# K020480: RBM

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Mar 12, 2002 after 27 days
- Product code: KGS (Retention Device, Suture)
- Device class: 1
- Regulation: 21 CFR 878.4930
- Recalls of this device: 1 (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.
16 later devices descend from it; 1 cites it directly.
0 of 20 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.

## Most influential descendants
- K072322: Ultra Fast-Fix and Ultra Fast-Fix AB Meniscal Repair Systems (2007), 15 descendants of its own
- K073149: Meniscal Cinch (2008), 9 descendants of its own
- K132043: Arthrex Speedcinch (2013), 6 descendants of its own
- K190707: Arthrex SoftStitch (2020), 2 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

## Recalls of this device
- Mar 24, 2006 · Not classified · Z-0798-06: The implant consists of a T1 and T2 anchor which are joined together by a suture. The T2 portion of the implant may not advance into the deployment position preventing deployment of the T2 anchor.

## Indications for use
The RBM 1s intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue repair. The indications for the RBM are for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures such as shoulder stabilization (Bankart Repait), rotator cuff repai, meniscal repair, and gastrostormy.

Source page: https://510kreport.com/device/K020480
Methodology: https://510kreport.com/methodology