(30 days)
Not Found
No
The description focuses on the material properties and mechanical function of a bioabsorbable screw, with no mention of AI or ML.
No
A therapeutic device is one that treats a disease or condition. This device is used to fix bone fractures and other bone conditions, which is a treatment for these conditions. However, the device itself is a screw used for fixation and degrades over time, allowing the bone to heal. While it aids in the healing process, it doesn't actively treat in a therapeutic sense like medication or a therapy device would. It acts as a supportive device during the natural healing process.
No
The device is described as an implantable screw for fixing bone fractures, osteotomies, and other bone-related issues. Its function is to provide fixation and support during healing, not to diagnose a condition.
No
The device description clearly describes physical screws made of bioabsorbable material, intended for surgical implantation. There is no mention of software as the primary or sole component of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- ActivaScrew™ Function: The ActivaScrew™ is a surgical implant used for the fixation of bone fractures and other orthopedic procedures. It is directly implanted into the body to provide structural support during healing.
- Lack of Specimen Analysis: The provided description clearly states the device's purpose is mechanical fixation within the body. There is no mention of it being used to analyze biological specimens outside of the body.
Therefore, based on the provided information, the ActivaScrew™ is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ActivaScrew™ Products are indicated for fixation of bone fractures, osteotomies, arthrodeses, bone grafts and osteochondral fractures of upper extremity, ankle and foot in the presence of appropriate immobilization.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The ActivaScrew™ Products are indicated for fixation of bone fractures, osteotomies, arthrodeses, bone grafts and osteochondral fractures of upper extremity, ankle and foot in the presence of appropriate immobilization. Screws are available as non-cannulated and cannulated, fully and partially threaded, in several different sizes, including diameters of 2.0 – 4.5 mm and lengths of 10 - 90 mm.
The ActivaScrew™ Products are made of the completely bioabsorbable poly(L-lactide-coglycolide) (PLGA) material, and they degrade in vivo by hydrolysis into alpha-hydroxy acids that are metabolized by the body. As the operated bone fracture or osteotomy gains strength during healing, the ActivaScrew™ gradually loses its strength, however, maintaining its 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
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)
In vitro and mechanical bench testing determined that the ActivaScrew™ has substantially similar performance as compared to its predicate devices.
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
§ 888.3040 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
K081392 pge 1 of 2
Image /page/0/Picture/1 description: The image shows the logo for Bioretec. The logo consists of a stylized, curved shape that resembles a wing or a stylized letter 'B'. The shape is filled with a gradient, transitioning from light to dark. Below the shape, the word "bioretec" is written in lowercase letters.
JUN 1 8 2008
ઉ SPECIAL 510(k) SUMMARY
For the modification to Bioretec ActivaScrew™ (K072848)
MANUFACTURER
Bioretec Ltd. Hermiankatu 22, Modulight Building FI-33720 Tampere FINLAND
Contact person:
Mrs. Mari Ruotsalainen Quality and Regulatory Affairs Manager Phone: +358 20 778 9514 Fax: +358 3 317 0225 Mari.Ruotsalainen@bioretec.com
Date prepared: May 16th, 2008
DEVICE NAME
Trade Names: Bioretec ActivaScrew™, ActivaScrew™ Cannulated and ActivaScrew™M
Cannulated with ActivaPin™
Common Name: Screw, Fixation, Bone
ESTABLISHMENT REGISTRATION NUMBER
3005536892
DEVICE CLASSIFICATION AND PRODUCT CODE
Device Classification Name: Screw, Fixation, Bone Classification Panel: Orthopedic Regulation Number: 21 CFR 888.3040
Product Code: HWC
PREDICATE DEVICES
Special 510(k): Device Modification, Date: May 16" , 2008
Page G-1
1
Image /page/1/Picture/0 description: The image shows the logo for Bioretec. The logo consists of a stylized graphic above the word "bioretec" in lowercase letters. The graphic appears to be an abstract representation of a curved shape, possibly suggesting movement or growth. The overall design is simple and modern.
DEVICE DESCRIPTION AND PRINCIPLES OF OPERATION
The ActivaScrew™ Products are indicated for fixation of bone fractures, osteotomies, arthrodeses, bone grafts and osteochondral fractures of upper extremity, ankle and foot in the presence of appropriate immobilization. Screws are available as non-cannulated and cannulated, fully and partially threaded, in several different sizes, including diameters of 2.0 – 4.5 mm and lengths of 10 - 90 mm.
The ActivaScrew™ Products are made of the completely bioabsorbable poly(L-lactide-coglycolide) (PLGA) material, and they degrade in vivo by hydrolysis into alpha-hydroxy acids that are metabolized by the body. As the operated bone fracture or osteotomy gains strength during healing, the ActivaScrew™ gradually loses its strength, however, maintaining its 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 ActivaScrew™ bioabsorbable screw is substantially equivalent to biodegradable screws cited as predicate devices above.
The Bioretec ActivaScrew™ has the same intended use, principles of operation and technological characteristic as the previously cleared Bioretec ActivaScrew™ (K072848). The modifications do not raise any questions of safety and effectiveness.
In vitro and mechanical bench testing determined that the ActivaScrew™ has substantially similar performance as compared to its predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 8 2008
Bioretec Ltd. c/o Mrs. Mari Ruotsalainen Quality and Regulatory Affairs Manager Hermiankatu 22, Modulight Building FI-33720 Tampere FINLAND
Re: K081392
Trade/Device Name: ActivaScrew™, ActivaScrew™ Cannulated and
ActivaScrew™ Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: May 16, 2008 Received: May 19, 2008
Dear Mrs. 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.
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 (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.
3
Page 2 – Mrs. 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 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 vours.
Mark M. Mulhearn
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K 0813/2
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F Indications for Use Statement
| Submitter: | Bioretec Ltd. |
|---|---|
| 510(k) Number: | |
| Device Name: | ActivaScrew TM , ActivaScrew TM Cannulated and ActivaScrew TM Cannulated with ActivaPin TM |
Indications for Use:
The ActivaScrew™ Products are indicated for fixation of bone fractures, osteotomies, arthrodeses, bone grafts and osteochondral fractures of upper extremity, ankle and foot in the presence of appropriate immobilization.
Contraindications:
-
- Fractures and osteotomies of diaphyseal bone (except those in the hand and foot).
- Situations where internal fixation is otherwise contraindicated, e.g., active or potential 2. infection and where patient's co-operation cannot be guaranteed.
Prescription Use × (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) | |
|---|---|
| -------------------------------------------------------- | -- |
Nei/RPDal forman
Division of General, Restorative, and Neurological Devices
Page of
510(k) Number K081392
Special 510(k): Device Modification, Date: May 16th, 2008
Page F-1