510(k) · Cleared
ClearedStapix Superelastic Implant Bone Staples
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instratek, Inc. · JDR Staple, Fixation, Bone
Cleared on Feb 6, 2014 as substantially equivalent to K070031 (Memometal Technologies, 2007) and 2 other predicates after an 83-day review. Its family tree reaches back 4 generations to 1990. 3 later devices descend from it.
- Decided
- Feb 6, 2014
- Review
- 83 days
- Class
- Class II
- Product code
- JDR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K902307 (1990). 6 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK902307 Shaw II Hemostatic Surgery SystemHemostatic Surgery Corp. · 1990 · Recalled
- 3 generations backK993714 Memograph Staple, Warm SystemBiomedical Ent., Inc. · 2000
- 2 generations backK070031 Memometal Memory StaplesMemometal Technologies · 2007
- 1 generation backK122113 Memory Metal Staples, EasyclipStryker Corp. · 2013 · Recalled
- This deviceK133523 Stapix Superelastic Implant Bone StaplesInstratek, Inc. · 2014
- Descendant · cites it directly · 2 of its ownK162321 EasyClip XpressRestore Surgical, LLC Dba Instratek · 2017
- Descendant · 2 generations on · 1 of its ownK210582 EasyClip® and EasyClip® XpressStryker GmbH · 2022
- Descendant · 3 generations on · 0 of its ownK241932 OSSIOfiber® Compression StapleOSSIO, Ltd. · 2024
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K902307 | Shaw II Hemostatic Surgery System | Hemostatic Surgery Corp. | 1990 | 2 |
| −3 | K993714 | Memograph Staple, Warm System | Biomedical Ent., Inc. | 2000 | — |
| −2 | K070031 | Memometal Memory Staples | Memometal Technologies | 2007 | — |
| −1 | K122113 | Memory Metal Staples, Easyclip | Stryker Corp. | 2013 | 1 |
| 0 (this device) | K133523 | Stapix Superelastic Implant Bone Staples | Instratek, Inc. | 2014 | — |
| +1 | K162321 | EasyClip Xpress | Restore Surgical, LLC Dba Instratek | 2017 | — |
| +2 | K210582 | EasyClip® and EasyClip® Xpress | Stryker GmbH | 2022 | — |
| +3 | K241932 | OSSIOfiber® Compression Staple | OSSIO, Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 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? (3)
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…on name: Staple, Fixation, Bone JDR at 21 GFR Part 880.3030 Legally marketed device to Memometal Easyclip Cleared March 19, 2007 under K070031 which the device is Memory Metal Staples, Easyclip Cleared March 12, 2013 under substantially equivalent: K122113… | 2007 |
| * | K122113 | Memory Metal Staples, EasyclipSummary page 1…tal Easyclip Cleared March 19, 2007 under K070031 which the device is Memory Metal Staples, Easyclip Cleared March 12, 2013 under substantially equivalent: K122113 InteliFUSE, cleared June 29, 2005 under K051408 Description of the device: The Instratek STAPIXT… | 2013 |
| * | K051408 | Intelifuse, Inc. Warm System with StimulinksSummary page 1…Memory Metal Staples, Easyclip Cleared March 12, 2013 under substantially equivalent: K122113 InteliFUSE, cleared June 29, 2005 under K051408 Description of the device: The Instratek STAPIXTM Superelastic Implant Bone Staples kits are com… | 2005 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162321 | EasyClip Xpress | 2017 | 2 |
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 24 years and passes through 5 companies; a new generation was cleared every 7.1 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K162321 (Restore Surgical, LLC Dba Instratek, 2017) has gone furthest, with 2 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. 2014, 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 Instratek STAPIXTM Superelastic Implant is indicated for use in osteotomy and arthrodesis of bones and joints of the hands and feet.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133523 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133523: Stapix Superelastic Implant Bone Staples.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133523
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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