(85 days)
Not Found
No
The device description focuses on the material properties and mechanical function of bioabsorbable pins and nails for bone fixation. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is indicated for "fixation of bone fractures, osteotomies, arthrodeses and osteochondral fractures," which are conditions that require medical treatment or intervention, thus making the device therapeutic.
No
The device is indicated for the "fixation of bone fractures, osteotomies, arthrodeses and osteochondral fractures," which describes a therapeutic or surgical function, not a diagnostic one.
No
The device description explicitly states the devices are made of bioabsorbable poly(L-lactide-co-glycolide) (PLGA) and are physical pins/nails for bone fixation, indicating they are hardware devices, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "fixation of bone fractures, osteotomies, arthrodeses and osteochondral fractures". This is a surgical procedure performed directly on the body to stabilize bone.
- Device Description: The device is a bioabsorbable pin/nail made of PLGA, designed to be implanted into bone. This is a physical implant, not a reagent or instrument used to examine specimens from the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the body (blood, urine, tissue, etc.), providing diagnostic information, or being used in a laboratory setting.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used for mechanical fixation.
N/A
Intended Use / Indications for Use
The devices of Bioretec ActivaPin™ Product Group including ActivaPin™, ActivaPin™ Fusion, ActivaNail™ Conical and ActivaNail™ Flat are indicated for fixation of bone fractures, osteotomies, arthrodeses and osteochondral fractures in the presence of appropriate immobilization.
Product codes
HTY
Device Description
Bioretec ActivaPin™ Product Group covers Bioretec's bioabsorbable devices ActivaPin™ ActivaPin™ Fusion, ActivaNail™ Conical and ActivaNail™ Flat.
The Bioretec ActivaPin™ products do not differ significantly or at all in purpose, design, materials, function or any other feature related to safety and effectiveness. ActivaPin" is identical with a predicate device and the other devices of Bioretec's ActivaPin™ Product Group are its modifications. ActivaPin™ Fusion is the same as ActivaPin™, but its both ends are tapered. ActivaNail™ Conical and ActivaNail™ Flat are also ActivaPin™'s modifications with conical and flat heads. All pins of Bioretec ActivaPin™ Product Group are available in several different dimensions, including diameters of 1.5 - 3.2 mm and lengths of 5 - 70 mm.
The Bioretec ActivaPin™ Product Group devices are made of completely bioabsorbable poly(L-lactide-co-glycolide) (PLGA), and they degrade in vivo by hydrolysis into alphahydroxy acids that are metabolized by the body. As the operated bone fracture or osteotomy gains strength during healing, the Bioretec ActivaPin™ products gradually loses their strength, however, maintaining their function at least 8 weeks. Bioabsorption takes place within approximately two years thus eliminating the need for implant removal surgery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone fractures, osteotomies, arthrodeses and osteochondral fractures
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
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K080879 *lld
510(k) SUMMARY G
For the Bioretec ActivaPin™ Product Group
JUN 2 4 2008
MANUFACTURER
Bioretec Ltd. Hermiankatu 22, Modulight Building FI-33720 Tampere FINLAND
Contact person: Ms. Mari Ruotsalainen Quality Manager Phone: +358 20 778 9514 +358 3 317 0225 Fax: Mari. Ruotsalainen@bioretec.com
Date prepared: March 28th, 2008
DEVICE NAME
Bioretec ActivaPin™ Trade Name:
Bioretec ActivaPin™ Fusion
Bioretec ActivaNail™ Conical
Bioretec ActivaNail™ Flat
Common Name: Pin, Fixation
ESTABLISHMENT REGISTRATION NUMBER
Bioretec Ltd. Establishment Registration Number is 3005536892.
DEVICE CLASSIFICATION AND PRODUCT CODE
Device Classification Name: Pin, Fixation, Smooth Classification Panel: Orthopedic Regulation Number: 21 CFR 888.3040 Product Code: HTY
Traditional 510(k) Date: March 28th, 2008
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Image /page/1/Picture/1 description: The image shows a handwritten string of characters. The string starts with the letters 'KO', followed by the numbers '80879'. After the numbers, there is an asterisk symbol followed by the numbers '2/2'. The characters are written in black ink on a white background.
PREDICATE DEVICES
Bioretec ActivaPin™ (K061164)
DEVICE DESCRIPTION AND PRINCIPLES OF OPERATION
Bioretec ActivaPin™ Product Group covers Bioretec's bioabsorbable devices ActivaPin™ ActivaPin™ Fusion, ActivaNail™ Conical and ActivaNail™ Flat.
The Bioretec ActivaPin™ products do not differ significantly or at all in purpose, design, materials, function or any other feature related to safety and effectiveness. ActivaPin" is identical with a predicate device and the other devices of Bioretec's ActivaPin™ Product Group are its modifications. ActivaPin™ Fusion is the same as ActivaPin™, but its both ends are tapered. ActivaNail™ Conical and ActivaNail™ Flat are also ActivaPin™'s modifications with conical and flat heads. All pins of Bioretec ActivaPin™ Product Group are available in several different dimensions, including diameters of 1.5 - 3.2 mm and lengths of 5 - 70 mm.
The devices of Bioretec ActivaPin" Product Group are indicated for fixation of bone fractures, osteotomies, arthrodeses and osteochondral fractures in the presence of appropriate immobilization.
The Bioretec ActivaPin™ Product Group devices are made of completely bioabsorbable poly(L-lactide-co-glycolide) (PLGA), and they degrade in vivo by hydrolysis into alphahydroxy acids that are metabolized by the body. As the operated bone fracture or osteotomy gains strength during healing, the Bioretec ActivaPin™ products gradually loses their strength, however, maintaining their function at least 8 weeks. Bioabsorption takes place within approximately two years thus eliminating the need for implant removal surgery.
EQUIVALENCE TO MARKETED PRODUCTS
The devices of Bioretec ActivaPin™ Product Group are substantially equivalent to the previously cleared Bioretec ActivaPin™ (K061164).
The Bioretec ActivaPin™ products have the same intended use and principles of operation, and also the same technological characteristic and performance as the previously cleared Bioretec ActivaPin™ (K061164). Any differences between Bioretec ActivaPin™ products and predicate device do not raise any questions of safety and effectiveness.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Bioretec Ltd. % Ms. Mari Ruotsalainen Hermiankatu 22, Modulight Building FI-33720 Tampere Finland
Re: K080879 Trade/Device Name: Activa™ Product group Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY Dated: March 28, 2008 Received: March 31, 2008
Dear Ms. Ruotsalainen:
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.
JUN 2 4 2008
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Ms. Mari Ruotsalainen
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark H. Miller
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement F
Submitter: Bioretec Ltd. 510(k) Number:
Device Name:
ActivaPin™ ActivaPin™ Fusion ActivaNail™ Conical ActivaNail™ Flat
Indications for Use:
The devices of Bioretec ActivaPin™ Product Group including ActivaPin™, ActivaPin™ Fusion, ActivaNail™ Conical and ActivaNail™ Flat are indicated for fixation of bone fractures, osteotomies, arthrodeses and osteochondral fractures in the presence of appropriate immobilization.
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)
Varlare Brienm
Division of General, Restorative, and Neurological Devices
Page __ of
510(k) Number K080879
Traditional 510(k) Date: March 280, 2008