# K023388: Mitek Rapidloc-PDS Meniscal Repair System

- Pathway: 510(k) (Special)
- Applicant: Mitek Worldwide
- Decided: Dec 27, 2002 after 79 days
- Product code: JDR (Staple, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K970119 (1998). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002406: Mitek 2GII Meniscal Repair System, Mitek Products (2001) Summary page 1.
- K970119: Mitek Absorbable Polydioxanone (PDS) H Fix, Mitek Products (1998)

## Most influential descendants
- K092836: Omnispan Meniscal Repair System/0 Degree, Model 228140, Rapidloc A2 Meniscal Repair System/12 Degree, Model 228141 (2010), 0 descendants of its own
- K082518: Dual Needle Suture Passer System (2009), 0 descendants of its own

## Indications for use
The RAPIDLOC-PDS Meniscal Repair System is intended for use in the arthroscopic fixation of longitudinal vertical meniscus lesions (bucket-handle lesions) located in the vascularized area of the meniscus (red-red and red-white areas).

Source page: https://510kreport.com/device/K023388
Methodology: https://510kreport.com/methodology