K Number
K133932
Device Name
INION FREEDOMPIN
Manufacturer
Date Cleared
2014-04-11

(109 days)

Product Code
Regulation Number
888.3040
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The INION FreedomPin™ products are indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace).
Device Description
The Inion FreedomPin™ products are intended to maintain accurate alignment of fragments of fractured bone in the presence of appropriate immobilization. The INION FreedomPin™ products are 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 pins are dyed green for better visualization during the surgical procedure by a minimal amount of Drug and Cosmetic (D&C) Green No. 6, which is used in several biodegradable sutures and implants. Inion FreedomPins have nominal dimensions ranging from 1.5 - 3.2 mm in diameter and 30 - 70 mm in length. In addition, sterile Pin Kits are offered which contain 2-3 pins and the required sterile, single use instruments needed for the insertion. 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 resterilized. Inion FreedomPins provide fixation and are not intended to replace healthy bone or withstand the stress of full load bearing. Inion FreedomPins are designed to be used with customized instrumentation consisting of drill bits. K-wires, applicators. and arthroscopic pistons and tips.
More Information

No
The device description focuses on the material properties and mechanical function of a biodegradable bone pin. There is no mention of AI or ML in the intended use, device description, or performance studies.

Yes
The device is indicated for "maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts," which directly addresses a disease or condition (bone fractures, osteotomies) and is intended to restore structure and function, fitting the definition of a therapeutic device.

No

This device is described as an implantable pin intended for maintaining alignment and fixation of bone fractures, osteotomies, arthrodeses, or bone grafts. Its function is to provide mechanical support, not to diagnose a condition.

No

The device description clearly states that the device is a physical pin made of degradable co-polymers and includes physical instruments for insertion. It is a hardware device, not software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for "maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts." This is a therapeutic and structural function within the body.
  • Device Description: The device is a physical implant (pin) made of degradable polymers, designed to provide mechanical support to bone.
  • Lack of In Vitro Diagnostic Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening.

IVD devices are used to perform tests on samples taken from the body to provide information about a person's health status. This device is a surgical implant used to physically stabilize bone.

N/A

Intended Use / Indications for Use

The Inion FreedomPin™ products are intended to maintain accurate alignment of fragments of fractured bone in the presence of appropriate immobilization.

The Inion FreedomPin™ products are indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace).

Product codes

HTY

Device Description

The Inion FreedomPin™ products are intended to maintain accurate alignment of fragments of fractured bone in the presence of appropriate immobilization.

The INION FreedomPin™ products are 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 pins are dyed green for better visualization during the surgical procedure by a minimal amount of Drug and Cosmetic (D&C) Green No. 6, which is used in several biodegradable sutures and implants.

Inion FreedomPins have nominal dimensions ranging from 1.5 - 3.2 mm in diameter and 30 - 70 mm in length. In addition, sterile Pin Kits are offered which contain 2-3 pins and the required sterile, single use instruments needed for the insertion. 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 resterilized.

Inion FreedomPins provide fixation and are not intended to replace healthy bone or withstand the stress of full load bearing.

Inion FreedomPins are designed to be used with customized instrumentation consisting of drill bits. K-wires, applicators. and arthroscopic pistons and tips.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

bone

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 testing in shear, bending, pull-out and torsion was performed to verify the strength and fixation properties of Inion FreedomPin™ and to compare them to the predicate devices. Testing was conducted initially and during in vitro degradation.

In vitro degradation testing was carried out to determine the degradation profile (i.e., change in material and mechanical properties) and verify the sufficiency of the mechanical stability over healing period as the polymer degrades during in virro degradation and to ensure the degradation of the Inion FreedomPin™.

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.

The data demonstrates that the intended use, material composition and scientific technology, degradation profile and mechanical properties of Inion FreedomPin™ are substantially equivalent with the predicate device Inion OTPS Biodegradable Pin (K050275). The devices have passed the tests for functionality and handling in simulated clinical use settings.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K050275

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

APR 1 1 2014

510(k) SUMMARY Inion FreedomPin™

Image /page/0/Picture/2 description: The image shows the word "INION" in white letters against a black background. The letters are bold and slightly fuzzy, giving them a textured appearance. The word is horizontally oriented and centered in the image.

K133932 page 1 of 2

| Manufacturer and submitter: | Inion Oy,
Lääkärinkatu 2,
FIN-33520 Tampere, FINLAND |
|-------------------------------------------|------------------------------------------------------------------------------|
| Date: | December 16, 2013 |
| Contact person | Kati Marttinen, Quality and Regulatory Director |
| | Phone: +358 10 830 6600 |
| | Fax: +358 10 830 6691 |
| | kati.marttinen@inion.com |
| Establishment registration
number | 9710629 |
| Trade name of the device | Inion FreedomPin™ |
| Device classification and
product code | Class II |
| | Classification Panel: Orthopaedic |
| | Product Code: HTY |
| | Common name: Bone fixation pin |
| | Regulation number: 888.3040 |
| Predicate device | Inion OTPS Biodegradable Pin (K050275) |
| Conformance with performance
standards | Compliance to voluntary consensus standards is listed in the
application. |

Device description and principles of operation

The Inion FreedomPin™ products are intended to maintain accurate alignment of fragments of fractured bone in the presence of appropriate immobilization.

The INION FreedomPin™ products are made of degradable co-polymers composed of Llactic 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 pins are dyed green for better visualization during the surgical procedure by a minimal amount of Drug and Cosmetic (D&C) Green No. 6, which is used in several biodegradable sutures and implants.

Inion FreedomPins have nominal dimensions ranging from 1.5 - 3.2 mm in diameter and 30 - 70 mm in length. In addition, sterile Pin Kits are offered which contain 2-3 pins and the required sterile, single use instruments needed for the insertion. 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 resterilized.

Inion FreedomPins provide fixation and are not intended to replace healthy bone or withstand the stress of full load bearing.

1

510(k) SUMMARY Inion FreedomPin™

INION

K133932 page 2 of 2

Inion FreedomPins are designed to be used with customized instrumentation consisting of drill bits. K-wires, applicators. and arthroscopic pistons and tips.

Indications for use

The Inion FreedomPin™ products are indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace).

Performance testing for substantial equivalence determination

Mechanical testing in shear, bending, pull-out and torsion was performed to verify the strength and fixation properties of Inion FreedomPin™ and to compare them to the predicate devices. Testing was conducted initially and during in vitro degradation.

In vitro degradation testing was carried out to determine the degradation profile (i.e., change in material and mechanical properties) and verify the sufficiency of the mechanical stability over healing period as the polymer degrades during in virro degradation and to ensure the degradation of the Inion FreedomPin™.

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.

The data demonstrates that the intended use, material composition and scientific technology, degradation profile and mechanical properties of Inion FreedomPin™ are substantially equivalent with the predicate device Inion OTPS Biodegradable Pin (K050275). The devices have passed the tests for functionality and handling in simulated clinical use settings.

2

Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hamnshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 11. 2014

Inion Ov Ms. Kati Marttinen Quality and Regulatory Director Lääkärinkatu 2 FIN-33520 Tampere Finland

Re: K133932

Trade/Device Namc: Inion FreedomPin"M Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY Dated: March 3. 2014 Received: March 6. 2014

Dear Ms. 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. 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 docs 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

3

Page 2 - Ms. Kati Marttinen

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (2) 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Lori A. Wigqins

for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

4

K133932

Statement of Indications for Use

K133932 510(k) Number:

Device Name:

Inion FreedomPin™

The INION FreedomPin™ products are indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace).

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth南極rank -S

Division of Orthopedic Devices