(62 days)
Not Found
No
The summary describes a mechanical implant system for fracture fixation and does not mention any software, image processing, or AI/ML terms.
Yes
The device is a Trochanteric Nail System, which is used to treat fractures of the femur. This is a therapeutic intervention aimed at restoring function and healing the bone.
No
Explanation: The provided text describes the Trochanteric Nail System as a surgical implant used to treat fractures of the femur. Its stated use is for treatment, not for diagnosing a condition or disease.
No
The device description explicitly states it consists of physical components (intramedullary nail, lag screw, end cap, optional anti-rotation screw) made of Titanium, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant used to treat bone fractures. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the components of an intramedullary nail system, which are physical implants used in surgery.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail system is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal non-unions and malunions and revision procedures.
Product codes
87NDE, 87HSB
Device Description
The Trochanteric Long Nail System consists of an intramedullary nail, lag screw, end cap, and optional anti-rotation screw, all manufactured from Titanium (Ti-6Al-4V ELI) which are used to treat fractures of the femur.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
K010780, K871539, K973240, K981529
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
DEC 2 7 2001
K013563
page 1 of 2
510(k) Summary
| Name of Sponsor: | DePuy Orthopaedics, Inc.
700 Orthopaedic Drive
Warsaw, Indiana 46581-0988
Est. Reg. No. 1818910 | |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| 510(k) Contact: | Marcia J. Arentz
Senior Regulatory Associate
Phone: (219) 371-4944
FAX: (219) 371-4987 | |
| Trade Name: | Long Trochanteric Nail System | |
| Common Name: | Bone fixation device | |
| Classification: | Class II Device per 21 CFR 888.3020:
Intramedullary fixation rod
Description: Rod, Fixation, Intramedullary and
Accessories, Metallic and Non-collapsible | |
| Device Product Code: | Code: 87NDE or 87HSB
No performance standards have been established
under Section 514 of the Federal Food, Drug,
and Cosmetic Act for intramedullary nails. | |
| Substantially Equivalent Device: | ACE Trochanteric Nail
ACE AIM Femoral Nail
Synthes Proximal Femoral Nail
Smith & Nephew TriGen Nail | K010780
K871539
K973240
K981529 |
| Device Descriptions: | The Trochanteric Long Nail System consists of
an intramedullary nail, lag screw, end cap, and
optional anti-rotation screw, all manufactured
from Titanium (Ti-6Al-4V ELI) which are used
to treat fractures of the femur. | |
0000005
1
KWI3563
page 2 of 2
510(k) Summary (continued)
| Indications for use: | The Trochanteric Nail System is intended to treat
stable and unstable proximal fractures of the femur
including pertrochanteric fractures, intertrochanteric
fractures, high subtrochanteric fractures and
combinations of these fractures. The Trochanteric
Long Nail system is additionally indicated to treat
pertrochanteric fractures associated with shaft
fractures, pathologic fractures in osteoporotic bone
of the trochanteric and diaphyseal areas, long
subtrochanteric fractures, ipsilateral femoral
fractures, proximal or distal non-unions and
malunions and revision procedures. |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial equivalence: | The Trochanteric Nail System has the same
intended use, is manufactured from the same
material and has the same design features as the
predicate devices and is therefore substantially
equivalent. |
0000000
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 features a stylized depiction of a human figure with three flowing lines representing the body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the figure in a circular pattern.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 7 2001
Marcia J. Arentz Senior Regulatory Associate DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
Re: K013563
Trade Name: Trochanteric Long Nail System Regulation Number: 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: II Product Code: HSB Dated: October 21, 2001 Received: October 26, 2001
Dear Ms. Arentz:
We have reviewed your Section 510(k) premarket 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) 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.
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.
3
Page 2 - Ms. Marcia J. Arentz
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 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely vours.
Sincerely yours,
Mark N. Melhemor
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K013563
page 1 of 1
510(k) Number (if known):
Device Name: Long Trochanteric Nail System
Indications for Use:
The Trochanteric Nail System is intended to treat stable and unstable proximal fractures The frochanteric Nan Dystein is intenteric fractures, intertrochanteric fractures, high of the fremar fractures and combinations of these fractures. The Trochanteric Long Sublivenancere fractures and combinated to treat pertrochanteric fractures associated with Natt System is additionally marcures in osteoporotic bone of the trochanteric and shart fractures, paulonogro- nacteric fractures, ipsilateral femoral fractures, proximal or distal non-unions and malunions and revision procedures.
Concurrence of CDRH, Office of Device Evaluation
for Mark A. Milliken
(Division :11) Division c everal, Restorative and and ogical Devices
K 01356 510(k) Number _
000003
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use