(90 days)
Not Found
No
The summary describes a mechanical bone fixation device made of degradable polymers. There is no mention of software, algorithms, image processing, or any other components typically associated with AI/ML in medical devices. The performance studies focus on mechanical properties and degradation, not algorithmic performance.
Yes
The device is intended for the "maintenance of alignment and fixation of bone fractures, comminuted fractures, osteotomies, arthrodeses or bone grafts or allografts," which directly addresses a disease or condition (fractures, etc.) and restores a physiological function (bone alignment and fixation).
No
The device is a medical implant (screws) used for the maintenance of alignment and fixation of bone fractures, osteotomies, and arthrodeses, not for diagnosing conditions. Its intended use focuses on treatment and support during healing, not on identifying diseases or conditions.
No
The device description clearly states that the Inion CompressOn™ Screws are physical implants made of degradable co-polymers. The summary also describes mechanical testing and degradation testing of these physical screws. There is no mention of any software component.
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 Inion CompressOn™ products are for the "maintenance of alignment and fixation of bone fractures, comminuted fractures, osteotomies, arthrodeses or bone grafts or allografts". This describes a surgical implant used directly on the patient's body for structural support and healing.
- Device Description: The device is described as "cannulated headless compression screws made of degradable co-polymers". This is a physical implant designed to be inserted into bone.
- 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 treatment. IVDs are typically used in a laboratory or point-of-care setting to analyze biological samples.
The Inion CompressOn™ is a surgical implant used for orthopedic fixation.
N/A
Intended Use / Indications for Use
The Inion CompressOn™ products are intended for maintenance of alignment and fixation of bone fractures, comminuted fractures, osteotomies, arthrodeses or bone grafts (i.e., autografts or allografts) in the presence of appropriate additional immobilization (e.g., rigid fixation implants, cast or brace).
In addition, the Inion CompressOn™ Ø 3.5/4.0/4.5/5.0/6.0 mm products are specifically intended for use in following indications:
A. General indication: maintenance of reduction and fixation of cancellous bone fractures, osteotomies or arthrodeses of the upper extremity, ankle and foot in the presence of appropriate brace and/or immobilization.
B. Specific indications: fractures and osteotomies of the malleoli, and ankle fractures.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
Inion CompressOn™ Screws are cannulated headless compression screws made of degradable co-polymers composed of L-lactic acid and D-lactic acid. These polymers have a long history of safe medical use and they degrade in vivo by hydrolysis into alpha-hydroxy acids that are metabolised by the body. The implants retain sufficient strength to fulfil their intended function during the healing period of the fracture or osteotomy, and degrade gradually thereafter. Bioresorption takes place within two to four years. The implants are provided sterile to the user and are not to be re-used or re-sterilized.
Inion CompressOn™ Screws have nominal dimensions ranging from 2.7-6.0 mm in diameter and 12-90 mm in length. They are designed to be inserted using Inion® instrumentation: drill bits, bone taps, drill taps, screwdriver shafts, drill sleeves, K-wires and depth gauges. The screws can be inserted over a guide wire.
Inion CompressOn™ Screws provide fixation and are not intended to replace healthy bone or withstand the stress of full load bearing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper extremity, ankle and foot
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical torsion testing was conducted to determine and verify the sufficient mechanical properties of the Inion CompressOn™ screws for insertion. A mechanical pull-out test was conducted to verify that the pull-out properties of Inion CompressOn™ Screw are substantially equivalent with the predicate device Inion FreedomScrew™. The mechanical tests were conducted according to FDA recognized consensus standard ASTM F2502-11 Standard specification and test methods for absorbable plates and screws for internal fixation implants. In vitro degradation test was conducted in accordance with FDA recognized consensus standards ISO 13781:2017 Implants for surgery - Homopolymers, copolymers and blends on poly(lactide) - In vitro degradation testing and ASTM F1635-16 Standard Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants, to verify that the degradation rate and pull-out properties of Inion CompressOn™ Screw are substantially equivalent with the predicate device Inion FreedomScrew™M initially and over the healing period. The choice of test material was done in accordance with FDA recognized consensus standard ASTM F1839-08 (Re-approved 2016) Standard specification for rigid polyurethane foam for use as a standard material for testing orthopaedic devices and instruments.
Functional and handling test and simulated clinical use test were performed to verify that the implants, accessory instruments, packaging and instructions for use are functioning together as intended, and conform to the defined user needs and intended uses.
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.
Inion FreedomScrew™ (K123672)
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
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
January 13, 2021
Image /page/0/Picture/1 description: The image shows the logo for 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 is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Inion Oy Kati Marttinen VGM Quality and Regulatory Laakarinkatu 2 Tampere. 33520 Finland
Re: K203105
Trade/Device Name: Inion CompressOn Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: October 9, 2020 Received: October 15, 2020
Dear Kati Marttinen:
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
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; Shumaya Ali, MPH 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) K203105
Device Name Inion CompressOn™ Screw
Indications for Use (Describe)
The Inion CompressOn™ products are intended for maintenance of alignment and fixation of bone fractures, comminuted fractures, osteotomies, arthrodeses or bone grafts or allografts) in the presence of appropriate additional immobilization (e.g., rigid fixation implants, cast or brace).
In addition, the Inion CompressOn™ Ø 3.5/4.0/4.5/5.0/6.0 mm products are specifically intended for use in following indications:
A. General indication: maintenance of reduction of cancellous bone fractures, osteotomies or arthrodeses of the upper extremity, ankle and foot in the presence of appropriate brace and/or immobilization.
B. Specific indications: fractures and osteotomies of the malleoli, and ankle 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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3
510(k) SUMMARY Inion CompressOn™ Screw
| Manufacturer and submitter: | Inion Oy,
Lääkärinkatu 2,
FIN-33520 Tampere, FINLAND |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Date: | December 11, 2020 |
| Contact person | Kati Marttinen, VGM Quality and Regulatory
Phone: +358 10 830 6600
Fax: +358 10 830 6691
kati.marttinen@inion.com |
| Establishment registration
number | 9710629 |
| Trade name of the device | Inion CompressOn™ Screw |
| Device classification and
product code | Class II
Classification Panel: Orthopaedic
Product Code: HWC
Common name: Bone fixation screw
Regulation number: 888.3040 |
| Predicate device | Inion FreedomScrew™ (K123672) |
| Conformance with performance
standards | Compliance to voluntary consensus standards is
listed in the application. |
Device description and principles of operation
Inion CompressOn™ Screws are cannulated headless compression screws made of degradable co-polymers composed of L-lactic acid and D-lactic acid. These polymers have a long history of safe medical use and they degrade in vivo by hydrolysis into alpha-hydroxy acids that are metabolised by the body. The implants retain sufficient strength to fulfil their intended function during the healing period of the fracture or osteotomy, and degrade gradually thereafter. Bioresorption takes place within two to four years. The implants are provided sterile to the user and are not to be re-used or re-sterilized.
Inion CompressOn™ Screws have nominal dimensions ranging from 2.7-6.0 mm in diameter and 12-90 mm in length. They are designed to be inserted using Inion® instrumentation: drill bits, bone taps, drill taps, screwdriver shafts, drill sleeves, K-wires and depth gauges. The screws can be inserted over a guide wire.
Inion CompressOn™ Screws provide fixation and are not intended to replace healthy bone or withstand the stress of full load bearing.
4
510(k) SUMMARY Inion CompressOn™ Screw
Indications for use
The Inion CompressOn™ products are intended for maintenance of alignment and fixation of bone fractures, comminuted fractures, osteotomies, arthrodeses or bone grafts (i.e., autografts or allografts) in the presence of appropriate additional immobilization (e.g., rigid fixation implants, cast or brace).
In addition, the Inion CompressOn™ Ø 3.5/4.0/4.5/5.0/6.0 mm products are specifically intended for use in following indications:
A. General indication: maintenance of reduction and fixation of cancellous bone fractures, osteotomies or arthrodeses of the upper extremity, ankle and foot in the presence of appropriate brace and/or immobilization.
B. Specific indications: fractures and osteotomies of the malleoli, and ankle fractures.
Comparison with predicate device
The Inion CompressOn™ Screws have the same material composition, manufacturing method and indications for use as the predicate device. The differences compared to the predicate device are:
- Inion CompressOn™ Screws include larger diameter designs (5.0/6.0 mm) -
- -Inion CompressOn™ Screws are headless to reduce the risk of palpability/irritation
- Inion CompressOn™ Screws provide compression to the fracture/osteotomy line -
- Inion CompressOn™ Screws do not include a disposable insertion adapter -
- Inion CompressOn™ Screws are not intended for plate fixation. -
Performance testing for substantial equivalence determination
Mechanical torsion testing was conducted to determine and verify the sufficient mechanical properties of the Inion CompressOn™ screws for insertion. A mechanical pull-out test was conducted to verify that the pull-out properties of Inion CompressOn™ Screw are substantially equivalent with the predicate device Inion FreedomScrew™. The mechanical tests were conducted according to FDA recognized consensus standard ASTM F2502-11 Standard specification and test methods for absorbable plates and screws for internal fixation implants. In vitro degradation test was conducted in accordance with FDA recognized consensus standards ISO 13781:2017 Implants for surgery - Homopolymers, copolymers and blends on poly(lactide) - In vitro degradation testing and ASTM F1635-16 Standard Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants, to verify that the degradation rate and pull-out properties of Inion CompressOn™ Screw are substantially equivalent with the predicate device Inion FreedomScrew™M initially and over the healing period. The choice of test material was done in accordance with FDA recognized consensus standard ASTM F1839-08 (Re-approved 2016) Standard specification for rigid polyurethane foam for use as a standard material for testing orthopaedic devices and instruments.
Functional and handling test and simulated clinical use test were performed to verify that the implants, accessory instruments, packaging and instructions for use are functioning together as intended, and conform to the defined user needs and intended uses.
5
510(k) SUMMARY Inion CompressOn™ Screw
Conclusions
The data demonstrates that the intended use, material composition and scientific technology, degradation profile and mechanical properties of Inion CompressOn™ Screws are substantially equivalent with the predicate device Inion FreedomScrew™ (K123672). The devices have passed the tests for functionality and handling in simulated clinical use settings.