510(k) · Cleared
ClearedRXG Distraction 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 May 15, 2014 as substantially equivalent to K030425 (Walter Lorenz Surgical, Inc., 2004) and 3 other predicates after a 199-day review. Its family tree reaches back 9 generations to 1990.
- Decided
- May 15, 2014
- Review
- 199 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K904436 (1990). 37 ancestors in all, the oldest K900138 (1990). No later device cites it as a predicate yet.
- Root · 9 generations backK904436 Quickanchor (TM)Mitek Surgical Products, Inc. · 1990
- 5 generations between
- 3 generations backK051236 Resorb-X SFKLS-Martin L.P. · 2005
- 2 generations backK080862 Sonicweld RX (Resorb-X)KLS-Martin L.P. · 2008
- 1 generation backK112064 Resorb X-GKLS-Martin L.P. · 2012
- This deviceK133304 RXG Distraction SystemKLS-Martin L.P. · 2014
Show all 9 generations
- Root · 9 generations backK904436 Quickanchor (TM)Mitek Surgical Products, Inc. · 1990
- 8 generations backK962397 Statak Soft Tissue Attachment DeviceZimmer, Inc. · 1996
- 7 generations backK972783 Biofix Biodegradable Threaded Suture AnchorBionx Implants, Inc. · 1998
- 6 generations backK982139 Biosorbfx 1.5/2.0 Bioabsorbable Fixation SystemBionx Implants, Inc. · 1998
- 5 generations backK993061 Stryker Leibinger Resorbable Fixation SystemStryker Instruments · 1999
- 4 generations backK011590 Resorb-X Resorbable Plating SystemKLS-Martin L.P. · 2002
- 3 generations backK051236 Resorb-X SFKLS-Martin L.P. · 2005
- 2 generations backK080862 Sonicweld RX (Resorb-X)KLS-Martin L.P. · 2008
- 1 generation backK112064 Resorb X-GKLS-Martin L.P. · 2012
- This deviceK133304 RXG Distraction SystemKLS-Martin L.P. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K904436 | Quickanchor (TM) | Mitek Surgical Products, Inc. | 1990 | — |
| −8 | K962397 | Statak Soft Tissue Attachment Device | Zimmer, Inc. | 1996 | — |
| −7 | K972783 | Biofix Biodegradable Threaded Suture Anchor | Bionx Implants, Inc. | 1998 | — |
| −6 | K982139 | Biosorbfx 1.5/2.0 Bioabsorbable Fixation System | Bionx Implants, Inc. | 1998 | — |
| −5 | K993061 | Stryker Leibinger Resorbable Fixation System | Stryker Instruments | 1999 | — |
| −4 | K011590 | Resorb-X Resorbable Plating System | KLS-Martin L.P. | 2002 | — |
| −3 | K051236 | Resorb-X SF | KLS-Martin L.P. | 2005 | — |
| −2 | K080862 | Sonicweld RX (Resorb-X) | KLS-Martin L.P. | 2008 | — |
| −1 | K112064 | Resorb X-G | KLS-Martin L.P. | 2012 | — |
| 0 (this device) | K133304 | RXG Distraction System | KLS-Martin L.P. | 2014 | — |
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 | 3 | 0 |
| 2001 | 2 | 0 |
| 2004 | 1 | 0 |
| 2007 | 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? (4)
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 |
|---|---|---|---|
| * | K030425 | Lorenz Resorbable Distraction System or ExpanderSummary page 1…ssification: Bone Plate Class 11, 21 CER 872.4760, Product Code JEY Predicate Devices: LactoSorb Distraction (K030425, K002083) Resorb-X 0 (K112064), Zurich Distraction System (K010139) Device Description: The… | 2004 |
| * | K002083 | Lorenz Resorbable Distractor SystemSummary page 1…on: Bone Plate Class 11, 21 CER 872.4760, Product Code JEY Predicate Devices: LactoSorb Distraction (K030425, K002083) Resorb-X 0 (K112064), Zurich Distraction System (K010139) Device Description: The RxG Distr… | 2001 |
| * | K112064 | Resorb X-GSummary page 1…Class 11, 21 CER 872.4760, Product Code JEY Predicate Devices: LactoSorb Distraction (K030425, K002083) Resorb-X 0 (K112064), Zurich Distraction System (K010139) Device Description: The RxG Distraction System consists of implantable devices used to… | 2012 |
| * | K010139 | Zurich Distraction SystemSummary page 1…oduct Code JEY Predicate Devices: LactoSorb Distraction (K030425, K002083) Resorb-X 0 (K112064), Zurich Distraction System (K010139) Device Description: The RxG Distraction System consists of implantable devices used to lengthen or increase the dimension… | 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 24 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- 3 of the 37 ancestors have a recall of any class.
How does its category compare?
All JEY devicesJEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 RxG Distraction System includes devices intended for use in bone stabilization and elongation (lengthening) in the correction of congenital or developmental defects of the midface and alveolar ridge.
The RxG Distraction System also includes devices intended for use in bone stabilization and elongation (lengthening) in the correction of congenital or developmental defects of the mandible in patients 2 years old or younger.
The RxG Distraction System is not intended for load-bearing applications in adult or adolescent populations.
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/K133304 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133304: RXG Distraction System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133304
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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