510(k) · Cleared
ClearedOrthohelix Staple System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthohelix Surgical Designs, Inc. · JDR Staple, Fixation, Bone
Cleared on Aug 15, 2013 as substantially equivalent to K070031 (Memometal Technologies, 2007) and 1 other predicate after a 142-day review. Its family tree reaches back 3 generations to 1990. 1 later device descends from it.
- Decided
- Aug 15, 2013
- Review
- 142 days
- Class
- Class II
- Product code
- JDR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K902307 (1990). 4 ancestors in all. 1 later device descends from it, 1 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 deviceK130832 Orthohelix Staple SystemOrthohelix Surgical Designs, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK142148 Orthohelix Staple SystemOrthohelix Surgical Designs, Inc. · 2014
Most influential descendants
Showing 1 of 1 · See all- K142148Orthohelix Staple SystemOrthohelix Surgical Designs, Inc. · 2014 · cites it directly0descendants
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) | K130832 | Orthohelix Staple System | Orthohelix Surgical Designs, Inc. | 2013 | — |
| +1 | K142148 | Orthohelix Staple System | Orthohelix Surgical Designs, Inc. | 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 | 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? (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 |
|---|---|---|---|
| * | K070031 | Memometal Memory StaplesSummary page 1…ubstantial Equivalence: The new Orthol-eiXTM staples are substantially equivalent to the Stryker (Memometal Technologies) EasyClip Staple (K(070031) and the BioMedical Enterprises Inc. Speed Staple (K(993714). The Orthol-eixT M Staple System… | 2007 |
| * | K993714 | Memograph Staple, Warm SystemSummary page 1…the Stryker (Memometal Technologies) EasyClip Staple (K(070031) and the BioMedical Enterprises Inc. Speed Staple (K(993714). The Orthol-eixT M Staple System conforms to ASTM F2063 Standard Specification for Wrought Nickel-Tit… | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142148 | Orthohelix Staple System | 2014 | 0 |
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 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, K142148 (Orthohelix Surgical Designs, Inc., 2014) has gone furthest, with 0 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 OrthoHelix M Staple System is indicated for fixation in the hand and foot including
fractures, fusions, and osteotomies.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130832 · printed Nov 5, 2026
Cite this page
510(k) Report. “K130832: Orthohelix Staple System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K130832
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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