# K143356: NovoStitch Plus Meniscal Repair System

- Pathway: 510(k) (Traditional)
- Applicant: Ceterix Orthopaedics, Inc.
- Decided: Jul 21, 2015 after 239 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: 4 generations back to K990088 (1999). 15 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121413: Crossfix II Memiscal Repair Device, Cayenne Medical, Inc. (2012) Summary page 4.
- K063778: Force Fiber Polyethylene Nonabsorbable Suture, Teleflex Medical (2007) Summary page 4.

## Most influential descendants
- K180531: NovoStitch Pro Meniscal Repair System (2018), 1 descendant of its own
- K181772: NovoStitch Pro Meniscal Repair System, CTX-A004 (size 0) (2018), 0 descendants of its own

## Indications for use
The NovoStitch Plus Meniscal Repair System is intended for approximation of soft tissue in meniscal repair procedures.

Source page: https://510kreport.com/device/K143356
Methodology: https://510kreport.com/methodology