510(k) · Cleared
ClearedRestore Bunion Correction System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nextremity Solutions · JDR Staple, Fixation, Bone
Cleared on Aug 28, 2013 as substantially equivalent to K121277 (Z-Medical GmbH & Co. KG, 2012) and 2 other predicates after a 134-day review. Its family tree reaches back 7 generations to 2000. 15 later devices descend from it.
- Decided
- Aug 28, 2013
- Review
- 134 days
- Class
- Class II
- Product code
- JDR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K000684 (2000). 57 ancestors in all, the oldest K792022 (1979). 15 later devices descend from it, 4 citing it directly.
- Root · 7 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 6 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
- 5 generations backK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
- 4 generations backK021626 Hallu PlatesNew Deal, S.A. · 2002
- 3 generations backK040907 Arthrex Small Fragment Plates and ScrewsArthrex, Inc. · 2004
- 2 generations backK052614 Low Profile Plate and Screw SystemArthrex, Inc. · 2005
- 1 generation backK103705 Low Profile ScrewsArthrex, Inc. · 2011
- This deviceK131061 Restore Bunion Correction SystemNextremity Solutions · 2013
- Descendant · cites it directly · 8 of its ownK170214 Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC · 2017
- Descendant · 2 generations on · 5 of its ownK183011 Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics · 2019
- Descendant · 3 generations on · 4 of its ownK193614 FINE Osteotomy around the kneeBodycad Laboratories, Inc. · 2020
- Descendant · cites it directly · 3 of its ownK242415 TMC Compression Implant SystemTreace Medical Concepts · 2024
- Descendant · 4 generations on · 3 of its ownK211646 FINE OsteotomyBodycad Laboratories, Inc. · 2021
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC · 2017 · cites it directly8descendants
- K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics · 2019 · 2 generations on5descendants
- K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc. · 2020 · 3 generations on4descendants
- K242415TMC Compression Implant SystemTreace Medical Concepts · 2024 · cites it directly3descendants
- K211646FINE OsteotomyBodycad Laboratories, Inc. · 2021 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −6 | K011335 | Synths One-Third Tubular DCL Plate | Synthes (Usa) | 2001 | 2 |
| −5 | K012655 | Congruent Bone Plate System | Acu Med, Inc. | 2001 | 16 |
| −4 | K021626 | Hallu Plates | New Deal, S.A. | 2002 | — |
| −3 | K040907 | Arthrex Small Fragment Plates and Screws | Arthrex, Inc. | 2004 | — |
| −2 | K052614 | Low Profile Plate and Screw System | Arthrex, Inc. | 2005 | — |
| −1 | K103705 | Low Profile Screws | Arthrex, Inc. | 2011 | — |
| 0 (this device) | K131061 | Restore Bunion Correction System | Nextremity Solutions | 2013 | — |
| +1 | K170214 | Additive Orthopaedics Locking Lattice Plate | Additive Orthopaedics, LLC | 2017 | — |
| +2 | K183011 | Additive Orthopaedics Patient Specific 3D Locking Lattice Plates | Additive Orthopaedics | 2019 | — |
| +3 | K193614 | FINE Osteotomy around the knee | Bodycad Laboratories, Inc. | 2020 | — |
| +1 | K242415 | TMC Compression Implant System | Treace Medical Concepts | 2024 | — |
| +4 | K211646 | FINE Osteotomy | Bodycad Laboratories, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1989 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 8 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 5 | 0 |
| 2003 | 3 | 0 |
| 2005 | 6 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K121277 | Z-Snap Off Screw, Z-Double Thread Compression Screw, Z-Guide Wire, Z-StapleSummary page 1…-Medical GmbH &Co. KG Z-Guide Staple (Marketed as Z-Medical Staple) [510(k) K121277] Arthrex Inc. Arthrex Low Profile Screw (Marketed as Arthrex Lo… | 2012 |
| * | K103705 | Low Profile ScrewsSummary page 1…Arthrex Low Profile Screw (Marketed as Arthrex Low Profile Screw) [5 10(k) K103705] Biomet Trauma BioDriveTM Micro Screw System (Marketed as BioDri… | 2011 |
| * | K092670 | Biodrive Micro Screw SystemSummary page 1…BioDriveTM Micro Screw System (Marketed as BioDriveTM Micro Nail Plate/Screw) [5 10O(k) K092670] 6 K131061… | 2009 |
What descends from it? (15)
See all 154 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 13 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- 10 of the 57 ancestors have a recall of any class.
- Of its descendants, K170214 (Additive Orthopaedics, LLC, 2017) has gone furthest, with 8 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. 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 RestoreTM Fixation System is indicated for alignment, stabilization and fusion of fractures, osteotomies and arthrodesis of small bones such as the foot and ankle.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131061 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131061: Restore Bunion Correction System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131061
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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