# K101616: The Grapplr and Grapplr Extender

- Pathway: 510(k) (Traditional)
- Applicant: Tag Medical Corp.
- Decided: Jan 6, 2011 after 211 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: 9 generations back to K792022 (1979). 56 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070167: Endobutton Direct, Smith & Nephew Inc., Endoscopy Division (2007) Summary page 1.
- K081098: Endobutton Continuous Loop (CL), Smith & Nephew Inc., Endoscopy Division (2008) Summary page 1.
- K070780: Conmed Linvatec XO Button, Conmed Linvatec (2007) Summary page 1.

## Most influential descendants
- K142653: G-Lok and G-Lok XL Extender (2014), 0 descendants of its own

## Indications for use
The GrappLR Tm and GraPPLR TM Extender are intended to provide suspension fixation for soft tissue to bone in the repair of the natural ligament or tendon disruption or assist in reconstruction surgeries and to assist in the management of reconstructive surgeries.

Source page: https://510kreport.com/device/K101616
Methodology: https://510kreport.com/methodology