510(k) · Cleared
ClearedResorb-X SF
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 Aug 22, 2005 as substantially equivalent to K011590 (KLS-Martin L.P., 2002) after a 101-day review. Its family tree reaches back 6 generations to 1990. 6 later devices descend from it.
- Decided
- Aug 22, 2005
- Review
- 101 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K904436 (1990). 27 ancestors in all, the oldest K900138 (1990). 6 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK904436 Quickanchor (TM)Mitek Surgical Products, Inc. · 1990
- 5 generations backK962397 Statak Soft Tissue Attachment DeviceZimmer, Inc. · 1996
- 4 generations backK972783 Biofix Biodegradable Threaded Suture AnchorBionx Implants, Inc. · 1998
- 3 generations backK982139 Biosorbfx 1.5/2.0 Bioabsorbable Fixation SystemBionx Implants, Inc. · 1998
- 2 generations backK993061 Stryker Leibinger Resorbable Fixation SystemStryker Instruments · 1999
- 1 generation backK011590 Resorb-X Resorbable Plating SystemKLS-Martin L.P. · 2002
- This deviceK051236 Resorb-X SFKLS-Martin L.P. · 2005
- Descendant · cites it directly · 4 of its ownK080862 Sonicweld RX (Resorb-X)KLS-Martin L.P. · 2008
- Descendant · 2 generations on · 2 of its ownK112064 Resorb X-GKLS-Martin L.P. · 2012
- Descendant · 2 generations on · 0 of its ownK141385 Depuy Synthes Injectable Polymer System (Ips)Depuy Synthes Companies of Johnson & Johnson · 2015 · Recalled
- Descendant · 3 generations on · 0 of its ownK133304 RXG Distraction SystemKLS-Martin L.P. · 2014
- Descendant · 2 generations on · 0 of its ownK121606 Resorb-X GKLS-Martin L.P. · 2013
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K080862Sonicweld RX (Resorb-X)KLS-Martin L.P. · 2008 · cites it directly4descendants
- K112064Resorb X-GKLS-Martin L.P. · 2012 · 2 generations on2descendants
- K141385Depuy Synthes Injectable Polymer System (Ips)Depuy Synthes Companies of Johnson & Johnson · 2015 · 2 generations on0descendants
- K133304RXG Distraction SystemKLS-Martin L.P. · 2014 · 3 generations on0descendants
- K121606Resorb-X GKLS-Martin L.P. · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K904436 | Quickanchor (TM) | Mitek Surgical Products, Inc. | 1990 | — |
| −5 | K962397 | Statak Soft Tissue Attachment Device | Zimmer, Inc. | 1996 | — |
| −4 | K972783 | Biofix Biodegradable Threaded Suture Anchor | Bionx Implants, Inc. | 1998 | — |
| −3 | K982139 | Biosorbfx 1.5/2.0 Bioabsorbable Fixation System | Bionx Implants, Inc. | 1998 | — |
| −2 | K993061 | Stryker Leibinger Resorbable Fixation System | Stryker Instruments | 1999 | — |
| −1 | K011590 | Resorb-X Resorbable Plating System | KLS-Martin L.P. | 2002 | — |
| 0 (this device) | K051236 | Resorb-X SF | KLS-Martin L.P. | 2005 | — |
| +1 | K080862 | Sonicweld RX (Resorb-X) | KLS-Martin L.P. | 2008 | — |
| +2 | K112064 | Resorb X-G | KLS-Martin L.P. | 2012 | — |
| +2 | K141385 | Depuy Synthes Injectable Polymer System (Ips) | Depuy Synthes Companies of Johnson & Johnson | 2015 | 1 |
| +3 | K133304 | RXG Distraction System | KLS-Martin L.P. | 2014 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 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? (1)
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 1…n Name: Bone Plate Classification Name and Number: Bone Plate (872.4760) Regulatory Class: II Predicate Devices: RESORB-X® Resorbable Plating System (K01 1590) Siroson L and Sirosonic Ultrasonic Scalers (K033640) EMS Piezon® Master 600 (K022328… | 2002 |
| † | K033640 | Siroson L and Sirosonic L Ultrasonic Scalers | 2003 |
| † | K022328 | Ems Piezon Master 600 | 2002 |
What descends from it? (6)
2 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 15 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 27 ancestors has a recall of any class.
- Of its descendants, K080862 (KLS-Martin L.P., 2008) has gone furthest, with 4 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.
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 RESORB-X® SF is intended for fractures of the craniofacial skeleton including, but not limited to, comminuted fractures of the naso-ethomoidal and infraorbital areas, comminuted fractures of the frontal sinus wall, and midface fractures; and reconstructive procedures of the midface or craniofacial skeleton. The RESORB-X® SF pins are designed only to be inserted with the RESORB-X® SF Sonotrode device. The RESORB-X® SF is NOT intended for use in the…
Read the full statement (122 words)
The RESORB-X® SF is intended for fractures of the craniofacial skeleton including, but not limited to, comminuted fractures of the naso-ethomoidal and infraorbital areas, comminuted fractures of the frontal sinus wall, and midface fractures; and reconstructive procedures of the midface or craniofacial skeleton. The RESORB-X® SF pins are designed only to be inserted with the RESORB-X® SF Sonotrode device.
The RESORB-X® SF is NOT intended for use in the mandible or full load-bearing situations, nor in areas of active infection or for patients with conditions including blood supply limitations, insufficient quantity or quality of bone, or latent infections.
The RESORB-X® SF Sonotrode is NOT intended for any other use and is only intended for use for insertion of the RESORB-X® SF pins.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051236 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051236: Resorb-X SF.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051236
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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