(261 days)
Not Found
Not Found
No
The 510(k) summary describes a mechanical external fixation system and does not mention any AI or ML components or functionalities.
Yes
The device is intended for the treatment of bone conditions, including fractures, osteotomy, and reconstructive surgery, which are therapeutic interventions.
No
The device description clearly states it is an external fixation device used for treating bone conditions, not for diagnosing them.
No
The device description explicitly states it is composed of pins or wires inserted into the bone and an external frame, indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This is done outside of the body (in vitro).
- Dyna-EXTOR II Function: The Dyna-EXTOR II is an external fixation system. It is a medical device that is applied directly to the body to stabilize bones. It does not analyze any biological samples.
The provided information clearly describes a device used for surgical and orthopedic procedures, not for laboratory testing of biological specimens.
N/A
Intended Use / Indications for Use
The Dyna-EXTOR(L) II and Dyna-EXTOR(M) II external fixation systems are intended for the treatment of bone conditions that can be corrected or improved by external skeletal traction or fixation, including osteotomy, arthrodesis, fracture and reconstructive surgery.
The Dyna-EXTOR(SM) II external fixation system is intended for use in upper extremity applications for the reduction, alignment and stabilization of intra-articular and extra-articular fractures, corrective osteotomies, and soft tissue deformities.
Dyna-EXTOR(ST) II external fixation system is intended for use in external fixation of fractures and/ or reconstruction of small bones, including metacarpal and metatarsal.
Product codes (comma separated list FDA assigned to the subject device)
KTT
Device Description
The Dyna-EXTOR II is unilateral external fixation device. The system has 4 detailed systems according to the intended use. The Dyna-EXTOR 11 external fixation system is composed of pins or wires inserted into the bone, above and below the fracture or surgery site. These pins are then attached to a strong external frame. This allows the bone to be held relatively firmly, while some mobility and weight bearing can take place.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Testing was conducted according to ASTM F1541-02.
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.
Not Found
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.
Howmedica Mono-tube system and components, Orthofix Penning system and Orthofix Minirail system and the Stryker-Howmedica Apex Pin
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
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
K110426 (pg 1/2)
NOV - 2 2011
510(k) Summary
Submitted on behalf of:
| Company Name: | BK Meditech Co, Ltd | |
|---|---|---|
| Address: | 215-5 Yodang-Li, Yanggam-Myun | |
| Hwasung-Si, Kyunggi-Do | ||
| Republic of Korea 445-931 | ||
| Telephone: | 82-133529135 | |
| Fax: | 82-313529134 |
by:
Elaine Duncan, M.S.M.E., RAC President, Paladin Medical, Inc. PO Box 560 Stillwater, MN 55082 715-549-6035 715-549-5380
| CONTACT PERSON: | |
|---|---|
| DATE PREPARED: | |
| TRADE NAME: | |
| COMMON NAME: | |
| CLASSIFICATION NAME: | |
| PRO CODE: |
Telephone:
Fax:
Elaine Duncan October 12, 2011 Dyna-EXTOR® II External Fixation System External Fixation System bone fixation fastener KTT
SUBSTANTIALLY EQUIVALENT TO:
This system is substantially equivalent to Howmedica Mono-tube system and components, Orthofix Penning system and Orthofix Minirail system and the Stryker-Howmedica Apex Pin according to materials used, configuration, indications for use, and as shown by comparative testing and testing to standards.
DESCRIPTION of the DEVICE:
The Dyna-EXTOR II is unilateral external fixation device. The system has 4 detailed systems according to the intended use. The Dyna-EXTOR 11 external fixation system is composed of pins or wires inserted into the bone, above and below the fracture or surgery site. These pins are then attached to a strong external frame. This allows the bone to be held relatively firmly, while some mobility and weight bearing can take place.
INDICATIONS FOR USE:
The Dyna-EXTOR(L) II and Dyna-EXTOR(M) II external fixation systems are intended for the treatment of bone conditions that can be corrected or improved by external skeletal traction or fixation, including osteotomy, arthrodesis, fracture and reconstructive surgery.
510(k) Submission
1
510(k) Summary-Continued
The Dyna-EXTOR(SM) II external fixation system is intended for use in upper extremity applications for the reduction, alignment and stabilization of intra-articular and extraarticular fractures, corrective osteotomies, and soft tissue deformities.
Dyna-EXTOR(ST) II external fixation system is intended for use in external fixation of fractures and/ or reconstruction of small bones, including metacarpal and metatarsal.
SUMMARY of TESTING:
Testing was conducted according to ASTM F1541-02.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
BK Meditech Co, Ltd. % Paladin Medical Ms. Elaine Duncan, M.S.M.E., RAC President P.O. Bo 560 Stillwater, Minnesota 55082
NOV - 2 2011
Re: K110426
Trade/Device Name: Dyna-EXTOR II External Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: October 12, 2011 Received: October 14, 2011
Dear Ms. Duncan:
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-interstatecommerce 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. 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
3
Page 2 - Ms. Elaine Duncan, M.S.M.E., RAC
CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Ernst Keith
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K | 0426 (pg |/ |)
Device Name: Dyna-EXTOR II External Fixation System
The Dyna-EXTOR(L) II and Dyna-EXTOR(M) II external fixation systems are intended for the treatment of bone conditions that can be corrected or improved by external skeletal traction or fixation, including osteotomy, arthrodesis, fracture and reconstructive surgery.
The Dyna-EXTOR(SM) II external fixation system is intended for use in upper extremity applications for the reduction, alignment and stabilization of intra-articular and extra-articular fractures, corrective osteotomies, and soft tissue deformities.
Dyna-EXTOR(ST) II external fixation system is intended for use in external fixation of fractures and/ or reconstruction of small bones, including metacarpal and metatarsal.
Prescription Use X (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)
Michael
Page 1 of 1
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K110426