(118 days)
Not Found
No
The summary describes a mechanical orthopedic implant and associated surgical tools, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as "a closed section, cannulated, curved intramedullary fixation device" intended "to stabilize shaft fractures...for fixation of fractures of the tibia," and "for treatment of mal-unions as well as prophylactic nailings of impending pathological fractures," indicating its use in treating medical conditions.
No
The device is an intramedullary nail system intended for the fixation of tibia fractures, mal-unions, and prophylactic nailings. It is a treatment device, not for diagnosis.
No
The device description clearly outlines physical components made of titanium alloy (nails, screws, end caps) and ancillary instrumentation (drills, reusable/disposable instruments), 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: The intended use is to stabilize shaft fractures of the tibia. This is a surgical procedure performed directly on the patient's bone.
- Device Description: The device is an intramedullary nail system, which is an implantable medical device used for internal fixation of fractures.
- 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) as a surgical implant.
N/A
Intended Use / Indications for Use
The DISTALOCK Tibial IM Nail System is intended to stabilize shaft fractures between the proximal and distal third of the tibia. Indications include transverse, comminuted, spiral, oblique, and segmental fractures. The Tibial Nail may also be used for treatment of mal-unions as well as prophylactic nailings of impending pathological fractures.
Product codes (comma separated list FDA assigned to the subject device)
HSB
Device Description
The DGIMED Ortho DISTALOCK™ Tibial Intramedullary Nail System permits an intramedullary approach for fixation of fractures of the tibia: The DISTALOCK™ Tibial Naillis a closed section, cannulated, curved intramedullary fixation device containing four proximal (three static and one dynamic) and three distal holes to accept locking screws which thread transversely though the proximal and distal third of the tibia. The DISTALOCK™ Tibia Intramedullary Nail System includes the following components: DISTALOCK™ Tibial Intramedullary nails, locking screws and end caps made of titanium alloy. The DISTALOCK™ Tibial Ancillary Instrumentation includes the DISTALOCK™ Tibial Drill and other disposable and reusable instruments needed for accessing the tibial medullary canal; preparing the bone for placement and installation of the nail and locking screws, and removal of the nail and locking screws if required.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tibia
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)
The biological safety of the DISTALOCK™ Tibial Intramedullary Nail System was achieved through the selection of materials that demonstrated appropriate levels of biocompatibility. Human factor analysis was conducted and concluded that the DISTALOCK™ Tibial Intramedullary Nail System presented acceptable human factors features in both the functioning of the device and usage of the labeling. Bench testing and cadaver testing were conducted to ensure the performance and safety of the DISTALOCK™ Tibial Intramedullary Nail System and to demonstrate substantial equivalency to the predicate device.
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
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.
0
K132830 (page 1/2)
JAN - 6 2014
Image /page/0/Picture/2 description: The image shows the logo for DGIMED ORTHO. The logo is in black and white and features the letters "DGIMED" in a bold, sans-serif font. The letter "I" is inside of a black circle. Below the letters is the word "ORTHO".
| Common/Usual Name: | DISTALOCK™ Tibial Intramedullary Nail System |
|---|---|
| Product Trade Name: | DISTALOCK™ Tibial Intramedullary Nail System |
| Classification Name: | Rod, Fixation, Intramedullary and Accessories |
| Class II per 21 CFR § 888.3020 | |
| Product Code HSB | |
| Predicate Device: | Smith & Nephew TriGen Tibial Nail System K051557 |
| Manufacturer: | DGIMED Ortho, Inc. |
| 12400 Whitewater Drive, Suite 2010 | |
| Minnetonka, MN 55343 | |
| Contact: | Scott Youngstrom |
| VP of Finance, Chief Operating Officer | |
| Date Prepared: | September 5, 2013 |
Device Description:
The DGIMED Ortho DISTALOCK™ Tibial Intramedullary Nail System permits an intramedullary approach for fixation of fractures of the tibia: The DISTALOCK™ Tibial Naillis a closed section, cannulated, curved intramedullary fixation device containing four proximal (three static and one dynamic) and three distal holes to accept locking screws which thread transversely though the proximal and distal third of the tibia. The DISTALOCK™ Tibia Intramedullary Nail System includes the following components: DISTALOCK™ Tibial Intramedullary nails, locking screws and end caps made of titanium alloy. The DISTALOCK™ Tibial Ancillary Instrumentation includes the DISTALOCK™ Tibial Drill and other disposable and reusable instruments needed for accessing the tibial medullary canal; preparing the bone for placement and installation of the nail and locking screws, and removal of the nail and locking screws if required.
12400 Whitewater Drive, Suite 2010, Minnetonka, MN 55343
1
Image /page/1/Picture/1 description: The image shows the text "DGIMED" in large, bold letters. Below the text is the word "ORTHO" in smaller letters. The letters "IM" are inside of a black circle.
Indications for Use:
The DISTALOCK Tibial IM Nail System is intended to stabilize shaft fractures between the proximal and distal third of the tibia. Indications include transverse, comminuted, spiral, oblique, and segmental fractures. The Tibial Nail may also be used for treatment of mal-unions as well as prophylactic nailings of impending pathological fractures
Substantial Equivalence Comparison:
Results of design verification and validation testing demonstrate that the DISTALOCK™ Tibial Intramedullary Nail System is as safe as the predicate device. The risk assessment results, together with the results of design verification and validation testing presented in this submission, confirm that the DISTALOCK™ Tibial Intramedullary Nail System raises no new questions of safety or effectiveness compared to the predicate device. The DISTALOCK™ Tibial Intramedullary Nail System has been shown to be substantially equivalent to the legally marketed device for the purpose of 510(k) clearance.
Summary of Non-Clinical Testing:
The biological safety of the DISTALOCK™ Tibial Intramedullary Nail System was achieved through the selection of materials that demonstrated appropriate levels of biocompatibility. Human factor analysis was conducted and concluded that the DISTALOCK™ Tibial Intramedullary Nail System presented acceptable human factors features in both the functioning of the device and usage of the labeling. Bench testing and cadaver testing were conducted to ensure the performance and safety of the DISTALOCK™ Tibial Intramedullary Nail System and to demonstrate substantial equivalency to the predicate device.
No new risks or efficacy concerns other than those identified with the predicate device were raised. Results of non-clinical testing demonstrated that the DISTALOCK ™ Tibial Intramedullary Nail System is safe and effective for its intended use.
Conclusion:
The DISTALOCK™ Tibial Intramedullary Nail System has similar intended use, material biosafety profile, and technical characteristics as the predicate device. Non-clinical testing was conducted to verify the safety and performance of the DISTALOCK ™ Tibial Intramedullary Nail System and to ensure the device functions as intended and meets design specifications. As a result, the DISTALOCK™ Tibial Intramedullary Nail System. has been demonstrated to be substantially equivalent to the predicate device and is safe and effective for its intended use.
12400 Whitewater Drive, Suite 2010, Minnetonka, MN 55343
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 fashion around the symbol. The logo is black and white and appears to be a scanned image.
Public Health Service
Food and Drug Administration 0903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 6, 2014
DGIMED Ortho, Incorporated Mr. Scott Youngstrom Vice President of Finance, Chief Operating Officer 12400 Whitewater Drive, Suite 2010 Minnetonka, Minnesota 55343
Re: K132830
Trade/Device Name: DISTALOCK™ Tibial Intramedullary Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: November 4, 2013 Received: November 14, 2013
Dear Mr. Youngstrom:
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. Ilsting 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,
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
3
Page 2 - Mr. Scott Youngstrom
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Lori A. Wiqqins
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
5.0 INDICATION FOR USE STATEMENT
K132830 510(k) Number (if known): Not Yet Assigned
Device Name: DISTALOCK™ Tibial Intramedullary Nail System
Indications for Use:
Intended to stabilize shaft fractures between the proximal and distal third of the tibia. Indications include transverse, comminuted, spiral, oblique, and segmental fractures. The Tibial Nail may also be used for treatment of mal-unions as well as prophylactic nailings of impending pathological fractures.
Prescription Use: X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Casey E. Hanley, Ph.D.
Division of Orthopedic Devices
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