# K993714: Memograph Staple, Warm System

- Pathway: 510(k) (Traditional)
- Applicant: Biomedical Ent., Inc.
- Decided: Feb 25, 2000 after 115 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
Longest line of descent: 1 generation back to K902307 (1990). 2 ancestors in all.
222 later devices descend from it; 18 cite it directly.
0 of 225 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964226: Memory Staple (20 Sizes Available), Landos, Inc. (1997) Summary page 2.
- K902307: Shaw II Hemostatic Surgery System, Hemostatic Surgery Corp. (1990) Summary page 2.
- (no number) Zimmer Epiphyseal and Fracture staples: named in the summary without a submission number
- (no number) Smith & Nephew’s Richard’s Regular Fixation Staple: named in the summary without a submission number
- (no number) Accu-Temp surgical cautery device: named in the summary without a submission number

## Most influential descendants
- K011716: The Uni-Clip Staple (2001), 117 descendants of its own
- K070031: Memometal Memory Staples (2007), 114 descendants of its own
- K061594: Large Uni-Clip Staple (2006), 103 descendants of its own
- K070447: Newdeal Compression Plate (2007), 102 descendants of its own
- K093914: Newdeal Compression Plates (2011), 98 descendants of its own

## Indications for use
The Memograph® 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) fixation of soft tissue to bone such as anterior cruciate reconstruction.

Source page: https://510kreport.com/device/K993714
Methodology: https://510kreport.com/methodology