# K170923: JAWS (TM) Nitinol Staple System

- Pathway: 510(k) (Traditional)
- Applicant: Paragon 28
- Decided: Jul 24, 2017 after 117 days
- Product code: JDR (Staple, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K001354 (2001). 4 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001354: Memograph; Osstaple - Orthopedic Uses for Small Bone and Fragment Fixation for the Memograph Staple System, Biomedical Ent., Inc. (2001) Summary page 5.
- K061798: Biopro Memory Staple, Biopro, Inc. (2006) Summary page 5.
- K002695: Memodyn Staple, Telos Medical Equipment (2001) Summary page 5.
- K123363: Super Staple (TM) Classic, Metric Medical Devices, Inc. (2013) Summary page 5.

## Most influential descendants
- K223056: JAWS Nitinol Staple System (2023), 2 descendants of its own
- K230550: JAWS Nitinol Staple System (2023), 1 descendant of its own
- K261121: Megalodon Dynamic Compression System (2026), 0 descendants of its own

## Recalls of this device
- Dec 19, 2017 · Class II · Z-2261-2018: Missing drill guide as stated in the package.

## Indications for use
The JAWS™ Nitinol Staple System implants are indicated for use in osteotomy, arthrodesis and fragment fixation of bones and joint of the foot including fixation of small bone fragments (i.e. small fragments of bone which are not comminuted to the extent to preclude staple placement) located in the long bones of the lower extremities such as the fibula and tibia.

Source page: https://510kreport.com/device/K170923
Methodology: https://510kreport.com/methodology