# K051362: Inion Anchron Biodegradable Anchor System, Model Anc-6000

- Pathway: 510(k) (Traditional)
- Applicant: Inion OY
- Decided: Aug 4, 2005 after 71 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: 1 generation back to K970896 (1997). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970896: Mitek 3.5 MM Panalok Wedge Absorbable Suture Anchor System, ETHICON, Inc. (1997) Summary page 1.

## Most influential descendants
- K062782: Inion Anchron Plus Biodegradable Anchor System, Model Anc-6001 (2006), 0 descendants of its own

## Indications for use
The INION ANCHRONTM 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/K051362
Methodology: https://510kreport.com/methodology