510(k) · Cleared
ClearedMemometal Memory Staples
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Memometal Technologies · JDR Staple, Fixation, Bone
Cleared on Mar 19, 2007 as substantially equivalent to K964226 (Landos, Inc., 1997) and 1 other predicate after a 75-day review. Its family tree reaches back 2 generations to 1990. 114 later devices descend from it.
- Decided
- Mar 19, 2007
- Review
- 75 days
- Class
- Class II
- Product code
- JDR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K902307 (1990). 3 ancestors in all. 114 later devices descend from it, 13 citing it directly.
- Root · 2 generations backK902307 Shaw II Hemostatic Surgery SystemHemostatic Surgery Corp. · 1990 · Recalled
- 1 generation backK993714 Memograph Staple, Warm SystemBiomedical Ent., Inc. · 2000
- This deviceK070031 Memometal Memory StaplesMemometal Technologies · 2007
- Descendant · cites it directly · 58 of its ownK111678 Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited · 2012 · Recalled
- Descendant · cites it directly · 29 of its ownK124045 Fuseforce Implant SystemSolana Surgical, LLC · 2013
- Descendant · 2 generations on · 28 of its ownK141784 Ortho Solutions Ultos Plating SystemOrtho Solutions Limited · 2014 · Recalled
- Descendant · 2 generations on · 24 of its ownK131722 I.T.S. Extremity Fixation SystemsI.T.S. GmbH · 2013 · Recalled
- Descendant · 2 generations on · 19 of its ownK162674 BioPro Foot Plating SystemsBiopro, Inc. · 2017
Showing 5 of 114 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 114 · See all- K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited · 2012 · cites it directly58descendants
- K124045Fuseforce Implant SystemSolana Surgical, LLC · 2013 · cites it directly29descendants
- K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited · 2014 · 2 generations on28descendants
- K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH · 2013 · 2 generations on24descendants
- K162674BioPro Foot Plating SystemsBiopro, Inc. · 2017 · 2 generations on19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K902307 | Shaw II Hemostatic Surgery System | Hemostatic Surgery Corp. | 1990 | 2 |
| −1 | K993714 | Memograph Staple, Warm System | Biomedical Ent., Inc. | 2000 | — |
| 0 (this device) | K070031 | Memometal Memory Staples | Memometal Technologies | 2007 | — |
| +1 | K111678 | Ortho Solutions Extremity Fixation Implants for Osteosysnthesis | Ortho Solutions Limited | 2012 | 1 |
| +1 | K124045 | Fuseforce Implant System | Solana Surgical, LLC | 2013 | — |
| +2 | K141784 | Ortho Solutions Ultos Plating System | Ortho Solutions Limited | 2014 | 2 |
| +2 | K131722 | I.T.S. Extremity Fixation Systems | I.T.S. GmbH | 2013 | 2 |
| +2 | K162674 | BioPro Foot Plating Systems | Biopro, Inc. | 2017 | — |
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 |
|---|---|---|
| 2012 | 3 | 0 |
| 2013 | 5 | 0 |
| 2014 | 7 | 0 |
| 2015 | 7 | 0 |
| 2016 | 4 | 0 |
| 2017 | 12 | 0 |
| 2018 | 6 | 0 |
| 2019 | 6 | 0 |
| 2020 | 6 | 0 |
| 2021 | 6 | 0 |
| 2022 | 7 | 0 |
| 2023 | 18 | 0 |
| 2024 | 10 | 0 |
| 2025 | 7 | 0 |
| 2026 | 10 | 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? (2)
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 1…CLIP - FOR FUSION) Common Name MEMORY STAPLE Classification Name Staple, Fixation, Bone Legally marketed K964226 MEMORY STAPLE (LANDOS - DEPUY Inc) predicate devices K993714 MEMOGRAPH STAPLE (BIOMEDICAL ENT. INC) Description… | 1997 |
| * | K993714 | Memograph Staple, Warm SystemSummary page 1…ORY STAPLE Classification Name Staple, Fixation, Bone Legally marketed K964226 MEMORY STAPLE (LANDOS - DEPUY Inc) predicate devices K993714 MEMOGRAPH STAPLE (BIOMEDICAL ENT. INC) Description MEMOMETAL MEMORY STAPLES are single-use bone… | 2000 |
What descends from it? (114)
See all 11413 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111678 | Ortho Solutions Extremity Fixation Implants for Osteosysnthesis | 2012 | 58 |
| K124045 | Fuseforce Implant System | 2013 | 29 |
| K122113 | Memory Metal Staples, Easyclip | 2013 | 13 |
| K112794 | Eos Small Bone Fixation System | 2012 | 9 |
| K142727 | CrossCLIP Implant System | 2014 | 8 |
| K153395 | OS2-C Compression Staple | 2016 | 7 |
| K123926 | Metasurg Nitinol Staple Implant | 2013 | 6 |
| K112837 | Vilex EZ-Staple (Memory Bone Fixation Staple) | 2012 | 5 |
| K153770 | OS2(R)-VP Varisation Staple | 2016 | 4 |
| K133523 | Stapix Superelastic Implant Bone Staples | 2014 | 3 |
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?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 9.5 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K111678 (Ortho Solutions Limited, 2012) has gone furthest, with 58 descendants of its own.
- 6 other devices also cite its predicate K964226.
How does its category compare?
All JDR devicesJDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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 MEMOMETAL MEMORY STAPLES (MEMOCLIP, EASYCLIP and FOR FUSION) are indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070031 · printed Nov 5, 2026
Cite this page
510(k) Report. “K070031: Memometal Memory Staples.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K070031
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