(29 days)
Not Found
No
The document describes a mechanical screw system and does not mention any AI or ML components or functionalities.
Yes.
This device is used for the fixation of bones and joints, which implies a therapeutic purpose by supporting healing and stability.
No
The device description indicates it is a titanium screw used for fixation of fractures, ligament reconstruction, arthrodesis, and osteotomies. This describes a surgical implant for treatment, not a device that identifies or characterizes a disease or condition.
No
The device description explicitly states it is a "titanium screw," which is a physical hardware component, 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 describes the device as being used for the fixation of fractures, ligament reconstruction, arthrodesis, osteotomies, and osteochondritis dissecans within the human body. These are all surgical procedures performed directly on the patient.
- Device Description: The device is described as a titanium screw designed to be inserted into bone. This is a surgical implant, not a diagnostic tool used to examine samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test biological samples (like blood, urine, tissue), or to provide information about a patient's health status based on such testing.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or screening purposes. This device is used in vivo (within the body) for surgical repair and stabilization.
N/A
Intended Use / Indications for Use
The Propeller Head Small Cannulated Screw System is indicated for the following conditions:
- Fixation of fractures in long bones such as the fibula, tibia, humerus, radius and ulna . as well as fractures in the patella.
- Fixation of the small bones such as those in the foot, ankle, wrist and elbow. ●
- . Ligament reconstruction
- Arthrodesis of the foot, ankle, wrist and elbow. .
- Small bone osteotomies .
- Osteochondritis dissecans
Product codes
87HWC
Device Description
The Propeller Head Small Cannulated Screw System is a titanium screw that has cutting flutes in the head, which allows it to cut into the bone, thus countersinking itself. The screw is also cannulated to allow insertion over a quide wire. The threads are selfdrilling and self-tapping.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fibula, tibia, humerus, radius and ulna, patella, foot, ankle, wrist and 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing: Mechanical testing demonstrated the modified device performed as well as or better than the previously marketed devices. Clinical Testing: Clinical testing was not used to establish substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Self-Countersinking Bone Screw (K013534)
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
BIOMET
Page 1 of 1
JAN 0 9 2003
SUMMARY OF SAFETY AND EFFECTIVENESS
| Applicant or Sponsor: | Biomet Orthopedics, Inc
56 E. Bell Drive
P.O. Box 587
Warsaw, IN 46581-0587 |
|-----------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| Contact Person: | Kacy Arnold, RN, MBA
Telephone: (574) 372-1644
Fax: (574) 372-1683 |
| Proprietary Name: | Propeller Head Small Cannulated Screw System |
| Common or Usual Name: | Bone Screw |
| Device Classification: | Screw, Fixation, Bone (888.3040) |
| Device Product Code: | 87HWC |
| Legally Marketed Devices
To Which Substantial
Equivalence Is Claimed: | Self-Countersinking Bone Screw (K013534) |
Indications for Use: The Propeller Head Small Cannulated Screw System is indicated for the following conditions:
- Fixation of fractures in long bones such as the fibula, tibia, humerus, radius and ulna . as well as fractures in the patella.
- Fixation of the small bones such as those in the foot, ankle, wrist and elbow. ●
- . Ligament reconstruction
- Arthrodesis of the foot, ankle, wrist and elbow. .
- Small bone osteotomies .
Device Description: The Propeller Head Small Cannulated Screw System is a titanium screw that has cutting flutes in the head, which allows it to cut into the bone, thus countersinking itself. The screw is also cannulated to allow insertion over a quide wire. The threads are selfdrilling and self-tapping.
Non-Clinical Testing: Mechanical testing demonstrated the modified device performed as well as or better than the previously marketed devices.
Clinical Testing: Clinical testing was not used to establish substantial equivalence.
MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587
.
SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582
()FFICE 574.267.6639 FAX 574.267.8137
Image /page/0/Picture/18 description: The image contains a small, solid black square in the lower left portion of the frame. The square is not perfectly formed, with some slight irregularities along its edges. The rest of the image is a blank white space, providing a high contrast background for the black square.
E-MAH. biomet@biomet.com
1
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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around it. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing the wings and a stylized head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 0 9 2003
Kacy Arnold, RN, MBA Regulatory Affairs Specialist Biomet. Inc. P.O. Box 587 Warsaw, IN 46581-0587
Re: K024086
Trade/Device Name: Propeller Head Small Cannulated Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: December 9, 2002 Received: December 11, 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 quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Kacy Arnold, RN, MBA
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" (21 CFR Part 807.97) you may obtain. 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 vours,
R. Mark N. Milliken
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
3
Page 1 of 1
510 (k) Number (if known) : _ KO 2 4 08 6
Device Name: Propeller Head Small Cannulated Screw System
Indications for Use: The Propeller Head Small Cannulated Screw System is indicated for the following conditions:
- Fixation of fractures in long bones. .
- Fixation of the small bones, including those in the foot, patella, ankle, wrist and . elbow.
- Ligament reconstruction ●
- Arthrodesis of the foot, ankle, wrist and elbow. .
- Small bone osteotomies ●
- Osteochondritis dissecans
for Mink A. Millerson
of General. Restorative and Notice rical Devices
510(k) Number K024086
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter-Use (Optional Format 1-2-96)