510(k) · Cleared
ClearedArcus Staple System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nextremity Solutions, Inc. · JDR Staple, Fixation, Bone
Cleared on Sep 4, 2015 as substantially equivalent to K121277 (Z-Medical GmbH & Co. KG, 2012) and 1 other predicate after a 126-day review. Its family tree reaches back 4 generations to 1996. 1 later device descends from it.
- Decided
- Sep 4, 2015
- Review
- 126 days
- Class
- Class II
- Product code
- JDR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K961522 (1996). 13 ancestors in all, the oldest K894929 (1989). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK961522 Kirschner Wire (K-Wire) and Steinmann PinSynvasive Technology, Inc. · 1996
- 3 generations backK030665 Bone WireStork Instrumente GmbH · 2003
- 2 generations backK100736 Kirschner and Guide WiresSmt Schilling Metalltechnik GmbH · 2010
- 1 generation backK121277 Z-Snap Off Screw, Z-Double Thread Compression Screw, Z-Guide Wire…Z-Medical GmbH & Co. KG · 2012
- This deviceK151160 Arcus Staple SystemNextremity Solutions, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK210456 Ligament StapleMedacta International S.A. · 2021
Most influential descendants
Showing 1 of 1 · See all- K210456Ligament StapleMedacta International S.A. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K961522 | Kirschner Wire (K-Wire) and Steinmann Pin | Synvasive Technology, Inc. | 1996 | — |
| −3 | K030665 | Bone Wire | Stork Instrumente GmbH | 2003 | — |
| −2 | K100736 | Kirschner and Guide Wires | Smt Schilling Metalltechnik GmbH | 2010 | — |
| −1 | K121277 | Z-Snap Off Screw, Z-Double Thread Compression Screw, Z-Guide Wire, Z-Staple | Z-Medical GmbH & Co. KG | 2012 | — |
| 0 (this device) | K151160 | Arcus Staple System | Nextremity Solutions, Inc. | 2015 | — |
| +1 | K210456 | Ligament Staple | Medacta International S.A. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1996 | 1 | 0 |
| 2005 | 4 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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 |
|---|---|---|---|
| * | K121277 | Z-Snap Off Screw, Z-Double Thread Compression Screw, Z-Guide Wire, Z-StapleSummary page 4…Z-Medical, Z-Guide Staple System (Marketed as Z-Staple) [510(k) K121277] Memometal Technologies Varisation Staple (Marketed as Varisati… | 2012 |
| * | K070033 | Memometal Varisation, Models AV26-08, AV26-10, AV90-08 and AV90-10Summary page 4…es Varisation Staple (Marketed as Varisation Staple) [510(k) K070033] Description The Nextremity Solutions Arcus™ Staple System is a set, consisting of: A bone staple. 2. Necessary surg… | 2007 |
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 |
|---|---|---|---|
| K210456 | Ligament Staple | 2021 | 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 19 years and passes through 5 companies; a new generation was cleared every 6.5 years on median.
- 1 of the 13 ancestors has a recall of any class.
- Of its descendants, K210456 (Medacta International S.A., 2021) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K121277.
How does its category compare?
All JDR devicesJDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Nextremity Solutions Arcus™ Staple System is indicated for fixation of bone fractures, bone reconstruction, ligament, soft tissue and tendon.
Examples include:
· Fixation of bone fragments or small bones fractures
· Fracture management in the foot and hand
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151160 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151160: Arcus Staple System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151160
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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