# K971358: Bio-Interference Screw, 7 MM, 8 MM, 9 MM

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Jul 9, 1997 after 89 days
- Product code: MAI (Fastener, Fixation, Biodegradable, Soft Tissue)
- 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
No predicates in its family tree.
135 later devices descend from it; 5 cite it directly.
0 of 136 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) Arthrex, Inc.’s Bio-Interference Screw: named in the summary without a submission number
- (no number) Linvatec’s BioScrew: named in the summary without a submission number

## Most influential descendants
- K990454: Bio-Interference Screw (1999), 119 descendants of its own
- K993975: Absolute Absorbable Interference Screw (1999), 118 descendants of its own
- K013572: Mitek Biocryl Interference Screws (2002), 117 descendants of its own
- K032717: Biocryl Rapide Interference Screw (2004), 107 descendants of its own
- K060830: Milagro Interference Screw (2006), 103 descendants of its own

## Indications for use
To provide interference fixation of bone-tendon-bone and soft tissue- grafts in ACIL, reconstruction through arthroscopy or arthrotory.

Source page: https://510kreport.com/device/K971358
Methodology: https://510kreport.com/methodology