(80 days)
Not Found
No
The device description focuses on the physical characteristics and materials of resorbable screws and related instruments, with no mention of software, algorithms, or AI/ML capabilities.
No
The device is a resorbable screw system used for fixation in mandibular osteotomy procedures, which is a supportive role in healing, not a therapy to directly treat a disease or condition.
No
The device is a resorbable screw system used for fixation in mandibular osteotomy procedures, not for diagnosing medical conditions.
No
The device description explicitly states that the system consists of resorbable screws and related insertion devices, which are physical hardware components.
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. This information is used for diagnosis, monitoring, or screening.
- Device Description: The provided description clearly states that the Synthes RapidSorb PLUS screws are implants used for fixation in mandibular osteotomy procedures. They are physically inserted into the body to hold bone fragments together.
- Intended Use: The intended use is for surgical fixation, not for analyzing biological samples.
Therefore, based on the provided information, the Synthes RapidSorb PLUS screws are a surgical implant device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Synthes' RapidSorb PLUS screws are indicated for use as fixation in mandibular osteotomy procedures, including:
- sagital split osteotomy .
- vertical ramus osteotomy .
- inferior border osteotomy 0
- subapical osteotomy .
- genioplasty.
Product codes (comma separated list FDA assigned to the subject device)
DZL
Device Description
Synthes' RapidSorb PLUS Screw System consists of resorbable screws and related insertion devices, including screwdrivers, drills, and taps, for use as fixation in mandibular osteotomies. The screws themselves are of various sizes and are made of Poly (L-lactide-co-Glycolide) polymer that resorbs in approximately 12 months.
RapidSorb PLUS screws are provided sterile in a pouch constructed of a clear-film outer pouch and a foil laminate inner pouch. The screws are provided sterile, for single use only, and should not be resterilized.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandibular
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.
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
.
1. 510(k) Summary
:
.
| Sponsor: | Synthes (USA)
1230 Wilson Drive
West Chester, PA 19380 | JAN 2 5 2010 |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Company
Contact: | Jeffrey L. Dow, JD
Director, Clinical & Regulatory Affairs
Synthes Biomaterials
484 356 9720
dow.jeff@synthes.com | |
| Device Name: | Synthes RapidSorb PLUS Screw System | |
| Classification: | Class II, 21 CFR §872.4880 - Screw, Fixation, Intraosseous | |
| Product Code
Predicate Device: | DZL
Synthes Rapid Resorbable Fixation System (K062789)
Biomet LactoSorb® Screws (K981666) | |
| Device
Description: | Synthes' RapidSorb PLUS Screw System consists of
resorbable screws and related insertion devices, including
screwdrivers, drills, and taps, for use as fixation in
mandibular osteotomies. The screws themselves are of
various sizes and are made of Poly (L-lactide-co-Glycolide)
polymer that resorbs in approximately 12 months. | |
| | RapidSorb PLUS screws are provided sterile in a pouch
constructed of a clear-film outer pouch and a foil laminate
inner pouch. The screws are provided sterile, for single use
only, and should not be resterilized. | |
| Intended Use: | Synthes' RapidSorb PLUS screws are indicated for use as
fixation in mandibular osteotomy procedures, including:
● sagital split osteotomy
● vertical ramus osteotomy
● inferior border osteotomy
● subapical osteotomy
● genioplasty. | |
1
Substantial Equivalence:
Documentation is provided that demonstrates that the RapidSorb PLUS Screw System is substantially equivalent' to other legally marketed devices.
1 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, 21 USC §301 et seq., and as applied under 21 CFR Part 807, Subpart E, under which a device can be marketed without pre-market approval or reclassification. A determination of substantial equivalence 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 U.S. patent laws or their application by the courts.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three lines above it, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Jeffery L. Dow, JD Director, Clinical & Regulatory Affairs Synthes (USA) 1230 Wilson Drive West Chester, Pennsylvania 19380
JAN 2 5 2010
Re: K093464
Trade/Device Name: Synthes RapidSorb PLUS Screw System Regulation Number: 21CFR 872,4880 Regulation Name: Intraosseous Fixation Screw or wire Regulatory Class: II Product Code: DZL Dated: November 5, 2009 Received: November 6, 2009
Dear Mr. Dow:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
3
Page 2- Mr. Dow
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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)-796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Wh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
1. Indications for Use
Unknown 510(k) Number (if known):
Indications:
Synthes' RapidSorb PLUS screws are indicated for use as fixation in mandibular osteotomy procedures, including:
- sagital split osteotomy .
- vertical ramus osteotomy .
- inferior border osteotomy 0
- subapical osteotomy .
- genioplasty.
Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Per 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)
RSBetz DDS for Dr. K.P. Mulay
(Division Sign-Off)
livision of Anesthesiology, General Hospital ifection Control, Dental Devices
510(k) Number: K093464