510(k) · Cleared
ClearedAxsos Locking Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Corp. · HRS Plate, Fixation, Bone
Cleared on Dec 19, 2011 as substantially equivalent to K082807 (Synthes (Usa), 2008) and 1 other predicate after a 77-day review. Its family tree reaches back 4 generations to 1998.
- Decided
- Dec 19, 2011
- Review
- 77 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K981372 (1998). 13 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK981372 Synthes 3.0 MM PC-Fix SystemSynthes (Usa) · 1998
- 3 generations backK991407 Synthes Locking Calcaneal PlatesSynthes (Usa) · 1999
- 2 generations backK033669 Smith & Nephew Locking Bone Plate System (Locking Bone Plates and…Smith & Nephew, Inc. · 2003 · Recalled
- 1 generation backK082807 Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with…Synthes (Usa) · 2008
- This deviceK112926 Axsos Locking Plate SystemStryker Corp. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K981372 | Synthes 3.0 MM PC-Fix System | Synthes (Usa) | 1998 | — |
| −3 | K991407 | Synthes Locking Calcaneal Plates | Synthes (Usa) | 1999 | — |
| −2 | K033669 | Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws) | Smith & Nephew, Inc. | 2003 | 1 |
| −1 | K082807 | Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded… | Synthes (Usa) | 2008 | — |
| 0 (this device) | K112926 | Axsos Locking Plate System | Stryker Corp. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 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 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? (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 |
|---|---|---|---|
| * | K082807 | Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded IndicationsSummary page 3…isons showed that the proposed device is substantially equivalent in intended use, design, materials and performance characteristics to the following predicate devices: K082807- Synthes 3.5 and 4.5mm Locking Compression Plate (LCP) System K0605 14- Stryker Locked Plating System… | 2008 |
| * | K060514 | Stryker Plating SystemSummary page 1…he U.S. FDA to provide authorization to add the pediatric indication to a specific subset of plates, screws and inserts of the previously cleared Stryker Plating System (K0605 14). The components from the previously cleared system, some of which carry the pediatric indication, will make-up the system to be… | 2006 |
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 13 years and passes through 3 companies; a new generation was cleared every 4.5 years on median.
- 3 of the 13 ancestors have a recall of any class.
- 42 other devices also cite its predicate K082807.
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 AxSOS™ Small Fragment Plating System is intended for internal fixation, stabilization and support of fractures as well as bone fixation after osteotomies in the following: In Adults: * 4mm Waisted Compression Plate - radius, ulna, distal tibia, fibula, distal humerus, clavicle * 4mm Locking Insert * 4mm Locking Screws * 3.5mm Conical Screws * 3mm One Third Tubular Plate - fibula, metatarsals, metacarpals * 4mm Reconstruction Plate - humerus…
Read the full statement (208 words)
The Stryker AxSOS™ Small Fragment Plating System is intended for internal fixation, stabilization and support of fractures as well as bone fixation after osteotomies in the following:
In Adults:
* 4mm Waisted Compression Plate - radius, ulna, distal tibia, fibula, distal humerus, clavicle
* 4mm Locking Insert
* 4mm Locking Screws
* 3.5mm Conical Screws
* 3mm One Third Tubular Plate - fibula, metatarsals, metacarpals
* 4mm Reconstruction Plate - humerus, pelvis
In Pediatrics:
* 4mm Waisted Compression Plate - radius, ulna, distal tibia, distal humerus, clavicle
* 4mm Locking Insert
* 4mm Locking Screws
* 3.5mm Cortical Screws
The Stryker AxSOS™ Basic Fragment Plating System is intended for internal fixation, stabilization and support of long bone fractures as well as bone fixation osteotomnies in the following:
In Adults:
* 5mm Waisted Compression Plate - Broad -femur, tibia, humerus, pelvis
* 5mm Waisted Compression Plate - Narrow - femur, tibia, humerus, pelvis
* 5mm Locking Insert
* 5mm Locking Screws
* 4.5mm Conical Screws
* 5mm Reconstruction Plate - femur, tibia, humerus, pelvis
In Pediatrics:
* 5mm Waisted Compression Plate - Broad -femur, tibia, humerus
* 5mm Waisted Compression Plate - Narrow - femur, tibia, humerus
* 5mm Locking Insert
* 5mm Locking Screws
* 4.5mm Cortical Screws
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112926 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112926: Axsos Locking Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112926
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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