510(k) · Cleared
ClearedResorb X-G
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 23, 2012 as substantially equivalent to K080862 (KLS-Martin L.P., 2008) and 2 other predicates after a 248-day review. Its family tree reaches back 8 generations to 1990. 2 later devices descend from it.
- Decided
- Mar 23, 2012
- Review
- 248 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K904436 (1990). 31 ancestors in all, the oldest K900138 (1990). 2 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK904436 Quickanchor (TM)Mitek Surgical Products, Inc. · 1990
- 7 generations backK962397 Statak Soft Tissue Attachment DeviceZimmer, Inc. · 1996
- 6 generations backK972783 Biofix Biodegradable Threaded Suture AnchorBionx Implants, Inc. · 1998
- 5 generations backK982139 Biosorbfx 1.5/2.0 Bioabsorbable Fixation SystemBionx Implants, Inc. · 1998
- 4 generations backK993061 Stryker Leibinger Resorbable Fixation SystemStryker Instruments · 1999
- 3 generations backK011590 Resorb-X Resorbable Plating SystemKLS-Martin L.P. · 2002
- 2 generations backK051236 Resorb-X SFKLS-Martin L.P. · 2005
- 1 generation backK080862 Sonicweld RX (Resorb-X)KLS-Martin L.P. · 2008
- This deviceK112064 Resorb X-GKLS-Martin L.P. · 2012
- Descendant · cites it directly · 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 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K904436 | Quickanchor (TM) | Mitek Surgical Products, Inc. | 1990 | — |
| −7 | K962397 | Statak Soft Tissue Attachment Device | Zimmer, Inc. | 1996 | — |
| −6 | K972783 | Biofix Biodegradable Threaded Suture Anchor | Bionx Implants, Inc. | 1998 | — |
| −5 | K982139 | Biosorbfx 1.5/2.0 Bioabsorbable Fixation System | Bionx Implants, Inc. | 1998 | — |
| −4 | K993061 | Stryker Leibinger Resorbable Fixation System | Stryker Instruments | 1999 | — |
| −3 | K011590 | Resorb-X Resorbable Plating System | KLS-Martin L.P. | 2002 | — |
| −2 | K051236 | Resorb-X SF | KLS-Martin L.P. | 2005 | — |
| −1 | K080862 | Sonicweld RX (Resorb-X) | KLS-Martin L.P. | 2008 | — |
| 0 (this device) | K112064 | Resorb X-G | KLS-Martin L.P. | 2012 | — |
| +1 | 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 | 2 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 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 |
|---|---|---|---|
| * | K080862 | Sonicweld RX (Resorb-X)Summary page 1…rb-X G Classification: Class 11, §872.4760- Bone Plate Product Code: JEY Predicate Devices: SonicWeld RX (Resorb-X) (K080862) Synthes (USA) Rapid Resorbable Fixation System (K(062789) Biom… | 2008 |
| * | K062789 | Synthes (Usa) Rapid Resorbable Fixation SystemSummary page 2…ffers in chemical composition from the SonicWeld-RX (Resorb-X) (PDLLA) material, but is the same as that in K062789 and K.992355. Performance Testing: Chemical analysis to ISO 10993-12, -18 and mechanical… | 2007 |
| * | K992355 | Lactosorb Trauma Plating SystemSummary page 1…Synthes (USA) Rapid Resorbable Fixation System (K(062789) Biomet, Inc. Lactosorb Trauma Plating System (K(992355) Device Description: KLS Martin Resorb-XCG is a resorbable fixation system similar… | 1999 |
What descends from it? (2)
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 22 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
- 2 of the 31 ancestors have a recall of any class.
- Of its descendants, K133304 (KLS-Martin L.P., 2014) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K080862.
How does its category compare?
All JEY devicesJEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Resorb-X G is intended for use in non-load bearing fracture repair and reconstructive procedures in adolescent and adult populations. In addition, resorbable meshes, plates 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 oral and maxillofacial reconstruction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112064 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112064: Resorb X-G.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112064
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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