(90 days)
Not Found
No
The summary describes a mechanical system for jaw immobilization and makes no mention of AI or ML.
Yes
The device is used for temporary jaw immobilization, which is a therapeutic intervention for conditions requiring stabilization of the intermaxillary and maxillo-mandibular areas.
No
Explanation: The device is indicated for intermaxillary and maxillo-mandibular fixation, which is a treatment or support function, not for diagnosing a condition.
No
The device description explicitly states that the system consists of physical components like brackets, arch bars, and instrumentation, which are hardware used for temporary jaw immobilization.
Based on the provided information, the Synthes Quick Lock™ IMF System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "intermaxillary and maxillo-mandibular fixation," which is a mechanical process for immobilizing the jaw. This is a physical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device consists of "brackets, arch bars and instrumentation" used to "facilitate temporary jaw immobilization." These are physical components used for mechanical support and fixation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide diagnostic information. The Synthes Quick Lock™ IMF System is a surgical/mechanical device used for fixation.
N/A
Intended Use / Indications for Use
Synthes Quick Lock TM IMF System is indicated for use in intermaxillary and maxillo-mandibular fixation.
Product codes
DYX
Device Description
The Synthes Quick Lock TM IMF System consists of brackets, arch bars and instrumentation which are used to facilitate temporary jaw immobilization. The Synthes Quick Lock TM Bracket is a dental bracket that provides an attachment point for MMF wires and elastics. It incorporates a high tensile strength fiber that circumdentially attaches the bracket to the dentition. The Quick Lock TM Arch Bar and Arch Bar Bracket provide additional support to the dental arch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intermaxillary and maxillo-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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.4600 Intraoral ligature and wire lock.
(a)
Identification. An intraoral ligature and wire lock is a metal device intended to constrict fractured bone segments in the oral cavity. The bone segments are stabilized by wrapping the ligature (wire) around the fractured bone segments and locking the ends together.(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 stylized image inside. To the right of the word is a small circle with an R inside, indicating a registered trademark.
| JUN 23 1999 | K991004 |
|---|---|
| Attachment VIII: | Summary of Safety and Effectiveness Information [510(k) Summary] |
| SUBMITTER | Synthes (USA) 1690 Russell Road Paoli, PA 19301 (610) 647-9700 |
| Contact: Sheri L. Musgnung | |
| COMMON OR USUAL NAME | Lock, Wire, and Ligature, Intraoral |
| DEVICE CLASSIFICATION: | Class II, 21 CFR 872.4700 |
| PREDICATE DEVICE: | Dimac Medical, Inc. Dimac Wires (K910090) W. Lorenz Traditional Wire and Arch Bars, Unisplint (K820944) Wall-Omnisplint Maxillofacial Fracture Kit (K number unkown) |
| DESCRIPTION: | The Synthes Quick Lock TM IMF System consists of brackets, arch bars and instrumentation which are used to facilitate temporary jaw immobilization. |
| The Synthes Quick Lock TM Bracket is a dental bracket that provides an attachment point for MMF wires and elastics. It incorporates a high tensile strength fiber that circumdentially attaches the bracket to the dentition. The Quick Lock TM Arch Bar and Arch Bar Bracket provide additional support to the dental arch. | |
| INTENDED USE: | Synthes Quick Lock TM IMF System is indicated for use in intermaxillary and maxillo-mandibular fixation. |
| MATERIAL: | 316L Stainless Steel, Ti-6Al-7NB, Vectran fiber, and Nylon |
CONFIDENTIAL
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 stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 23 1999
Ms. Sheri L. Musgnung Requlatory Affairs Specialist Synthes (USA) 1690 Russell Road Post Office Box 1766 Paoli, Pennsylvania 19301
K991004 Re : Synthes Quick Lock™ IMF System Trade Name: Requlatory Class: II DYX Product Code: Dated: March 22, 1999 March 25, 1999 Received:
Dear Ms. Musgnung:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.
2
Page 2 - Ms. Musgnung
this response to your premarket notification Please note: Please note: 'this responde co four and might have under submission docs not arroos any canny one for devices under the sections 331 through 312 on control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA described in your stority promance of your device to a legally finding of substancial equivalence of follassification for your marketed predicate device robalesice to proceed to the market.
If you desire specific advice for your device on our labeling II you desire bpcollis and additionally 809.10 for in regulacion (ir devices), please contact the Office of Villo diagnostic devices// proade otionally, for questions on Compirance at (501) sectising of your device, please contact the promotion and adversioning 301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
the regulation entitled, "Misbranding by reference fo information on your responsibilities under the Act may be Information on your with the first of Small Manufacturers Assistance obcathed from che brying (800) 638-2041 or (301) 443-6597 or at at its coll free namber (e://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital 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 registered trademark symbol is located to the upper right of the word "SYNTHES".
| 2.0 | Indications for Use Statement |
|---|---|
| ------------ | -------------------------------------- |
| Page | 1 of 1 |
|---|---|
| ------ | -------- |
| 510(k) Number (if known): | K991004 |
|---|---|
| Device Name: | Synthes Quick Lock™ IMF System |
Indications For Use:
Synthes Quick Lock™ IMF System is indicated for use in intermaxillary and maxillo-mandibular fixation.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ___ (Per 21 CFR 801.109)
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
Suan Rumsey
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital 510(k) Number .
CONFIDENTIAL