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)

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.

AI/ML Overview

This document is a 510(k) summary for the Inion Anchron™ Plus Biodegradable Anchor System. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria with quantifiable performance metrics.

Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth cannot be extracted directly from this document.

However, I can provide the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Reported Device Performance
Intended Use	"secure fixation of soft tissue to bone in conjunction with appropriate immobilization."
Material Composition	Made of co-polymers PLDLA. Same as predicate device.
Degradation Profile	Retains most of its strength up to 16 weeks; bioresorption within three years. Indicated as substantially equivalent to predicate.
Mechanical Properties	Indicated as substantially equivalent to predicate.
Sterility	"provided sterile to the user"
Shelf Life	3 years

Explanation of the "Acceptance Criteria": The document performs a substantial equivalence assessment. This means the "acceptance criteria" are primarily based on demonstrating that the new device is as safe and effective as a legally marketed predicate device. The performance data presented (degradation profile, mechanical properties) are to establish this equivalence, rather than meeting a specific numerical target for a new, novel characteristic.

2. Sample size used for the test set and the data provenance:

The document mentions "in vitro testing" for the degradation profile. It does not provide specific sample sizes for this testing.
The data provenance is implied to be from the manufacturer, Inion Oy, in Finland.
The study is likely prospective in nature, as it involves testing of the manufactured device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The substantial equivalence assessment relies on internal testing and comparison to the predicate device, not on external expert consensus for a "ground truth" derived from patient data.

4. Adjudication method for the test set:

This information is not applicable and not provided. Adjudication methods are typically relevant for studies involving human interpretation (e.g., medical imaging, clinical outcomes reviewed by multiple experts), which is not the primary focus of this 510(k) submission for a medical device.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a biodegradable anchor system, not an AI-assisted diagnostic or monitoring tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This question is not applicable as the device is a physical medical implant, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the "degradation profile" and "mechanical properties," the "ground truth" would be established by direct measurement in laboratory settings according to established scientific and engineering principles (e.g., measuring strength over time, analyzing material composition).
For the overall "equivalence" claim, the ground truth is the predicate device's established safety and effectiveness.

8. The sample size for the training set:

This question is not applicable as the device is not an AI model requiring a training set.

9. How the ground truth for the training set was established:

This question is not applicable as the device is not an AI model requiring a training set.

Summary

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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.

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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 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:

1. 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
1. Elbow: · Biceps tendon reattachment
1. Ankle: · Achilles tendon repair/reconstruction
- · Lateral stabilization
- · Medial stabilization at the medial talus site
1. 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:

1. Shoulder: Bankart repair
- · SLAP lesion repair
- · Rotator cuff repair
- · Capsule shift repair (glenoid rim)

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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.

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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

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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

Page 1 of 1

Regulation Number and Section

§ 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.