# K211563: Pitch-Patchs

- Pathway: 510(k) (Traditional)
- Applicant: Xiros, Ltd.
- Decided: Aug 13, 2021 after 85 days
- Product code: FTL (Mesh, Surgical, Polymeric)
- 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: 10 generations back to K921895 (1992). 51 ancestors in all.
2 later devices descend 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)
- K072370: Surgicraft Surgical Mesh System, Surgicraft, Ltd. (2008) Summary page 4.
- K070961: Biomerix Surgical Mesh, Model: RCR-01, Biomerix Corporation (2008) Summary page 4.

## Most influential descendants
- K241219: FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN) (2024), 1 descendant of its own
- K253867: FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit (2026), 0 descendants of its own

## Indications for use
The Pitch-Patch 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 Pitch-Patch is not intended to replace normal body structure 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/K211563
Methodology: https://510kreport.com/methodology