# K153558: Ventix Suture Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing Corp
- Decided: Apr 21, 2016 after 129 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: 9 generations back to K792022 (1979). 61 ancestors in all.
No later device cites it as a predicate yet.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060693: Microstrike and Allthread Peek Suture Anchor, Arthrotek, Inc. (2006) Summary page 4.
- K150768: JuggerKnot Soft Anchors, Biomet Manufacturing Corp (2015) Summary page 4.

## Indications for use
The Ventix Suture Anchors are indicated for use in soft tissue reattachment procedures in the shoulder, wrist’hand, ankle/foot, elbow, and knee. Specific indications are: Shoulder: Bankart repair, SLAP lesion repair, acromio- clavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair, pectoralis major repair. Wrist/Hand: Scapholunate ligament reconstruction, ulnar/radial collateral ligament reconstruction. Ankle/Foot: Lateral stabilization, medial stabilization, Achilles tendon repair/reconstruction, hallux valgus reconstruction, mid- and forefoot reconstruction. Elbow: Ulnar or radial collateral ligament reconstruction, biceps tendon reconstruction, Lateral epicondylitis repair Knee: Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis, and patellar ligament/tendon repair, medial patellofemoral ligament (MPFL) repair or reconstruction, quadriceps tendon repair. Hip: Proximal hamstring repair

Source page: https://510kreport.com/device/K153558
Methodology: https://510kreport.com/methodology