510(k) · Cleared
ClearedStryker Leibinger Resorbable Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Instruments · MAI Fastener, Fixation, Biodegradable, Soft Tissue
Cleared on Nov 19, 1999 as substantially equivalent to K982531 (Howmedica Corp., 1998) and 3 other predicates after a 67-day review. Its family tree reaches back 4 generations to 1990. 79 later devices descend from it.
- Decided
- Nov 19, 1999
- Review
- 67 days
- Class
- Class II
- Product code
- MAI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K904436 (1990). 24 ancestors in all, the oldest K900138 (1990). 79 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK904436 Quickanchor (TM)Mitek Surgical Products, Inc. · 1990
- 3 generations backK962397 Statak Soft Tissue Attachment DeviceZimmer, Inc. · 1996
- 2 generations backK972783 Biofix Biodegradable Threaded Suture AnchorBionx Implants, Inc. · 1998
- 1 generation backK982139 Biosorbfx 1.5/2.0 Bioabsorbable Fixation SystemBionx Implants, Inc. · 1998
- This deviceK993061 Stryker Leibinger Resorbable Fixation SystemStryker Instruments · 1999
- Descendant · cites it directly · 73 of its ownK011590 Resorb-X Resorbable Plating SystemKLS-Martin L.P. · 2002
- Descendant · 2 generations on · 65 of its ownK060177 KLS Martin Rigid Fixation - SterileKLS Martin L.P. · 2006
- Descendant · 3 generations on · 61 of its ownK070169 KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P. · 2007
- Descendant · 4 generations on · 45 of its ownK151983 KLS Martin LSS Plating SystemKLS Martin L.P. · 2016
- Descendant · 5 generations on · 39 of its ownK202889 Able Medical Devices Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D.B.A. Able Medical Devices · 2021
Showing 5 of 79 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 79 · See all- K011590Resorb-X Resorbable Plating SystemKLS-Martin L.P. · 2002 · cites it directly73descendants
- K060177KLS Martin Rigid Fixation - SterileKLS Martin L.P. · 2006 · 2 generations on65descendants
- K070169KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P. · 2007 · 3 generations on61descendants
- K151983KLS Martin LSS Plating SystemKLS Martin L.P. · 2016 · 4 generations on45descendants
- K202889Able Medical Devices Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D.B.A. Able Medical Devices · 2021 · 5 generations on39descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K904436 | Quickanchor (TM) | Mitek Surgical Products, Inc. | 1990 | — |
| −3 | K962397 | Statak Soft Tissue Attachment Device | Zimmer, Inc. | 1996 | — |
| −2 | K972783 | Biofix Biodegradable Threaded Suture Anchor | Bionx Implants, Inc. | 1998 | — |
| −1 | K982139 | Biosorbfx 1.5/2.0 Bioabsorbable Fixation System | Bionx Implants, Inc. | 1998 | — |
| 0 (this device) | K993061 | Stryker Leibinger Resorbable Fixation System | Stryker Instruments | 1999 | — |
| +1 | K011590 | Resorb-X Resorbable Plating System | KLS-Martin L.P. | 2002 | — |
| +2 | K060177 | KLS Martin Rigid Fixation - Sterile | KLS Martin L.P. | 2006 | — |
| +3 | K070169 | KLS Martin Quick Disc, Sternal Talon and Sternal Plating - Sterile | KLS Martin L.P. | 2007 | — |
| +4 | K151983 | KLS Martin LSS Plating System | KLS Martin L.P. | 2016 | — |
| +5 | K202889 | Able Medical Devices Valkyrie Thoracic Fixation System | Jm Longyear Manufacturing, LLC D.B.A. Able Medical Devices | 2021 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 4 | 0 |
| 2023 | 10 | 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 MAI? 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 MAI device
- #1 K203495 Arthrex SwiveLock Anchorscore 35.2 · 11 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 |
|---|---|---|---|
| * | K982531 | Howmedica Leibinger Resorbable Fixation SystemSummary page 1…s 616-323-7700 x3814 September 7, 1999 The Stryker Leibinger Resorbable Fixation System is equivalent to the Howmedica Leibinger Resorbable Fixation System, Howmedica, K982531; the LactoSorb Trauma Plating System, Walter Lorenz, subsidiary of Biomet, K971870; the Macropore Protective Sheet (Protego Syste… | 1998 |
| * | K971870 | Lactosorb Trauma Plating SystemSummary page 1…System is equivalent to the Howmedica Leibinger Resorbable Fixation System, Howmedica, K982531; the LactoSorb Trauma Plating System, Walter Lorenz, subsidiary of Biomet, K971870; the Macropore Protective Sheet (Protego System), Pacific Materials and Interfaces, K972913; and the BiosorbFX 1.5/2.0 Bioabsorba… | 1997 |
| * | K972913 | Macropore Protective Sheet (Protego System)Summary page 1…31; the LactoSorb Trauma Plating System, Walter Lorenz, subsidiary of Biomet, K971870; the Macropore Protective Sheet (Protego System), Pacific Materials and Interfaces, K972913; and the BiosorbFX 1.5/2.0 Bioabsorbable Fixation System, Bionx Implants, Inc., K982139. Device Description The Stryker Leibing… | 1998 |
| * | K982139 | Biosorbfx 1.5/2.0 Bioabsorbable Fixation SystemSummary page 1…he Macropore Protective Sheet (Protego System), Pacific Materials and Interfaces, K972913; and the BiosorbFX 1.5/2.0 Bioabsorbable Fixation System, Bionx Implants, Inc., K982139. Device Description The Stryker Leibinger Resorbable Fixation System is a modification of the Howmedica Leibinger Resorbable Fi… | 1998 |
What descends from it? (79)
See all 793 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 9 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- 1 of the 24 ancestors has a recall of any class.
- Of its descendants, K011590 (KLS-Martin L.P., 2002) has gone furthest, with 73 descendants of its own.
- 3 other devices also cite its predicate K982531.
How does its category compare?
All MAI devicesMAI Fastener, Fixation, Biodegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MAI
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAI
54in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAI
40in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MAI
2,148in 2025
MAUDE reports naming product code MAI, 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 | 4 | 100 | 0 | 272 |
| 2008 | 3 | 83 | 0 | 172 |
| 2009 | 9 | 74 | 0 | 88 |
| 2010 | 4 | 122 | 0 | 89 |
| 2011 | 9 | 90 | 5 | 129 |
| 2012 | 6 | 56 | 10 | 171 |
| 2013 | 6 | 135 | 0 | 166 |
| 2014 | 4 | 86 | 0 | 149 |
| 2015 | 5 | 95 | 0 | 182 |
| 2016 | 3 | 191 | 0 | 301 |
| 2017 | 9 | 113 | 0 | 478 |
| 2018 | 13 | 108 | 0 | 1,590 |
| 2019 | 9 | 41 | 2 | 1,248 |
| 2020 | 9 | 78 | 40 | 957 |
| 2021 | 8 | 115 | 0 | 1,267 |
| 2022 | 6 | 136 | 0 | 1,425 |
| 2023 | 8 | 34 | 0 | 1,718 |
| 2024 | 7 | 53 | 0 | 2,300 |
| 2025 | 8 | 54 | 0 | 2,148 |
| 2026 | 5 | 69 | 1 | — |
What is it indicated for?
The Stryker Leibinger 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993061 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993061: Stryker Leibinger 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/K993061
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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