(87 days)
K-951809
Not Found
No
The document describes a mechanical implant system for fracture fixation and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML.
No
The device is an orthopedic implant (nail system) used for internal fixation of femoral fractures, not a therapeutic device in the sense of delivering treatment like heat, light, or medication.
No
The device is an orthopedic implant (locking nail system) used for internal fixation of femoral fractures, not for diagnosing medical conditions.
No
The device description explicitly states it is a "locking nail system" consisting of "intramedullary nails, femoral neck blades, and distal locking pins," which are physical hardware components.
Based on the provided information, 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, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the Friedl Gliding Nail System is an implantable device used for the internal fixation of bone fractures in the femur. It is a surgical implant, not a device that analyzes biological samples.
The information provided describes a medical device used in vivo (within the body) for surgical treatment, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Friedl Gliding Nail System is an all-purpose locking nail system for ensuring primary load stability in:
- pertrochanteric femoral fractures -
- subtrochanteric femoral fractures and -
- lateral femoral neck fractures. -
Internal fixation with the long Fried! Gliding Nail is indicated in all combination injuries involving the lateral femoral neck or trochanter region and femoral shaft fractures. Thanks to its biomechanical characteristics, the Friedl Gliding Nail system is also suitable for medial femoral neck fractures with retention of the head and simple femoral shaft fractures down to the distal metaphysis. Gliding nail fixation can also be used to secure pathological fractures or to provide weightbearing stability after varus and valgus revision osteotomies of the proximal femur.
Product codes
KTT
Device Description
The FRIEDL Gliding Nail System is an all-purpose locking nail system for primary load stability in pertrochanteric femoral fractures, subtrochanteric femoral fractures, and lateral femoral neck fractures. This system consists of several sizes of intramedullary nails, femoral neck blades, and distal locking pins. The Fried Gliding Nail System is made of Wrought High Nitrogen Stainless Steel according to ISO 5832-9.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral fractures, femoral neck, femoral shaft, proximal femur
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
K-951809
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
Image /page/0/Picture/0 description: The image shows the logo for HHL Consulting. The letters "HHL" are in large, bold, black font and are slanted to the right. The word "CONSULTING" is in a smaller, bold, black font and is also slanted to the right.
FEB 1 9 1998
Image /page/0/Picture/3 description: The image shows a caduceus symbol, which is often associated with medicine and healthcare. The symbol features a staff with two snakes coiled around it, and a pair of wings at the top. The staff is straight and vertical, while the snakes are intertwined in a symmetrical pattern. The wings are spread out on either side of the staff, adding to the overall visual balance of the symbol.
510(k) Summary of Safety and Effectiveness Information
(as required by 807.92c), prepared by Hartmut Loch, President of HHL Consulting for PLUS Orthopedics in San Diego, California November 10, 1997
FRIEDL Gliding Nail System Trade name:
Compression Hip Nail Common name:
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Classification name: Component, 87KTT, Regulation Number 888.3030.
The FRIEDL Gliding Nail System is an all-purpose locking nail Description: system for primary load stability in pertrochanteric femoral fractures, subtrochanteric femoral fractures, and lateral femoral neck fractures. This system consists of several sizes of intramedullary nails, femoral neck blades, and distal locking pins. The Fried Gliding Nail System is made of Wrought High Nitrogen Stainless Steel according to ISO 5832-9.
The Friedl Gliding Nail System is an all-purpose locking nail system Indications: for ensuring primary load stability in:
- pertrochanteric femoral fractures ﺪ
- subtrochanteric femoral fractures and - .
- lateral femoral neck fractures. ﺘ
Internal fixation with the long Fried! Gliding Nail is indicated in all combination injuries involving the lateral femoral neck or trochanter region and femoral shaft fractures. Thanks to its biomechanical characteristics, the Friedl Gliding Nail system is also suitable for medial femoral neck fractures with retention of the head and simple femoral shaft fractures down to the distal metaphysis. Gliding nail fixation can also be used to secure pathological fractures or to provide weightbearing stability after varus and valgus revision osteotomies of the proximal femur.
Comparable Features to Predicate Device: The FRIEDL Gliding Nail System is comparable to the Gliding Nail from Encore Orthopedics, Inc., which was cleared for marketing by FDA on July 13, 1995 (K-951809).
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 9 1998
Mr. Hartmut Loch President HHL Consulting Representing PLUS Orthopedics 835 Cortez Lane 94404 Foster City, California
K974409 Re : FRIEDL Gliding Nail System Trade Name: Regulatory Class: II Product Code: KTT Dated: November 10, 1997 November 24, 1997 Received:
Dear Mr. Loch:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A- -----substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: .... . . . this response to your premarket notification submission does not affect any obligation you might have under sections 531 __________________________________________________________________________________________________________________ through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Mr. Hartmut Loch
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Cella M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page 1 of of 1 -
510(k) Number (if known): __ K974409
Device Name: FRIEDL GLIDING NAIL SYSTEM
Indications for Use:
The Friedl Gliding Nail System is an all-purpose locking nail system for ensuring primary load stability in:
- pertrochanteric femoral fractures -
- subtrochanteric femoral fractures and -
- lateral femoral neck fractures. -
Internal fixation with the long Fried! Gliding Nail is indicated in all combination injuries involving the lateral femoral neck or trochanter region and femoral shaft fractures. Thanks to its biomechanical characteristics, the Friedl Gliding Nail system is also suitable for medial femoral neck fractures with retention of the head and simple femoral shaft fractures down to the distal metaphysis. Gliding nail fixation can also be used to secure pathological fractures or to provide weightbearing stability after varus and valgus revision osteotomies of the proximal femur.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
bōōēēē
OR
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. Kq74409
Prescription Use (Per 21 CFR 801.109).
Over-The-Counter Use
(Optional Format 1-2-96