(89 days)
Not Found
No
The device description details a purely mechanical telescoping tube mechanism for bone distraction, with no mention of software, algorithms, or any components that would suggest AI/ML functionality. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is intended to stabilize and lengthen bone in craniofacial-maxillofacial and mandibular deficiencies or post-traumatic defects, which is a therapeutic function.
No
The device is described as a stabilizer and lengthener for bone distraction, which is a therapeutic function rather than a diagnostic one.
No
The device description clearly describes a physical, mechanical device (telescoping tube mechanism, pin clamps, wheel, jack screw) used for bone distraction, indicating it is a hardware medical device.
Based on the provided information, the Synthes MLA is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's a "stabilizer and lengthener to be used in craniofacial-maxillofacial and mandibular deficiencies or post-traumatic defects, where gradual bone distraction is required." This describes a surgical implant or device used directly on the patient's body for a therapeutic purpose (bone lengthening).
- Device Description: The description details a mechanical device with tubes, clamps, and a wheel for adjusting length. This is consistent with a surgical instrument or implant, not a device used to test samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests, or providing diagnostic information based on in vitro analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Synthes MLA does not fit this description.
N/A
Intended Use / Indications for Use
The Synthes MLA is intended for use as a stabilizer and lengthener to be used in craniofacial-maxillofacial and mandibular deficiencies or post-traumatic defects, where gradual bone distraction is required.
Product codes (comma separated list FDA assigned to the subject device)
MON
Device Description
Synthes MLA is a telescoping tube mechanism, consisting of two tubes with pin clamps on the end of each tube. The tube mechanism expands and contracts by turning an outer wheel (clockwise to contract and counterclockwise to expand). The wheel is secured in place by a jack screw which has an axially retained threaded shaft with a round end. The pin clamps secure 2.0 - 2.5 mm K-wires to the tubes. The MLA is available in two sizes: One has lengths ranging from 75 mm to 110 mm; the other has lengths ranging from 100 mm to 160 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
craniofacial-maxillofacial and 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
§ 872.4760 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.
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Attachment VII: Summary of Safety and Effectiveness Info. [510(k) Summary]
| SUBMITTER | Synthes (USA) 1690 Russell Road Paoli, PA 19301 (610) 647-9700 Contact: Sheri L. Musgnung |
|---|---|
| COMMON OR USUAL NAME: | Wire, Fixation, Intraosseous |
| DEVICE CLASSIFICATION: | Class II, 21 CFR 872.4880 |
| PREDICATE DEVICE: | Howmedica's Hoffmann Mini Lengthening Apparatus (K792561) |
| DESCRIPTION: | Synthes MLA is a telescoping tube mechanism, consisting of two tubes with pin clamps on the end of each tube. The tube mechanism expands and contracts by turning an outer wheel (clockwise to contract and counterclockwise to expand). The wheel is secured in place by a jack screw which has an axially retained threaded shaft with a round end. The pin clamps secure 2.0 - 2.5 mm K-wires to the tubes. The MLA is available in two sizes: One has lengths ranging from 75 mm to 110 mm; the other has lengths ranging from 100 mm to 160 mm. |
| INTENDED USE: | Synthes MLA is intended for use as a stabilizer and lengthener to be used in craniofacial-maxillofacial and mandibular deficiencies or post-traumatic defects, where gradual bone distraction is required. |
1
Image /page/1/Picture/10 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract symbol consisting of three curved lines that resemble human figures. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the symbol. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 10 1997
Ms. Sheri L. Musgnung 'Regulatory Affairs Associate SYNTHES (USA) 1690 Russell Road Post Office Box 1766 Paoli, Pennsylvania 19301
Re : K973018 Synthes Mini Lengthening Apparatus Trade Name: Regulatory Class: Unclassified MON Product Code: Dated: August 12, 1997 Received: August 13, 1997
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 reqistration, listing of devices, qood manufacturing practice, labeling, and prohibitions aqainst 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ರ್ಗ 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 Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
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the Act for devices under the Electronic Product Radiation 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 finding of substantial equivalence of your device to a legally marketed 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 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://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
3
SYNTHES (USA)
1690 Russell Road Post Office Box 1766 Paoli, Pennsylvania 19301 Telephone 610-647-9700
| Page | 1 of 1 |
|---|---|
| ------ | -------- |
KG73018 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The Synthes MLA is intended for use as a stabilizer and lengthener to be used in I no Synaires maxillofacial and mandibular deficiencies or post-traumatic defects, where gradual bone distraction is required.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
Susan Runner
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device 510(k) Number J