510(k) · Cleared
ClearedSonicweld RX (Resorb-X)
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 Jul 21, 2008 as substantially equivalent to K011590 (KLS-Martin L.P., 2002) and 2 other predicates after a 116-day review. Its family tree reaches back 7 generations to 1990. 4 later devices descend from it.
- Decided
- Jul 21, 2008
- Review
- 116 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K904436 (1990). 29 ancestors in all, the oldest K900138 (1990). 4 later devices descend from it, 3 citing it directly.
- 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 deviceK080862 Sonicweld RX (Resorb-X)KLS-Martin L.P. · 2008
- Descendant · cites it directly · 2 of its ownK112064 Resorb X-GKLS-Martin L.P. · 2012
- Descendant · cites it directly · 0 of its ownK141385 Depuy Synthes Injectable Polymer System (Ips)Depuy Synthes Companies of Johnson & Johnson · 2015 · Recalled
- Descendant · 2 generations on · 0 of its ownK133304 RXG Distraction SystemKLS-Martin L.P. · 2014
- Descendant · cites it directly · 0 of its ownK121606 Resorb-X GKLS-Martin L.P. · 2013
Most influential descendants
Showing 4 of 4 · See all- K112064Resorb X-GKLS-Martin L.P. · 2012 · cites it directly2descendants
- K141385Depuy Synthes Injectable Polymer System (Ips)Depuy Synthes Companies of Johnson & Johnson · 2015 · cites it directly0descendants
- K133304RXG Distraction SystemKLS-Martin L.P. · 2014 · 2 generations on0descendants
- K121606Resorb-X GKLS-Martin L.P. · 2013 · cites it directly0descendants
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) | K080862 | Sonicweld RX (Resorb-X) | KLS-Martin L.P. | 2008 | — |
| +1 | K112064 | Resorb X-G | KLS-Martin L.P. | 2012 | — |
| +1 | K141385 | Depuy Synthes Injectable Polymer System (Ips) | Depuy Synthes Companies of Johnson & Johnson | 2015 | 1 |
| +2 | K133304 | RXG Distraction System | KLS-Martin L.P. | 2014 | — |
| +1 | K121606 | Resorb-X G | KLS-Martin L.P. | 2013 | — |
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 | 5 | 0 |
| 1999 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 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 |
|---|---|---|---|
| * | K011590 | Resorb-X Resorbable Plating SystemSummary page 2…SF pins are designed to be used in conjunction with RESORB-X® Resorbable Plating System plates (K011590). Technological Characteristics: Similarities to Predicate The S… | 2002 |
| * | K051236 | Resorb-X SFSummary page 1…gulatory Class: 11 Predicate Devices: Resorb-X Resorbable Plating System (KO1 1590) Resorb-X SF (K051236) Synthes (USA) Rapid Resorbable Fixation System (K062789) Intended… | 2005 |
| * | K062789 | Synthes (Usa) Rapid Resorbable Fixation SystemSummary page 1…(KO1 1590) Resorb-X SF (K051236) Synthes (USA) Rapid Resorbable Fixation System (K062789) Intended Use: The KLS Martin SonicWeld RX (Resorb-X) is intended for use in fracture re… | 2007 |
What descends from it? (4)
3 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 18 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- 2 of the 29 ancestors have a recall of any class.
- Of its descendants, K112064 (KLS-Martin L.P., 2012) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K011590.
How does its category compare?
All JEY devicesJEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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 KLS Martin SonicWeld RX (Resorb-X) is intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in pediatric and adult populations. In addition, resorbable meshes, plates, screws and pins may be used in non-load bearing applications for maintaining the relative position of, and/or containing, bony fragments, bone grafts (autograft or allograft), or bone graft substitutes in reconstruction of the craniofacial or…
Read the full statement (141 words)
The KLS Martin SonicWeld RX (Resorb-X) is intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in pediatric and adult populations. In addition, resorbable meshes, plates, screws and pins may be used in non-load bearing applications for maintaining the relative position of, and/or containing, bony fragments, bone grafts (autograft or allograft), or bone graft substitutes in reconstruction of the craniofacial or mandibular areas.
The device is not intended for load bearing indications unless used in conjunction with traditional rigid fixation. The KLS Martin SonicWeld RX (Resorb-X) is not intended for areas with active or latent infection or for patient conditions including limited blood supply or insufficient quantity or quality of bone. These devices are not intended for use in the spine.
The SonicWeld Rx pins are designed only to be inserted with the SonicWeld Rx Sonotrode device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080862 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080862: Sonicweld RX (Resorb-X).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080862
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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