# K970119: Mitek Absorbable Polydioxanone (PDS) H Fix

- Pathway: 510(k) (Traditional)
- Applicant: Mitek Products
- Decided: Jan 30, 1998 after 381 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
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Acufex “T” Fix Device: named in the summary without a submission number
- (no number) PDS II Suture: named in the summary without a submission number

## Most influential descendants
- K002406: Mitek 2GII Meniscal Repair System (2001), 4 descendants of its own
- K023388: Mitek Rapidloc-PDS Meniscal Repair System (2002), 2 descendants of its own
- 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
- K053492: Bioduct (2007), 0 descendants of its own

## Indications for use
Mitek meniscal fasteners "H" Fix PDS are intended for use in the repair or torn meniscal tissue in the red/red zone of the meniscus (outer 1/3 ) as well as the repair of a separation of the meniscus from the synovium

Source page: https://510kreport.com/device/K970119
Methodology: https://510kreport.com/methodology