
- Intended Use: The intended use is for the fixation of fractures and other bone issues. This is a surgical procedure, not a diagnostic test performed on a sample outside the body.
The information provided clearly describes a surgical device, not a diagnostic one.
N/A
Intended Use / Indications for Use
The AREX SCRU2 headless compression screw is intended for fixation of intra-articular and extra-articular fractures of the upper and lower extremities, as well as non-unions of small bones and bone fragments, arthrodesis of small joints, bunionectomies and osteotomies. Examples include scaphoid and other carpal bones, metacarpais, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.
Product codes
HWC
Device Description
The AREX SCRU 2 Headless Compression Screws are cannulated, self drilling, self tapping, dual-pitch threaded devices which can be countersunk into the bone. The screw is available in titanium alloy with and OD of 2 5 or 3 mm and lengths from 10mm up to 45 mm, in increments of 5 mm. The screws are supplied non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Upper and lower extremities, scaphoid and other carpal bones, metacarpais, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Zimmer Herbert Bone Screw (K792022), Synthes Cannulated Screw System (K050636)
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
81011 p. 1/2
NOV - 7 2008
AREXUSA™
1335 Merrybrook Road Collegeville, PA 19421
Office: (610) 584-6870 Fax: (610) 584-6807
Email: arexusa@earthlink.net Web: www.arexuse.com
PREMARKET NOTIFICATION 510(k) SUMMARY (As Required By 21 CFR 807.93)
Date of Preparation: April 7, 2008
Applicant:
AREX USA LLC 1335 Merrybrook Rd. Collegeville, PA 19403
Contact Individual
Trade Name
Cannulated Compression Screw
AREX SCRU 2 Headless Compression Screw
Zimmer Herbert Bone Screw (K792022)
Synthes Cannulated Screw System (K050636)
Ellen Hokanson, President
610-584-6870
Common Name
888.3040 Regulation
HWC Product Code:
Pin. Fixation Threaded Classification Name
Class II Classification
Predicate Device Name:
Device Description:
The AREX SCRU 2 Headless Compression Screws are cannulated, self drilling, self tapping, dual-pitch threaded devices which can be countersunk into the bone. The screw is available in titanium alloy with and OD of 2 5 or 3 mm and lengths from 10mm up to 45 mm, in increments of 5 mm. The screws are supplied non-sterile.
1
Intended Use
The AREX SCRU2 headless compression screw is intended for fixation of intra-articular and extra-articular fractures of the upper and lower extremities, as well as nonunions of small bones and bone fragments, arthrodesis of small joints, bunionectomies and osteotomies. Examples include scaphoid and other carpal bones, metacarpais, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.
Technology Characteristics:
The design, materials and indications for use of the AREX SCRU 2 headless compression screws are equivalent to devices previously approved for market in the United States.
Conclusion:
The design, materials and indications for use demonstrate that the AREX SCRU 2 headless compression screws are substantially equivalent to the predicate devices, and safe and effective for use, when used in accordance with the supplied instructions for use.
11/7/08
Ellen Hokanson Date President
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services, USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread. The eagle is facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Arex USA LLC % Ms. Ellen Hokanson President 1335 Merrybrook Road Collegeville, Pennsylvania 19403
NOV - 7 2008
Re: K081011
Trade/Device Name: Arex SCRU 2 Headless Compression Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: October 21, 2008 Received: October 22, 2008
Dear Ms. Hokanson:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set
3
Page 2 - Ms. Ellen Hokanson
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N Millican
Mark N. Melkerson Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510K Number: K081011
Device Name: AREX SCRU2 Headless Compression Screw
Indications for Use:
The AREX SCRU2 headless compression screw is intended for fixation of intra-articular and extra-articular fractures of the upper and lower extremities, as well as non-unions of small bones and bone fragments, arthrodesis of small joints, bunionectomies and osteotomies. Examples include scaphoid and other carpal bones, metacarpais, tarsals, metatarsals, patella, ulmar styloid, capitellum, radial head and radial styloid.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use No
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Mellman
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number
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