(56 days)
No
The device description and performance studies focus on the mechanical properties, biocompatibility, and sterilization of bone plates and screws, with no mention of AI or ML capabilities.
Yes.
This device is intended to treat fractures ("treat fractures, nonunions of the proximal tibia") which is a therapeutic purpose.
No
This device, the AFFINITY Proximal Tibia System, is intended to treat fractures and nonunions of the proximal tibia, which is a therapeutic function, not a diagnostic one. It consists of plates and screws used for fixation and restoration of bones.
No
The device description explicitly states it consists of "anatomical plates and screws" made from titanium, which are physical hardware components, not software. The performance studies also focus on mechanical and material properties of these hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for treating fractures and nonunions of the proximal tibia. This is a surgical intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The description details anatomical plates and screws made of biocompatible materials for bone fixation. This is consistent with a surgical implant, not a diagnostic device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
- Performance Studies: The performance studies focus on mechanical properties (bend, torsion, pullout strength), biocompatibility, and sterilization, which are relevant for surgical implants, not IVDs.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. The AFFINITY Proximal Tibia System is a surgical device used to physically fix bone fractures.
N/A
Intended Use / Indications for Use
AFFINITY Proximal Tibia System is intended to treat fractures, nonunions of the proximal tibia including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic, and fractures with associated shaft fractures.
- Simple metaphyseal fractures (Classification AO 41-A2) ●
- Multifragmentary metaphyseal fractures (Classification AO 41-A3)
- Simple bicondylar fractures (Classification A041-C1, 41-C2)
- Multifragmentary bicondylar fractures (Classification AO 41-C3) ●
- Simple joint, simple metaphyseal fractures (Classification AO 41-C1)
- . Diaphisary fractures (Classification AO 42A and 42B)
Product codes
HRS, HWC
Device Description
AFFINITY Proximal Tibia System consists of anatomical plates and screws for the placement of the proximal tibial condyles, improving the restoration of the original structure. Similarly, in combination with the variable angle technique, it allows for the placement of screws in different configurations providing appropriate support for the correct healing of fractures.
The AFFINITY Proximal Tibia System consists of pre-contoured bone fixation plates and screws. The plates are made from biocompatible commercially pure titanium grade 4 according to ISO 5832-2 and ASTM F67 standard. The screws are made from biocompatible titanium alloy (Ti6Al4V) according to ISO 5832-3 and ASTM F136 standard.
The AFFINITY Proximal Tibia System plates can be fixed with variable angle technique.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal tibia
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 testing was conducted.
- Static and fatigue four-point bend testing following ASTM F382-17 Standard.
- Torsion strength, insertion torque, and pullout strength testing following ASTM F543-17 Standard.
- Fretting corrosion testing following ASTM F897-02 Standard.
- Biocompatibility testing following ISO 10993-1:2018 and FDA Guidance.
- Sterilization validation following ISO 17665-1, AAMI TIR12, ISO TIR17665-2, and ISO 14937 to a sterility Assurance Level (SAL) of 10-6.
Clinical testing was not necessary for the substantial equivalence determination.
Key results:
- Mechanical testing was performed using FDA consensus standards and laboratory test methods and compared to the predicate device and scientific literature.
- Biocompatibility was demonstrated as per FDA consensus standards.
- Sterilization was demonstrated as per FDA consensus standards and all test method acceptance criteria were met.
Key Metrics
Not Found
Predicate Device(s)
K132554, K171808, K191641, K203282, K043185, K123964
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
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March 21, 2022
Techfit Digital Surgery INC. Leidy Johanna Toro-Gonzalez Regulatory Affairs Specialist 1511 Aviation Center Pkwy. Suite 220H Daytona Beach, Florida 32114
Re: K220199
Trade/Device Name: AFFINITY Proximal Tibia System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: January 19, 2022 Received: January 24, 2022
Dear Leidy Johanna Toro-Gonzalez:
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.
1
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) 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 medical devices and radiation-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.
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma 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) K220199
Device Name AFFINITY Proximal Tibia System
Indications for Use (Describe)
AFFINITY Proximal Tibia System is intended to treat fractures, nonunions of the proximal tibia including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic, and fractures with associated shaft fractures.
- · Simple metaphyseal fractures (Classification AO 41-A2)
- · Multifragmentary metaphyseal fractures (Classification AO 41-A3)
- · Simple bicondylar fractures (Classification AO41-C1, 41-C2)
- Multifragmentary bicondylar fractures (Classification AO 41-C3)
- · Simple joint, simple metaphyseal fractures (Classification AO 41-C1)
- · Diaphisary fractures (Classification AO 42A and 42B)
| 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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3
K220199 510(k) Summary 21 CFR 807.92
Submitter information
| Company name | Techfit Digital Surgery INC. |
|---|---|
| Establishment registration number | 3016560308 |
| Street Address | 1511 Aviation Center Pkwy, Suite 220H |
| City | Daytona Beach, Florida |
| Zip code | FL 32114 |
| Country | United States |
| Phone number | (605) 517-0321 |
| Principal contact person | Leidy Johanna Toro-González |
| Contact title | Regulatory Affairs Specialist |
| Contact e-mail address | leidy.toro@imsampedro.com |
| Additional contact person | Liliana Zuluaga Idárraga |
| Contact title | Technical Director |
| Contact e-mail address | liliana.zuluaga@imsampedro.com |
Submission date
The submission date of this Traditional 510(k) submission is the 19th of January 2022.
Submission information
| Trade name | AFFINITY Proximal Tibia System |
|---|---|
| Common or Usual name | Plate, Fixation, Bone |
| Classification name | 21 CFR 888.3030 Single/multiple component metallic bone fixation |
| appliances and accessories (Primary) | |
| 21 CFR 888.3040 Smooth or threaded metallic bone fixation fastener | |
| Product code (classification regulation) | HRS/HWC |
| Classification Panel | Orthopedic |
| Device class | Class II |
Primary Predicate device
The predicate device to which substantial equivalence is claimed to:
| Predicate device: | |
|---|---|
| Trade or proprietary or model name | aap LOQTEQ® Proximal Tibia Plate 3.5 System |
| 510(k) number | K132554 |
| Decision date | 10/03/2013 |
| Product code | HRS |
| Manufacturer | AAP Implantate AG |
| Review Panel | Orthopedic |
Additional Predicate device 1
| Trade or proprietary or model name | TDM Plate and Screw System |
|---|---|
| 510(k) number | K171808 |
| Decision date | 03/15/2018 |
| Product code | HRS, HWC |
| Manufacturer | TDM Co. Ltd. |
| Review Panel | Orthopedic |
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Additional Predicate device 2
| Trade or proprietary or model name | AFFINITY – Variable Angle Distal Radius System |
|---|---|
| 510(k) number | K191641 |
| Decision date | 09/16/2019 |
| Product code | HRS, HWC |
| Manufacturer | Industrias Médicas Sampedro S.A.S |
| Review Panel | Orthopedic |
Additional Predicate device 3
| Trade or proprietary or model name | TECHFIT Patient-Specific Maxillofacial System |
|---|---|
| 510(k) number | K203282 |
| Decision date | 05/19/2021 |
| Product code | JEY |
| Manufacturer | Industrias Médicas Sampedro S.A.S |
| Review Panel | Dental |
Additional Predicate device 4
| Trade or proprietary or model name | SYNTHES 3.5mm Cortex Screws |
|---|---|
| 510(k) number | K043185 |
| Decision date | 02/03/2005 |
| Product code | HWC |
| Manufacturer | SYNTHES (USA) |
| Review Panel | Orthopedic |
Additional Predicate device 5
| Trade or proprietary or model name | AXSOS 3 TI Locking Plate System |
|---|---|
| 510(k) number | K123964 |
| Decision date | 03/28/2013 |
| Product code | HRS |
| Manufacturer | Stryker Trauma AG |
| Review Panel | Orthopedic |
Device Description
AFFINITY Proximal Tibia System consists of anatomical plates and screws for the placement of the proximal tibial condyles, improving the restoration of the original structure. Similarly, in combination with the variable angle technique, it allows for the placement of screws in different configurations providing appropriate support for the correct healing of fractures.
AFFINITY Proximal Tibia System consists of pre-contoured bone fixation plates and screws. The plates are made from biocompatible commercially pure titanium grade 4 according to ISO 5832-2 and ASTM F67 standard. The screws are made from biocompatible titanium alloy (Ti6Al4V) according to ISO 5832-3 and ASTM F136 standard.
The AFFINITY Proximal Tibia System plates can be fixed with variable angle technique.
5
Indications for use
AFFINITY Proximal Tibia System is intended to treat fractures, nonunions of the proximal tibia including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic, and fractures with associated shaft fractures.
- Simple metaphyseal fractures (Classification AO 41-A2) ●
- Multifragmentary metaphyseal fractures (Classification AO 41-A3)
- Simple bicondylar fractures (Classification A041-C1, 41-C2)
- Multifragmentary bicondylar fractures (Classification AO 41-C3) ●
- Simple joint, simple metaphyseal fractures (Classification AO 41-C1)
- . Diaphisary fractures (Classification AO 42A and 42B)
Comparison to the predicate devices
The predicate devices AFFINITY - Variable Angle Distal Radius System (K191641) and TECHFIT Patient-Specific Maxillofacial System (K203182) plates and screws are manufactured in the same materials and using similar manufacturing methods. Also, the AFFINITY - Variable Angle Distal Radius System (K191641) uses the same variable angle technology to subject device.
Both The AFFINITY – Variable Angle Distal Radius System (K191641) and TECHFIT Patient-Specific Maxillofacial System (K203182), were selected as predicate devices to support the fretting corrosion test, the biological tests, the packing test, and chemical characterization tests. The fretting corrosion test, the biological tests, and the chemical characterization tests do not depend on the system's shape but on the type of materials that enter in contact, manufacturing materials, and manufacturing methods.
The TDM Plate and Screw System (K171808) was selected as a predicate device solely for the side-by-side mechanical performance testing with the AFFINITY Proximal Tibia System, according to ASTM F382 "Standard Specification and Test Method for Metallic Bone Plates". Since the TDM Plate and Screw System has the same intended use and manufacturing material, and similar plate design to the subject device. The TDM Plate and Screw System plates dimensions are comparable to the subject device. Both plate thickness and length of this predicate device fall within the range of the subject device.
Predicate devices screws' design share the locking and cortical screws design feature with the subject device. Both The Synthes 3.5 mm Cortex Screws (K043185) and AXSOS 3 TI Locking Plate System (K123964) have longer screws than the subject device. The AFFINITY Proximal Tibia System screws diameters fall within the Synthes 3.5 mm Cortex Screws and AXSOS 3 TI Locking Plate System diameter range as also the lengths from 10mm to 95 mm. and these were selected as predicate devices solely for the side-by-side mechanical performance testing with the AFFINITY Proximal Tibia System, according to ASTM F543 "Standard Specification and Test Methods for Metallic Medical Bone Screws".
The TDM Plate and Screw System (K171808), AFFINITY - Variable Angle Distal Radius System (K191641), TECHFIT Patient-Specific Maxillofacial System (K203182), The Synthes 3.5 mm Cortex Screws (K043185), and AXSOS 3 TI Locking Plate System (K123964) are comparable to the AFFINITY Proximal Tibia System.
6
Performance Testing – Non-clinical
- Static and fatique four-point bend testing. Static and fatigue four-point bend tests were performed following the Standard Specification and Test Method for Metallic Bone Plates, indicated in ASTM F382-17 Standard.
- Torsion strength, insertion torque, and pullout strength testing. Torsion strength, insertion torque, and pullout strength tests were performed following the Standard Specification and Test Methods for Metallic Medical Bone Screws, indicated in ASTM F543-17 Standard.
- Fretting corrosion testinq
The fretting corrosion testing was performed following the Standard Test Method for Measuring Fretting Corrosion, indicated in ASTM F897-02 Standard.
-
Biocompatibility.
For the assessment of biological endpoints, the procedures and provisions of ISO 10993-1:2018 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process", as well as FDA Guidance "Use of International Standard ISO 10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process", dated 04 September 2020, were applied. -
. Sterilization.
Sterilization validation was conducted in accordance with international standard ISO 17665-1, AAMI TIR12, ISO TIR17665-2 and ISO 14937 to a sterility Assurance Level (SAL) of 10-°.
Performance Testing - Clinical
Clinical testing was not necessary for the substantial equivalence determination.
Substantial Equivalence Conclusion
Based on the indications for use, technological characteristics, performance testing, and comparison to predicate devices, the AFFINITY Proximal Tibia System shows to be substantially equivalent to the predicate devices.
- Mechanical testing was performed using FDA consensus standards and laboratory test methods and compared to the predicate device and scientific literature.
- Biocompatibility was demonstrated as per FDA consensus standards.
- Sterilization was demonstrated as per FDA consensus standards and all test method acceptance criteria were met.