(243 days)
No
The summary describes a mechanical orthopedic implant system with added features for bone cement delivery. There is no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is a system of nails and screws intended for the treatment of bone fractures, which is a therapeutic purpose.
No
This device is a surgical implant (Trochanteric Fixation Nail-Advanced System) used for treating bone fractures, not for diagnosing conditions.
No
The device description clearly states it consists of physical components made of metallic materials (Ti-15Mo, Ti-6Al-7Nb, 40Co-20Cr-16Fe-15Ni-7Mo) and is intended for surgical implantation. It is a hardware device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for the treatment of bone fractures in the femoral region. This is a surgical intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The device is described as a nail system with components for fixation, including a femoral head element with perforations for bone cement delivery. This is consistent with a surgical implant used to stabilize bone.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is a surgical implant used for the mechanical stabilization of bone fractures.
N/A
Intended Use / Indications for Use
The Synthes Trochanteric Fixation Nail- Advanced (TFNA) System is intended for treatment of fractures in adults and adolescents (12-21) in which the growth plates have fused. Specifies the system is indicated for: Stable and unstable pertrochanteric fractures, Intertrochanteric fractures, Basal neck fractures, Combinations of pertrochanteric, intertrochanteric, and basal neck fractures. The Long Nail is additionally intended for treatment of fractures in adults and adolescents (12-21) in which the growth plates have fused for the following indications: Subtrochanteric fractures, Pertrochanteric fractures associated with shaft fractures, Pathologic fractures (including prophylactic use) in both trochanteric and diaphyseal regions, Long Subtrochanteric fractures, Proximal or distal non-unions, malunions and revisions. Both the short and long TFNA systems are additionally indicated for use with cleared polymethylmethacrylate (PMMA) bone cement that can be delivered through the fenestrated blade or screw via a cannula in skeletally mature adults with risk of cut-out or device instability due to poor bone quality.
Product codes
HSB, KTT
Device Description
The DePuy Synthes TFNA Augmentation System consists of components to the predicate DePuy Synthes TFNA System with added perforations to the femoral head elements. The perforations enable the delivery of cleared PMMA bone cement(s) to be delivered through the helical blade/femoral neck screw in patients with poor bone quality and/or increased risk of fixation failure at the implant/bone interface. The materials of manufacture are the same as those used to manufacture the predicate TFNA hardware: Ti-15Mo (ASTM F-2066); Ti-6Al-7Nb (ASTM F1295); 40Co-20Cr-16Fe-15Ni-7Mo (ASTM F1058)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femoral head, trochanteric and diaphyseal regions
Indicated Patient Age Range
Adults and adolescents (12-21) in which the growth plates have fused. Skeletally mature adults for PMMA bone cement use.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The proposed DePuy Synthes TFNA Augmentation System has similar intended use, indications, design characteristics, functionality, materials, and performance characteristics in comparison to the predicate devices. The following assessments have been completed to demonstrate substantial equivalence performance specifications: - Dynamic fatigue testing comparing the fenestrated and non-fenestrated head elements - Biomechanical evaluation of cut-out resistance Additional evaluations were conducted to confirm the ability of the fenestrated hardware to deliver bone cement in a controlled and predicable manner. - Flow patterns - Extraction validations
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Alta Dome and Plunger (K961213)
Reference Device(s)
DePuy Synthes TFNA System (K131548)
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 symbol that resembles a stylized human figure in profile, with three overlapping faces suggesting community and support.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 26, 2016
Synthes (USA) Products, LLC Christopher Medberry, Ph.D. Senior Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K160167
Trade/Device Name: DePuy Synthes TFNA Augmentation System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB, KTT Dated: August 25, 2016 Received: August 26, 2016
Dear Dr. Medberry:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K160167
Device Name
DePuy Synthes TFNA Augmentation System
Indications for Use (Describe)
The Synthes Trochanteric Fixation Nail- Advanced (TFNA) System is intended for treatment of fractures in adults and adolescents (12-21) in which the growth plates have fused.
Specifically the system is indicated for:
- · Stable and unstable pertrochanteric fractures
- · Intertrochanteric fractures
- Basal neck fractures
- · Combinations of pertrochanteric, intertrochanteric, and basal neck fractures
The Long Nail is additionally intended for treatment of fractures in adults and adolescents (12- 21) in which the growth plates have fused for the following indications:
- · Subtrochanteric fractures
- Pertrochanteric fractures associated with shaft fractures
- · Pathologic fractures (including prophylactic use) in both trochanteric and diaphyseal regions
- · Long Subtrochanteric fractures
- · Proximal or distal non-unions, malunions and revisions
Both the short and long TFNA systems are additionally indicated for use with cleared polymethylmethacrylate (PMMA) bone cement that can be delivered through the fenestrated blade or screw via a cannula in skeletally mature adults with risk of cut-out or device instability due to poor bone quality.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------- |
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| Sponsor: | DePuy Synthes
Christopher J. Medberry, Ph.D.
1301 Goshen Parkway
West Chester, PA, 19380
Office: (610) 719-6806
Fax: (484) 356-9682 |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared | September 23, 2016 |
| Proprietary Name: | DePuy Synthes TFNA Augmentation System |
| Classification: | Classification: 888.3020, 888.3030
Product Code: HSB, KTT |
| Predicate Device: | Alta Dome and Plunger (K961213) |
| Reference Device: | DePuy Synthes TFNA System (K131548) |
| Device Description: | The DePuy Synthes TFNA Augmentation System consists of components to
the predicate DePuy Synthes TFNA System with added perforations to the
femoral head elements. The perforations enable the delivery of cleared PMMA
bone cement(s) to be delivered through the helical blade/femoral neck screw in
patients with poor bone quality and/or increased risk of fixation failure at the
implant/bone interface.
The materials of manufacture are the same as those used to manufacture the
predicate TFNA hardware: Ti-15Mo (ASTM F-2066); Ti-6Al-7Nb (ASTM
F1295); 40Co-20Cr-16Fe-15Ni-7Mo (ASTM F1058) |
| Indications for Use | The Synthes Trochanteric Fixation Nail- Advanced (TFNA) System is
intended for treatment of fractures in adults and adolescents (12-21) in which
the growth plates have fused.
Specifically the system is indicated for:
Stable and unstable pertrochanteric fractures Intertrochanteric fractures Basal neck fractures Combinations of pertrochanteric, intertrochanteric, and basal neck
fractures
The Long Nail is additionally intended for treatment of fractures in adults and
adolescents (12-21) in which the growth plates have fused for the following
indications:
Subtrochanteric fractures Pertrochanteric fractures associated with shaft fractures Pathologic fractures (including prophylactic use) in both trochanteric
and diaphyseal regions |
| | Long Subtrochanteric fractures Proximal or distal non-unions, malunions and revisions |
| | Both the short and long TFNA systems are additionally indicated for use with
cleared polymethylmethacrylate (PMMA) bone cement that can be delivered
through the fenestrated blade or screw via a cannula in skeletally mature
adults with risk of cut-out or device instability due to poor bone quality |
| Substantial
Equivalence: | The proposed DePuy Synthes TFNA Augmentation System has similar
intended use, indications, design characteristics, functionality, materials, and
performance characteristics in comparison to the predicate devices.
The following assessments have been completed to demonstrate substantial
equivalence performance specifications: Dynamic fatigue testing comparing the fenestrated and non-fenestrated
head elements Biomechanical evaluation of cut-out resistance Additional evaluations were conducted to confirm the ability of the fenestrated
hardware to deliver bone cement in a controlled and predicable manner. Flow patterns Extraction validations |
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