(253 days)
Not Found
No
The device description and intended use focus solely on the mechanical components and surgical application of the intramedullary nail system. There is no mention of any software, algorithms, or data processing capabilities that would suggest the use of AI or ML.
Yes
The device is a system of intramedullary nails and accompanying instrumentation designed for fracture fixation and stabilization of the femur, which is a therapeutic purpose.
No
The device is a surgical implant designed for the fixation of fractures in the femur, not for diagnosing medical conditions.
No
The device description clearly states it consists of "intramedullary nails and their accompanying instrumentation" and lists specific hardware components like "Nail, Lag Screw, Secondary Screw, Lag Cap, Locking Screws, Set Screws, and Nail End Cap." This indicates a physical medical device, not a software-only one.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The Progen™ Trochanteric Nail System is described as an intramedullary nail system used for the fixation and stabilization of bone fractures in the femur. This is a surgical implant, not a device that analyzes biological samples.
- Intended Use: The intended use clearly states the device is for the fixation of various types of femoral fractures. This is a therapeutic intervention, not a diagnostic test.
The information provided about the device's materials, components, and testing (sterilization, shelf life, biocompatibility, mechanical testing) further supports that it is a surgical implant and not an IVD.
N/A
Intended Use / Indications for Use
The Progen™ short trochanteric nail is indicated for fixation of various types of stable and unstable neck, intertrochanteric, and peritrochanteric fractures.
The Progen™ long trochanteric nail is intended for fixation of stable femoral fractures occurring from the base of the femoral neck extending distally to a point approximal to the intercondylar notch including fractures of the basilar neck, intertrochanteric fractures, subtrochanteric fracture, femoral shaft fractures, pathological fractures, impending pathological fractures, tumor resection, nonunion, and revisions.
Product codes (comma separated list FDA assigned to the subject device)
HSB, JDS
Device Description
The Progen™ Trochanteric Nail System consists of temporary fixation intramedullary nails and their accompanying instrumentation designed for fracture fixation and stabilization of the femur. The implants are available in various lengths and diameters to accommodate a range of patient anatomy. Each of the intramedullary nails is secured by a sequence of screws that transect through holes in the proximal and distal sections of each nail.
The Progen™ Trochanteric Nail System consists of single-use intramedullary nails for stable and unstable neck, intertrochanteric, pertrochanteric, and subtrochanteric fractures and combinations of these fractures. The system consists of Nail, Lag Screw, Secondary Screw, Lag Cap, Locking Screws, Set Screws, and Nail End Cap. The nails and accompanying components are manufactured from titanium alloy (Ti-6Al-4V ELI). Additionally, the Nails and Lag Screws have a Type II anodized surface treatments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femur
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Sterilization: Validated to a sterility assurance level of 10^6 in accordance with ISO 11137-1:2006, Am1:2013 and ISO 11137-2:2013. Results comply with standards.
Shelf Life: Packaging validated in accordance with ISO 11607-1:2006 and ISO 11607-2:2006. Results comply with standards.
Biocompatibility: Contact materials verified in accordance with ISO 10993-1:2009. Results comply with standards.
Mechanical Testing:
- Full construct fatigue cantilever loading test per ASTM F384:2017
- Full construct static cantilever loading test per ASTM F384:2017
- Bone screw axial pullout strength test per ASTM F543:2017
- Bone screw driving torque per ASTM F543:2017
- Bone screw torsional properties test per ASTM F543:2017
- Static Four-Point bend test per ASTM F1264:2016(e1)
- Bending Fatigue test per ASTM F1264:2016(e1)
- Static Torsional Stiffness Test ASTM F1264:2016(e1)
Clinical Testing: None provided for basis of substantial equivalence.
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.
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
§ 888.3020 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.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services - USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The FDA logo is a recognizable symbol of the agency's role in regulating and overseeing food and drug products in the United States.
Ortho Development® Corporation Drew Weaver Director of Regulatory Affairs 12187 South Business Park Drive Draper, Utah 84020
Re: K211086
Trade/Device Name: The Progen™ Trochanteric Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB, JDS Dated: November 23, 2021 Received: November 24, 2021
Dear Drew Weaver:
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. 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 located 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.
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
December 21, 2021
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; 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 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,
For Jiping Chen, Ph.D., M.P.H. Acting Division 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
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Indications for Use
510(k) Number (if known) K211086
Device Name The Progen™ Trochanteric Nail System
Indications for Use (Describe)
The Progen™ short trochanteric nail is indicated for fixation of various types of stable and unstable neck, intertrochanteric, and peritrochanteric fractures.
The Progen™ long trochanteric nail is intended for fixation of stable femoral fractures occurring from the base of the femoral neck extending distally to a point approximal to the intercondylar notch including fractures of the basilar neck, intertrochanteric fractures, subtrochanteric fracture, femoral shaft fractures, pathological fractures, impending pathological fractures, tumor resection, nonunion, and revisions.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image shows the text "K211086 Page 1 of 4" at the top. Below the text is a logo for Ortho Development. The logo features a stylized purple circle with curved lines emanating from the left side, followed by the word "ORTHO" in bold, purple letters. Underneath "ORTHO" is the word "DEVELOPMENT" in a smaller, lighter font.
510(k) Summary
In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR §807.92, the following summary of information is provided:
| Name of the Sponsor: | Ortho Development® Corporation |
|---|---|
| 12187 South Business Park Drive | |
| Draper, Utah 84020 | |
| 510(k) Primary Contact: | Name: Drew Weaver |
| Position: Director of Regulatory and Clinical Affairs | |
| Telephone: (801) 619-3419 | |
| Email: dweaver@orthodevelopment.com | |
| 510(k) Secondary Contact: | Name: Stan Despres |
| Position: V.P. Product Development | |
| Telephone: (801) 376-6231 | |
| Email: stan@orthodevelopment.com | |
| Date Prepared: | December 14, 2021 |
| Submission Type: | Traditional 510(k) |
| Proprietary Name: | The Progen™ Trochanteric Nail System |
| Common Name: | Intramedullary fixation rod and accessories |
| Classification: | 21 CFR 888.3020 |
| Device Class: | Class II |
| Device Product Code: | HSB, JDS |
| Primary Predicate Device: | Gamma3® Nail System (K043431) |
| Secondary Predicate Device: | TriGen InterTAN (K040212) |
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Image /page/4/Picture/1 description: The image shows the text "K211086 Page 2 of 4" at the top. Below the text is a logo for "ORTHO DEVELOPMENT". The logo consists of a purple circle with three curved lines emanating from the left side, followed by the word "ORTHO" in large purple letters and the word "DEVELOPMENT" in smaller letters below.
5.1 Device Description:
The Progen™ Trochanteric Nail System consists of temporary fixation intramedullary nails and their accompanying instrumentation designed for fracture fixation and stabilization of the femur. The implants are available in various lengths and diameters to accommodate a range of patient anatomy. Each of the intramedullary nails is secured by a sequence of screws that transect through holes in the proximal and distal sections of each nail.
The Progen™ Trochanteric Nail System consists of single-use intramedullary nails for stable and unstable neck, intertrochanteric, pertrochanteric, and subtrochanteric fractures and combinations of these fractures. The system consists of Nail, Lag Screw, Secondary Screw, Lag Cap, Locking Screws, Set Screws, and Nail End Cap. The nails and accompanying components are manufactured from titanium alloy (Ti-6Al-4V ELI). Additionally, the Nails and Lag Screws have a Type II anodized surface treatments.
5.2 Indication for Use:
The Progen™ short trochanteric nail is indicated for fixation of various types of stable and unstable neck, intertrochanteric, and peritrochanteric fractures.
The Progen™ long trochanteric nail is intended for fixation of stable and unstable femoral fractures occurring from the base of the femoral neck extending distally to a point approximately 10cm proximal to the intercondylar notch including fractures of the basilar neck, intertrochanteric fractures, peritrochanteric fractures, subtrochanteric fracture, femoral shaft fractures, pathological fractures, impending pathological fractures, tumor resection, nonunion, malunion, and revisions.
5.3 Comparison of Technological Characteristic:
The Progen™ Trochanteric Nail System is technologically similar to the already cleared predicate device Gamma3® Nail System (K043431) and TriGen InterTAN (K040212) in terms of indication for use/ intended use, technological characteristics, basic design, device material, mechanical performance and principle of operation.
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Image /page/5/Picture/1 description: The image shows the text "K211086 Page 3 of 4" at the top. Below the text is a logo for a company called "ORTHO DEVELOPMENT". The logo features a stylized purple circle with curved lines emanating from it, followed by the company name in a bold, sans-serif font.
5.4 Performance Data:
Sterilization
The Progen™ Trochanteric Nail System is gamma radiation sterilized and was validated to a sterility assurance level of 106 in accordance with the following standards:
- ISO 11137-1:2006, Am1:2013, Sterilization of health care products Requirements . for validation and routine control - Radiation sterilization; and
- . ISO 11137-2:2013, Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose.
Validation results indicate that the Progen™ Trochanteric Nail System complies with the standards.
Shelf Life
The packaging of The Progen™ Trochanteric Nail System was validated in accordance with the following standards:
- . ISO 11607-1:2006 Packaging for terminally sterilized medical devices - Part 1: requirements for materials, sterile barrier systems and packaging systems; and
- . ISO 11607-2:2006 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes.
Validation results indicate that the packaging for the Progen™ Trochanteric Nail System complies with the standards.
Biocompatibility
The Progen™ Trochanteric Nail System contact materials were verified in accordance with the following standards:
- . ISO 10993-1:2009, Biological evaluation of medical device – Part 1: Evaluation and testing within a risk management process.
Validation results indicate that the biological evaluation complies with the standard.
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Image /page/6/Picture/1 description: The image shows the text "K211086 Page 4 of 4" at the top, followed by a logo for "ORTHO DEVELOPMENT". The logo features a stylized purple circle with curved lines emanating from it, followed by the word "ORTHO" in bold purple letters. Below "ORTHO" is the word "DEVELOPMENT" in smaller, lighter letters with a trademark symbol.
Mechanical Testing
The following mechanical testing were performed on The Progen™ Trochanteric Nail System
- . Full construct fatigue cantilever loading test per ASTM F384:2017
- . Full construct static cantilever loading test per ASTM F384:2017
- . Bone screw axial pullout strength test per ASTM F543:2017
- Bone screw driving torque per ASTM F543:2017
- Bone screw torsional properties test per ASTM F543:2017
- Static Four-Point bend test per ASTM F1264:2016(e1)
- Bending Fatigue test per ASTM F1264:2016(e1)
- . Static Torsional Stiffness Test ASTM F1264:2016(e1)
Clinical Testing
None provided for basis of substantial equivalence.
5.5 Substantial Equivalence Conclusion:
Verification and Validation activities were conducted to establish the performance of The Progen™ Trochanteric Nail System. The results of these activities demonstrate that The Progen™ Trochanteric Nail System is as safe, as effective, and performs as well as legally marketed predicates.
Bases on similarities in indication for use/intended use, technological characteristic, basic design, device material, and principle of operation, The Progen™ Trochanteric Nail System is considered substantially equivalent to the previously cleared predicate devices.