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AxSOS 3 Ti - AxSOS 3 Ti

FDA 510(k)FDA UDIEUDAMED

Class II (US FDA 510(k))

510(k) K162439Ref 940152Model 08858251002819TFRef 607485SModel 08858251003123SARef 627444SModel 08858251003098T4Ref 661750SRef 437514Model 08858251005293TJRef 437534

by Stryker GmbH

Identity

Trade Name
AXSOS EUDAMEDFDA UDI
Generic Name
Orthopaedic fixation plate, non-bioabsorbable FDA UDI
Orthopaedic bone screw (non-sliding) FDA UDI
Instrument tray, reusable FDA UDI
Device Name
AXSOS 3 INSTRUMENTS - TRAYS AND TRAY ACCESSORIES - CLASS I - NON STERILE EUDAMED
AXSOS 3 - SCREW - TITANIUM ALLOY - CLASS IIB - STERILE EUDAMED
AXSOS 3 - PLATE - TITANIUM ALLOY - CLASS IIB - STERILE EUDAMED
AXSOS - PLATE - STAINLESS STEEL - CLASS IIB - NON STERILE EUDAMED
Distal Medial Tibia Plate FDA UDI
Distal Lateral Femur Plate TS FDA UDI
Cortex Screw FDA UDI
Plate Insert with tag Proximal Lateral Tibia FDA UDI
Model / Reference
627444S EUDAMEDFDA UDI
437514 EUDAMEDFDA UDI
661750S EUDAMEDFDA UDI
437534 EUDAMEDFDA UDI
940152 EUDAMEDFDA UDI
08858251002819TF EUDAMED
08858251003123SA EUDAMED
607485S EUDAMED
08858251003098T4 EUDAMED
08858251005293TJ EUDAMED
Description
Distal Medial Tibia Plate FDA UDI
Distal Lateral Femur Plate TS FDA UDI
Cortex Screw FDA UDI
Plate Insert with tag Proximal Lateral Tibia FDA UDI

Identifiers

Catalog Number
627444S FDA UDI
437514 FDA UDI
661750S FDA UDI
437534 FDA UDI
940152 FDA UDI
Primary DI / UDI-DI
07613327082692 EUDAMEDFDA UDI
07613154396139 EUDAMEDFDA UDI
04546540686756 EUDAMEDFDA UDI
07613154396276 EUDAMEDFDA UDI
07613327089257 EUDAMEDFDA UDI
07613252649502 EUDAMED
Basic UDI-DI
08858251002819TF EUDAMED
08858251003123SA EUDAMED
08858251003098T4 EUDAMED
08858251005293TJ EUDAMED
Direct Marketing DI
07613327089257 EUDAMED
510(k) Number
K162439 FDA 510(k)
K061012 FDA UDI
FDA Product Code
HRS FDA 510(k)FDA UDI
HWC FDA UDI
LXH FDA UDI
EMDN Code
P091280 OSTEOSYNTHESIS DEVICES, DEVICES FOR TENDON AND LIGAMENT SYNTHESIS - ACCESSORIES EUDAMED
P09120601 CORTICAL SCREWS EUDAMED
P09120599 BONE FIXATION PLATES - OTHER EUDAMED
GMDN Term
Orthopaedic fixation plate, non-bioabsorbable FDA UDI
Orthopaedic bone screw (non-sliding) FDA UDI
Instrument tray, reusable FDA UDI
Models / Variants
AxSOS 3 Ti FDA 510(k)FDA UDIEUDAMED
Stryker Plating System FDA 510(k)FDA UDIEUDAMED

Classification

Device Class
Class I EUDAMEDFDA UDI
Class IIb EUDAMED
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 888.3030 FDA 510(k)
Regulation Number
888.3030 FDA 510(k)FDA UDI
888.3040 FDA UDI
888.4540 FDA UDI
Market of Registration
Netherlands EUDAMED
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDIEUDAMEDFDA UDI

Single Use

Yes

FDA UDIFDA UDI

Implantable

Yes

EUDAMEDFDA UDIEUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Sutures

Yes

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDIFDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDIFDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Conditional FDA UDI

Dimensions & Sizes

Size
Length — 227.0 Millimeter FDA UDI
Length — 310.0 Millimeter FDA UDI
Length — 50.0 Millimeter FDA UDI

The AxSOS 3 Ti; Stryker Plating System is a monoaxial locking plate designed for long bone fracture fixation. It features a titanium alloy construction with a patented screw-to-plate interface, enabling secure fixation through both locking and non-locking screws. This system is categorized under orthopedic plating devices and is intended for internal stabilization of fractures in long bones, such as the femur.

The device is supplied as a sterile, single-use system and is regulated under FDA 510(k) clearance (K162439) and MDR compliance. It includes streamlined instrumentation to facilitate efficient intraoperative use. The system is available in various configurations tailored for distal femur applications, with specific plate and screw sizes detailed in the accompanying technical documentation. Storage and handling follow standard sterile orthopedic implant protocols.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: AxSOS 3 Ti Plating - Stryker, AxSOS 3 Ti Distal Lateral Femur | Stryker, PDF AxSOS 3 Titanium Locking Plate System - Stryker MedEd

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Stryker GmbH

Sources (12)

  • FDA 510(k) K162439 24 fields · synced Sep 30, 2026
  • FDA UDI e18e3421-41dc-4046-8558-602e082a0bd2 35 fields · synced May 30, 2026
  • FDA UDI c8cebf71-d5d8-4336-977b-c4d4fdf2e6f5 36 fields · synced May 30, 2026
  • FDA UDI ab041c91-6759-40eb-b772-8fc3fb5ceaed 35 fields · synced May 30, 2026
  • FDA UDI 92026ef9-e49e-4faa-b3e0-141b7848bbef 36 fields · synced May 30, 2026
  • FDA UDI ecd395b3-1461-4bc3-8591-ac52788766d0 34 fields · synced May 30, 2026
  • EUDAMED d3e4607a-38a2-487f-a75d-38ac391996fd 61 fields · synced Sep 17, 2026
  • EUDAMED e6e01395-0d49-46ad-afb8-4145e983e5e3 61 fields · synced Sep 17, 2026
  • EUDAMED 859409a4-f723-48bd-8fb8-7a4cf6857401 61 fields · synced Sep 30, 2026
  • EUDAMED 817dc42c-4da8-4a22-b2b6-c0e902b9b82e 61 fields · synced Sep 30, 2026
  • EUDAMED a546621f-75ec-4358-a688-534bb60487e7 61 fields · synced Sep 30, 2026
  • EUDAMED 03b2086f-bad6-4059-b4bb-4bb6cf25ea29 61 fields · synced Sep 30, 2026