(54 days)
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 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 (i.e. Femoral/Recon Antegrade Nail) are indicated for the following: subtrochanteric fractures with lesser trochanteric involvement; ipsilateral femoral shaft/neck fractures; and intertrochanteric fractures.
In addition to indications for interlocking intramedullary nails, devices that utilize a retrograde femoral surgical approach (i.e. Retrograde/Tibial and Supracondylar Nails) 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.
Intramedullary locking nails (i.e. TriGen® Nails) are for single use only.
The subject devices are line additions to the TriGen® Intramedullary Nail System. These line additions are comprised of retrograde femoral and tibial intramedullary nails and a nail cap. All described components are manufactured from titanium material.
This 510(k) submission describes the TriGen® Meta-Nail Retrograde Femoral & Tibial Nails, which are line additions to an existing intramedullary nail system. The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices through design, material, and operational similarities, and through mechanical performance testing.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" for the device, but it notes that the device must be "capable of withstanding expected in vivo loading without failure" to be substantially equivalent. The performance "reported" is that the device meets this implicitly understood requirement.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Withstand expected in vivo loading without failure | "A review of the test data for the subject devices indicates that they are equivalent to the predicate devices currently in clinical use and are capable of withstanding expected in vivo loading without failure." |
| Maintain identical principle of operation to predicate devices | "The principle of operation of the subject devices is identical to that of the predicates. There are no changes in intended use, performance specifications or method of operation." |
| Maintain similar indications for use, design, and materials | "Substantial equivalence for TriGen® Meta-Nail Retrograde Femoral & Tibial Nails is based on their similarities in indications for use, design features, operational principles, and material composition when compared to the predicate devices cleared under the following submissions: K981529, Smith & Nephew Titanium (TriGen®) Intramedullary Nail System and K051557, TriGen® Retrograde Femoral, Supracondylar, and Tibial Nails." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document refers to "test data" being reviewed, but does not specify the sample size for this test set, nor does it provide information on the data provenance (e.g., country of origin, retrospective or prospective). Given the nature of a 510(k) for an intramedullary nail, the "test data" most likely refers to mechanical bench testing rather than clinical data on human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. For mechanical testing, there wouldn't typically be "experts" establishing a "ground truth" in the same way clinical studies do. The ground truth for such testing would be defined by engineering specifications and standards for device performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided as the "test set" appears to refer to mechanical performance data, not a clinical study requiring adjudication of findings.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not provided and not applicable. This submission is for an intramedullary nail, which is a physical implant, not an AI-powered diagnostic device that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is an intramedullary nail, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the mechanical "test data" mentioned, the ground truth would be established by engineering specifications and recognized standards for the mechanical properties and performance of intramedullary nails, ensuring they can withstand physiological loads. It would not typically involve expert consensus, pathology, or outcomes data in the clinical sense directly for the device's mechanical integrity.
8. The sample size for the training set
This information is not applicable and not provided. This is a medical device (intramedullary nail) submission, not an AI/machine learning product that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable and not provided as there is no training set for this type of medical device.
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K061019
ness
510(k) Summary of Safety and Effect TriGen® Meta-Nail Retrograde Femoral & Tibial Nails
| Submitted by: | Smith & Nephew, Inc.Orthopaedic Division1450 Brooks RoadMemphis, TN 38116 | Date: April 12, 2006 |
|---|---|---|
| JUN - 6 2006 | ||
| Contact Person: | David Henley, Senior Regulatory Affairs Specialist | |
| Proprietary Name: | TriGen® Meta-Nail Retrograde Femoral & Tibial Nails | |
| Common Name: | Intramedullary Nail | |
| Classification Name and Reference: | 21 CFR 888.3020 - Intramedullary Fixation Rod, Class II | |
| Device Product Code and Panel Code: | IDS / Orthopaedics / 87 |
Device Description:
The subject devices are line additions to the TriGen® Intramedullary Nail System. These line additions are comprised of retrograde femoral and tibial intramedullary nails and a nail cap. All described components are manufactured from titanium material.
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; bone lengthening. Interlocking intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of 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 fi.e. Femoral/Recon Antegrade Nail) are indicated for the following: subtrochanteric fractures with lesser trochanteric involvement; ipsilateral femoral shaft/neck fractures; and intertrochanteric fractures.
In addition to indications for intramedullary nails, devices that utilize a retrograde femoral surgical approach (i.e. Retrograde/Tibial and Supracondylar Nails) 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.
Intramedullary locking nails (i.e. TriGen® Nails) are for single use only.
Technological Characteristics:
The principle of operation of the subject devices is identical to that of the predicates. There are no changes in intended use, performance specifications or method of operation. A review of the test data for the subject devices indicates that they are equivalent to the predicate devices currently in clinical use and are capable of withstanding expected in vivo loading without failure.
Substantial Equivalence Information:
Substantial equivalence for TriGen® Meta-Nail Retrograde Femoral & Tibial Nails is based on their similarities in indications for use, design features, operational principles, and material composition when compared to the predicate devices cleared under the following submissions: K981529, Smith & Nephew Titanium (TriGen®) Intramedullary Nail System and K051557, TriGen® Retrograde Femoral, Supracondylar, and Tibial Nails.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three parallel lines that curve upwards. The logo is surrounded by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement. The text is written in all capital letters.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN -6 2006
Smith & Nephew, Inc % Mr. David Henley Orthopaedic Division 7450 Brooks Road Memphis, Tennessee 38116
Re: K061019
Trade/Device Name: TriGen® Meta-Nail Retrograde Femoral & Tibial Nails Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: JDS Dated: May 19, 2006 Received: May 22, 2006
Dear Mr. Henley:
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 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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
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Page 2 - Mr. David Henley
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), please contact the Office of Compliance at (240)-276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Hubert Levin as
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name:
Indications For Use:
AND/OR Over-The-Counter Use Prescription Use (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
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Page 4 - Mr. David Henley
OC Numbers:
.
:
| Division of Enforcement A | 240-276-0115 | |
|---|---|---|
| Dental, ENT and Ophthalmic Devices Branch | 240-276-0115 | |
| OB/GYN, Gastro. & Urology Devices Branch | 240-276-0115 | |
| General Hospital Devices Branch | 240-276-0115 | |
| General Surgery Devices Branch | 240-276-0115 | |
| Division of Enforcement B | 240-276-0120 | |
| Cardiovascular & Neurological Devices Branch | 240-276-0120 | |
| Orthopedic, Physical Medicine & Anesthesiology Devices Br | 240-276-0120 |
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:
:
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Premarket Notification Indications for Use Statement
510(k) Number (if known):
TriGen® Meta-Nail Retrograde Femoral & Tibial Nails Device Name:
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; bone lengthening and shortening. Interlocking intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of 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 (i.e. Femoral/Recon Antegrade Nail) are indicated for the following: subtrochanteric fractures with lesser trochanteric involvement; ipsilateral femoral shaft/neck fractures; and intertrochanteric fractures.
In addition to indications for interlocking intramedullary nails, devices that utilize a retrograde femoral surgical approach (i.e. Retrograde/Tibial and Supracondylar Nails) 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.
Intramedullary locking nails (i.e. TriGen® Nails) are for single use only.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ and/or (Per 21 CFR 801, 109)
Over-the-Counter Use (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hubert Lemmer
and Neurological Devices
510(k) Number K061019
§ 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.