(88 days)
Not Found
Not Found
No
The document describes a mechanical orthopedic screw and does not mention any software, algorithms, or AI/ML capabilities.
No.
The device is described as a screw intended for the fixation of fractures and non-unions of small bones, which is a supportive mechanical function, not a therapeutic action like delivering medication or stimulating healing through biochemical or physical means.
No
The device is a screw intended for fixation of fractures and non-unions, which is a therapeutic rather than a diagnostic function.
No
The device description clearly describes a physical screw, which is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the Synthes 2.4 mm Cannulated Compression Screw is a surgical implant used for the fixation of fractures and non-unions of bones. It is a physical device inserted into the body.
Therefore, this device falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Synthes 2.4 mm Cannulated Compression Screw is intended for fixation of fractures and non-unions of small bones and small bone arthrodeses, including, but not limited to, scaphoid fractures; intra-articular fractures of the tarsals, metatarsals, carpals and metacarpals; bunionectomies and osteotomies; arthrodeses of small joints (e.g. phalanges); fractures of the patella, ulna and radial styloid.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
Synthes 2.4 mm Cannulated Compression Screw is a partially threaded self-tapping and self-drilling screw that can be guided into a position using a guidewire. The threaded head is designed to be recessed below or sit flush with the near cortex and features a StarDrive™ head. Synthes 2.4 mm Cannulated Compression Screws are available in various lengths.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Small bones (e.g., scaphoid, tarsals, metatarsals, carpals, metacarpals, phalanges, patella, ulna, radial styloid)
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Synthes 2.4 mm Cannulated Screw
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
AUG 0 9 2002
K021556
page 1 of 1
3.0 510(k) Summary
| Sponsor: | Synthes (USA)
1690 Russell Road
Paoli, PA 19301
(610) 647-9700
Contact: Bonnie Smith |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Synthes 2.4 mm Cannulated Compression Screw |
| Classification: | Class II, as per Title 21 of the Code of Federal Regulations, Section
888.3040: "Smooth or threaded metallic bone fixation fastener". |
| Predicate Device: | Synthes 2.4 mm Cannulated Screw |
| Device Description: | Synthes 2.4 mm Cannulated Compression Screw is a partially threaded
self-tapping and self-drilling screw that can be guided into a position
using a guidewire. The threaded head is designed to be recessed below
or sit flush with the near cortex and features a StarDrive™ head.
Synthes 2.4 mm Cannulated Compression Screws are available in
various lengths. |
| Intended Use: | Synthes 2.4 mm Cannulated Compression Screw is intended for
fixation of fractures and non-unions of small bones and small bone
arthrodeses, including, but not limited to, scaphoid fractures; intra-
articular fractures of the tarsals, metatarsals, carpals and metacarpals;
bunionectomies and osteotomies; arthrodeses of small joints (e.g.
phalanges); fractures of the patella, ulna and radial styloid. |
| Materials: | Stainless steel |
1
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three wavy lines representing the department's mission. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
AUG 0 9 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Bonnie J. Smith Senior Regulatory Affairs Associate Synthes® (USA) 1690 Russell Road P.O. Box 1766 Paoli, PA 19301
Re: K021556
Trade/Device Name: Synthes(USA) 2.4 mm Cannulated Compression Screw Regulation Number: 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: May 10, 2002 Received: May 13, 2002
Dear Ms. Smith:
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.
2
Page 2 - Ms. Bonnie J. Smith
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,
sincerely yours,
for Mark A. Millburn
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
2.0 Indications for Use Statement
Page of l 1
510(k) Number (if known):
Device Name:
INDICATIONS:
Synthes 2.4 mm Cannulated Compression Screw is intended for fixation of fractures and non-unions of small bones and small bone arthrodeses, including, but not limited to, scaphoid fractures; intra-articular fractures of the tarsals, metatarsals, carpals and metacarpals; bunionectomies and osteotomies; arthrodeses of small joints (e.g. phalanges); fractures of the patella, ulna and radial styloid.
Synthes (USA) 2.4 mm Cannulated Compression Screw
Mark N. Melkerson
vision of Cararal, Restorative and Neurolog cal Devices
510(k) Number: K021556
(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
CONFIDENTIAL Premarket Notification 510(k): Synthes 2.4 mm Cannulated Compression Screw
1004