510(k) · Cleared
Recalled · Class II · 2020Memory Metal Staples, Easyclip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Corp. · JDR Staple, Fixation, Bone
Cleared on Mar 12, 2013 as substantially equivalent to K070031 (Memometal Technologies, 2007) after a 238-day review. Its family tree reaches back 3 generations to 1990. 13 later devices descend from it. It has been recalled once.
- Decided
- Mar 12, 2013
- Review
- 238 days
- Class
- Class II
- Product code
- JDR
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K902307 (1990). 4 ancestors in all. 13 later devices descend from it, 6 citing it directly.
- Root · 3 generations backK902307 Shaw II Hemostatic Surgery SystemHemostatic Surgery Corp. · 1990 · Recalled
- 2 generations backK993714 Memograph Staple, Warm SystemBiomedical Ent., Inc. · 2000
- 1 generation backK070031 Memometal Memory StaplesMemometal Technologies · 2007
- This deviceK122113 Memory Metal Staples, EasyclipStryker Corp. · 2013
- Descendant · cites it directly · 3 of its ownK133523 Stapix Superelastic Implant Bone StaplesInstratek, Inc. · 2014
- Descendant · cites it directly · 2 of its ownK243658 TMC Compression Implant SystemTreace Medical Concepts · 2024
- Descendant · cites it directly · 2 of its ownK162321 EasyClip XpressRestore Surgical, LLC Dba Instratek · 2017
- Descendant · cites it directly · 2 of its ownK161426 NeoSpan Compression Staple Impant w/instrumentsIn2bones USA, LLC · 2016 · Recalled
- Descendant · cites it directly · 2 of its ownK142111 Arcad Compressive Osteosynthesis Staple, Express Compressive…Novatsep · 2014
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K133523Stapix Superelastic Implant Bone StaplesInstratek, Inc. · 2014 · cites it directly3descendants
- K243658TMC Compression Implant SystemTreace Medical Concepts · 2024 · cites it directly2descendants
- K162321EasyClip XpressRestore Surgical, LLC Dba Instratek · 2017 · cites it directly2descendants
- K161426NeoSpan Compression Staple Impant w/instrumentsIn2bones USA, LLC · 2016 · cites it directly2descendants
- K142111Arcad Compressive Osteosynthesis Staple, Express Compressive Osteosynthesis StapleNovatsep · 2014 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K902307 | Shaw II Hemostatic Surgery System | Hemostatic Surgery Corp. | 1990 | 2 |
| −2 | K993714 | Memograph Staple, Warm System | Biomedical Ent., Inc. | 2000 | — |
| −1 | K070031 | Memometal Memory Staples | Memometal Technologies | 2007 | — |
| 0 (this device) | K122113 | Memory Metal Staples, Easyclip | Stryker Corp. | 2013 | — |
| +1 | K133523 | Stapix Superelastic Implant Bone Staples | Instratek, Inc. | 2014 | — |
| +1 | K243658 | TMC Compression Implant System | Treace Medical Concepts | 2024 | — |
| +1 | K162321 | EasyClip Xpress | Restore Surgical, LLC Dba Instratek | 2017 | — |
| +1 | K161426 | NeoSpan Compression Staple Impant w/instruments | In2bones USA, LLC | 2016 | 2 |
| +1 | K142111 | Arcad Compressive Osteosynthesis Staple, Express Compressive Osteosynthesis… | Novatsep | 2014 | — |
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 |
|---|---|---|
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 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? (1)
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 |
|---|---|---|---|
| * | K070031 | Memometal Memory StaplesSummary page 1…parison showed that the proposed device is substantially equivalent in intended, use, materials and performance characteristics to the following predicate devices: gK070031 - Memometal Memory Staples Non-Clinical Testing: Dimensional (geometric cross section) and engineering strength analyses as well… | 2007 |
What descends from it? (13)
See all 136 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133523 | Stapix Superelastic Implant Bone Staples | 2014 | 3 |
| K243658 | TMC Compression Implant System | 2024 | 2 |
| K162321 | EasyClip Xpress | 2017 | 2 |
| K161426 | NeoSpan Compression Staple Impant w/instruments | 2016 | 2 |
| K142111 | Arcad Compressive Osteosynthesis Staple, Express Compressive Osteosynthesis Staple | 2014 | 2 |
| K210582 | EasyClip® and EasyClip® Xpress | 2022 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 25, 2020 | Class II | Z-0457-2021 | Under Investigation by firm | The device has the potential to release nickel above the acceptable margin of safety in pediatric patients who weigh less than 20 kg (44.09 lbs) when 2 or more implants are used. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 4 companies; a new generation was cleared every 7.1 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K133523 (Instratek, Inc., 2014) has gone furthest, with 3 descendants of its own.
- 12 other devices also cite its predicate K070031.
How does its category compare?
All JDR devicesJDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 MEMORY METAL 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/K122113 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122113: Memory Metal Staples, Easyclip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122113
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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