(7 days)
Not Found
Not Found
No
The 510(k) summary describes a material modification to a mechanical orthopedic screw and washer. There is no mention of software, algorithms, or any technology related to AI or ML.
No
The device, a screw, is used for fixation and repair, suggesting a structural and supportive role rather than directly administering therapy.
No
The device description clearly states its intended uses are for surgical fixation and repair (e.g., acromioclavicular reduction, coracoclavicular fixation, muscle transfers), which are therapeutic or reconstructive procedures, not diagnostic ones.
No
The device description explicitly states it is a "Bosworth Coraco-Clavicular Screw and the associated washer," which are physical hardware components used in surgical procedures. The submission is for a material modification to these hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. They are used outside of the body.
- Device Description and Intended Use: The description clearly states the device is a "Bosworth Coraco-Clavicular Screw" intended for surgical procedures involving bone fixation and repair in the shoulder area (acromioclavicular and coracoclavicular). This is an implantable device used within the body.
The information provided describes a surgical implant, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
The Bosworth Coraco-Clavicular Screw is intended for uses in cases of acromioclavicular reduction and acromioclavicular fixation; acromioclavicular reduction; coracoclavicular ligament repair, and coracoclavicular fixation; a combination of the aforementioned indications; distal clavicle extension; and muscle transfers.
Product codes
HWC
Device Description
This Special 510(k) submission is intended to address a material modification to the Bosworth Coraco-Clavicular Screw and the associated washer for use with the screw. The material modification involves changing the material from cast cobalt chromium alloy to wrought cobalt chromium alloy. The design, intended use, packaging and sterilization of the subject devices are identical to those of predicate devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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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)
Not Found
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
Special 510(k) Summary: Device Modification to the Bosworth Coraco-Clavicular Screw
Submission Information
Name and Address of the Sponsor of the 510(k) Submission:
Contact Person:
Howmedica Osteonics Corp 59 Route 17 Allendale, NJ 07401-1677
Karen Ariemma Regulatory Affairs Specialist
Date of Summary Preparation:
September 30, 2002
Device Identification
Bosworth Coraco-Clavicular Screw Proprietary Name: Common Name: Bone Screw Classification Name and Reference: Single/multiple component metallic bone fixation appliances and accessories, 21 CFR $888.3030
This Special 510(k) submission is intended to address a material modification to the Bosworth Coraco-Clavicular Screw and the associated washer for use with the screw. The material modification involves changing the material from cast cobalt chromium alloy to wrought cobalt chromium alloy. The design, intended use, packaging and sterilization of the subject devices are identical to those of predicate devices.
Intended Use
The intended use of the modified devices, as described in its labeling, has not changed as a result of this modification. These devices are intended for use in cases of acromioclavicular reduction and acromioclavicular fixation; acromioclavicular reduction, coracoclavicular ligament repair, and coracoclavicular fixation; a combination of the aforementioned indications; distal clavicle excision; and muscle transfers.
Statement of Technological Comparison
Analysis demonstrates comparable properties of the subject to the predicate device.
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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 caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The logo is black and white and appears to be slightly distressed.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Karen Ariemma Regulatory Affairs Specialist Howmedica Osteonics Corporation 59 Route 17 Allendale, NJ 07401-1677
Re: K023294
Trade/Device Name: Bosworth Coraco-Clavicular Screw and Washer Regulation Number: 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HWC Dated: September 30, 2002 Received: October 2, 2002
Dear Ms. Ariemma:
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.
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Page 2 - Ms. Karen Ariemma
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, 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/dsma/dsmamain.html
Sincerely yours.
Stippl Rode
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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510(k) Number (if known): K (m) 3099
Device Name: Bosworth Coraco-Clavicular Screw and Washer
Indications for Use
The Bosworth Coraco-Clavicular Screw is intended for uses in cases of acromioclavicular reduction and acromioclavicular fixation; acromioclavicular reduction; coracoclavicular ligament repair, and coracoclavicular fixation; a combination of the aforementioned indications; distal clavicle extension; and muscle transfers.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Hypt Plurde
on Sign-Off) vision of General, Restorative and Neurological Devices
510(k) Number K023294