510(k) · Cleared
ClearedResorb-X Resorbable Plating System
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 Mar 20, 2002 as substantially equivalent to K955729 (Poly-Medics,Inc., 1996) and 9 other predicates after a 301-day review. Its family tree reaches back 5 generations to 1990. 73 later devices descend from it.
- Decided
- Mar 20, 2002
- Review
- 301 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 5 generations to K904436 (1990). 26 ancestors in all, the oldest K900138 (1990). 73 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK904436 Quickanchor (TM)Mitek Surgical Products, Inc. · 1990
- 4 generations backK962397 Statak Soft Tissue Attachment DeviceZimmer, Inc. · 1996
- 3 generations backK972783 Biofix Biodegradable Threaded Suture AnchorBionx Implants, Inc. · 1998
- 2 generations backK982139 Biosorbfx 1.5/2.0 Bioabsorbable Fixation SystemBionx Implants, Inc. · 1998
- 1 generation backK993061 Stryker Leibinger Resorbable Fixation SystemStryker Instruments · 1999
- This deviceK011590 Resorb-X Resorbable Plating SystemKLS-Martin L.P. · 2002
- Descendant · cites it directly · 65 of its ownK060177 KLS Martin Rigid Fixation - SterileKLS Martin L.P. · 2006
- Descendant · 2 generations on · 61 of its ownK070169 KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P. · 2007
- Descendant · 3 generations on · 45 of its ownK151983 KLS Martin LSS Plating SystemKLS Martin L.P. · 2016
- Descendant · 4 generations on · 39 of its ownK202889 Able Medical Devices Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D.B.A. Able Medical Devices · 2021
- Descendant · 5 generations on · 36 of its ownK220782 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody…Alphatec Spine, Inc. · 2022
Showing 5 of 73 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 73 · See all- K060177KLS Martin Rigid Fixation - SterileKLS Martin L.P. · 2006 · cites it directly65descendants
- K070169KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P. · 2007 · 2 generations on61descendants
- K151983KLS Martin LSS Plating SystemKLS Martin L.P. · 2016 · 3 generations on45descendants
- K202889Able Medical Devices Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D.B.A. Able Medical Devices · 2021 · 4 generations on39descendants
- K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc. · 2022 · 5 generations on36descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K904436 | Quickanchor (TM) | Mitek Surgical Products, Inc. | 1990 | — |
| −4 | K962397 | Statak Soft Tissue Attachment Device | Zimmer, Inc. | 1996 | — |
| −3 | K972783 | Biofix Biodegradable Threaded Suture Anchor | Bionx Implants, Inc. | 1998 | — |
| −2 | K982139 | Biosorbfx 1.5/2.0 Bioabsorbable Fixation System | Bionx Implants, Inc. | 1998 | — |
| −1 | K993061 | Stryker Leibinger Resorbable Fixation System | Stryker Instruments | 1999 | — |
| 0 (this device) | K011590 | Resorb-X Resorbable Plating System | KLS-Martin L.P. | 2002 | — |
| +1 | K060177 | KLS Martin Rigid Fixation - Sterile | KLS Martin L.P. | 2006 | — |
| +2 | K070169 | KLS Martin Quick Disc, Sternal Talon and Sternal Plating - Sterile | KLS Martin L.P. | 2007 | — |
| +3 | K151983 | KLS Martin LSS Plating System | KLS Martin L.P. | 2016 | — |
| +4 | K202889 | Able Medical Devices Valkyrie Thoracic Fixation System | Jm Longyear Manufacturing, LLC D.B.A. Able Medical Devices | 2021 | — |
| +5 | K220782 | IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System… | Alphatec Spine, Inc. | 2022 | — |
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 |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 8 | 0 |
| 2024 | 13 | 0 |
| 2025 | 15 | 0 |
| 2026 | 12 | 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? (10)
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 |
|---|---|---|---|
| * | K955729 | Lactosorb Trauma Plating SystemSummary page 1…Lane New Port Ritchey, Florida 34655 Phone: 813-645-2855 Fax: 813-645-2856 Art Ward Resorb-X Resorbable Plating System Plate, Fixation, Bone, Non-Spinal, Non-Metallic K955729, K960988, K971870, K974309, K992158 — W. Lorenz Lactosorb® Trauma Plating System K972913 — Macropore Protective Sheet K974554 —… | 1996 |
| * | K960988 | Lactosorb Trauma Plating SystemSummary page 1…Port Ritchey, Florida 34655 Phone: 813-645-2855 Fax: 813-645-2856 Art Ward Resorb-X Resorbable Plating System Plate, Fixation, Bone, Non-Spinal, Non-Metallic K955729, K960988, K971870, K974309, K992158 — W. Lorenz Lactosorb® Trauma Plating System K972913 — Macropore Protective Sheet K974554 — Synthes… | 1996 |
| * | K971870 | Lactosorb Trauma Plating SystemSummary page 1…hey, Florida 34655 Phone: 813-645-2855 Fax: 813-645-2856 Art Ward Resorb-X Resorbable Plating System Plate, Fixation, Bone, Non-Spinal, Non-Metallic K955729, K960988, K971870, K974309, K992158 — W. Lorenz Lactosorb® Trauma Plating System K972913 — Macropore Protective Sheet K974554 — Synthes Resorbabl… | 1997 |
| * | K974309 | Lactosorb PanelsSummary page 1…ida 34655 Phone: 813-645-2855 Fax: 813-645-2856 Art Ward Resorb-X Resorbable Plating System Plate, Fixation, Bone, Non-Spinal, Non-Metallic K955729, K960988, K971870, K974309, K992158 — W. Lorenz Lactosorb® Trauma Plating System K972913 — Macropore Protective Sheet K974554 — Synthes Resorbable Fixatio… | 1998 |
| * | K992158 | Lactosorb SheetsSummary page 1…Phone: 813-645-2855 Fax: 813-645-2856 Art Ward Resorb-X Resorbable Plating System Plate, Fixation, Bone, Non-Spinal, Non-Metallic K955729, K960988, K971870, K974309, K992158 — W. Lorenz Lactosorb® Trauma Plating System K972913 — Macropore Protective Sheet K974554 — Synthes Resorbable Fixation System… | 1999 |
| * | K972913 | Macropore Protective Sheet (Protego System)Summary page 1…rb-X Resorbable Plating System Plate, Fixation, Bone, Non-Spinal, Non-Metallic K955729, K960988, K971870, K974309, K992158 — W. Lorenz Lactosorb® Trauma Plating System K972913 — Macropore Protective Sheet K974554 — Synthes Resorbable Fixation System K982139 — BioSorbFX, Bioabsorbable Fixation System K9… | 1998 |
| * | K974554 | Synthes Resorbable Fixation SystemSummary page 1…Fixation, Bone, Non-Spinal, Non-Metallic K955729, K960988, K971870, K974309, K992158 — W. Lorenz Lactosorb® Trauma Plating System K972913 — Macropore Protective Sheet K974554 — Synthes Resorbable Fixation System K982139 — BioSorbFX, Bioabsorbable Fixation System K982531 — Howemedica Fixation System K9… | 1998 |
| * | K982139 | Biosorbfx 1.5/2.0 Bioabsorbable Fixation SystemSummary page 1…729, K960988, K971870, K974309, K992158 — W. Lorenz Lactosorb® Trauma Plating System K972913 — Macropore Protective Sheet K974554 — Synthes Resorbable Fixation System K982139 — BioSorbFX, Bioabsorbable Fixation System K982531 — Howemedica Fixation System K993061 — Stryker Leibinger System The KLS-Mart… | 1998 |
| * | K982531 | Howmedica Leibinger Resorbable Fixation SystemSummary page 1…Lactosorb® Trauma Plating System K972913 — Macropore Protective Sheet K974554 — Synthes Resorbable Fixation System K982139 — BioSorbFX, Bioabsorbable Fixation System K982531 — Howemedica Fixation System K993061 — Stryker Leibinger System The KLS-Martin Resorb-X resorbable plating system consists of a… | 1998 |
| * | K993061 | Stryker Leibinger Resorbable Fixation SystemSummary page 1…2913 — Macropore Protective Sheet K974554 — Synthes Resorbable Fixation System K982139 — BioSorbFX, Bioabsorbable Fixation System K982531 — Howemedica Fixation System K993061 — Stryker Leibinger System The KLS-Martin Resorb-X resorbable plating system consists of all necessary Instrumentation to employ… | 1999 |
What descends from it? (73)
See all 733 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 12 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 1 of the 26 ancestors has a recall of any class.
- Of its descendants, K060177 (KLS Martin L.P., 2006) has gone furthest, with 65 descendants of its own.
- 5 other devices also cite its predicate K955729.
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 KLS-Martin Resorb-X System 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 KLS-Martin Resorb-X System 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K011590 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011590: Resorb-X Resorbable Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011590
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026