# K915889: Mitek Bone Anchor, Modification

- Pathway: 510(k) (Traditional)
- Applicant: Mitek Surgical Products, Inc.
- Decided: Oct 22, 1992 after 307 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
No predicates in its family tree.
80 later devices descend from it; 6 cite it directly.
0 of 81 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K960439: LM Bone Anchor (1996), 60 descendants of its own
- K963812: LM Bone Anchor (Orthopedics) (1996), 58 descendants of its own
- K091549: Conmed Linvatec Soft Tissue to Bone System (2009), 56 descendants of its own
- K111779: Y-Knot All-Suture Anchor Model HF13 (2011), 29 descendants of its own
- K131035: Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) HI-FI Sutures, 1.8MM (2013), 17 descendants of its own

Source page: https://510kreport.com/device/K915889
Methodology: https://510kreport.com/methodology