# K151897: MultiFIX® P Knotless Fixation Device

- Pathway: 510(k) (Special)
- Applicant: ArthroCare Corporation
- Decided: Aug 6, 2015 after 27 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 K921873 (1992). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120096: Multifix P Knotless Fixation Device, ArthroCare Corporation (2012) Summary page 4.

## Indications for use
The MultiFIX P Knotless Fixation Device is indicated for use in fixation of soft tissue to bone. Examples of such procedures include: Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis and deltoid repair. Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction and midfoot reconstruction. Foot: Hallux valgus reconstruction. Elbow: Tennis elbow repair, biceps tendon attachment. Knee: Extra-capsular repairs; reattachment of medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions.

Source page: https://510kreport.com/device/K151897
Methodology: https://510kreport.com/methodology