(88 days)
Not Found
No
The device description and intended use are purely mechanical, and there is no mention of AI, ML, image processing, or any data-driven analysis.
Yes
The device is described as a "Modular Head Bone Screw" indicated for "Fixation of fractures" and "Ligament reconstruction," which are interventions for treating medical conditions, classifying it as a therapeutic device.
No
Explanation: The device description and intended use indicate it is an orthopedic screw used for fracture fixation, ligament reconstruction, arthrodesis, and osteotomies. These are surgical treatments, not diagnostic procedures.
No
The device description clearly states it is a "metal screw shaft with a corresponding resorbable screw head" and an "optional corresponding metal screw head," indicating it is a physical hardware device, not software.
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 and Intended Use: The provided information clearly describes a surgical implant (a bone screw) used for fixing fractures and performing other orthopedic procedures directly on the patient's bones and ligaments. It is not used to analyze samples outside the body.
The description and intended use are entirely focused on a device used in vivo (within the living body) for structural support and fixation.
N/A
Intended Use / Indications for Use
The Modular Head Bone Screw is indicated for the following conditions:
- Fixation of fractures in long bones such as the fibula, tibia, humerus, radius u and ulna, as well as fractures in the patella
- l Fixation of small bones such as those in the foot, ankle, wrist and elbow
- 트 Ligament reconstruction
- Arthrodesis of the foot, ankle, wrist and elbow ■
- Small bone osteotomies 해
- Osteochondritis dissecans 트
Product codes
HWC
Device Description
This device is a metal screw shaft with a corresponding resorbable screw head. It also has an optional corresponding metal screw head for back-up purposes should the resorbable screw head become contaminated in the surgical environment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fibula, tibia, humerus, radius, ulna, patella, foot, ankle, wrist, elbow
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
Non-Clinical Testing: Mechanical testing was performed to establish substantial equivalence to the predicate devices.
Clinical Testing: Clinical testing was not used to establish substantial equivalence to predicate devices.
Key Metrics
Not Found
Predicate Device(s)
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
DEC 0 2 2002
BIOMET
Ko 295.2 page(4)
Summary of Safety and Effectiveness
| Applicant/Sponsor: | Biomet Orthopedics, Inc.
P.O. Box 587
Warsaw, IN 46581-0587 |
|--------------------|---------------------------------------------------------------------------|
| Contact Person: | Kacy Arnold, RN, MBA
Telephone: (574) 372-1644
Fax: (574) 372-1683 |
| Proprietary Name: | Modular Head Bone Screw |
| Common Name: | Bone Screw |
Classification Name: Screw, fixation, bone (888.3040)
Legally Marketed Devices to Which Substantial Equivalence is Claimed:
Device Description:
This device is a metal screw shaft with a corresponding resorbable screw head. It also has an optional corresponding metal screw head for back-up purposes should the resorbable screw head become contaminated in the surgical environment.
Indications for Use: The Modular Head Bone Screw is indicated for the following conditions:
- Fixation of fractures in long bones such as the fibula, tibia, humerus, radius u and ulna, as well as fractures in the patella
- l Fixation of small bones such as those in the foot, ankle, wrist and elbow
- 트 Ligament reconstruction
- Arthrodesis of the foot, ankle, wrist and elbow ■
- Small bone osteotomies 해
- Osteochondritis dissecans 트
Summary of Technologies: The Modular Head Bone Screw's technological characteristics are similar to or identical to the predicate devices.
Non-Clinical Testing: Mechanical testing was performed to establish substantial equivalence to the predicate devices.
Clinical Testing: Clinical testing was not used to establish substantial equivalence to predicate devices.
MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587 - - - - - - - - -
SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582
0000000
1 -
■
E =
1
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird with three curved lines representing its wings or feathers.
Public Health Service
DEC 02 2002
ood and Drug Administration 200 Corporate Boulevard Rockville MD 20850
Biomet Orthopedics, Inc. · Kacy Arnold, RN, MBA Regulatory Affairs Specialist P. O. Box 587 Warsaw, Indiana 46581
Re: K022952
Trade/Device Name: Modular Head Bone Screw Regulation Number: 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: September 4, 2002 Received: September 5, 2002
Dear Ms. Arnold:
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
2
Page 2 - Ms. Kacy Arnold
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 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,
Miriam C. Provost
(Celia M. Witten, Ph.D., MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510 (k) Number (if known) :
Device Name: Modular Head Bone Screw
Indications for Use:
The indications for the use of the Modular Head Bone Screw include:
- Fixation of fractures in long bones such as the fibula, tibia, humerus, radius and 비 ulna, as well as fractures in the patella
- Fixation of small bones such as those in the foot, ankle, wrist and elbow 해
- Ligament reconstruction 피
- Arthrodesis of the foot, ankle, wrist and elbow 트
- Small bone osteotomies 비
- 트 Osteochondritis dissecans
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use 112 (Per 21 CFR 801.109)
OR
Over-The-Counter-Use (Optional Format 1-2-96)
Muriam C. Provost
Division Sign Off
Sivision Sign-Off) Division of General, Restorative and Neurological Devices
060003