(83 days)
Not Found
No
The description focuses on the mechanical components of a physical external fixator and does not mention any software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is intended to "stabilize and provide treatment for fractures of the maxillofacial area," which is a therapeutic purpose.
No
Explanation: The device description and intended use clearly state that the KLS Martin Xternal Fixator is designed to stabilize and treat fractures, which are therapeutic functions, not diagnostic ones. It is a physical medical device used for fixation rather than for identifying or analyzing medical conditions.
No
The device description explicitly states it consists of physical components like titanium pins, clamps, rods, and screw caps, which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The KLS Martin Xternal Fixator is a physical device consisting of pins, clamps, and rods made of titanium or acrylic. It is surgically implanted to stabilize bone fractures.
- Intended Use: The intended use is to stabilize and treat fractures of the maxillofacial area. This is a direct intervention on the body, not an analysis of a specimen taken from the body.
The description clearly indicates a surgical implant used for structural support and treatment of bone fractures, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
KLS Martin Xternal Fixator is intended to stabilize and provide treatment for fractures of the maxillofacial area, including severe open mandibular fractures, highly comminuted closed fractures, nonunions and delayed unions (especially associated with infection), fractures associated with infections, tumor resections, facial deformity corrections, gunshot wounds, pan facial fractures, burn maintenance, and bone grafting defects.
Product codes
MON
Device Description
The KLS Martin Xternal Fixator consists of 3.2mm titanium pins in various lengths that are fixated to the bone. The titanium pins are held in place with titanium pin clamps and a 4mm titanium rod or can be held in place with an acrylic bar and titanium screw caps.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillofacial area, 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)
Stryker External Fixation System (K071628), Synthes Mandible External Fixator (K050378), Bi-Phase Set, Oral, Maxillofacial Surgery (K901095)
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
Ko 7 27 64
kts martin L.P.
510(K) SUMMARY
DEC & 0 2007
| 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: | 21 September 2007 |
| Device Name: | KLS Martin Xternal Fixator |
| Trade Name: | Xternal Fixator |
| Common Name: | External Fixation Device |
| Classification Name and Number: | External Mandibular Fixator and/or Distractor (21 CFR 872.4760) |
| Regulatory Class: | II |
| Predicate Devices: | Stryker External Fixation System (K071628) |
| Synthes Mandible External Fixator (K050378) | |
| Bi-Phase Set, Oral, Maxillofacial Surgery (K901095) | |
| Intended Use: | KLS Martin Xternal Fixator is intended to stabilize and provide treatment for fractures of the maxillofacial area, including severe open mandibular fractures, highly comminuted closed fractures, nonunions and delayed unions (especially associated with infection), fractures associated with infections, tumor resections, facial deformity corrections, gunshot wounds, pan facial fractures, burn maintenance, and bone grafting defects. |
1
Device Description:
The KLS Martin Xternal Fixator consists of 3.2mm titanium pins in various lengths that are fixated to the bone. The titanium pins are held in place with titanium pin clamps and a 4mm titanium rod or can be held in place with an acrylic bar and titanium screw caps.
Technological Characteristics:
Similarities to Predicate:
The KLS Martin Xternal Fixator is very similar in fixation and providing stabilization for maxillofacial fractures as the Stryker External Fixation System (K071628) and the Synthes Mandible External Fixator (K050378)
Differences to Predicate:
The KLS Martin Xternal Fixator offers the surgeon an optional method of securing the fixation pins by utilizing an acrylic bar that is made by the surgeon.
Substantial Equivalence:
The KLS Martin Xternal Fixator is substantially equivalent in fixation and providing stabilization for maxillofacial fractures as the Stryker External Fixation System (K071628) and the Synthes Mandible External Fixator (K050378)
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes forming its wing, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 0 2007
Ms. Jennifer Damato Director Regulatory Affairs/ Quality Assurance KLS Martin, L.P. 11239 Street Johns Industrial, Parkway South Jacksonville, Florida 32246
Re: K072764
Trade/Device Name: KLS Martin Xternal Fixator Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: MON Dated: November 26, 2007 Received: December 3, 2007
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 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 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. 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 begin 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 vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance 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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Susan Kumar
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):
Device Name: KLS Martin Xternal Fixator
Indications For Use:
Indications For Use: KLS Martin Xternal Fixator is intended to stabilize and provide treatment for fractures of the maxillofacial area, including severe open mandibular fractures, highly comminuted closed fractures, nonunions and delayed unions (especially associated with infection), fractures associated with infections, tumor resections, facial deformity corrections, gunshot wounds, pan facialfractures, burn maintenance, and bone grafting defects.
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 Runner
Page 1 of 1
Page 1 of