(107 days)
Landos SCARF Thread-Head Screw, Zimmer Herbert-Whipple Bone Screw, Osteomed M3 Screw
Not Found
No
The device description and intended use are for a mechanical bone screw, and there is no mention of AI, ML, image processing, or performance studies related to algorithmic analysis.
Yes
The device is described as a "threaded bone fixation screw" used for "fixation of fracture, fusion of a joint or bone reconstruction," which are therapeutic interventions.
No
Explanation: The device description states its intended use is for "Fixation of fracture, fusion of a joint or bone reconstruction". This indicates it is a surgical implant used for treatment, not for diagnosing a condition.
No
The device description clearly states it is a "threaded bone fixation screw" made of "titanium alloy," indicating it is a physical hardware device.
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, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states the device is a "threaded bone fixation screw" used for "Fixation of fracture, fusion of a joint or bone reconstruction (osteotomy) of the mid-foot, metatarsals and phalanges of the foot." This is a surgical implant used directly on the body for structural support and repair.
Therefore, based on its function and intended use, 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
This screw is to be implanted for the fixation of fractures, fusion of a joint or bone reconstruction of the mid-foot, metatarsals and phalanges of the foot.
Product codes
HWC
Device Description
The 34mm SCARF Thread-Head Screw is a threaded bone fixation screw that is 3.0mm in diameter and 34mm in length. It is made of thanium alloy and is cannulated with a threaded head. This screw is an extension of the product line for the SCARF Thread-Head Screw.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mid-foot, metatarsals and phalanges of the foot.
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.
Landos SCARF Thread-Head Screw, Zimmer Herbert-Whipple Bone Screw, Osteomed M3 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
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
☑ 006
SUMMARY OF SAFETY AND EFFECTIVENESS
MANUFACTURER IDENTIFICATION:
Medinov-AMP 27 à 31 rue Lucien Langenieux 42335 Roanne FRANCE
JUL - 9 1997
ESTABLISHMENT REGISTRATION NUMBER (Manufacturer):
9681744
1818910
Class II
SPONSOR IDENTIFICATION:
Cheryl Hastings DePuy, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, IN 46580
ESTABLISHMENT REGISTRATION NUMBER (Sponsor):
34mm SCARF Thread-Head Screw PROPRIETARY NAME: 87HWC
PRODUCT CLASSIFICATION CODE:
PROPOSED REGULATORY CLASS:
DESCRIPTION:
The 34mm SCARF Thread-Head Screw is a threaded bone fixation screw that is 3.0mm in diameter and 34mm in length. It is made of thanium alloy and is cannulated with a threaded head. This screw is an extension of the product line for the SCARF Thread-Head Screw.
INDICATIONS AND INTENDED USE:
This screw is to be implanted for the fixation of fractures, fusion of a joint or bone reconstruction of the mid-foot, metatarsals and phalanges of the foot.
PREDICATE DEVICES:
The predicate devices for this screw are the Landos SCARF Thread-Head Screw, the Zimmer Herbert-Whipple Bone Screw and the Osteomed M3 Screw.
1
Image /page/1/Picture/1 description: The image contains the words "Public Health Service" in a simple, sans-serif font. The text is black against a white background. The words are stacked on top of each other, with "Public Health" on the top line and "Service" on the bottom line.
Image /page/1/Picture/2 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 with three human profiles incorporated into its body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
·Ms. Cheryl Hastings DePuy, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
JUL - 9 1997
K971068 Re : 34mm SCARF Thread-Head™ Screw Requlatory Class: II Product Code: HWC May 30, 1997 Dated: Received: June 2, 1997
Dear Ms. Hastings:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions of the The general controls provisions of the Act include Act. requirements for annual reqistration, 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಡ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through
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Page 2 - Cheryl Hastings
542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or . requlations.
This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Colia M. Witter, Ph.D.
Celia M. Witter, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
K971068 510(k) Number (if known): _
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use: -- ------------------------------------
Fixation of fracture, fusion of a joint or bone reconstruction (osteotomy) of the mid-foot, metatarsals and phalanges of the foot.
CONFIDENTIAL
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Divisior Sign-Off)
Division of Restorative Devices
510(k) Number: K971068
Prescription Use X
(Per 21 CFR 801.109)
OR
Over-the-Counter Use __
(Optional Format 1-2-96)