(97 days)
Not Found
No
The 510(k) summary describes a mechanical bone plate and screw system for fracture fixation. There is no mention of AI, ML, image processing, or any software-driven decision-making or analysis.
Yes
The device is indicated for temporary stabilization of long bone fractures, which is a therapeutic purpose.
No
The device is described as a "Locking Plate" intended for "temporary stabilization of long bone fractures." Its purpose is to physically stabilize fractures, not to diagnose them.
No
The device description explicitly states it consists of "plates" with "threaded holes and 'finger holes' for the corresponding screws," indicating a physical hardware component used for fracture stabilization.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided information clearly describes a surgical implant (a bone plate) used for the temporary stabilization of bone fractures. This is a device that is implanted into the body to provide structural support.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens. Its function is purely mechanical and structural within the body.
Therefore, based on the provided information, the AngleFix T Locking Plate is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The AngleFix T Locking Plate is indicated for temporary stabilization of long bone fractures including:
- Proximal and distal fractures including joint fractures of the humerus, tibia and . other long bones
- Metaphyseal, supracondylar, peri-articular, intra-articular, and intra-articular . condylar fractures
- Diaphyseal fractures .
- Ankle fractures .
- Simple, comminuted and depression fractures ●
- Non-unions and malunions .
- Osteotomies and bone reconstruction t
- Fractures in normal or osteoporotic bone 9
Product codes
KTT
Device Description
The AngleFix T Locking Plate consists of plates to accommodate the patients' anatomy. Each plate has threaded holes and "finger holes" for the corresponding screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Long bones, humerus, tibia, ankle
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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 pre-clinical testing performed indicated that the AngleFix T Locking Plate is substantially equivalent to the predicate devices and is adequate for the intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
SEP 0 8 2009
K0916619
4. 510(k) Summary according to 807.92(c)
| Contact: | Mike Sinsheimer
AngleFix Tech, LLC.
1723 Beverly Drive
Charlotte, NC 28207
704-363-7532 |
|-----------------|-----------------------------------------------------------------------------------------------------|
| Trade Name: | AngleFix T Locking Plate |
| Product Class: | Class II |
| Classification: | 21 CFR §888.3030
Single/multiple component metallic bone fixation
appliances and accessories |
| Product Codes: | KTT |
| Panel Code: | 87 |
Indications for Use: The AngleFix T Locking Plate is indicated for temporary stabilization of long bone fractures including:
- Proximal and distal fractures including joint fractures of the humerus, tibia and . other long bones
- Metaphyseal, supracondylar, peri-articular, intra-articular, and intra-articular . condylar fractures
- Diaphyseal fractures .
- Ankle fractures .
- Simple, comminuted and depression fractures ●
- Non-unions and malunions .
- Osteotomies and bone reconstruction t
- Fractures in normal or osteoporotic bone 9
The AngleFix T Locking Plate consists of plates to accommodate the patients' anatomy. Each plate has threaded holes and "finger holes" for the corresponding screws.
Predicate Device(s):
Device Description:
and the Synthes AxSOS Plus Locking Plate System (K061012).
Performance Testing:
The pre-clinical testing performed indicated that the AngleFix T Locking Plate is substantially equivalent to the predicate devices and is adequate for the intended use.
Howmedica VariAx Locking plate System (K060613), the
Synthes 3.5mm LCP Distal Humerus System (K033995)
e i of
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the department's emblem in the center. The emblem features a stylized caduceus, a symbol often associated with medicine and healthcare, with a bird-like design incorporated into it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
SEP 0 8 2009
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 . Silver Spring, MD 20993-0002
AngleFix Tech, LLC % Silver Pine Consulting Mr. Richard Jansen, Pharm D. 135 Guild Avenue Apple Valley, Minnesota 55124
Re: K091619
Trade/Device Name: AngleFix T Locking Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories
Regulatory Class: II Product Code: KTT Dated: May 31, 2009 Received: June 10, 2009
Dear Mr. Jansen
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 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 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.
2
Page 2- Mr. Richard Jansen, Pharm D.
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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Barbara Buchend
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
3. Statement of Indications for Use
510(k) Number (if known): (09116 19
Indications for Use:
The AngleFix T Locking Plate is indicated for temporary stabilization of long bone fractures including:
- Proximal and distal fractures including joint fractures of the humerus, tibia and . other long bones
- Metaphyseal, supracondylar, peri-articular, intra-articular, and intra-articular . condylar fractures
- Diaphyseal fractures .
- Ankle fractures .
- Simple, comminuted and depression fractures .
- Non-unions and malunions
- Osteotomies and bone reconstruction
- Fractures in normal or osteoporotic bone
Prescription Use 1 (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 CDRH, Office of Device Evaluation (ODE)
Souita for mxm
(Division Sign O
(Division Sign-Off Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number_K09) 6/9