(45 days)
Howmedica Asnis III Cannulated Screw System, Synthes 6.5 mm Cancellous Screw
Not Found
No
The device description and intended use are purely mechanical, describing a surgical screw. There is no mention of software, algorithms, or any technology that would suggest AI/ML.
No.
The device description indicates it is a surgical implant (screws for bone fusion) and not a device that administers therapy.
No
Explanation: The device description states that the product is a "Synthes (USA) 6.5 mm Cancellous Screw," which is an orthopedic implant used for fusions and reconstructions, not for diagnosing medical conditions.
No
The device description clearly states it is a physical screw made of Stainless Steel or Titanium Alloy, which is a hardware component.
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.
- Device Description and Intended Use: The description clearly states that the Synthes 6.5 mm Cancellous Screws are intended for use in surgical procedures involving bones in the hindfoot, midfoot, and ankle. They are physical implants used to stabilize bone structures.
There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.
N/A
Intended Use / Indications for Use
Synthes (USA) 6.5 mm Cancellous Screws are intended for use in hindfoot and midfoot fusions, subtalar fusions, calcaneal osteotomies, midfoot reconstruction, and ankle arthrodeses.
Product codes
HWC
Device Description
The Synthes (USA) 6.5 mm Cancellous Screws incorporate a fully threaded shaft, 4.0 mm core diameter, and have a flat head profile with rounded edges. They are available in lengths ranging from 60 mm to 130 mm in both Stainless Steel and Titanium Alloy. The screws are provided STERILE and NON STERILE.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hindfoot, midfoot, ankle
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)
Howmedica Asnis III Cannulated Screw System, Synthes 6.5 mm Cancellous Screw
Reference Device(s)
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.
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Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a logo that appears to be a stylized human figure inside of a circle. The logo and the word "SYNTHES" are underlined by a thin black line. The image is simple and clear, with a focus on the brand name.
3.0
JUL 2 7 2006 510(k) Summary Page _________________________________________________________________________________________________________________________________________________________________________ Sponsor: Synthes (USA) 1301 Goshen Parkway West Chester, PA 19380 (610) 719-6948 Device Name: Synthes (USA) 6.5 mm Cancellous Screws Classification: 21 CFR 888.3040: Smooth or Threaded Metallic Bone Fixation Fastener. Predicate Devices: Howmedica Asnis III Cannulated Screw System Synthes 6.5 mm Cancellous Screw Device Description: The Synthes (USA) 6.5 mm Cancellous Screws incorporate a fully threaded shaft, 4.0 mm core diameter, and have a flat head profile with rounded edges. They are available in lengths ranging from 60 mm to 130 mm in both Stainless Steel and Titanium Alloy. The screws are provided STERILE and NON STERILE. Intended Use: Synthes (USA) 6.5 mm Cancellous Screws are intended for use in hindfoot and midfoot fusions, subtalar fusions, calcaneal osteotomies, midfoot reconstruction, and ankle arthrodeses. Substantial Information presented supports substantial equivalence. Equivalence:
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services (HHS). The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with three lines forming a stylized bird-like shape. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 27 2006
Synthes (USA) % Ms. Deborah L. Jackson, RAC Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K061621
Trade/Device Name: Synthes (USA) 6.5 mm Cancellous Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: June 9, 2006 Received: June 15, 2006
Dear Ms. Jackson:
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. Drue, 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. Iisting 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 Codc of Federal Regulations. Title 21, Parts 800 to 898. In addition, FDA mav 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. Deborah L. Jackson, RAC
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 (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Hubert Lemercier
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/3/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a logo that appears to be a stylized representation of a person. There is a horizontal line underneath the word "SYNTHES" and the logo. The logo and the word "SYNTHES" are the main focus of the image.
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Indications for Use
510(k) Number (if known):
Device Name:
Synthes (USA) 6.5 mm Cancellous Screws
Indications for Use:
Synthes (USA) 6.5 mm Cancellous Screws are intended for use in hindfoot and midfoot fusions, subtalar fusions, calcaneal osteotomies, midfoot reconstruction, and ankle arthrodeses.
X Prescription Use (Per 21 CFR 801.109)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (QDE)
Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K061621