# K012081: Dynamic Compression Shape Memory Alloy (Sma) Staple System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek, Inc.
- Decided: Oct 1, 2001 after 90 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The DYNAMIC COMPRESSION SMA Staple System is indicated for use in: (1) Hand and foot bone fragment and osteotomy fixation and joint arthrodesis, (2) Fixation of proximal tibial metaphysis osteotomy, and (3) Fixation of soft tissue to bone such as in anterior cruciate ligament reconstruction.

Source page: https://510kreport.com/device/K012081
Methodology: https://510kreport.com/methodology