# K062782: Inion Anchron Plus Biodegradable Anchor System, Model Anc-6001

- Pathway: 510(k) (Special)
- Applicant: Inion OY
- Decided: Nov 9, 2006 after 52 days
- Product code: MAI (Fastener, Fixation, Biodegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K970896 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051362: Inion Anchron Biodegradable Anchor System, Model Anc-6000, Inion OY (2005) Summary page 3.

## Indications for use
The INION ANCHRONT M 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 2. Elbow: Biceps tendon reattachment 3. Ankle: Achilles tendon repair/reconstruction; Lateral stabilization; Medial stabilization at the medial talus site 4. 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)

Source page: https://510kreport.com/device/K062782
Methodology: https://510kreport.com/methodology