510(k) · Cleared
ClearedSonicweld RX Endobrow Fixation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KLS-Martin L.P. · JEY Plate, Bone
Cleared on Sep 21, 2006 as substantially equivalent to K051236 (KLS-Martin L.P., 2005) and 2 other predicates after a 112-day review. Its family tree reaches back 7 generations to 1990.
- Decided
- Sep 21, 2006
- Review
- 112 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K904436 (1990). 32 ancestors in all, the oldest K900138 (1990). No later device cites it as a predicate yet.
- Root · 7 generations backK904436 Quickanchor (TM)Mitek Surgical Products, Inc. · 1990
- 6 generations backK962397 Statak Soft Tissue Attachment DeviceZimmer, Inc. · 1996
- 5 generations backK972783 Biofix Biodegradable Threaded Suture AnchorBionx Implants, Inc. · 1998
- 4 generations backK982139 Biosorbfx 1.5/2.0 Bioabsorbable Fixation SystemBionx Implants, Inc. · 1998
- 3 generations backK993061 Stryker Leibinger Resorbable Fixation SystemStryker Instruments · 1999
- 2 generations backK011590 Resorb-X Resorbable Plating SystemKLS-Martin L.P. · 2002
- 1 generation backK051236 Resorb-X SFKLS-Martin L.P. · 2005
- This deviceK061507 Sonicweld RX Endobrow FixationKLS-Martin L.P. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K904436 | Quickanchor (TM) | Mitek Surgical Products, Inc. | 1990 | — |
| −6 | K962397 | Statak Soft Tissue Attachment Device | Zimmer, Inc. | 1996 | — |
| −5 | K972783 | Biofix Biodegradable Threaded Suture Anchor | Bionx Implants, Inc. | 1998 | — |
| −4 | K982139 | Biosorbfx 1.5/2.0 Bioabsorbable Fixation System | Bionx Implants, Inc. | 1998 | — |
| −3 | K993061 | Stryker Leibinger Resorbable Fixation System | Stryker Instruments | 1999 | — |
| −2 | K011590 | Resorb-X Resorbable Plating System | KLS-Martin L.P. | 2002 | — |
| −1 | K051236 | Resorb-X SF | KLS-Martin L.P. | 2005 | — |
| 0 (this device) | K061507 | Sonicweld RX Endobrow Fixation | KLS-Martin L.P. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 5 | 0 |
| 1997 | 2 | 0 |
| 1998 | 6 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2005 | 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 JEY? 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 JEY device
- #1 K252246 Leforte MMF Systemscore 15.6 · 16 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 |
|---|---|---|---|
| * | K051236 | Resorb-X SF | 2005 |
| * | K051845 | The Bioplate Resorbable Endobrow Fixation SystemSummary page 1…ass: II Predicate Devices: Resorb-X SF (KO5i1236) The Bioplate Resorbable Endobrow Fixation System (K051 845) LactoSorb Craniofacial Anchor-Push Screw (KOl1 3557) Intended Use:… | 2005 |
| * | K013557 | Lactosorb Craniofacial Anchor-Push Screw | 2001 |
What descends from it?
No later submission names this one as a predicate yet.
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 16 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 2 of the 32 ancestors have a recall of any class.
- 1 other device also cites its predicate K051236.
How does its category compare?
All JEY devicesJEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JEY
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JEY
159in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JEY
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JEY
1,003in 2025
MAUDE reports naming product code JEY, 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 | 9 | 115 | 0 | 29 |
| 2008 | 7 | 84 | 3 | 24 |
| 2009 | 4 | 121 | 6 | 93 |
| 2010 | 6 | 199 | 85 | 215 |
| 2011 | 5 | 75 | 0 | 241 |
| 2012 | 10 | 194 | 0 | 428 |
| 2013 | 8 | 126 | 1 | 766 |
| 2014 | 6 | 223 | 0 | 616 |
| 2015 | 7 | 160 | 0 | 767 |
| 2016 | 1 | — | 0 | 558 |
| 2017 | 5 | 190 | 0 | 568 |
| 2018 | 7 | 255 | 0 | 608 |
| 2019 | 6 | 163 | 0 | 595 |
| 2020 | 6 | 198 | 1 | 680 |
| 2021 | 4 | 299 | 0 | 451 |
| 2022 | 5 | 135 | 0 | 344 |
| 2023 | 2 | — | 0 | 495 |
| 2024 | 5 | 159 | 0 | 696 |
| 2025 | 2 | — | 0 | 1,003 |
| 2026 | 3 | 258 | 0 | — |
What is it indicated for?
The SonicWeld Rx Endobrow Fixation will be used to support non-load bearing tissues of the craniofacial skeleton, including but not limited to endobrow fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061507 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061507: Sonicweld RX Endobrow Fixation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061507
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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