(85 days)
No
The summary describes a system of physical implants (plates, screws, drills, sonotrode tips) for rigid fixation in oral-maxillo-cranio-facial surgery. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI or ML.
No.
The device is used for stabilization and fixation of bones, which is a structural and mechanical function, not a therapeutic intervention in the medical sense of treating a disease or condition.
No
The device description and intended uses consistently describe the product as osteosynthesis products for stabilization and fixation of fractured or reconstructed bone structures, which are therapeutic functions, not diagnostic.
No
The device description explicitly lists physical components such as titanium plates, screws, twist drills, and sonotrode tips, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes the device as being used for the stabilization and fixation of bone fractures and reconstruction in the oral-maxillo-cranio-facial region. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device description lists components like titanium plates, screws, drills, and sonotrode tips. These are all surgical instruments and implants used in orthopedic and reconstructive surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for surgical intervention.
N/A
Intended Use / Indications for Use
The KLS Martin Rigid Fixation - Sterile is intended to provide KLS Martin's osteosynthesis products in sterile packaging. These products have been previously cleared for sale and providing them sterile does not change the already cleared intended use.
KLS-Martin Rigid Fixation - Sterile is intended to provide, in sterile packaging, osteosynthesis products with the following indications for use.
K051236: The RESORB-X® SF Sonotrode is only intended for use for insertion of the RESORB-X® SF pins.
K032442: The KLS Martin Mandibular/Reconstruction System II is intended for use in the stabilization and fixation of mandibular fractures and mandibular reconstruction.
K971297: The KLS Martin Centre-Drive Drill-Free screws are intended for use in rigid i internal fixation of the oral-maxillo-cranio-facial bones. The bone screws are used to anchor plates which are contoured to fit the bony surface and stabilize the bone fragments. The addition of the self drilling feature is the only difference between the submitted device and the predicate device reference.
K944565: The KLS-Martin Micro Osteosynthesis System is used in oral-maxillocranio-facial surgery to stabilize fractured bone structures. The bone segments are attached to the plate with screws to prevent movement of the segments.
K944561: The KLS-Martin Micro Osteosynthesis System is used in oral-maxillo-cranio facial surgery to stabilize fractured bone structures. The bone segments are attached to the plate with screws to prevent movement of the segments.
Product codes
JEY
Device Description
The KLS Martin Rigid Fixation - Sterile includes titanium plates of various shapes and thickness, titanium screws of various length and diameter, stainless steel twist drills of various length and diameter and stainless steel sonotrode tips that are provided in sterile packaging.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Mandibular, oral-maxillo-cranio-facial bones
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)
K032442, K011590, K971297, K944561, K944565
Reference Device(s)
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
APR 1 8 2006
ﺎ
kıs martın.ı.p.
510(K) SUMMARY
| Submitter: | KLS-Martin, L.P.
11239-1 St. Johns Industrial Parkway South
Jacksonville, FL 32246
Phone: 904-641-7746
Fax: 904-641-7378 |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jennifer Damato
Director RA/QA |
| Date of Summary: | 12 January 2006 |
| Device Name: | KLS Martin Rigid Fixation- Sterile |
| Trade Name: | Sterile Packaged Rigid Fixation |
| Common Name: | Bone Plate |
| Classification
Name and Number: | Bone Plate (CFR 872.4760) |
| Regulatory Class: | II |
| Predicate Devices: | KLS-Martin Mandibular/Reconstruction System II (K032442)
Resorb-X Resorbable Plating System (K011590)
Centre-Drive Drill-Free Screw (K971297)
Micro Osteosynthesis System (1.0) (K944561)
KLS-Martin Micro Osteosynthesis System (1.5mm) (K944565) |
| Device
Description: | The KLS Martin Rigid Fixation - Sterile includes
titanium plates of various shapes and thickness,
titanium screws of various length and diameter,
stainless steel twist drills of various length and
diameter and stainless steel sonotrode tips that are
provided in sterile packaging. |
:
1
Intended Use:
The KLS Martin Rigid Fixation - Sterile is intended to provide KLS Martin's osteosynthesis products in sterile packaging. These products have been previously cleared for sale and providing them sterile does not change the already cleared intended use.
Technological Characteristics:
Similarities to Predicate
KLS Martin Rigid Fixation - Sterile is identical in manufacturing and design to the KLS-Martin Mandibular/Reconstruction System II (K032442), Centre-Drive Drill-Free Screw (K971297) Micro Osteosynthesis System (1.0) (K944561) and KLS-Martin Micro Osteosythesis System(1.5mm) (K944565).
Sterilization method of the KLS Martin Rigid Fixation -Sterile will be by gamma radiation which is the exact same process as cleared in Resorb-X Resorbable Plating System (K011590)
Differences to Predicate
KLS Martin Rigid Fixation - Sterile will be packaged sterile and will have different stock numbers from originally cleared stock numbers to identify the product as sterile.
Substantial Equivalence:
KLS Martin Rigid Fixation - Sterile are substantially equivalent to the KLS-Martin Mandibular/Reconstruction System II (K032442), Centre-Drive Drill-Free Screw (K971297) Micro Osteosynthesis System (1.0) (K944561) and KLS-Martin Osteosythesis Micro System(1.5mm) (K944565).
KLS Martin Rigid Fixation - Sterile are substantially equivalent to the Resorb-X Resorbable Plating System (K011590) in packaging and sterilization methods.
2
Image /page/2/Picture/1 description: The image shows a circular logo with text around the perimeter and a stylized symbol in the center. The text around the perimeter appears to be the name of a government organization, possibly related to health or human services. The central symbol consists of three curved lines that resemble a stylized bird or abstract design. The logo is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 8 2006
Ms. Jennifer Damato KLS Martin, L.P. 11239-1 St. Johns Industrial Parkway South Jacksonville, Florida 32246
Re: K060177
Trade/Device Name: KLS Martin Rigid Fixation - Sterile Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: January 12, 2006 Received: January 23, 2006
Dear Ms. Damato:
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 (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 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 Ms. Jennifer Damato
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); 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.
This letter will allow you to continue marketing your device as described in your Section 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 Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Will y Michael. Evils
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
4
Indications for Use
510(k) Number (if known): K060177
Device Name: KLS Martin Rigid Fixation - Sterile
Indications for Use: KLS-Martin Rigid Fixation - Sterile is intended to provide, in sterile packaging, osteosynthesis products with the following indications for use.
K051236: The RESORB-X® SF Sonotrode is only intended for use for insertion of the RESORB-X® SF pins.
K032442: The KLS Martin Mandibular/Reconstruction System II is intended for use in the stabilization and fixation of mandibular fractures and mandibular reconstruction.
K971297: The KLS Martin Centre-Drive Drill-Free screws are intended for use in rigid i internal fixation of the oral-maxillo-cranio-facial bones. The bone screws are used to anchor plates which are contoured to fit the bony surface and stabilize the bone fragments. The addition of the self drilling feature is the only difference between the submitted device and the predicate device reference.
K944565: The KLS-Martin Micro Osteosynthesis System is used in oral-maxillocranio-facial surgery to stabilize fractured bone structures. The bone segments are attached to the plate with screws to prevent movement of the segments.
K944561: The KLS-Martin Micro Osteosynthesis System is used in oral-maxillo-cranio facial surgery to stabilize fractured bone structures. The bone segments are attached to the plate with screws to prevent movement of the segments.
Prescription Use (Part 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 Evaluation (ODE)
Susan Thorpe
Page 1 of
eneral Hos
K060172
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