(27 days)
Synthes 1.0 / 1.2 mm Craniofacial Screws, KLS Martin 1.0mm System Center-Drive Screw System
Not Found
No
The summary describes a mechanical screw and does not mention any software, algorithms, or AI/ML terms.
No.
The device is a screw used for fixation of fractures during surgery, which is a structural component and not a device that provides therapy.
No.
The device description and intended uses clearly indicate it is a surgical implant (screws for fracture fixation), not a device used to diagnose a medical condition.
No
The device description clearly states it is a "1.0mm Ti. Cortex Screws," which are physical implants made of titanium. This is a hardware device, 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 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 that the Synthes 1.0mm Ti. Cortex, Self-drilling Screws are implants intended for use in surgical procedures to fix fractures in specific anatomical areas (nasoethmoidal, infraorbital, frontal sinus wall, craniofacial, maxillofacial). They are physically inserted into the body.
Therefore, based on the provided information, this device is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Synthes 1.0mm Ti. Cortex screws are intended for use as follows: Specific Indications: Nasoethmoidal fractures Infraorbital area fractures Frontal sinus wall fractures Infant craniofacial surgery General Indications: Maxillofacial surgery
Product codes (comma separated list FDA assigned to the subject device)
DZL
Device Description
The 1.0mm Ti. Cortex Screws are self-drilling, have a flat head profile with rounded edges with a cruciform recess, and are available in lengths from 2 - 4 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nasoethmoidal, Infraorbital area, Frontal sinus wall fractures, Craniofacial, Maxillofacial
Indicated Patient Age Range
Infant (for craniofacial surgery)
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 1.0 / 1.2 mm Craniofacial Screws, KLS Martin 1.0mm System Center-Drive Screw System
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
§ 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.
0
Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in bold black letters with a registered trademark symbol. To the right of the word is the number "K05 06 06" written in black ink. There is a horizontal line below the word "SYNTHES" and the number.
| 3.0 | 510(k) Summary | APR 6 | 2005 | Page 1 | of 1 |
|---|---|---|---|---|---|
| Sponsor: | Synthes (USA) | ||||
| 1302 Wrights Lane East | |||||
| West Chester, PA 19380 | |||||
| (610) 719-5000 | |||||
| Device Name: | Synthes 1.0mm Ti. Cortex, Self-drilling Screws (Craniofacial) | ||||
| Classification: | 21 CFR 872.4880: Screw, Fixation, Intraosseous | ||||
| Predicate Device: | Synthes 1.0 / 1.2 mm Craniofacial Screws | ||||
| KLS Martin 1.0mm System Center-Drive Screw System | |||||
| Device Description: | The 1.0mm Ti. Cortex Screws are self-drilling, have a flat head | ||||
| profile with rounded edges with a cruciform recess, and are | |||||
| available in lengths from 2 - 4 mm. | |||||
| Intended Use: | The Synthes 1.0mm Ti. Cortex screws are intended for use as follows: | ||||
| Specific Indications: | |||||
| Nasoethmoidal fractures Infraorbital area fractures Frontal sinus wall fractures Infant craniofacial surgery General Indications: Maxillofacial surgery | |||||
| Substantial | |||||
| Equivalence: | Documentation is provided which demonstrates that the Synthes | ||||
| 1.0mm Ti. Cortex 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the words "Public Health Service" in bold, black font. The words are stacked on top of each other, with "Public Health" on the top line and "Service" on the bottom line. The text appears to be extracted from a document or publication.
Image /page/1/Picture/2 description: The image is a seal for the Department of Health & Human Services USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that converge at the bottom.
2005 APR 6
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Kathy Anderson Regulatory Affairs Manager Synthes (USA) 1302 Wrights Lane East West Chester, Pennsylvania 19380
Re: K050606
Trade/Device Name: Synthes (USA) 1.0mm Ti. Cortex, Self-Drilling Screws Regulation Number: 872.4880 Regulation Name: Intraosseous Fixation Screw or Wire Regulatory Class: II Product Code: DZL Dated: March 9, 2005 Received: March 10, 2005
Dear Ms. Anderson:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave to rowed your 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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendments, or to are road Cosmetic Act (Act) that do not require approval of a premarket the Federal F 00d; Drag, drag, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions of a 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 IT your device is olassinod (500 modditional controls. Existing major regulations afficting (1 MA), it may of subject to tax and 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. Anderson
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 mean that I Drimas made statutes and regulations administered by other Federal agencies. or the Act of any I eact is requirements, including, but not limited to: registration r ou inting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and ilsung (21 et read on 1), a quality systems (QS) regulation (21 CFR Part 820); and if requirents as between as 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) This letter will and in yoursely of substantial equivalence of your device to a promainer level 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), rr you docute of the Office of Compliance at (240) 276-0115. 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 maj overn 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/industry/support/index.html.
Sincerely vours.
Chu Lin, Ph.D.
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
3
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 design inside. A horizontal line runs underneath the word. There is a registered trademark symbol to the right of the word.
Page 1 l of
Indications for Use
510(k) Number (if known):
Synthes (USA) 1.0mm Ti. Cortex. Self-drilling Screws
Device Name:
2.0
Indications for Use:
The Synthes 1.0mm Ti. Cortex, Self-drilling Screws are intended for use as follows:
Specific Indications:
- Nasoethmoidal fractures .
- Infraorbital area fractures .
- Frontal sinus wall fractures .
- Infant craniofacial surgery .
General Indications:
- Maxillofacial surgery .
Prescription Use _ X ____________________________________________________________________________________________________________________________________________________________________________ (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 (ODE)
| Suan Runne | |
|---|---|
| Division Sign-Off) | |
| Division of Anesthesiology, General Hospital, Infection Control, Dental Devices | |
| (k) Number: | 1050606 |