# K241219: FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN)

- Pathway: 510(k) (Traditional)
- Applicant: ZuriMED Technologies AG
- Decided: Dec 11, 2024 after 224 days
- Product code: OWX (Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K921895 (1992). 52 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211563: Pitch-Patchs, Xiros, Ltd. (2021) Summary page 5.

## Most influential descendants
- K253867: FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit (2026), 0 descendants of its own

## Indications for use
The FiberLocker System is a single use device intended to be used for reinforcement of the rotator cuff, following or during repair by suture or suture anchors, where weakness exists in the soft tissue. The FiberLocker System is not intended to replace normal body structures or provide the full mechanical strength to support the rotator cuff. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide mechanical strength for the repair.

Source page: https://510kreport.com/device/K241219
Methodology: https://510kreport.com/methodology