(51 days)
No
The device description and performance studies focus on mechanical properties and biocompatibility of metal plates and screws, with no mention of AI or ML.
Yes
Explanation: The device, THP™ Hip Fracture Plating System, is indicated for open reduction and internal fixation of proximal femur fractures, which is a therapeutic intervention. It is designed to stabilize fractures, thus treating a medical condition.
No
The device is a surgical implant designed for the internal fixation of proximal femur fractures, which is a treatment, not a diagnostic, function.
No
The device description explicitly states it is a set of metal plates and screws, which are hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "open reduction and internal fixation of a wide variety of fractures of the proximal femur." This describes a surgical procedure performed directly on the patient's body to stabilize a broken bone.
- Device Description: The device is described as "a set of metal plates and associated screws designed to affix to the lateral aspect of the proximal femur and provide fracture stabilization." This is a physical implant used within the body.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
This device is clearly an implantable surgical device used for orthopedic fixation, not a device used for testing samples outside the body.
N/A
Intended Use / Indications for Use
The THP Hip Fracture Plating System is indicated for use in the open reduction and internal fixation of a wide variety of fractures of the proximal femur: intracapsular fractures and intertrochanteric fractures.
Product codes
JDO, KTT, HWC
Device Description
THP Hip Fracture Plating System is a set of metal plates and associated screws designed to affix to the lateral aspect of the proximal femur and provide fracture stabilization for femoral neck fractures and intertrochanteric fractures. The THP 5.0mm Cortical Screws are both locking and non-locking. The locking screws contain external threads that can be used to lock the threaded holes on the plate body, while the non-locking screws do not include the external threads to complete this task.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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
Non-Clinical Performance and Conclusions:
Shelf Life - The minimum sterilization dose was verified using method VDmax 25 per ISO 11137-2:2013, "Sterilization of health care products – Radiation Part 2: Establishing Radiation Dose".
Biocompatibility – The minor changes in geometry do not affect the biological safety of the plates, screws, and instruments in this submission. The original Biocompatibility testing was conducted per ISO 10993-1 and Good Laboratory Practices (21 CFR 58). All testing passed.
Bacterial Endotoxin Test (BET) - Testing has been performed to establish product non-pyrogenicity.
Performance Evaluation -Testing conducted on the proposed device is summarized below.
Mechanical Testing - Shaft Screws FX00080-09 . This study demonstrated that the mechanical strength of the proposed device is statistically equivalent to that of the predicate devices.
Hip FX Plate Construct Fatigue Testing FX00080-. 10 - This study demonstrated that the proposed device can withstand a cyclic moment load equal to or greater than the predicate device.
Hip Fx vs. CHS Plate Construct Fatigue Test FX00080-05 - This study demonstrated that the proposed device can withstand a fatigue load, of the 2 Screw and 3 Screw constructs in a simulated bone with an intertrochanteric fracture, equal or greater than the predicate device.
Conclusions: The data presented in this submission show that the changes do not affect the safety and/or effectiveness of the subject devices and that the subject devices will perform in a substantially equivalent manner to the predicate devices.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for these devices to show substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
February 7, 2018
Biomet, Inc. Annette Minthorn Regulatory Affairs Sr. Specialist 56 East Bell Drive Warsaw, Indiana 46582
Re: K173826
Trade/Device Name: THPTM Hip Fracture Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: JDO, KTT, HWC Dated: December 15, 2017 Received: December 18, 2017
Dear Ms. Minthorn:
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 Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Katherine D. Kavlock -S
for 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)
K173826
Device Name
THPTM Hip Fracture Plating System
Indications for Use (Describe)
The THP™ Hip Fracture Plating System is indicated for use in the open reduction and internal fixation of a wide variety of fractures of the proximal femur: intracapsular fractures and intertrochanteric fractures.
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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BIOM ET
Traditional 510(k) Premarket Notification
510(k) Summary
| Sponsor: | Biomet, Inc.
56 East Bell Drive
P.O. Box 587
Warsaw, IN 46581
Establishment Registration Number: 1825034 |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Annette Minthorn
Sr. Specialist, Trauma Regulatory Affairs
Telephone: 574-372-4294
Fax: (574) 372-4605 |
| Date: | 15 December 2017 |
| Trade Name: | THP TM Hip Fracture Plating System |
| Common Name: | Fracture Plates and Cortical Screws |
| Classification Names
and References: | JDO - Device, fixation, proximal femoral, implant
(21 CFR § 888.3030)
KTT - Single/multiple component metallic bone fixation
appliances and accessories (21 CFR § 888.3030)
HWC - Smooth or threaded metallic bone fixation fastener
(21 CFR § 888.3040) |
| Classification Panel: | Orthopedics/87 |
| Predicate Device(s): | Biomet Hip Fracture Plating System (Biomet, K140018,
cleared 04-April-2014)
Captured Hip Screw System (Biomet, K813554, cleared
12-January-1982) |
| Purpose and Device
Description: | THP Hip Fracture Plating System is a set of metal plates
and associated screws designed to affix to the lateral
aspect of the proximal femur and provide fracture
stabilization for femoral neck fractures and
intertrochanteric fractures. |
4
| | The THP 5.0mm Cortical Screws are both locking and
non-locking. The locking screws contain external threads
that can be used to lock the threaded holes on the plate
body, while the non-locking screws do not include the
external threads to complete this task. |
|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | The THP Hip Fracture Plating System is indicated for use
in the open reduction and internal fixation of a wide
variety of fractures of the proximal femur: intracapsular
fractures and intertrochanteric fractures. |
| Comparison to Predicate Device: | The THP Hip Fracture Plating System 5.0mm cortical
screws are subject of this submission in part to a corrective
action. These screws will replace the 4.5mm cortical
screws that were cleared in K140018 with the TSP
Fracture Plates. These screws were found to have a head
breakage issue and thus were recalled. The 5.0mm
cortical screws were designed to address the head
breakage issue, tested and proven not only eliminate the
head breakage, but were also found to be 106.6% stronger
than the equivalent 4.5mm TSP in max failure torque, as
well as an increase of 21.1% in max failure torque when
compared to the equivalent CHS screws (cleared in
K813554).
In addition, the THP Hip Fracture Plating System plates
underwent the following modifications: removed the
posterior guide wire hole, updated anterior guide wire hole
to accept 2.5mm guide wire, added proximal sweep for
anatomical fit, and replaced compression hole with
locking hole (4 hole only). These modifications are the
subject of this submission. The original THP plates were
cleared in K140018. These plates were not part of the
recall. The modifications made are to enhance the plates
and do not represent a new worse case. |
| Performance Data (Nonclinical
and/or Clinical): | Non-Clinical Performance and Conclusions:
Shelf Life - The minimum sterilization dose was verified
using method VDmax 25 per ISO 11137-2:2013,
"Sterilization of health care products – Radiation
Part 2: Establishing Radiation Dose".
Biocompatibility – The minor changes in geometry do
not affect the biological safety of the plates, screws,
and instruments in this submission. The original |
5
Biocompatibility testing was conducted per ISO 10993-1 and Good Laboratory Practices (21 CFR 58). All testing passed.
- . Bacterial Endotoxin Test (BET) - Testing has been performed to establish product non-pyrogenicity.
Performance Evaluation -Testing conducted on the proposed device is summarized below.
Mechanical Testing - Shaft Screws FX00080-09 . This study demonstrated that the mechanical strength of the proposed device is statistically equivalent to that of the predicate devices.
Hip FX Plate Construct Fatigue Testing FX00080-. 10 - This study demonstrated that the proposed device can withstand a cyclic moment load equal to or greater than the predicate device.
. Hip Fx vs. CHS Plate Construct Fatigue Test FX00080-05 - This study demonstrated that the proposed device can withstand a fatigue load, of the 2 Screw and 3 Screw constructs in a simulated bone with an intertrochanteric fracture, equal to or greater than the predicate device.
Conclusions: The data presented in this submission show that the changes do not affect the safety and/or effectiveness of the subject devices and that the subject devices will perform in a substantially equivalent manner to the predicate devices.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for these devices to show substantial equivalence.