(138 days)
No
The device description and intended use focus solely on the mechanical components and surgical instrumentation for treating femoral fractures. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.
Yes
The device is an intramedullary nailing system used for the treatment of fractures and stabilization after tumor resection in the proximal femur, which are therapeutic interventions.
No
The device is an intramedullary nailing system used for the treatment of fractures and stabilization after tumor resection in the proximal femur, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly lists and describes physical implants (nails, screws) and instrumentation, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes the device as being used for the intramedullary treatment of fractures and stabilization after tumor resection in the proximal femur. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as a system of implants (nails, screws) and instrumentation used for surgical fixation of bones. This is consistent with a surgical device, not a diagnostic test performed on biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
Therefore, the I.T.S. Intramedullary Nailing System (INS) - Proximal Femur is a surgical implant/device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The indications for the I.T.S. Intramedullary Nailing System (INS) - Proximal Femur include intramedullary treatment of fractures and stabilization after tumor resection in the area of the proximal femur, as well as combinations that additionally affect the shaft area using the long nails.
The indications for use of the I.T.S. INS Proximal Femur include:
All Nails:
- · Stable and unstable pertrochanteric fractures
- · Intertrochanteric fractures
- · Combinations of fractures listed above
Additionally for Long Nails:
- Subtrochanteric fractures
- · Proximal fractures as listed above associated with shaft fractures
- · Pathological fractures in regions as listed above
- · Nonunions and malunions in regions as listed above
Product codes
HSB, HWC
Device Description
The I.T.S. INS Proximal Femur Nail consists of the following implants:
-
Nails: The Proximal Femur Nails are designed for the treatment of femoral fractures. The Femur Nails are available in distal diameters ranging from 9 to 14mm and lengths of 180mm (short nail), 240mm (intermediate nail), and 260 to 480mm in 20mm increments (long nail). 180mm and 240mm nails have a single, oblong hole distally, while all nails with a length over 260 have a round hole, an oblong hole and another round hole for distal fixation. The oblong hole allows for both static and dynamic locking configurations. All Trochanteric Nails are locked proximally with a Lag Screw. The set screw engages with the lag screw and allows translation while preventing rotation. Endcaps close the top of the nail and are available in 0mm, 5mm, 10mm, 15mm and 20mm lengths.
-
Lag Screw
Lag screws are cannulated with a major diameter of 10.5mm and lengths ranging from 70mm to 130mm in 5mm increments. They are available in titanium alloy (Ti-6Al-4V ELI) per ASTM F136. -
Set Screw
There are two types of set screws available. Inferior short and standard with a diameter of 6.6mm. The Length of the inferior short version is 45mm and the standard lengths are 70 to 130mm in 5mm increments. They are available in titanium alloy (Ti-6Al-4V ELI) per ASTM F136. -
Distal Cortical Locking Screw
Distal locking screws are fully threaded, with a diameter of 5.0mm and lengths ranging from 25mm to 120mm in 5mm increments (2.5mm increments available from 25-70mm). Thev are available in titanium alloy (Ti-6Al-4V ELI) per ASTM F136. -
Instrumentation
I.T.S. INS Proximal Femoral Nail Instrumentation consists of implant-specific targeting devices which help facilitate insertion of the nails, lag screws, and distal locking screws. Targeting devices are manufactured from stainless steel and carbon fibre reinforced PEEK. Other instrumentation includes drills, drill guides, k-wires and screwdrivers.
All nails and screws are provided Sterile for single-use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal femur, shaft area
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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
Clinical data was not required for this submission. The following non-clinical laboratory testing was performed to establishing equivalence to predicate, including:
- Fatigue Testing of the nail screw construct
- Performance testing following the consensus standards ASTM F543 & ASTM F1264
Testing demonstrated that the I.T.S. INS Proximal Femoral Nail is substantially equivalent in mechanical performance to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Stryker - Gamma3 System (K200869)
Reference Device(s)
Stryker - Gamma4 System (K213328), Smith & Nephew - Intertan (K040212), Synthes De Puy – Proximal Femoral Nail (K970097), Orthofix - Chimaera Hip Fracture System (K161466)
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
February 12, 2024
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services. To the right of the symbol, there is the FDA logo in blue, followed by the words "U.S. FOOD & DRUG" in a larger font and "ADMINISTRATION" in a smaller font below it, also in blue.
I.T.S. GmbH Florian Grill Head of Quality & Regulatory Affairs, Head of R&D Autal 28 Lassnitzhoehe, Styria 8301 Austria
Re: K233134
Trade/Device Name: I.T.S. INS Proximal Femur Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB, HWC Dated: January 11, 2024 Received: January 11, 2024
Dear Florian Grill:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Joseph P. Russell Digitally signed by Joseph P. Russell -S -2 Date: 2024.02.12 14:12:32 -05'00'
for: Farzana Sharmin, PhD Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K233134
Device Name I.T.S. INS Proximal Femur Nail
Indications for Use (Describe)
The indications for the I.T.S. Intramedullary Nailing System (INS) - Proximal Femur include intramedullary treatment of fractures and stabilization after tumor resection in the area of the proximal femur, as well as combinations that additionally affect the shaft area using the long nails.
The indications for use of the I.T.S. INS Proximal Femur include:
All Nails:
- · Stable and unstable pertrochanteric fractures
- · Intertrochanteric fractures
- · Combinations of fractures listed above
Additionally for Long Nails:
- Subtrochanteric fractures
- · Proximal fractures as listed above associated with shaft fractures
- · Pathological fractures in regions as listed above
- · Nonunions and malunions in regions as listed above
| 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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3
510(k) Submission I.T.S. GmbH I.T.S. INS Proximal Femur Nail
510(k) Summary
In Accordance with 21 CFR 807.92 of the Federal Code of Regulations 510(k) Summary
| NAME OF FIRM: | I.T.S. GmbH
Autal 28
Lassnitzhoehe, 8301
Austria
www.its-implant.com |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) FIRM CONTACT: | Jennifer Hadfield
Qserve Group US, Inc.
350 S Main Street, Suite 309
Doylestown, Pennsylvania, 18901, United States
Tel. No. 215-6003103
e-mail: jennifer.hadfield@qservegroup.com |
| TRADE NAME: | I.T.S. INS Proximal Femur Nail |
| DATE: | February 11, 2024 |
| COMMON NAME: | Rod, fixation, intramedullary and accessories
Screw, fixation, bone |
| REGULATORY CLASS: | Classification Name: Intramedullary Fixation Rod / Smooth or
threaded metallic bone fixation fastener |
| | Classification: 21 CFR 888.3020 / 888.3040 |
| | Device Class: Class II |
| DEVICE PRODUCT CODE: | HSB HWC |
| SUBSTANTIAL EQUIVALENCE: | |
| PRIMARY PREDICATE
REFERENCE DEVICES | Stryker - Gamma3 System (K200869)
Stryker - Gamma4 System (K213328)
Smith & Nephew - Intertan (K040212)
Synthes De Puy – Proximal Femoral Nail (K970097)
Orthofix - Chimaera Hip Fracture System (K161466) |
| DEVICE DESCRIPTION: | The I.T.S. INS Proximal Femur Nail consists of the following implants:
- Nails: |
| | The Proximal Femur Nails are designed for the treatment of femoral
fractures. The Femur Nails are available in distal diameters ranging
from 9 to 14mm and lengths of 180mm (short nail), 240mm
(intermediate nail), and 260 to 480mm in 20mm increments (long
nail). 180mm and 240mm nails have a single, oblong hole distally, |
while all nails with a length over 260 have a round hole, an oblong hole and another round hole for distal fixation. The oblong hole
4
510(k) Submission I.T.S. GmbH I.T.S. INS Proximal Femur Nail
allows for both static and dynamic locking configurations. All Trochanteric Nails are locked proximally with a Lag Screw. The set screw engages with the lag screw and allows translation while preventing rotation. Endcaps close the top of the nail and are available in 0mm, 5mm, 10mm, 15mm and 20mm lengths.
-
- Lag Screw
Lag screws are cannulated with a major diameter of 10.5mm and lengths ranging from 70mm to 130mm in 5mm increments. They are available in titanium alloy (Ti-6Al-4V ELI) per ASTM F136.
- Lag Screw
-
- Set Screw
There are two types of set screws available. Inferior short and standard with a diameter of 6.6mm. The Length of the inferior short version is 45mm and the standard lengths are 70 to 130mm in 5mm increments. They are available in titanium alloy (Ti-6Al-4V ELI) per ASTM F136.
- Set Screw
-
- Distal Cortical Locking Screw
Distal locking screws are fully threaded, with a diameter of 5.0mm and lengths ranging from 25mm to 120mm in 5mm increments (2.5mm increments available from 25-70mm). Thev are available in titanium alloy (Ti-6Al-4V ELI) per ASTM F136.
- Distal Cortical Locking Screw
-
- Instrumentation
I.T.S. INS Proximal Femoral Nail Instrumentation consists of implant-specific targeting devices which help facilitate insertion of the nails, lag screws, and distal locking screws. Targeting devices are manufactured from stainless steel and carbon fibre reinforced PEEK. Other instrumentation includes drills, drill guides, k-wires and screwdrivers.
- Instrumentation
All nails and screws are provided Sterile for single-use.
The indications for the I.T.S. Intramedullary Nailing System (INS) -INDICATION FOR USE: Proximal Femur include intramedullary treatment of fractures and stabilization after tumor resection in the area of the proximal femur, as well as combinations that additionally affect the shaft area using the long nails.
The indications for use of the I.T.S. INS Proximal Femur include: All Nails:
- · Stable and unstable pertrochanteric fractures
- Intertrochanteric fractures
- · Combinations of fractures listed above
Additionally for Long Nails:
- · Subtrochanteric fractures
- · Proximal fractures as listed above associated with shaft fractures
- · Pathological fractures in regions as listed above
- · Nonunions and malunions in regions as listed above
5
| CLINICAL TESTING: | Clinical data was not required for this submission. |
|---|---|
| NON-CLINICAL TESTING: | The following non-clinical laboratory testing was performed to |
| establishing equivalence to predicate, including: | |
| • Fatigue Testing of the nail screw construct | |
| • Performance testing following the consensus standards ASTM F543 | |
| & ASTM F1264 | |
| Testing demonstrated that the I.T.S. INS Proximal Femoral Nail is | |
| substantially equivalent in mechanical performance to the predicate | |
| device. | |
| SUMMARY OF | |
| TECHNOLOGICAL | |
| CHARACTERISTICS: | The I.T.S.INS Proximal Femur Nail is substantially equivalent |
| in material, geometry, design, indications and operational principles to | |
| the predicate systems legally marketed in the US listed above. | |
| CONCLUSIONS: | Based on the similarity in material, geometry, design, indications and |
| operational principles, as well as both the Engineering Analysis and | |
| Performance Testing, the I.T.S. INS Proximal Femur Nail has been | |
| demonstrated to be substantially equivalent (SE) to the predicate | |
| devices. |