# K152262: Ventix Knotless Anchors

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing Corp
- Decided: Mar 8, 2016 after 210 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K943806 (1995). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070389: Peek Knotless Anchors, Biomet Sports Medicine, Inc. (2007) Summary page 4.

## Indications for use
The Ventix Knotless Anchor is indicated for use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, and knee. Specific indications as follows: Shoulder — Bankart repair, SLAP repair, acromio-clavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, and deltoid repair. Wrist/Hand - Scapholunate ligament reconstruction and ulnar/radial collateral ligament reconstruction. Ankle/Foot - Lateral stabilization, medial stabilization, Achilles tendon repair/reconstruction, hallux valgus reconstruction, and mid- and forefoot reconstruction. Elbow — Ulnar or radial collateral ligament reconstruction, biceps tendon reconstruction, and lateral epicondylitis repair Knee - Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis, patellar ligament/tendon repair, extra-capsular repair, patellar realignment and repair, and Vastus Medialis Obliquus (VMO) Muscle Advancement. The Ventix Knotless anchors are also indicated for supplementary fixation when used in conjunction with a primary fixation device in ACL repair and reconstruction surgical procedures requiring graft fixation.

Source page: https://510kreport.com/device/K152262
Methodology: https://510kreport.com/methodology