(73 days)
Not Found
Not Found
No
The 510(k) summary describes a mechanical bone screw and does not mention any software, algorithms, or AI/ML capabilities.
No
This device is a compression screw used for fixation of bone fractures and reconstruction, which falls under surgical implantation for structural support rather than therapy.
No
The device is a Multi-Use Compression Screw intended for fixation of bone fractures or reconstruction, which is a therapeutic rather than diagnostic function.
No
The device description clearly indicates it is a physical screw made of stainless steel, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "fixation of bone fractures or for bone reconstruction" in the foot or hand. This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details a physical implantable device (a screw) made of stainless steel, with specific dimensions and features for surgical insertion into bone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze biological samples. This device is an implantable surgical device used inside the body.
N/A
Intended Use / Indications for Use
The Multi-Use Compression Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:
-Mono or Bi-Cortical osteotomies in the foot or hand
-Distal or Proximal metatarsal or metacarpal osteotomies
-Weil osteotomy
-Fusion of the first metatarsophalangeal joint and interphalangeal joint
-Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.)
-Akin type osteotomy
-Arthrodesis base first metatarsal cuneiform joint to reposition and stabilize metatarsus varus primus
-Calcaneus/ cuboid arthrodesis
-talar/ navicular arthrodesis
Product codes
HWC
Device Description
The design features of the Multi-Use Compression Screw are summarized below:
- Manufactured from Stainless Steel .
- Offered in two diameters: 3.0mm and 4.3mm .
- Offered in lengths ranging from 10mm-60mm .
- Offered in two thread lengths: short and long .
- Self drilling and self tapping features on both distal and proximal . threads
- Proximal threaded head is fully recessed into bone to allow for a zero . profile once fully inserted
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot or hand
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)
The safety and effectiveness of the Multi-use Compression Screw is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Newdeal BOLD® Compression Screw, Newdeal I.CO.S.® Screw
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
K043/02
JAN 2 1 2005
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of the Multi-use Compression Screw.
Submitted By: | Wright Medical Technology, Inc. |
---|---|
Date: | November 4, 2004 |
Contact Person: | Wesley L. Reed |
Regulatory Affairs Specialist | |
Proprietary Name: | Multi-Use Compression Screw |
Common Name: | Bone Fixation Screw |
Classification Name and Reference: | 21 CFR 888.3040 Smooth or threaded metallic bone |
fixation fastener - Class II | |
Device Product Code and Panel Code: | 21 CFR 888.3040 Smooth or threaded metallic bone |
fixation fastener - Class II |
DEVICE INFORMATION
A. INTENDED USE
The Multi-Use Compression Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:
-Mono or Bi-Cortical osteotomies in the foot or hand
-Distal or Proximal metatarsal or metacarpal osteotomies
-Weil osteotomy
-Fusion of the first metatarsophalangeal joint and interphalangeal joint
-Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.)
-Akin type osteotomy
-Arthrodesis base first metatarsal cuneiform joint to reposition and stabilize metatarsus varus primus
-Calcaneus/ cuboid arthrodesis
-talar/ navicular arthrodesis
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B. DEVICE DESCRIPTION
The design features of the Multi-Use Compression Screw are summarized below:
- Manufactured from Stainless Steel .
- Offered in two diameters: 3.0mm and 4.3mm .
- Offered in lengths ranging from 10mm-60mm .
- Offered in two thread lengths: short and long .
- Self drilling and self tapping features on both distal and proximal . threads
- Proximal threaded head is fully recessed into bone to allow for a zero . profile once fully inserted
C. SUBSTANTIAL EQUIVALENCE INFORMATION
The design features, material, and indications for use of the Multi-use Compression Screw are substantially equivalent to the previously cleared Newdeal BOLD® Compression Screw and the Newdeal I.CO.S.® Screw. This was confirmed by testing conforming to ASTM 543-02. The safety and effectiveness of the Multi-use Compression Screw is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 1 2005
Mr. Wesley L. Reed Regulatory Affairs Specialist Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002
Re: K043102
Trade/Device Name: Multi-Use Compression Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: November 5, 2004 Received: November 9, 2004
Dear Mr. Reed:
We have reviewed your Section 510(k) premarket notification of intent to market the device wf nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrease of the enactment date of the Medical Device Amendments, or to conninered processified in accordance with the provisions of the Federal Food, Drug, de rices mat have been recuire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The 1 ou may, dicrerere, market of the Act include requirements for annual registration, listing of general controls pro resuring 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 rr your device is elassified (overal controls. Existing major regulations affecting your device can may be our leases to cases as 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 r lease be act not a a determination that your device complies with other requirements of the Act that I Drimas intatutes and regulations administered by other Federal agencies. You must of any I occur statutes and regisments, including, but not limited to: registration and listing (2 l 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.
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Page 2 - Mr. Wesley L. Reed
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin maneting of substantial equivalence of your device to a legally premarket notification: "The PPF mailing of cation 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 If you desire specific advice ice your 240) 276-0115. Also, please note the regulation entitled, Connact the Ories of Come of Comment notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark A. Millerson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: Multi-Use Compression Screw
Indications For Use:
The Multi-Use Compression Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:
-Mono or Bi-Cortical osteotomies in the foot or hand
-Distal or Proximal metatarsal or metacarpal osteotomies
-Weil osteotomy
-Frsion of the first metatarsophalangeal joint and interphalangeal joint -Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.)
-Akin type osteotomy
-Arthrodesis base first metatarsal cuneiform joint to reposition and stabilize metatarsus varus primus
-Calcaneus/ cuboid arthrodesis
-talar/ navicular arthrodesis
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
Use
rt C)
No
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office Division of General. Restorative, and Neurological Devices
510(k) Number K043102
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