(27 days)
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 .
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.
I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves a device meets those criteria. The document is a 510(k) summary and FDA clearance letter for a medical device (Synthes 1.0mm Ti. Cortex, Self-drilling Screws), focusing on its substantial equivalence to predicate devices and its intended use. It does not include:
- A table of acceptance criteria or reported device performance.
- Details about sample sizes for test sets, data provenance, or training sets.
- Information on expert ground truth establishment, adjudication methods, or MRMC studies.
- Mention of standalone algorithm performance or the type of ground truth used for performance evaluation.
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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 EastWest 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 ScrewsKLS Martin 1.0mm System Center-Drive Screw System | ||||
| Device Description: | The 1.0mm Ti. Cortex Screws are self-drilling, have a flat headprofile with rounded edges with a cruciform recess, and areavailable 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 | ||||
| SubstantialEquivalence: | Documentation is provided which demonstrates that the Synthes1.0mm Ti. Cortex Screws are substantially equivalent to otherlegally marketed devices.The term "substantial equivalence" as used in this 510(k)notification is limited to the definition of substantial equivalencefound in the Federal Food, Drug and Cosmetic Act, as amendedand as applied under 21CFR 807, Subpart E under which a devicecan be marketed without premarket approval or reclassification. Adetermination of substantial equivalency under this notification isnot intended to have any bearing whatsoever on the resolution ofpatent infringement suits or any other patent matters. Nostatements related to, or in support of substantial equivalenceherein shall be construed as an admission against interest under theUS Patent Laws or their application by the courts. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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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.
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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
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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 |
§ 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.