(86 days)
Not Found
Not Found
No
The description focuses on the mechanical properties and intended use of a surgical screw and guidewire, with no mention of AI or ML capabilities.
No.
The device is an orthopedic implant (screw) used for fracture fixation, which falls under surgical repair rather than a therapeutic treatment in the conventional sense of drug or biological therapies.
No
The device is a cannulated screw for fracture fixation, which is a therapeutic device, not a diagnostic one. Its purpose is to physically stabilize bones, not to diagnose a condition.
No
The device description clearly describes a physical screw and guidewires, which are hardware components, 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Device Description and Intended Use: The description and intended use of the Synthes 6.5 mm Cannulated Screw clearly indicate it is a surgical implant used for fracture fixation of bones. This is a procedure performed inside the body (in vivo) to physically stabilize bone fragments.
The device's function is mechanical and structural, not diagnostic based on analyzing biological samples.
N/A
Intended Use / Indications for Use
Synthes 6.5 mm Cannulated Screw is intended for fracture fixation of large bones and large bone fragments, such as femoral neck fractures; slipped capital femoral epiphyses; an adjunct to DHS in basilar neck fractures; tibial plateau fractures; ankle arthrodeses; pediatric femoral neck fractures; intercondylar femur fractures; SI joint disruptions; and subtalar arthrodeses.
Product codes
HWC, OUR
Device Description
Synthes 6.5 mm Cannulated Screw is a self-tapping and self-drilling screw with a cancellous thread that can be guided into a position via a guidewire. Screws are available partially or fully threaded, in thread / screw lengths of 16 mm / 30 - 200 mm, 32 mm / 45 - 200 mm and full / 20 - 200 mm. Synthes 2.8 mm guidewires in 300 and 450 mm lengths are used for precise placement in bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
large bones and large bone fragments, such as femoral neck fractures; slipped capital femoral epiphyses; basilar neck fractures; tibial plateau; ankle; pediatric femoral neck; intercondylar femur; SI joint; subtalar
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Synthes 7.3 mm Cannulated Screw, Alphatec 6.5 Cannulated 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
6 2002 SEP
l932
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 6.5 mm Cannulated Screw |
| Classification: | The classification for Synthes 6.5 mm Cannulated Screw is Class II, as
per Title 21 of the Code of Federal Regulations, Section 888.3040:
"Smooth or threaded metallic bone fixation fastener". |
| Predicate Device: | Predicate devices for the Synthes 6.5 mm Cannulated Screw are the
Synthes 7.3 mm Cannulated Screw and the Alphatec 6.5 Cannulated
Screw. |
| Device Description: | Synthes 6.5 mm Cannulated Screw is a self-tapping and self-drilling
screw with a cancellous thread that can be guided into a position via a
guidewire. Screws are available partially or fully threaded, in thread /
screw lengths of 16 mm / 30 - 200 mm, 32 mm / 45 - 200 mm and full
/ 20 - 200 mm. Synthes 2.8 mm guidewires in 300 and 450 mm
lengths are used for precise placement in bone. |
| Intended Use: | Synthes 6.5 mm Cannulated Screw is intended for fracture fixation of
large bones and large bone fragments, such as femoral neck fractures;
slipped capital femoral epiphyses; an adjunct to DHS in basilar neck
fractures; tibial plateau fractures; ankle arthrodeses; pediatric femoral
neck fractures; intercondylar femur fractures; SI joint disruptions; and
subtalar arthrodeses. |
| Materials: | Stainless steel and titanium alloy |
: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : Synthes (USA) Premarket Notification 510(k): 6.5 mm Cannulated Screw
. .
•005
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with its wings spread, formed by three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
APR - 7 2011
Synthes % Bonnie J. Smith Senior Regulatory Affairs Associate 1690 Russell Road Paoli, Pennsylvania 19301
Re: K021932
Trade/Device Name: Synthes 6.5 mm Cannulated Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, OUR Dated: June 10, 2002 Received: June 12, 2002
Dear Ms. Smith:
This letter corrects our substantially equivalent letter of September 06, 2002.
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
2
Page 2 - Bonnie J. Smith
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Ais B. Duta
for
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
2.0 Indications for Use Statement
of Page l l
510(k) Number (if known):
KO21932
Device Name:
INDICATIONS:
Synthes (USA) 6.5 mm Cannulated Screw
Synthes 6.5 mm Cannulated Screw is intended for fracture fixation of large bones and large bone fragments, such as femoral neck fractures; slipped capital femoral epiphyses; an adjunct to DHS in basilar neck fractures; tibial plateau fractures; ankle arthrodeses; pediatric femoral neck fractures; intercondylar femur fractures; SI joint disruptions; and subtalar arthrodeses.
(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
Division Sign
Restorative
Synthes (USA) Premarket Notification 510(k): 6.5 mm Canmiller & Schoumber . ·004