# K123363: Super Staple (TM) Classic

- Pathway: 510(k) (Traditional)
- Applicant: Metric Medical Devices, Inc.
- Decided: Jan 3, 2013 after 63 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.
11 later devices descend from it; 3 cite it directly.
0 of 12 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) Memory Staple (Depuy): named in the summary without a submission number
- (no number) Memory Staple (BioPro, Inc.): named in the summary without a submission number
- (no number) EasyClip (Memometal Inc.): named in the summary without a submission number
- (no number) OSStaple (BioMedical Enterprises, Inc.): named in the summary without a submission number

## Most influential descendants
- K162354: Sniper Staple System (2017), 5 descendants of its own
- K170923: JAWS (TM) Nitinol Staple System (2017), 3 descendants of its own
- K223056: JAWS Nitinol Staple System (2023), 2 descendants of its own
- K230550: JAWS Nitinol Staple System (2023), 1 descendant of its own
- K172405: Sniper Staple System, Non-Sterile (2017), 1 descendant of its own

## Indications for use
The Super Staple is intended for 1) hand and foot bone fragment and osteotomy fixation and joint arthrodesis, 2) fixation of proximal tibial metaphysis osteotomy and 3) adjunctive fixation of small bone fragments (i.e. small fragments of bone which are not comminuted to the extent to preclude staple placement). These fragments may be located in long bones such as the femur, fibula and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in flat bones such as the pelvis, scapula and sternum.

Source page: https://510kreport.com/device/K123363
Methodology: https://510kreport.com/methodology