# K002261: MR-III

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Oct 23, 2000 after 90 days
- Product code: GAS (Suture, Nonabsorbable, Synthetic, Polyester)
- Device class: 2
- Regulation: 21 CFR 878.5000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K925573 (1993). 2 ancestors in all.
30 later devices descend from it; 3 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925573: Acufex T-Bar, Acufex Microsurgical, Inc. (1993) Summary page 1.
- K942442: Acufex T-Fix Delivery System, Acufex Microsurgical, Inc. (1994) Summary page 1.

## Most influential descendants
- K092508: Fast-Fix 360 Meniscal Repair System, Striaght, Curved, Reverse Curved,Fast Fix 360 AB Meniscal Repair System, Straight, (2010), 17 descendants of its own
- K020480: RBM (2002), 16 descendants of its own
- K072322: Ultra Fast-Fix and Ultra Fast-Fix AB Meniscal Repair Systems (2007), 15 descendants of its own
- 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
- K073149: Meniscal Cinch (2008), 9 descendants of its own

## Indications for use
MR-III is intended for use as a suture retention device to facilitate pecutaneous or endoscopic soft tissue repair. The indications for the MR-III are 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/K002261
Methodology: https://510kreport.com/methodology