(38 days)
KLS Martin 1.0mm System Center-Drive Screw System, Synthes Maxillofacial Titanium Micro Set
Not Found
No
The summary describes a mechanical device (screws) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device, Synthes 1.0/1.2 mm craniofacial screws, is an implantable surgical screw used for fracture fixation in craniofacial and maxillofacial surgery, which is a structural or supportive role rather than directly curing, treating, or preventing disease, which defines a therapeutic device.
No
Explanation: This device is described as a surgical implant (screws) used for fixation in craniofacial and maxillofacial surgeries, not for diagnosing medical conditions.
No
The device description clearly states it is a physical screw, which is a hardware component.
Based on the provided information, 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 1.0/1.2 mm craniofacial screws are implants used for fixing fractures in specific anatomical areas of the skull and face. They are physically inserted into the body during surgery.
Therefore, this device falls under the category of a surgical implant, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Synthes 1.0/1.2 mm craniofacial screws are intended for use as follows: Specific Indications: - Nasoethmoidal fractures . - Infraorbital area fractures . - Frontal sinus wall fractures . - Infant craniofacial surgery . General Indications: - Maxıllofacial surgery .
Product codes
DZL
Device Description
The 1.0/1.2 mm Craniofacial Screws are either self-drilling or self- tapping, have a flat head profile with rounded edges with a cruciform recess, and are available in various lengths.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nasoethmoidal fractures, Infraorbital area fractures, Frontal sinus wall fractures, Craniofacial, Maxillofacial
Indicated Patient Age Range
Infant
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)
KLS Martin 1.0mm System Center-Drive Screw System, Synthes Maxillofacial Titanium Micro Set
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.4880 Intraosseous fixation screw or wire.
(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image shows the number K041887 written in black ink at the top. Below the number is the word "SYNTHES" in bold black letters. There is a logo to the left of the word, and a line below the word.
AUG 1 9 2004
:
| 3.0 | 510(k) Summary | Page 1 of 1 |
|---|---|---|
| Sponsor: | SYNTHES (USA) | |
| 1690 Russell Road | ||
| Paoli, PA 19301 | ||
| (610) 647-9700 | ||
| Device Name: | Synthes 1.0/1.2 mm Craniofacial Screws | |
| Classification: | 21 CFR 872.4880: Screw, Fixation, Intraosseous | |
| Predicate Device: | KLS Martin 1.0mm System Center-Drive Screw System | |
| Synthes Maxillofacial Titanium Micro Set | ||
| Device Description: | The 1.0/1.2 mm Craniofacial Screws are either self-drilling or self- | |
| tapping, have a flat head profile with rounded edges with a | ||
| cruciform recess, and are available in various lengths. | ||
| Intended Use: | The Synthes 1.0/1.2 mm Craniofacial screws are intended for use as follows: | |
| Specific Indications: | ||
| Nasoethmoidal fracturesInfraorbital area fracturesFrontal sinus wall fracturesInfant craniofacial surgery General Indications: | ||
| Maxillofacial surgery | ||
| Substantial | ||
| Equivalence: | Documentation is provided which demonstrates that the Synthes | |
| 1.0/1.2mm Craniofacial Screws are substantially equivalent to other | ||
| legally marketed devices. | ||
| The term "substantial equivalence" as used in this 510(k) | ||
| notification is limited to the definition of substantial equivalence | ||
| found in the Federal Food, Drug and Cosmetic Act, as amended and | ||
| as applied under 21CFR 807, Subpart E under which a device can | ||
| be marketed without premarket approval or reclassification. A | ||
| determination of substantial equivalency under this notification is | ||
| not intended to have any bearing whatsoever on the resolution of | ||
| patent infringement suits or any other patent matters. No | ||
| statements related to, or in support of substantial equivalence herein | ||
| shall be construed as an admission against interest under the US | ||
| Patent Laws or their application by the courts. |
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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three wing-like shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 9 2004
Ms. Lisa M. Boyle Regulatory Associate Synthes (USA) 1690 Russell Road Paoli, Pennsylvania 19301
Re: K041887
Trade/Device Name: Synthes (USA) 1.0/1.2 mm Craniofacial Screws Regulation Number: 872.4880 Regulation Name: Intraosseous Fixation Screw or Wire Regulatory Class: II Product Code: DZL Dated: July 8, 2004 Received: July 13, 2004
Dear Ms. Boyle:
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.
2
Page 2 - Ms. Boyle
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 pract.ice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); a nd if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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) 594-4613. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental 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 circular logo with a stylized figure inside. A horizontal line runs beneath the word "SYNTHES" and the logo. A small registration mark is located to the right of the word.
of 1 Page 1
2.0
Indications for Use
510(k) Number (if known):
Device Name:
Synthes (USA) 1.0/1.2 mm Craniofacial Screws
141887
Indications for Use:
The Synthes 1.0/1.2 mm craniofacial screws are intended for use as follows:
Specific Indications:
- Nasoethmoidal fractures .
- Infraorbital area fractures .
- Frontal sinus wall fractures .
- Infant craniofacial surgery .
General Indications:
- Maxıllofacial surgery .
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 (ODF) (Division Sign Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number. `tcy/1/ff)