# K190125: FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire

- Pathway: 510(k) (Traditional)
- Applicant: T.A.G. Medical Products Corporation, Ltd.
- Decided: May 19, 2019 after 111 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: 6 generations back to K925573 (1993). 21 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121861: Smith & Nephew Ultra Fast-Fix Meniscal Repair System, Smith & Nephew Ultra Fast-Fix AB Meniscal Repair System, Smith & N, Smith & Nephew, Inc. (2012) Summary page 4.
- K111564: Maxfire Marxmen Meniscal Repair Device, Biomet Sports Medicine (2011) Summary page 4.
- K132043: Arthrex Speedcinch, Arthrex, Inc. (2013) Summary page 4.
- K943949: Polyviolene Surgicl Suture, Look, Inc. (1994) Summary page 4.

## Most influential descendants
- K221731: FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire (2022), 1 descendant of its own
- K244015: SuperBall-RC™ (2025), 0 descendants of its own

## Indications for use
The FiberStitch™ Meniscal Repair Device is intended for use as a suture retention device to facilitate endoscopic soft tissue procedures. The FiberStitch™ Meniscal Repair Device is indicated for use in meniscal repair procedures.

Source page: https://510kreport.com/device/K190125
Methodology: https://510kreport.com/methodology