(29 days)
K98 3942
Not Found
No
The document describes a system of intramedullary nails and accessories for orthopedic fixation. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities. The focus is on the mechanical properties and anatomical applications of the implants.
No.
The device, an Intramedullary Nail System, is used for the fixation of fractures and arthrodesis, which are procedures to stabilize bones or joints, not to actively treat a disease or condition in a therapeutic manner beyond structural support.
No
The device is an intramedullary nail system used for fixation of fractures and arthrodesis, which are therapeutic interventions rather than diagnostic procedures. Its purpose is to treat or stabilize existing conditions, not to identify or diagnose them.
No
The device description explicitly states that the system includes physical components manufactured from stainless steel and UHMWPE, which are hardware materials.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as an implantable medical device used for the fixation of bone fractures and arthrodesis (joint fusion). This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device is described as a system of nails and accessories made from stainless steel and UHMWPE, which are materials commonly used in orthopedic implants.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information about a patient's health status through in vitro testing.
- Anatomical Site: The device is used directly on bone tissue within the body.
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
Indications for interlocking intramedullary nails include simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures: prophylactic nailing of impending pathologic fractures: reconstruction, following tumor resection and grafting; supracondylar fractures; and bone lengthening. Interlocking intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.
In addition to the indications for interlocking intramedullary nails, devices that contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability are indicated for the following: subtrochanteric fractures with lesser trochanteric involvement: ipsilateral femoral shaft/neck fractures; and intertrochanteric fractures.
In addition to the indications for interlocking intramedullary nails, devices that utilize a retrograde femoral surgical approach are indicated for the following: severely comminuted supracondylar fractures with or without difficult intra-articular extension; fractures that require opening the knee joint to stabilize the femoral condylar segment; and fractures above total knee implants.
Indications for the ReVision Nail include the following: degeneration, deformity, or trauma of both the tibiotalar and talocalcaneal articulations in the hindfoot; tibiocalcaneal arthrodesis; combined arthrodesis of the ankle and sub-talar joints; avascular necrosis of the ankle and sub-talar joints; failed total ankle replacement with sub-talar intrusion; failed ankle arthrodesis with insufficient talar body; rheumatoid arthritis; severe deformity secondary to untreated talipes equinovarus or neuromuscular disease; and severe pilon fractures with trauma to the sub-talar joint.
Knee Fusion Nails are intended for intramedullary knee arthrodesis.
Ender Nails are indicated as follows: fracture of the neck, trochanteric region of the femur; distal femoral fractures with a distal fragment 10 cm or longer; tibial shaft fractures; and proximal humeral fractures.
Product codes
JDS
Device Description
The Intramedullary Nail System includes femoral, tibial, ulnaradial, humeral, ankle fusion, knee fusion nails and accessories. Components are manufactured from stainless steel and UHMWPE.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Long bones, femoral head, femoral shaft/neck, intertrochanteric, knee joint, tibiotalar and talocalcaneal articulations in the hindfoot, ankle, sub-talar joints, femur, tibia, humerus, ulna/radius, knee
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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.
K98 3942, Trimax Nail System
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
§ 888.3030 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
510(k) Summary Intramedullary Nail System
Smith & Nephew, Inc
K98 3942
Submitter's name: Submitter's address: Submitter's telephone number: Contact person: Date summary prepared:
1450 Brooks Road, Memphis, TN 38116 901/399-5861 JoAnn Kuhne November 4, 1998
Trade or proprietary device name: Common or unusual name: Classification name: Legally marketed predicate device:
Intramedullary Nail Intramedullary Nail Title 21 CFR 888.3020 - Intramedullary Fixation Rod Class II Trimax Nail System
Subject device description:
The Intramedullary Nail System includes femoral, tibial, ulnaradial, humeral, ankle fusion, knee fusion nails and accessories. Components are manufactured from stainless steel and UHMWPE.
Subject device intended use:
Indications for interlocking intramedullary nails include simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures: prophylactic nailing of impending pathologic fractures: reconstruction, following tumor resection and grafting; supracondylar fractures; and bone lengthening. Interlocking intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.
In addition to the indications for interlocking intramedullary nails, devices that contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability are indicated for the following: subtrochanteric fractures with lesser trochanteric involvement: ipsilateral femoral shaft/neck fractures; and intertrochanteric fractures.
In addition to the indications for interlocking intramedullary nails, devices that utilize a retrograde femoral surgical approach are indicated for the following: severely comminuted supracondylar fractures with or without difficult intra-articular extension; fractures that require opening the knee joint to stabilize the femoral condylar segment; and fractures above total knee implants.
Indications for the ReVision Nail include the following: degeneration, deformity, or trauma of both the tibiotalar and talocalcaneal articulations in the hindfoot; tibiocalcaneal arthrodesis; combined arthrodesis of the ankle and sub-talar joints; avascular necrosis of the ankle and sub-talar joints; failed total ankle replacement with sub-talar intrusion; failed ankle arthrodesis with insufficient talar body; rheumatoid arthritis; severe deformity secondary to untreated talipes equinovarus or neuromuscular disease; and severe pilon fractures with trauma to the sub-talar joint.
Knee Fusion Nails are intended for intramedullary knee arthrodesis.
Ender Nails are indicated as follows: fracture of the neck, trochanteric region of the femur; distal femoral fractures with a distal fragment 10 cm or longer; tibial shaft fractures; and proximal humeral fractures.
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510(k) Summary (cont.) Intramedullary Nail System
Technological characteristics:
The Intramedullary Nail System is similar to the devices listed below.
- Titanium Femoral/Recon Antegrade Nail and the Femoral Retrograde/Tibial Nail 1. (Smith & Nephew Orthopaedics)
- TriMax Femoral/Recon Antegrade Nail and the 1 piece Femoral Retrograde Nail 2. (Smith & Nephew Orthopaedics)
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- AIM Femoral, Supracondylar, Tibial Nails (DePuy Ace)
- Titanium Unreamed Femoral Nail System (Synthes) 4.
- Kuntscher Nails for the femur, tibia, ulna/radius, and humerus 5. (Smith & Nephew Orthopaedics)
- Uniflex Tibial and Humeral Nail Systems (Biomet) 6.
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- Grosse & Kempf Tibial Nail (Howmedica)
- Alta Tibial/Humeral Modular Trauma System (Howmedica) 8.
- True/Flex IM Rod System for the Humerus, Ulna and Radius (Applied Osteo Systems) 9.
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- Small Bone Locking Nail (Biomet)
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- Polarus Humeral and AF Rods (Acumed)
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- Atlas Fracture Proximal Humeral Nail (Biomet)
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- Tibia-Talus-Calcaneus Nail (Smith & Nephew Orthopaedics)
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- Knee Fusion Nail (Smith & Nephew Orthopaedics)
All of the devices listed above are similar in design to the Intramedullary Nail System. The new devices have the same technological characteristics as the predicate device.
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three stylized wing segments.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
4 1998 DEC
Ms. JoAnn M. Kuhne Manager, Regulatory Affairs Smith & Nephew, Inc. 1450 Brooks Road Memphis, Tennessee 38116
Re : K983942 Intramedullary Nail System Trade Name: Regulatory Class: II Product Code: JDS Dated: November 4, 1998 November 5, 1998 Received:
Dear Ms. Kuhne:
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 The general controls provisions of the Act 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 requlations 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 requlation 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.
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Page 2 - Ms. JoAnn M. Kuhne
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,
Celia M. Witten, Ph.D., M.D.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Abbreviated Premarket Notification Indications Statement Intramedullary Nail System Smith & Nephew Inc.
Indications for interlocking intramedullary nails include simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening. Interlocking intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.
In addition to the indications for interlocking intramedullary nails, devices that contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability are indicated for the following: subtrochanteric fractures with lesser trochanteric involvement; ipsilateral femoral shaft/neck fractures; and intertrochanteric fractures.
In addition to the indications for interlocking intramedullary nails, devices that utilize a retrograde femoral surgical approach are indicated for the following: severely comminuted supracondylar fractures with or without difficult intra-articular extension; fractures that require opening the knee joint to stabilize the femoral condylar segment; fractures above total knee implants.
Indications for the ReVision Nail include the following: degeneration, deformity, or trauma of both the tibiotalar and talocalcaneal articulations in the hindfoot; tibiocalcaneal arthrodesis; combined arthrodesis of the ankle and sub-talar joints; avascular necrosis of the ankle and sub-talar joints; failed total ankle replacement with sub-talar intrusion; failed ankle arthrodesis with insufficient talar body; rheumatoid arthritis; severe deformity secondary to untreated talipes equinovarus or neuromuscular disease; and severe pilon fractures with trauma to the sub-talar joint.
Knee Fusion Nails are intended for intramedullary knee arthrodesis.
Ender Nails are indicated as follows: fracture of the neck, trochanteric, and subtrochanteric region of the femur; distal femoral fractures with a distal fragment 10 cm or longer; tibial shaft fractures; and proximal humeral fractures.
basee
Prescription Use (Per 21 CFR 801.109)