510(k) · Cleared
ClearedStryker Resorbable Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Leibinger GmbH & Co KG · JEY Plate, Bone
Cleared on Aug 5, 2023 as substantially equivalent to K213777 (Stryker Leibinger Micro Implants, 2022) after a 142-day review. Its family tree reaches back 7 generations to 1990.
- Decided
- Aug 5, 2023
- Review
- 142 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K904436 (1990). 28 ancestors in all, the oldest K900138 (1990). No later device cites it as a predicate yet.
- 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 backK113109 Stryker Resorbable Fixation SystemStryker · 2011
- 1 generation backK213777 Stryker Resorbable Fixation SystemStryker Leibinger Micro Implants · 2022
- This deviceK230733 Stryker Resorbable Fixation SystemStryker Leibinger GmbH & Co KG · 2023
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 | K113109 | Stryker Resorbable Fixation System | Stryker | 2011 | — |
| −1 | K213777 | Stryker Resorbable Fixation System | Stryker Leibinger Micro Implants | 2022 | — |
| 0 (this device) | K230733 | Stryker Resorbable Fixation System | Stryker Leibinger GmbH & Co KG | 2023 | — |
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 |
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 |
|---|---|---|---|
| * | K213777 | Stryker Resorbable Fixation SystemSummary page 3…nts). The self-tapping screws and low profile emergency screws are designed to be compatible with the components (plates, meshes) of the Delta Resorbable Fixation System K213777. Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) O… | 2022 |
| † | K050535 | Stryker MMF Screw | 2005 |
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 33 years and passes through 7 companies; a new generation was cleared every 1.6 years on median.
- 1 of the 28 ancestors has a recall of any class.
- 1 other device also cites its predicate K213777.
How does its category compare?
All JEY devicesJEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 self-tapping screws and low profile emergency screws are intended for use in the fixation of
bones of the maxillofacial and midfacial skeleton affected by trauma or for reconstruction, and can be
used in pediatric patients older than 29 days and up to two (2) years of age (infants). The self-tapping
screws and low profile emergency screws are designed to be compatible with the components (plates,
meshes) of the Delta Resorbable Fixation System K213777.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230733 · printed Nov 4, 2026
Cite this page
510(k) Report. “K230733: Stryker Resorbable Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K230733
Report an extraction error
Are you the manufacturer?
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