(62 days)
Not Found
No
The summary describes a mechanical screw for bone fixation and reduction and does not mention any AI or ML components or functions.
Yes
The device is described as "intended to provide fixation and anatomically reduce two bones or bone portions," explicitly addressing conditions like "scapholunate ligament repair, scapholunate reduction, lunotriquetral ligament repair, lunotriquetral reduction, and carpal instability," which are therapeutic interventions.
No
The device is a bone reduction screw intended for fixation and anatomical reduction of bones, which is a therapeutic rather than a diagnostic function.
No
The device description clearly describes a physical screw assembly intended for surgical implantation, not a software product.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided information clearly describes a surgical implant (a bone screw) used to physically fix and reduce bone portions. It is used in the body during surgery, not to test samples outside the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, chemical reactions, or diagnostic testing.
This device is a surgical implant used for orthopedic procedures.
N/A
Intended Use / Indications for Use
The Bone Reduction Screw is intended to provide fixation and anatomically reduce two bones or bone portions. Specifically, these indications include scapholunate ligament repair, scapholunate reduction, lunotriquetral ligament repair, lunotriquetral reduction, and carpal instability.
Product codes
HWC
Device Description
The ARC Surgical Bone Reduction Screw is a headless, cannulated twopiece screw assembly. The two-piece design incorporates the use of a distal and proximal screw component. The implant is used to anatomically reduce two bone portions. The distal screw component engages the distal bone portion and the proximal screw component engages the proximal bone component.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bones or bone portions, scapholunate, lunotriquetral, carpal
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)
Performance data is included in Section 10. A discussion of clinical and non-clinical tests is not applicable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K023294, K792022, K013775, K984209
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.
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Image /page/0/Picture/1 description: The image shows a logo for ARC Surgical. The logo features the letters "ARC" in a large, bold font, with the word "SURGICAL" in a smaller font underneath. To the right of the letters is a circle with a crosshair in the center, giving the logo a modern and professional look. The logo is in black and white.
ARC Surgical, LLC 21300 NW Jacobson Rd, Hillsboro, OR 97124
phone: (503) 645-9300 / fax: (503) 645-9304 / web: www.arcsurgical.com
510(k) Summary
This summary regarding 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
Submitter Information: Arc Surgical LLC 21300 NW Jacobson Rd Hillsboro, OR 97124 USA DEC 2 7 2006 Phone: (503) 645-9300 FAX: (503) 645-9304 Contact: Ed Boehmer, Regulatory Compliance Officer
Smooth or threaded metallic bone fixation fastener Classification Name: Screw, Fixation, Bone Common Name: Proprietary Name: Arc Surgical Bone Reduction Screw System Proposed Regulatory Class: Class II, 21 CFR 888.3040 Device Product Code: HWC Legally Marketed Equivalent Device(s): Howmedica Osteonics Bosworth CC Screw K023294 Zimmer Herbert Bone Screw K792022 Stryker Leibinger TwinFix Screw K013775 Biomet SS Cannulated Screw K984209
Device Description: The ARC Surgical Bone Reduction Screw is a headless, cannulated twopiece screw assembly. The two-piece design incorporates the use of a distal and proximal screw component. The implant is used to anatomically reduce two bone portions. The distal screw component engages the distal bone portion and the proximal screw component engages the proximal bone component.
Intended Use: The Bone Reduction Screw is intended to provide fixation and anatomically reduce two bones or bone portions. Specifically, these indications include scapholunate ligament repair, scapholunate reduction, lunotriquetral ligament repair, lunotriquetral reduction, and carpal instability.
These are similar to the intended use of predicate devices and do not raise new issues of safety and effectiveness.
Technological Characteristics: The screw is manufactured from 316L stainless steel per ASTM F-138.
Performance data is included in Section 10. A discussion of clinical and non-clinical tests is not applicable.
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Image /page/1/Picture/1 description: The image shows the logo for ARC Surgical. The logo features the letters "ARC" in a bold, sans-serif font, with the word "SURGICAL" in a smaller font below. To the right of the letters is a stylized circle with a crosshair in the center, giving the impression of a target or aiming device. The overall design is clean and professional, suggesting a company focused on precision and accuracy.
ARC Surgical, LLC 21300 NW Jacobson Rd, Hillsboro, OR 97124
phone: (503) 645-9300 / fax: (503) 645-9304 / web: www.arcsurgical.com
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Based upon the similarities with the predicate devices, the safety and effectiveness of the ARC Surgical Bone Reduction Screw System is substantially equivalent to the predicate devices referenced.
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Arc Surgical, LLC % Mr. Ed Boehmer Regulatory Compliance Officer 21300 NW Jacobson Road Hillsboro, Oregon 97124
DEC 2 7 2006
Re: K063244
Trade/Device Name: Arc Surgical Bone Reduction Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: October 20, 2006 Received: October 26, 2006
Dear Mr. Boehmer:
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 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
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Page 2 -- Mr. Ed Boehmer
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 Office of Compliance at (240) 276-0210 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Baubaze Buchus
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
KO63244 510(k) Number (if known): _
Arc Surgical Bone Reduction Screw System Device Name:
Indications For Use:
The bone reduction screw is intended to provide fixation and anatomically reduce two bones or bone portions. Specifically, these indications include scapholunate ligament repair, scapholunate reduction, lunotriquetral ligament repair, lunotriquetral reduction, and carpal instability.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 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)
Barbara Buchup for MYM
(Division Sign. Off
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K063244
Arc Surgical LLC Page 79