(52 days)
Not Found
No
The device description and intended use focus on a biodegradable anchor system for soft tissue fixation, with no mention of AI or ML capabilities.
No
The device is a biodegradable anchor system used for soft tissue to bone fixation, which is a structural and mechanical function, not a therapeutic one that treats or prevents a disease.
No
This device is a biodegradable anchor system used for soft tissue to bone fixation, not for diagnosing medical conditions.
No
The device description explicitly states the system consists of a degradable suture anchor, non-degradable braided surgical suture with needles, and a single-use suture anchor inserter. These are all physical 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 describes a device used for soft tissue to bone fixation in surgical procedures. This is a therapeutic and structural function within the body.
- Device Description: The description details a biodegradable suture anchor, surgical suture, and an inserter. These are all components used in a surgical setting to physically attach tissues.
- 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 samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze biological samples. This device is used inside the body for surgical repair.
N/A
Intended Use / Indications for Use
The INION ANCHRON™ PLUS BIODEGRADABLE ANCHOR SYSTEM is indicated for use in soft tissue to bone fixation in conjunction with appropriate post-operative immobilization as follows:
A. Open procedures:
- Shoulder:
- Bankart repair
- SLAP lesion repair
- Rotator cuff repair
- Capsule shift/capsulo-labral reconstruction at the anterior glenoid rim site
- Capsule shift/capsulo-labral reconstruction at the lesser tuberosity of the humerus
- Biceps tenodesis
- Acromio-clavicular separation
- Elbow:
- Biceps tendon reattachment
- Ankle:
- Achilles tendon repair/reconstruction
- Lateral stabilization
- Medial stabilization at the medial talus site
- Knee:
- Medial collateral ligament repair
- Lateral collateral ligament repair
- Joint capsule closure to anterior proximal tibia
- Posterior oblique ligament or joint capsule to tibia repair
- Extra capsular reconstruction / ITB tenodesis
- Patellar ligament and tendon avulsion repairs
B. Arthroscopic procedures:
- Shoulder:
- Bankart repair
- SLAP lesion repair
- Rotator cuff repair
- Capsule shift repair (glenoid rim)
Product codes (comma separated list FDA assigned to the subject device)
MAI
Device Description
Inion Anchron™ Plus Biodegradable Anchor System is intended to allow secure fixation of soft tissue to bone in conjunction with appropriate immobilization. The system consists of degradable suture anchor made of co-polymers PLDLA, non-degradable braided polyblend surgical suture with stainless steel needles, and a single-use suture anchor inserter. The suture anchors are dyed green. Based on in vitro testing: the suture anchors retain most of their strength up to 16 weeks and gradually loose their strength thereafter; and bioresorption takes place within three years.
Inion Anchron™ Plus Biodegradable Anchor system is provided sterile to the user. The shelf life of the device is 3 years.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Elbow, Ankle, Knee
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)
Based on the performance data and specifications presented, it can be concluded that the intended use, material composition and scientific technology, degradation profile and mechanical properties of the Inion Anchron™ Plus Biodegradable Anchor System are substantially equivalent with the predicate device Inion Anchron™ Biodegradable Anchor System (K051362).
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
§ 888.3030 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
Image /page/0/Picture/1 description: The image shows the word "INION" in large, bold, white letters against a black background. Below the word, in smaller white letters, is the phrase "Intelligent Solution". The text appears to be a logo or branding element, emphasizing a sense of intelligence and problem-solving.
510(k) SUMMARY for Inion Anchron™ Plus Biodegradable Anchor System (K062782) NOV - 9 2006
MANUFACTURER
Inion Oy, Lääkärinkatu 2, FIN-33520 Tampere, FINLAND
Contact Person
Kati Marttinen, Regulatory Affairs Specialist Lääkärinkatu 2. FIN-33520 Tampere Phone: +358 3 2306 600 Fax: +358 3 2306 691 kati.marttinen@inion.com
DEVICE NAME
Trade name: Inion Anchron™ Plus Biodegradable Anchor System Common/Usual Name: Suture anchor
ESTABLISHMENT REGISTRATION NUMBER
9710629
DEVICE CLASSIFICATION AND PRODUCT CODE
Classification Panel: Orthopedic Regulation Number: 21 CFR 888.3030 Regulation Name: Fastener, fixation, biodegradable, soft tissue Regulatory Class: Class II Product Code: MAI
PREDICATE DEVICE
Inion Anchron™ Biodegradable Anchor System (K051362)
CONFORMANCE WITH PERFORMANCE STANDARDS
No applicable mandatory performance standards exist for this device. Compliance to voluntary consensus standards is listed in the application.
1
Image /page/1/Picture/1 description: The image shows the word "INION" in large, bold, white letters against a black background. Below the word "INION", the phrase "Intelligent Solution" is written in a smaller, italicized font, also in white. The overall design is simple and clean, with a focus on the company name and its tagline.
DEVICE DESCRIPTION AND PRINCIPLES OF OPERATION
Inion Anchron™ Plus Biodegradable Anchor System is intended to allow secure fixation of soft tissue to bone in conjunction with appropriate immobilization. The system consists of degradable suture anchor made of co-polymers PLDLA, non-degradable braided polyblend surgical suture with stainless steel needles, and a single-use suture anchor inserter. The suture anchors are dyed green. Based on in vitro testing: the suture anchors retain most of their strength up to 16 weeks and gradually loose their strength thereafter; and bioresorption takes place within three years.
Inion Anchron™ Plus Biodegradable Anchor system is provided sterile to the user. The shelf life of the device is 3 years.
INDICATIONS FOR USE
The INION ANCHRON™ PLUS BIODEGRADABLE ANCHOR SYSTEM is indicated for use in soft tissue to bone fixation in conjunction with appropriate post-operative immobilization as follows:
A. Open procedures:
-
- Shoulder: Bankart repair
- · SLAP lesion repair
- · Rotator cuff repair
- · Capsule shift/capsulo-labral reconstruction at the anterior glenoid rim site
- · Capsule shift/capsulo-labral reconstruction at the lesser tuberosity of the humerus
- · Biceps tenodesis
- · Acromio-clavicular separation
-
- Elbow: · Biceps tendon reattachment
-
- Ankle: · Achilles tendon repair/reconstruction
- · Lateral stabilization
- · Medial stabilization at the medial talus site
-
- Knee: · Medial collateral ligament repair
- Lateral collateral ligament repair
- · Joint capsule closure to anterior proximal tibia
- · Posterior oblique ligament or joint capsule to tibia repair
- · Extra capsular reconstruction / ITB tenodesis
- · Patellar ligament and tendon avulsion repairs
B. Arthroscopic procedures:
-
- Shoulder: Bankart repair
- · SLAP lesion repair
- · Rotator cuff repair
- · Capsule shift repair (glenoid rim)
2
Image /page/2/Picture/1 description: The image shows the word "INION" in large, bold, white letters. Below the word "INION" is the phrase "Intelligent Solution" in a smaller font size. The background of the image is black, which creates a strong contrast with the white text.
EQUIVALENCE TO MARKETED PRODUCTS
Based on the performance data and specifications presented, it can be concluded that the intended use, material composition and scientific technology, degradation profile and mechanical properties of the Inion Anchron™ Plus Biodegradable Anchor System are substantially equivalent with the predicate device Inion Anchron™ Biodegradable Anchor System (K051362).
Inion Anchron™ Plus Biodegradable Anchor System is substantially equivalent to predicate Class II devices used for secure fixation of soft tissue to bone in conjunction with appropriate immobilization, because the differences between Inion Anchron™ Plus Biodegradable Anchor System and the predicate device do not raise new questions of safety and effectiveness.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, represented by three curved lines that suggest the head and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Inion Oy % Ms. Kati Marttinen Regulatory Affairs Specialist Lääkärinkatu 2 FIN-33520 Tampere FINLAND
NOV - 9 2006
K062782 Re:
Trade/Device Name: Inion Anchron Plus Biodegradable Anchor System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: MAI Dated: October 20, 2006 Received: October 23, 2006
Dear Ms. Marttinen:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have and have 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 for are waver 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
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Page 2 - Ms. Kati Marttinen
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. 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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,
barbara Beecher
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
| 510(k) Number: | K062782 |
|---|---|
| Device Name: | Inion ANCHRON™ PLUS Biodegradable Anchor System |
The INION ANCHRON™ PLUS BIODEGRADABLE ANCHOR SYSTEM is indicated for use in soft tissue to bone fixation in conjunction with appropriate post-operative immobilization as follows:
A. Open procedures:
- Shoulder:
- Bankart repair
- SLAP lesion repair
- Rotator cuff repair
- Capsule shift/capsulo-labral reconstruction at the anterior glenoid rim site
- Capsule shift/capsulo-labral reconstruction at the lesser tuberosity of the humerus
- Biceps tenodesis
- Acromio-clavicular separation
- Elbow:
- Biceps tendon reattachment
- Ankle:
- Achilles tendon repair/reconstruction
- Lateral stabilization
- Medial stabilization at the medial talus site
- Knee:
- Medial collateral ligament repair
- Lateral collateral ligament repair
- Joint capsule closure to anterior proximal tibia
- Posterior oblique ligament or joint capsule to tibia repair
- Extra capsular reconstruction / ITB tenodesis
- Patellar ligament and tendon avulsion repairs
B. Arthroscopic procedures:
- Shoulder:
- Bankart repair
- SLAP lesion repair
- Rotator cuff repair
- Capsule shift repair (glenoid rim)
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)
Saulala Pnehum for Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) (Division organ), Restorative,
ົວນັກ Neurological Devices
510(k) Number K062782
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