(35 days)
Not Found
Not Found
No
The summary describes a physical resorbable tack system and its intended use in craniofacial surgery. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections explicitly state "Not Found".
No.
The device is described as a system of resorbable tacks and accessory instruments used for fracture repair and reconstructive procedures, which are structural devices rather than therapeutic.
No
The device is a surgical fixation system used for fracture repair and reconstructive procedures, not for diagnosing conditions.
No
The device description explicitly states it consists of "resorbable tacks and accessory instruments," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used in surgical procedures for fracture repair and reconstruction of the craniofacial skeleton. This is a therapeutic and structural application, not a diagnostic one performed on in vitro samples.
- Device Description: The device consists of resorbable tacks and instruments used to implant them. This aligns with a surgical fixation device, not a device for analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on these samples, or providing diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
Synthes Rapid Resorbable Tack System is intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton. In addition, Rapid Resorbable Tacks may be used in non-load bearing applications for maintaining the relative position of and/or containing bony fragments, bone grafts (autograft or allograft) or bone graft substitutes in reconstruction of the craniofacial or mandibular areas.
Product codes
JEY
Device Description
The Synthes Rapid Resorbable Tack System consists of resorbable tacks and accessory instruments, which are additional components of the Synthes Rapid Resorbable Fixation System. The Rapid Resorbable Tack System consists of 1.5 mm tacks and 1.7 mm emergency tacks and are available in lengths ranging from 4 - 6 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
craniofacial skeleton, mandibular areas, spine (contraindicated)
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)
Synthes Resorbable Tack System, Synthes Rapid Resorbable Fixation System (aka Synthes Poly (L-Lactide-co-Glycolide) Resorbable Fixation System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.
0
Image /page/0/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 is underneath the word. The logo and text are likely part of a company or brand identity.
Kosozoq
510(k) Summary 3.0
Page _________________________________________________________________________________________________________________________________________________________________________
| Sponsor: | Synthes (USA)
1690 Russell Road
Paoli, PA 19301
(610) 647-9700 |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Synthes Rapid Resorbable Tack System |
| Classification: | Class II, 21 CFR §882.5360
Cranioplasty plate fastener |
| Predicate Device: | Synthes Resorbable Tack System
Synthes Rapid Resorbable Fixation System (aka Synthes Poly (L-
Lactide-co-Glycolide) Resorbable Fixation System |
| Device Description: | The Synthes Rapid Resorbable Tack System consists of resorbable
tacks and accessory instruments, which are additional components
of the Synthes Rapid Resorbable Fixation System. The Rapid
Resorbable Tack System consists of 1.5 mm tacks and 1.7 mm
emergency tacks and are available in lengths ranging from 4 - 6
mm. |
| Intended Use: | Synthes Rapid Resorbable Tack System is intended for use in
fracture repair and reconstructive procedures of the craniofacial
skeleton. In addition, Rapid Resorbable Tacks may be used in non-
load bearing applications for maintaining the relative position of
and/or containing bony fragments, bone grafts (autograft or allograft)
or bone graft substitutes in reconstruction of the craniofacial or
mandibular areas. |
| Contraindications: | These devices are not intended for use in load bearing applications,
such as the mandible, unless used in conjunction with traditional
rigid fixation. Synthes Rapid Resorbable Tacks are not intended for
areas with active or latent infection or for patient conditions
including limited blood supply or insufficient quantity or quality of
bone. These devices are not intended for use in the spine. |
| Substantial
Equivalence: | Documentation is provided which demonstrates that Synthes Rapid
Resorbable Tack System is substantially equivalent to other legally
marketed Synthes devices. |
Image /page/0/Picture/6 description: The image shows the number 000005 in a bold, sans-serif font. The numbers are black against a white background. The numbers are evenly spaced and aligned horizontally.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "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.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 4 - 2005
Ms. Sheri L. Musgnung Senior Regulatory Affairs Specialist Synthes (USA) 1690 Russell Road Paoli, Pennsylvania 19301
Re: K050204
Trade/Device Name: Synthes Rapid Resorbable Tack System Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: March 2, 2005 Received: March 3, 2005
Dear Ms. Musgnung:
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 vour 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. Musgnung
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA S Issualice of a substant as with other requirements
mean that FDA has made a determination that your device cod by ather Foderal agencies mean that FDA nas made a decemmandin and your and your and limited to: posicties.
of the Act or any Federal statutes and regulations administered to: positively of the Act of of Federal statutes and regiraments, including, but not limited to: registration
You must comply with all the Act's requirements and manufacturing programs and You must comply with an the Act 3 requirements art 801); good manufacturing practice.
and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CFR Fall 807), laboling (21 CFR Part 820); and 120); and if requirements as set form in the quality systems (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) I mis letter will anow you to begin mailering your substantial equivalence of your device to a premarket notification. The PDF Intellige or other of 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), II you desire specific advice for your de 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 may obtain other general meeting. International and Consumer Assistance at its toll-free Division of Director of Die (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Smith Michael MD
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 underlines the word "SYNTHES".
Indications for Use
| 510(k) Number (if known): | K050204 |
|---|---|
| Device Name: | Synthes Rapid Resorbable Tack System |
| Indications: | Synthes Rapid Resorbable Tack System is intended for use in |
| fracture repair and reconstructive procedures of the craniofacial | |
| skeleton. In addition, Rapid Resorbable Tacks may be used in | |
| non-load bearing applications for maintaining the relative | |
| position of and/or containing bony fragments, bone grafts | |
| (autograft or allograft) or bone graft substitutes in reconstruction of | |
| of the craniofacial or mandibular areas. | |
| Contraindications: | These devices are not intended for use in load bearing |
| applications, such as the mandible, unless used in conjunction | |
| with traditional rigid fixation. Synthes Rapid Resorbable Tacks | |
| are not intended for areas with active or latent infection or for | |
| patient conditions including limited blood supply or insufficient | |
| quantity or quality of bone. These devices are not intended for | |
| use in the spine. |
Prescription Use _ X (Per 21 CFR 801 Subpart D) 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 Eyaluation (ODE)
Station Sign-Off)
ision of Anesthesiology, General Hospital, Traction Control, Dental Devices
10(k) Number _________________________________________________________________________________________________________
.