510(k) · Cleared
ClearedMemograph Staple, Warm System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomedical Ent., Inc. · JDR Staple, Fixation, Bone
Cleared on Feb 25, 2000 as substantially equivalent to K964226 (Landos, Inc., 1997) and 1 other predicate after a 115-day review. Its family tree reaches back 1 generation to 1990. 222 later devices descend from it.
- Decided
- Feb 25, 2000
- Review
- 115 days
- Class
- Class II
- Product code
- JDR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K902307 (1990). 2 ancestors in all. 222 later devices descend from it, 18 citing it directly.
- Root · 1 generation backK902307 Shaw II Hemostatic Surgery SystemHemostatic Surgery Corp. · 1990 · Recalled
- This deviceK993714 Memograph Staple, Warm SystemBiomedical Ent., Inc. · 2000
- Descendant · cites it directly · 117 of its ownK011716 The Uni-Clip StapleNew Deal, S.A. · 2001 · Recalled
- Descendant · cites it directly · 114 of its ownK070031 Memometal Memory StaplesMemometal Technologies · 2007
- Descendant · 2 generations on · 103 of its ownK061594 Large Uni-Clip StapleNew Deal, S.A. · 2006
- Descendant · 3 generations on · 102 of its ownK070447 Newdeal Compression PlateNewdeal Sas · 2007 · Recalled
- Descendant · 4 generations on · 98 of its ownK093914 Newdeal Compression PlatesNewdeal Sas · 2011 · Recalled
Showing 5 of 222 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 222 · See all- K011716The Uni-Clip StapleNew Deal, S.A. · 2001 · cites it directly117descendants
- K070031Memometal Memory StaplesMemometal Technologies · 2007 · cites it directly114descendants
- K061594Large Uni-Clip StapleNew Deal, S.A. · 2006 · 2 generations on103descendants
- K070447Newdeal Compression PlateNewdeal Sas · 2007 · 3 generations on102descendants
- K093914Newdeal Compression PlatesNewdeal Sas · 2011 · 4 generations on98descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K902307 | Shaw II Hemostatic Surgery System | Hemostatic Surgery Corp. | 1990 | 2 |
| 0 (this device) | K993714 | Memograph Staple, Warm System | Biomedical Ent., Inc. | 2000 | — |
| +1 | K011716 | The Uni-Clip Staple | New Deal, S.A. | 2001 | 1 |
| +1 | K070031 | Memometal Memory Staples | Memometal Technologies | 2007 | — |
| +2 | K061594 | Large Uni-Clip Staple | New Deal, S.A. | 2006 | — |
| +3 | K070447 | Newdeal Compression Plate | Newdeal Sas | 2007 | 2 |
| +4 | K093914 | Newdeal Compression Plates | Newdeal Sas | 2011 | 5 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 4 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 5 | 0 |
| 2013 | 8 | 0 |
| 2014 | 15 | 0 |
| 2015 | 16 | 0 |
| 2016 | 10 | 0 |
| 2017 | 22 | 0 |
| 2018 | 13 | 0 |
| 2019 | 11 | 0 |
| 2020 | 19 | 0 |
| 2021 | 13 | 0 |
| 2022 | 15 | 0 |
| 2023 | 24 | 0 |
| 2024 | 16 | 0 |
| 2025 | 10 | 0 |
| 2026 | 13 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JDR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JDR device
- #1 K243658 TMC Compression Implant Systemscore 16.7 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K964226 | Memory Staple (20 Sizes Available)Summary page 2…878.4400, 4750 and 886-4115). The Memograph® Staple System is a Class II medical device. The Memograph® Staple is substantially equivalent to the Memory Staple™ (510(k) 964226). The Memory Staple™ and the Memograph® Staple use a shape memory material (Nitinol) to achieve compression when heat allows the… | 1997 |
| * | K902307 | Shaw II Hemostatic Surgery SystemSummary page 2…l and Fracture staples and Smith & Nephew’s Richard’s Regular Fixation Staple. The Warmsystem heating unit is substantially equivalent to the Hemostatic Surgical System (K902307) by Hemostatic surgery Corporation and the Accu-Temp surgical cautery device (preamendment) by Concept, Inc. These predicate devi… | 1990 |
| * | — | Zimmer Epiphyseal and Fracture staples Named without a submission number | |
| * | — | Smith & Nephew’s Richard’s Regular Fixation Staple Named without a submission number | |
| * | — | Accu-Temp surgical cautery device Named without a submission number |
What descends from it? (222)
See all 22218 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K011716 | The Uni-Clip Staple | 2001 | 117 |
| K070031 | Memometal Memory Staples | 2007 | 114 |
| K124022 | Speed Shift | 2013 | 20 |
| K142292 | Speed, Speed Shift, Speed Titan, Speed Arc | 2014 | 13 |
| K123926 | Metasurg Nitinol Staple Implant | 2013 | 6 |
| K051408 | Intelifuse, Inc. Warm System with Stimulinks | 2005 | 6 |
| K122871 | Compressyn Staple | 2013 | 4 |
| K143622 | dynaMX Compression Staple | 2015 | 3 |
| K153129 | dynaMX Tabbed Staple | 2016 | 2 |
| K172052 | Arthrex DynaNite Nitinol Staple | 2017 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All JDR devicesJDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JDR
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDR
65in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDR
11in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDR
314in 2025
MAUDE reports naming product code JDR, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 8 | 70 | 0 | 3 |
| 2008 | 5 | 89 | 1 | 14 |
| 2009 | 0 | — | 0 | 10 |
| 2010 | 2 | — | 0 | 35 |
| 2011 | 1 | — | 0 | 62 |
| 2012 | 1 | — | 0 | 34 |
| 2013 | 9 | 137 | 0 | 27 |
| 2014 | 11 | 97 | 0 | 49 |
| 2015 | 7 | 111 | 1 | 48 |
| 2016 | 6 | 101 | 0 | 76 |
| 2017 | 9 | 172 | 0 | 116 |
| 2018 | 8 | 107 | 1 | 239 |
| 2019 | 5 | 149 | 0 | 242 |
| 2020 | 4 | 161 | 1 | 234 |
| 2021 | 3 | 62 | 0 | 210 |
| 2022 | 5 | 107 | 11 | 202 |
| 2023 | 9 | 72 | 0 | 175 |
| 2024 | 4 | 29 | 0 | 206 |
| 2025 | 3 | 65 | 0 | 314 |
| 2026 | 2 | — | 2 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993714 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993714: Memograph Staple, Warm System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993714
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026