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 · HBW Fastener, Plate, Cranioplasty
Cleared on Aug 14, 2023 as substantially equivalent to K171152 (Stryker, 2017) and 1 other predicate after a 109-day review. Its family tree reaches back 9 generations to 1976.
- Decided
- Aug 14, 2023
- Review
- 109 days
- Class
- Class II
- Product code
- HBW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K761228 (1976). 58 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
- 5 generations between
- 3 generations backK112557 Stryker Universal Neuro 3 SystemStryker · 2012
- 2 generations backK151387 Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS…Stryker · 2015
- 1 generation backK171152 Stryker Universal Neuro III System AXS ScrewStryker · 2017
- This deviceK231208 Stryker Resorbable Fixation SystemStryker Leibinger GmbH & Co KG · 2023
Show all 9 generations
- Root · 9 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
- 8 generations backK963739 Leibinger - Luhr Small Orthopedic Bone ScrewsHowmedica Leibinger, Inc. · 1997
- 7 generations backK970912 Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc. · 1997
- 6 generations backK974785 Auto-Drive Bone ScrewOsteomed Corp. · 1998
- 5 generations backK023260 1.2MM Osteomed Auto-Drive Screw SystemOsteomed Corp. · 2002
- 4 generations backK031659 Universal Neuro SystemStryker Instruments · 2003
- 3 generations backK112557 Stryker Universal Neuro 3 SystemStryker · 2012
- 2 generations backK151387 Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS…Stryker · 2015
- 1 generation backK171152 Stryker Universal Neuro III System AXS ScrewStryker · 2017
- This deviceK231208 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 |
|---|---|---|---|---|---|
| −9 | K761228 | Luhr Mandibular Compression-Screw System | Howmedica Corp. | 1976 | — |
| −8 | K963739 | Leibinger - Luhr Small Orthopedic Bone Screws | Howmedica Leibinger, Inc. | 1997 | — |
| −7 | K970912 | Leibinger Self-Drilling Screw | Howmedica Leibinger, Inc. | 1997 | — |
| −6 | K974785 | Auto-Drive Bone Screw | Osteomed Corp. | 1998 | — |
| −5 | K023260 | 1.2MM Osteomed Auto-Drive Screw System | Osteomed Corp. | 2002 | — |
| −4 | K031659 | Universal Neuro System | Stryker Instruments | 2003 | — |
| −3 | K112557 | Stryker Universal Neuro 3 System | Stryker | 2012 | — |
| −2 | K151387 | Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver… | Stryker | 2015 | — |
| −1 | K171152 | Stryker Universal Neuro III System AXS Screw | Stryker | 2017 | — |
| 0 (this device) | K231208 | Stryker Resorbable Fixation System | Stryker Leibinger GmbH & Co KG | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 3 | 0 |
| 1988 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 3 | 0 |
| 1994 | 4 | 0 |
| 1995 | 3 | 0 |
| 1996 | 10 | 0 |
| 1997 | 3 | 0 |
| 1998 | 10 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 3 | 0 |
| 2011 | 1 | 0 |
| 2022 | 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 HBW? 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 HBW device
- #1 K251472 Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation…score 10.0 · 2 generations · no Class I recall
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K171152 | Stryker Universal Neuro III System AXS ScrewSummary page 5…K231208 Page 2 of 6 III. PREDICATE DEVICE [§807.92(a)(3)] A. Predicate Device: Stryker Universal Neuro III System AXS Screw – K171152 B. Reference Device: Stryker Resorbable Fixation System – K213777 IV. DEVICE DESCRIPTION [§807.92(a)(4)] A.… | 2017 |
| * | K213777 | Stryker Resorbable Fixation SystemSummary page 5…[§807.92(a)(3)] A. Predicate Device: Stryker Universal Neuro III System AXS Screw – K171152 B. Reference Device: Stryker Resorbable Fixation System – K213777 IV. DEVICE DESCRIPTION [§807.92(a)(4)] A. Submission Branch of Subject Device: Neurology (OHT5/DHT5A – Office of… | 2022 |
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 47 years and passes through 6 companies; a new generation was cleared every 3.5 years on median.
- 3 of the 58 ancestors have a recall of any class.
How does its category compare?
All HBW devicesHBW Fastener, Plate, Cranioplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · HBW
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HBW
Too few HBW 510(k)s in any year since 2007 to give a median.
Recalls per year · HBW
No recall names HBW since 2007.
Adverse event reports per year · HBW
3in 2025
MAUDE reports naming product code HBW, 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 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 14 |
| 2018 | 0 | — | 0 | 22 |
| 2019 | 0 | — | 0 | 20 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 1 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 1 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Delta Resorbable Fixation System is intended for use in the fixation of bones of the cranial skeleton affected by trauma or for reconstruction. The system can be used in both adult and pediatric patients.
The self-tapping screws and low profile emergency screws are intended for use in the fixation of bones of the cranial 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).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231208 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231208: 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/K231208
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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