510(k) · Cleared
ClearedPeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, 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 Apr 27, 2023 as substantially equivalent to K200398 (Stryker GmbH, 2020) and 3 other predicates after a 265-day review. Its family tree reaches back 18 generations to 1996. 8 later devices descend from it.
- Decided
- Apr 27, 2023
- Review
- 265 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 18 generations to K954385 (1996). 251 ancestors in all, the oldest K792022 (1979). 8 later devices descend from it, 4 citing it directly.
- Root · 18 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 14 generations between
- 3 generations backK172350 AxSOS 3 TiStryker GmbH · 2017
- 2 generations backK181091 AxSOS 3 TiStryker GmbH · 2018
- 1 generation backK200398 AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH · 2020
- This deviceK222381 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 · cites it directly · 1 of its ownK233017 TM Plating SystemTyber Medical, LLC · 2023
- Descendant · cites it directly · 1 of its ownK231257 Pangea Utility Plating System, Pangea PlatformStryker GmbH · 2023
Show all 18 generations
- Root · 18 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 17 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- 16 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- 15 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- 14 generations backK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
- 13 generations backK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
- 12 generations backK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
- 11 generations backK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
- 10 generations backK102156 Maxlock Extreme Extremity Plating System Distal Radius Plates and…Orthohelix Surgical Designs, Inc. · 2010 · Recalled
- 9 generations backK113048 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2012
- 8 generations backK122005 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2012
- 7 generations backK123203 Maxlock Extreme System Model MXLOrthohelix Surgical Designs, Inc. · 2012
- 6 generations backK132591 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2013
- 5 generations backK153379 AxSOS 3TiStryker GmbH · 2016
- 4 generations backK162439 AxSOS 3 Ti; Stryker Plating SystemStryker GmbH · 2017
- 3 generations backK172350 AxSOS 3 TiStryker GmbH · 2017
- 2 generations backK181091 AxSOS 3 TiStryker GmbH · 2018
- 1 generation backK200398 AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH · 2020
- This deviceK222381 PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti…Stryker GmbH · 2023
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- 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 · cites it directly1descendant
- K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH · 2023 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −17 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| −16 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| −15 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| −14 | K040598 | KLS Martin Hand Plating System | KLS-Martin L.P. | 2004 | — |
| −13 | K050868 | Maxlock | Orthohelix Surgical Designs, Inc. | 2005 | — |
| −12 | K073624 | Modular Foot System | Orthohelix Surgical Designs, Inc. | 2008 | 1 |
| −11 | K100618 | Maxlock Extreme Extremity Plating System with Variable Angle Technology | Orthohelix Surgical Designs, Inc. | 2010 | — |
| −10 | K102156 | Maxlock Extreme Extremity Plating System Distal Radius Plates and Screws | Orthohelix Surgical Designs, Inc. | 2010 | 1 |
| −9 | K113048 | Maxlock Extreme System | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −8 | K122005 | Maxlock Extreme System | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −7 | K123203 | Maxlock Extreme System Model MXL | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −6 | K132591 | Maxlock Extreme System | Orthohelix Surgical Designs, Inc. | 2013 | — |
| −5 | K153379 | AxSOS 3Ti | Stryker GmbH | 2016 | — |
| −4 | K162439 | AxSOS 3 Ti; Stryker Plating System | Stryker GmbH | 2017 | — |
| −3 | K172350 | AxSOS 3 Ti | Stryker GmbH | 2017 | — |
| −2 | K181091 | AxSOS 3 Ti | Stryker GmbH | 2018 | — |
| −1 | K200398 | AxSOS 3 AF System and AxSOS 3 Ti System | Stryker GmbH | 2020 | — |
| 0 (this device) | 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 | — |
| +1 | K233017 | TM Plating System | Tyber Medical, LLC | 2023 | — |
| +1 | K231257 | Pangea Utility Plating System, Pangea Platform | Stryker GmbH | 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 | 16 | 0 |
| 1997 | 2 | 0 |
| 1998 | 9 | 0 |
| 1999 | 9 | 0 |
| 2000 | 14 | 0 |
| 2001 | 18 | 0 |
| 2002 | 18 | 0 |
| 2003 | 8 | 0 |
| 2004 | 8 | 0 |
| 2005 | 16 | 0 |
| 2006 | 23 | 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 |
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2019 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 3 | 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? (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 |
|---|---|---|---|
| * | K200398 | AxSOS 3 AF System and AxSOS 3 Ti SystemSummary page 7…79 890 02 89 Fax: +41 32 641 66 60 Date: April 27, 2023 Primary Predicate: K200398 - AxSOS 3 Ti System, Stryker GmbH Additional Predicate: K192217 - NCB Plating System Distal Femur and Proximal T… | 2020 |
| * | K192217 | NCB Plating System Distal Femur and Proximal TibiaSummary page 7…: April 27, 2023 Primary Predicate: K200398 - AxSOS 3 Ti System, Stryker GmbH Additional Predicate: K192217 - NCB Plating System Distal Femur and Proximal Tibia, Zimmer GmbH… | 2019 |
| * | K172262 | EVOS Small Fragment Plating SystemSummary page 7…: K192217 - NCB Plating System Distal Femur and Proximal Tibia, Zimmer GmbH K172262 - EVOS Small Fragment Plating System, Smith & Nephew, Inc. K162439 – Stryker Plating Syste… | 2017 |
| * | K162439 | AxSOS 3 Ti; Stryker Plating SystemSummary page 7…GmbH K172262 - EVOS Small Fragment Plating System, Smith & Nephew, Inc. K162439 – Stryker Plating System, Stryker GmbH Device Description: This Traditional 510(k) submission is being suppli… | 2017 |
What descends from it? (8)
4 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 27 years and passes through 5 companies; a new generation was cleared every 1.0 years on median.
- 48 of the 251 ancestors have a recall of any class.
- Of its descendants, K231262 (Stryker GmbH, 2023) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K200398.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 PeriPRO™ Femur Plating System is indicated for internal fixation and stabilization of femur fractures and osteotomies in normal and osteopenic bone. This includes: Non-unions, malunions and deformities Fracture in the presence of intramedullary implants, including periprosthetic fractures The Variable Angle Fixation System is indicated for the internal fixation and stabilization of fractures and osteotomies of the femur in normal and osteopenic bone…
Read the full statement (325 words)
The PeriPRO™ Femur Plating System is indicated for internal fixation and stabilization of femur fractures and osteotomies in normal and osteopenic bone. This includes:
Non-unions, malunions and deformities
Fracture in the presence of intramedullary implants, including periprosthetic fractures
The Variable Angle Fixation System is indicated for the internal fixation and stabilization of fractures and osteotomies of the femur in normal and osteopenic bone, including:
Non-unions, malunions and deformities
Periprosthetic fractures
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 4 mm Waisted Compression Plate indications also include fixation of the scapula and the pelvis. Screws can also be used for arthrodesis.
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.
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/K222381 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222381: PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, 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/K222381
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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