510(k) · Cleared
ClearedAxSOS 3 AF System and AxSOS 3 Ti 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 Jun 5, 2020 as substantially equivalent to K163650 (Wrightmedicaltechnologyinc, 2017) and 4 other predicates after a 108-day review. Its family tree reaches back 17 generations to 1996. 9 later devices descend from it.
- Decided
- Jun 5, 2020
- Review
- 108 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 17 generations to K954385 (1996). 241 ancestors in all, the oldest K792022 (1979). 9 later devices descend from it, 3 citing it directly.
- Root · 17 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 13 generations between
- 3 generations backK162439 AxSOS 3 Ti; Stryker Plating SystemStryker GmbH · 2017
- 2 generations backK172350 AxSOS 3 TiStryker GmbH · 2017
- 1 generation backK181091 AxSOS 3 TiStryker GmbH · 2018
- This deviceK200398 AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH · 2020
- Descendant · cites it directly · 8 of its ownK222381 PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti…Stryker GmbH · 2023
- Descendant · cites it directly · 4 of its ownK231262 Pangea Femur Plating System, Pangea Fibula Plating System, Pangea…Stryker GmbH · 2023
- Descendant · 2 generations on · 2 of its ownK250163 T2 Alpha Femur Retrograde Nailing SystemStryker GmbH · 2025
- Descendant · 2 generations on · 1 of its ownK253640 T2 Alpha Femur Retrograde Nailing System; Pangea Femur…Stryker GmbH · 2026
- Descendant · 2 generations on · 1 of its ownK233017 TM Plating SystemTyber Medical, LLC · 2023
Show all 17 generations
- Root · 17 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 16 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- 15 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- 14 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- 13 generations backK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
- 12 generations backK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
- 11 generations backK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
- 10 generations backK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
- 9 generations backK102156 Maxlock Extreme Extremity Plating System Distal Radius Plates and…Orthohelix Surgical Designs, Inc. · 2010 · Recalled
- 8 generations backK113048 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2012
- 7 generations backK122005 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2012
- 6 generations backK123203 Maxlock Extreme System Model MXLOrthohelix Surgical Designs, Inc. · 2012
- 5 generations backK132591 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2013
- 4 generations backK153379 AxSOS 3TiStryker GmbH · 2016
- 3 generations backK162439 AxSOS 3 Ti; Stryker Plating SystemStryker GmbH · 2017
- 2 generations backK172350 AxSOS 3 TiStryker GmbH · 2017
- 1 generation backK181091 AxSOS 3 TiStryker GmbH · 2018
- This deviceK200398 AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH · 2020
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH · 2023 · cites it directly8descendants
- K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH · 2023 · cites it directly4descendants
- K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH · 2025 · 2 generations on2descendants
- K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH · 2026 · 2 generations on1descendant
- K233017TM Plating SystemTyber Medical, LLC · 2023 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −16 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| −15 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| −14 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| −13 | K040598 | KLS Martin Hand Plating System | KLS-Martin L.P. | 2004 | — |
| −12 | K050868 | Maxlock | Orthohelix Surgical Designs, Inc. | 2005 | — |
| −11 | K073624 | Modular Foot System | Orthohelix Surgical Designs, Inc. | 2008 | 1 |
| −10 | K100618 | Maxlock Extreme Extremity Plating System with Variable Angle Technology | Orthohelix Surgical Designs, Inc. | 2010 | — |
| −9 | K102156 | Maxlock Extreme Extremity Plating System Distal Radius Plates and Screws | Orthohelix Surgical Designs, Inc. | 2010 | 1 |
| −8 | K113048 | Maxlock Extreme System | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −7 | K122005 | Maxlock Extreme System | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −6 | K123203 | Maxlock Extreme System Model MXL | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −5 | K132591 | Maxlock Extreme System | Orthohelix Surgical Designs, Inc. | 2013 | — |
| −4 | K153379 | AxSOS 3Ti | Stryker GmbH | 2016 | — |
| −3 | K162439 | AxSOS 3 Ti; Stryker Plating System | Stryker GmbH | 2017 | — |
| −2 | K172350 | AxSOS 3 Ti | Stryker GmbH | 2017 | — |
| −1 | K181091 | AxSOS 3 Ti | Stryker GmbH | 2018 | — |
| 0 (this device) | K200398 | AxSOS 3 AF System and AxSOS 3 Ti System | Stryker GmbH | 2020 | — |
| +1 | K222381 | PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker… | Stryker GmbH | 2023 | — |
| +1 | K231262 | Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia… | Stryker GmbH | 2023 | — |
| +2 | K250163 | T2 Alpha Femur Retrograde Nailing System | Stryker GmbH | 2025 | — |
| +2 | K253640 | T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System | Stryker GmbH | 2026 | — |
| +2 | K233017 | TM Plating System | Tyber Medical, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 2 | 0 |
| 1981 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 4 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 4 | 0 |
| 1993 | 2 | 0 |
| 1994 | 8 | 0 |
| 1995 | 9 | 0 |
| 1996 | 15 | 0 |
| 1997 | 2 | 0 |
| 1998 | 9 | 0 |
| 1999 | 9 | 0 |
| 2000 | 13 | 0 |
| 2001 | 18 | 0 |
| 2002 | 18 | 0 |
| 2003 | 6 | 0 |
| 2004 | 7 | 0 |
| 2005 | 16 | 0 |
| 2006 | 22 | 0 |
| 2007 | 7 | 0 |
| 2008 | 11 | 0 |
| 2009 | 10 | 0 |
| 2010 | 8 | 0 |
| 2011 | 5 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2017 | 3 | 0 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 4 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 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? (5)
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 |
|---|---|---|---|
| * | K163650 | ORTHOLOC® 3Di Ankle Fusion Plating System Line ExtensionSummary page 5…S 3 Ti System HRS, HWC Primary Predicate: AxSOS 3 AF System Ortholoc 3Di Ankle Fusion Plating System, K163650 AxSOS 3 Ti System AxSOS 3 Ti System, K181091 Additional Predicate: Ax… | 2017 |
| * | K181091 | AxSOS 3 TiSummary page 5…Ortholoc 3Di Ankle Fusion Plating System, K163650 AxSOS 3 Ti System AxSOS 3 Ti System, K181091 Additional Predicate: AxSOS 3 Ti System… | 2018 |
| * | K024060 | Modification to Asnis Iii Cannulated Screw SystemSummary page 6…K200398 Page 2/3 Asnis III Cannulated Screw System, K024060 Stryker Locked Plating System, K050512 Monster Scre… | 2002 |
| * | K050512 | Stryker Locked Plating SystemSummary page 6…00398 Page 2/3 Asnis III Cannulated Screw System, K024060 Stryker Locked Plating System, K050512 Monster Screw System, K190586 Description: AxSOS 3 AF System AxSOS 3 AF (Ankle Fusion… | 2005 |
| * | K190586 | Monster® Screw SystemSummary page 6…nnulated Screw System, K024060 Stryker Locked Plating System, K050512 Monster Screw System, K190586 Description: AxSOS 3 AF System AxSOS 3 AF (Ankle Fusion) is an internal fixation system composed of sterile and non-sterile… | 2019 |
What descends from it? (9)
3 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 24 years and passes through 5 companies; a new generation was cleared every 10 months on median.
- 45 of the 241 ancestors have a recall of any class.
- Of its descendants, K222381 (Stryker GmbH, 2023) has gone furthest, with 8 descendants of its own.
- 2 other devices also cite its predicate K163650.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 AxSOS 3 Ankle Fusion System is indicated for arthrodesis of the ankle, which includes tibio-talo-calcaneal, tibio-talar, and tibio-calcaneal arthrodesis, in possible conjunction with osteotomies and fractures of the distal tibia, talus, and calcaneus. 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…
Read the full statement (124 words)
The AxSOS 3 Ankle Fusion System is indicated for arthrodesis of the ankle, which includes tibio-talo-calcaneal, tibio-talar, and tibio-calcaneal arthrodesis, in possible conjunction with osteotomies and fractures of the distal tibia, talus, and calcaneus.
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.
Screws can also be used for arthrodesis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200398 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200398: AxSOS 3 AF System and AxSOS 3 Ti System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200398
Report an extraction error
Are you the manufacturer?
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