# K092508: Fast-Fix 360 Meniscal Repair System, Striaght, Curved, Reverse Curved,Fast Fix 360 AB Meniscal Repair System, Straight,

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Jan 28, 2010 after 164 days
- Product code: GAT (Suture, Nonabsorbable, Synthetic, Polyethylene)
- Device class: 2
- Regulation: 21 CFR 878.5000
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K925573 (1993). 3 ancestors in all.
17 later devices descend from it; 4 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002261: MR-III, Smith & Nephew, Inc. (2000) Summary page 1.

## Cited in the summary but kept off the family tree
- K018331: Ethicon PDS Suture. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K121861: Smith & Nephew Ultra Fast-Fix Meniscal Repair System, Smith & Nephew Ultra Fast-Fix AB Meniscal Repair System, Smith & N (2012), 12 descendants of its own
- K190125: FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire (2019), 2 descendants of its own
- K180191: SuperBall Meniscal Repair System (2018), 2 descendants of its own
- K223500: SuperBall Meniscal Repair System (2023), 1 descendant of its own
- 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

## Recalls of this device
- Oct 14, 2010 · Not classified · Z-0419-2011: FasT-Fix 360 Needle Delivery System may not allow the T-2 (anchor) to advance for implantation.
- Oct 14, 2010 · Not classified · Z-0421-2011: FasT-Fix 360 Needle Delivery System may not allow the T-2 (anchor) to advance for implantation.
- Oct 14, 2010 · Not classified · Z-0420-2011: FasT-Fix 360 Needle Delivery System may not allow the T-2 (anchor) to advance for implantation.

## Indications for use
The Smith & Nephew FAST-FIX 360 Meniscal Repair System is intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures such as shoulder stabilization (Bankart Repair), rotator cuff repair, meniscal repair and gastrostomy.

Source page: https://510kreport.com/device/K092508
Methodology: https://510kreport.com/methodology