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 · HRS Plate, Fixation, Bone
Cleared on Dec 23, 2011 as substantially equivalent to K993061 (Stryker Instruments, 1999) and 2 other predicates after a 64-day review. Its family tree reaches back 5 generations to 1990. 3 later devices descend from it.
- Decided
- Dec 23, 2011
- Review
- 64 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K904436 (1990). 26 ancestors in all, the oldest K900138 (1990). 3 later devices descend from it, 1 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 deviceK113109 Stryker Resorbable Fixation SystemStryker · 2011
- Descendant · cites it directly · 2 of its ownK213777 Stryker Resorbable Fixation SystemStryker Leibinger Micro Implants · 2022
- Descendant · 2 generations on · 0 of its ownK231208 Stryker Resorbable Fixation SystemStryker Leibinger GmbH & Co KG · 2023
- Descendant · 2 generations on · 0 of its ownK230733 Stryker Resorbable Fixation SystemStryker Leibinger GmbH & Co KG · 2023
Most influential descendants
Showing 3 of 3 · See all- K213777Stryker Resorbable Fixation SystemStryker Leibinger Micro Implants · 2022 · cites it directly2descendants
- K231208Stryker Resorbable Fixation SystemStryker Leibinger GmbH & Co KG · 2023 · 2 generations on0descendants
- K230733Stryker Resorbable Fixation SystemStryker Leibinger GmbH & Co KG · 2023 · 2 generations on0descendants
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) | K113109 | Stryker Resorbable Fixation System | Stryker | 2011 | — |
| +1 | K213777 | Stryker Resorbable Fixation System | Stryker Leibinger Micro Implants | 2022 | — |
| +2 | K231208 | Stryker Resorbable Fixation System | Stryker Leibinger GmbH & Co KG | 2023 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 2 | 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 HRS? 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 HRS device
- #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 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 |
|---|---|---|---|
| * | K993061 | Stryker Leibinger Resorbable Fixation SystemSummary page 1…ZX, DZJ and HWC Predicate Device: -Stryker Leibinger Resorbable Fixation System - K993061 * Lactosorb 1.5mm Implants - Mesh Panels… | 1999 |
| * | K971870 | Lactosorb Trauma Plating SystemSummary page 1…System - K993061 * Lactosorb 1.5mm Implants - Mesh Panels -K971870 "Stryker Neuro 11 0.3mm Titanium Mesh… | 1997 |
| * | K983528 | Micro Dynamic MeshSummary page 1…-K971870 "Stryker Neuro 11 0.3mm Titanium Mesh - K983528 Page 8 of 53 Stryke… | 1998 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213777 | Stryker Resorbable Fixation System | 2022 | 2 |
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 21 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, K213777 (Stryker Leibinger Micro Implants, 2022) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K993061.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · HRS
54in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRS
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRS
2,306in 2025
MAUDE reports naming product code HRS, 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 | 35 | 63 | 2 | 339 |
| 2008 | 35 | 87 | 11 | 311 |
| 2009 | 47 | 85 | 3 | 435 |
| 2010 | 49 | 100 | 16 | 491 |
| 2011 | 43 | 88 | 5 | 773 |
| 2012 | 59 | 106 | 4 | 1,663 |
| 2013 | 56 | 89 | 11 | 2,643 |
| 2014 | 76 | 57 | 0 | 2,413 |
| 2015 | 56 | 97 | 7 | 3,095 |
| 2016 | 44 | 109 | 5 | 2,276 |
| 2017 | 57 | 122 | 3 | 2,220 |
| 2018 | 40 | 116 | 2 | 2,663 |
| 2019 | 46 | 89 | 25 | 3,359 |
| 2020 | 48 | 88 | 1 | 2,790 |
| 2021 | 40 | 87 | 9 | 2,442 |
| 2022 | 47 | 144 | 3 | 1,700 |
| 2023 | 40 | 120 | 1 | 2,049 |
| 2024 | 54 | 96 | 0 | 1,849 |
| 2025 | 54 | 90 | 1 | 2,306 |
| 2026 | 51 | 82 | 3 | — |
What is it indicated for?
The Stryker Resorbable Fixation System is intended for use in the fixation of bones of the craniofacial and midfacial skeleton affected by trauma or for reconstruction. The system can be used in both adult and pediatric patients but is not intended for use in the mandible and/or full load bearing procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113109 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113109: Stryker Resorbable Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113109
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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