510(k) · Cleared
ClearedAxSOS 3 Ti; Stryker Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker GmbH · HRS Plate, Fixation, Bone
Cleared on Feb 3, 2017 as substantially equivalent to K153379 (Stryker GmbH, 2016) and 1 other predicate after a 156-day review. Its family tree reaches back 14 generations to 1996. 24 later devices descend from it.
- Decided
- Feb 3, 2017
- Review
- 156 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 14 generations to K954385 (1996). 88 ancestors in all, the oldest K890939 (1989). 24 later devices descend from it, 3 citing it directly.
- Root · 14 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 10 generations between
- 3 generations backK123203 Maxlock Extreme System Model MXLOrthohelix Surgical Designs, Inc. · 2012
- 2 generations backK132591 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2013
- 1 generation backK153379 AxSOS 3TiStryker GmbH · 2016
- This deviceK162439 AxSOS 3 Ti; Stryker Plating SystemStryker GmbH · 2017
- Descendant · cites it directly · 17 of its ownK172350 AxSOS 3 TiStryker GmbH · 2017
- Descendant · 2 generations on · 11 of its ownK181091 AxSOS 3 TiStryker GmbH · 2018
- Descendant · cites it directly · 10 of its ownK203817 Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2021
- Descendant · 2 generations on · 9 of its ownK222465 Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2023
- Descendant · 3 generations on · 9 of its ownK200398 AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH · 2020
Show all 14 generations
- Root · 14 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 13 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- 12 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- 11 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- 10 generations backK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
- 9 generations backK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
- 8 generations backK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
- 7 generations backK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
- 6 generations backK102156 Maxlock Extreme Extremity Plating System Distal Radius Plates and…Orthohelix Surgical Designs, Inc. · 2010 · Recalled
- 5 generations backK113048 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2012
- 4 generations backK122005 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2012
- 3 generations backK123203 Maxlock Extreme System Model MXLOrthohelix Surgical Designs, Inc. · 2012
- 2 generations backK132591 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2013
- 1 generation backK153379 AxSOS 3TiStryker GmbH · 2016
- This deviceK162439 AxSOS 3 Ti; Stryker Plating SystemStryker GmbH · 2017
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K172350AxSOS 3 TiStryker GmbH · 2017 · cites it directly17descendants
- K181091AxSOS 3 TiStryker GmbH · 2018 · 2 generations on11descendants
- K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2021 · cites it directly10descendants
- K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2023 · 2 generations on9descendants
- K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH · 2020 · 3 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −13 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| −12 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| −11 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| −10 | K040598 | KLS Martin Hand Plating System | KLS-Martin L.P. | 2004 | — |
| −9 | K050868 | Maxlock | Orthohelix Surgical Designs, Inc. | 2005 | — |
| −8 | K073624 | Modular Foot System | Orthohelix Surgical Designs, Inc. | 2008 | 1 |
| −7 | K100618 | Maxlock Extreme Extremity Plating System with Variable Angle Technology | Orthohelix Surgical Designs, Inc. | 2010 | — |
| −6 | K102156 | Maxlock Extreme Extremity Plating System Distal Radius Plates and Screws | Orthohelix Surgical Designs, Inc. | 2010 | 1 |
| −5 | K113048 | Maxlock Extreme System | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −4 | K122005 | Maxlock Extreme System | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −3 | K123203 | Maxlock Extreme System Model MXL | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −2 | K132591 | Maxlock Extreme System | Orthohelix Surgical Designs, Inc. | 2013 | — |
| −1 | K153379 | AxSOS 3Ti | Stryker GmbH | 2016 | — |
| 0 (this device) | K162439 | AxSOS 3 Ti; Stryker Plating System | Stryker GmbH | 2017 | — |
| +1 | K172350 | AxSOS 3 Ti | Stryker GmbH | 2017 | — |
| +2 | K181091 | AxSOS 3 Ti | Stryker GmbH | 2018 | — |
| +1 | K203817 | Tyber Medical Anatomical Plating System | Tyber Medical, LLC | 2021 | — |
| +2 | K222465 | Tyber Medical Anatomical Plating System | Tyber Medical, LLC | 2023 | — |
| +3 | K200398 | AxSOS 3 AF System and AxSOS 3 Ti System | Stryker GmbH | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 4 | 0 |
| 2000 | 9 | 0 |
| 2001 | 8 | 0 |
| 2002 | 4 | 0 |
| 2003 | 4 | 0 |
| 2004 | 4 | 0 |
| 2005 | 7 | 0 |
| 2006 | 8 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2014 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 8 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K153379 | AxSOS 3TiSummary page 5…Mahwah, NJ 07430 Phone: (201) 831-6797 Date Prepared: February 2, 2017 Predicate Devices: AxSOS 3 Ti (K153379) Stryker Plating System (K060798)… | 2016 |
| * | K060798 | Stryker Plating SystemSummary page 5…Phone: (201) 831-6797 Date Prepared: February 2, 2017 Predicate Devices: AxSOS 3 Ti (K153379) Stryker Plating System (K060798) K162439 (Page 2 of 3) Description The AxSOS… | 2006 |
What descends from it? (24)
See all 243 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 21 years and passes through 5 companies; a new generation was cleared every 1.0 years on median.
- 18 of the 88 ancestors have a recall of any class.
- Of its descendants, K172350 (Stryker GmbH, 2017) has gone furthest, with 17 descendants of its own.
- 2 other devices also cite its predicate K153379.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
AxSOS 3 Ti is intended for long bone fracture fixation Indications include: • Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures • Non-unions and malunions • Normal and osteopenic bone • Osteotomies • Periprosthetic fractures of the femur and proximal tibia. The AxSOS 3 Ti Waisted Compression Plates are also indicated for fracture fixation of: • Periprosthetic fractures • Diaphyseal and metaphyseal areas of long bones in pediatric…
Read the full statement (270 words)
AxSOS 3 Ti is intended for long bone fracture fixation Indications include:
• Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures
• Non-unions and malunions
• Normal and osteopenic bone
• Osteotomies
• Periprosthetic fractures of the femur and proximal tibia.
The AxSOS 3 Ti Waisted Compression Plates are also indicated for fracture fixation of:
• Periprosthetic fractures
• Diaphyseal and metaphyseal areas of long bones in pediatric patients
The 4mm Waisted Compression Plate indications also include fixation of the scapula and the pelvis.
SPS Small Fragment Set The Stryker® Plating System, Small Frag Set is indicated for fractures of the metaphysis and/or the diaphysis of the following:
* One third tubular plate: fibula, metatarsals, metacarpals
* Fibular plate: fibula
» Compression plate: radius, ulna, distal tibia, fibula, distal humerus, clavicle
* Oblique T-plate: distal radius
* T-plate: distal radius, calcaneus, lateral clavicle
* Cloverleaf plate: proximal humerus, distal tibia
* Calcaneal plate: calcaneus
* Reconstructive plate: humerus, pelvis Screws are used either to fasten plates or similar devices onto bone, or, as lag screws, to hold together fragments of bone.
SPS Basic Fragment Set The Basic Fragment Set is intended for use in long bone fracture fixation. Reconstruction plates, wide and narrow straight and waisted compression plates are indicated for fixation of long bone fractures including but not limited: to fractures of the femur, the tibia, the humerus and the pelvis. T-plates, T-buttress plates and L-buttress plates are indicated for fractures at the proximal or distal end of long bones including but not limited to: fractures of the femoral condyles, the tibial plateau, the distal tibia and the proximal humerus.
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/K162439 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162439: AxSOS 3 Ti; Stryker Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162439
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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