# K170642: GRAVITY™ Soft Tissue Repair System

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Aug 22, 2017 after 173 days
- Product code: GAT (Suture, Nonabsorbable, Synthetic, Polyethylene)
- 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: 5 generations back to K990088 (1999). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063778: Force Fiber Polyethylene Nonabsorbable Suture, Teleflex Medical (2007) Summary page 5.
- K092533: Force Fiber Blue Ultra High Molecular Weight Polyethylene Non Absorbable Sutures, Beere Precision Medical Instruments, Kmedic, Telef (2009) Summary page 5.
- K133713: Charlotte (TM) Snap-Off Screw, Wrightmedicaltechnologyinc (2014) Summary page 5.

## Indications for use
The GRAVITY™ Plantar Plate Repair System are indicated for the following: GRAVITY™ Plantar Plate Repair System: • Distal metatarsal osteotomy (screw) • Plantar plate repair (suture) GRAVITY™ Needle Driver: • Approximation of soft tissues, including the use of allograft tissue for orthopedic surgeries

Source page: https://510kreport.com/device/K170642
Methodology: https://510kreport.com/methodology