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Asnis III Cannulated Screw System and Asnis PRO Cannulated Screw System

FDA 510(k)FDA UDIEUDAMED

Class II (US FDA 510(k))

510(k) K213199Ref 325250Model 08858251004519TERef 601622SModel 08858251006720TPRef 326640Ref 326885Ref 611325Model 08858251004526TBRef 325220SModel 08858251006717U2Ref 601630Ref 611315Ref 601650Ref 325620Ref 326560SRef 325638

by Stryker GmbH

Identity

Trade Name
Asnis® III EUDAMED
Asnis® PRO EUDAMED
ASNIS FDA UDI
Generic Name
Orthopaedic bone screw (non-sliding) FDA UDI
Device Name
ASNIS III AND ASNIS PRO - SCREW - STAINLESS STEEL - CLASS IIB - NON STERILE EUDAMED
ASNIS III AND ASNIS PRO - SCREW - TITANIUM ALLOY - CLASS IIB - STERILE EUDAMED
ASNIS III AND ASNIS PRO - SCREW - TITANIUM ALLOY - CLASS IIB - NON STERILE EUDAMED
ASNIS III AND ASNIS PRO - SCREW - STAINLESS STEEL - CLASS IIB - STERILE EUDAMED
ASNIS III Screw StSt FDA UDI
Cannulated Screw FDA UDI
Cannulated Screw - Full Thread FDA UDI
ASNIS III Screw Ti FDA UDI
Model / Reference
325250 EUDAMEDFDA UDI
325220S EUDAMEDFDA UDI
326640 EUDAMEDFDA UDI
601622S EUDAMEDFDA UDI
601630 EUDAMEDFDA UDI
326885 EUDAMEDFDA UDI
326560S EUDAMEDFDA UDI
611315 EUDAMEDFDA UDI
325638 EUDAMEDFDA UDI
611325 EUDAMEDFDA UDI
325620 EUDAMEDFDA UDI
601650 EUDAMEDFDA UDI
08858251004519TE EUDAMED
08858251006720TP EUDAMED
08858251004526TB EUDAMED
08858251006717U2 EUDAMED
Description
ASNIS III Screw StSt FDA UDI
Cannulated Screw FDA UDI
Cannulated Screw - Full Thread FDA UDI
ASNIS III Screw Ti FDA UDI

Identifiers

Catalog Number
325250 FDA UDI
325220S FDA UDI
326640 FDA UDI
601622S FDA UDI
601630 FDA UDI
326885 FDA UDI
326560S FDA UDI
611315 FDA UDI
325638 FDA UDI
611325 FDA UDI
325620 FDA UDI
601650 FDA UDI
Primary DI / UDI-DI
07613327142891 EUDAMEDFDA UDI
07613327075915 EUDAMEDFDA UDI
07613327078800 EUDAMEDFDA UDI
04546540086181 EUDAMEDFDA UDI
04546540086259 EUDAMEDFDA UDI
07613327143362 EUDAMEDFDA UDI
07613327522938 EUDAMEDFDA UDI
07613327077391 EUDAMEDFDA UDI
07613327143133 EUDAMEDFDA UDI
07613327143652 EUDAMEDFDA UDI
07613327076301 EUDAMEDFDA UDI
04546540086457 EUDAMEDFDA UDI
Basic UDI-DI
08858251004519TE EUDAMED
08858251006720TP EUDAMED
08858251004526TB EUDAMED
08858251006717U2 EUDAMED
510(k) Number
K213199 FDA 510(k)
FDA Product Code
HWC FDA 510(k)FDA UDI
HTN FDA UDI
OUR FDA UDI
EMDN Code
P09120603 CANNULATED SCREWS EUDAMED
GMDN Term
Orthopaedic bone screw (non-sliding) FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 888.3040 FDA 510(k)
Regulation Number
888.3040 FDA 510(k)FDA UDI
888.3030 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

No

EUDAMEDFDA UDIEUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

EUDAMEDFDA 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 UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDIFDA UDI

Manufacturing Date

No

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

Dimensions & Sizes

Size
Length — 50.0 Millimeter FDA UDI
Length — 20.0 Millimeter FDA UDI
Length — 40.0 Millimeter FDA UDI
Length — 22.0 Millimeter FDA UDI
Length — 30.0 Millimeter FDA UDI
Length — 85.0 Millimeter FDA UDI
Length — 160.0 Millimeter FDA UDI
Length — 115.0 Millimeter FDA UDI
Length — 38.0 Millimeter FDA UDI
Length — 125.0 Millimeter FDA UDI

The Asnis III and Asnis PRO Cannulated Screw Systems are orthopedic bone fixation devices classified as cannulated screws with washers. These devices are designed for fracture fixation in small bones, long bones, and the pelvis, featuring self-drilling and self-tapping cannulated screws with diameters of 4.0, 5.0, 6.5, and 8.0 mm, available in fully or partially threaded configurations.

The system is supplied sterile and intended for single-use in surgical settings. Screws are compatible with MRI environments and must be stored according to manufacturer instructions. Authorized under FDA 510(k) clearance (K213199) and MDR compliance, these devices are regulated as orthopedic implants under the HWC product code.

Frequently asked questions

What types of bones can the Asnis® III and Asnis® PRO Cannulated Screw Systems be used to fixate, and how do the screw diameters vary?

The Asnis® III and Asnis® PRO Cannulated Screw Systems are designed for fracture fixation in small bones, long bones, and the pelvis. The system offers cannulated screws in four diameters: 4.0 mm, 5.0 mm, 6.5 mm, and 8.0 mm. These screws are available in both fully and partially threaded configurations to accommodate different clinical scenarios and bone types.

Are the screws in this system reusable, and if not, what are the implications for surgical planning?

The Asnis® III and Asnis® PRO Cannulated Screw Systems are explicitly intended for single-use in surgical settings. This means each screw is designed to be used once per patient, ensuring sterility and reducing the risk of cross-contamination. Clinicians should plan accordingly, accounting for the number of screws needed per procedure and ensuring proper inventory management.

How should these screws be stored, and what special considerations apply to their handling?

The screws must be stored according to the manufacturer’s instructions to maintain sterility and integrity. Since they are supplied sterile and intended for single-use, they should be kept in their original packaging until ready for use. Additionally, the screws are MRI-compatible, so storage should avoid exposure to conditions that could compromise their structural integrity or sterility before surgery.

What distinguishes the Asnis® PRO system from the Asnis® III system in terms of design or intended use?

While the exact differences between the Asnis® III and Asnis® PRO systems are not detailed in the provided data, both are described as cannulated screws with washers designed for fracture fixation. The key distinction likely lies in specific design enhancements or clinical refinements in the PRO model, though the core applications (small bones, long bones, and pelvis) remain consistent. Both systems share the same diameter options (4.0–8.0 mm) and self-drilling/tapping features.

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: Asnis III Cannulated Screw System | Stryker, Asnis III Cannulated Screw System - Stryker, Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw ..., PDF Asnis® III Cannulated Screw System

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Stryker GmbH

Sources (25)

  • FDA 510(k) K213199 24 fields · synced Oct 6, 2026
  • FDA UDI 302e7d8d-1ac0-4bcd-8f1c-5237e78c923e 35 fields · synced May 30, 2026
  • FDA UDI 52754a79-2484-4c28-8cdc-9657246d77dd 35 fields · synced May 30, 2026
  • FDA UDI c666bd42-f356-43ab-a0c8-69abfecb1444 35 fields · synced May 30, 2026
  • FDA UDI 8d8b1eed-77b0-49e0-9af0-e2a00d5d78a4 35 fields · synced May 30, 2026
  • FDA UDI 5600262c-9854-46da-9959-fb6d27417b3c 35 fields · synced May 30, 2026
  • FDA UDI 2757fd11-1c3e-416b-b6a3-6fcd638764a5 35 fields · synced May 30, 2026
  • FDA UDI 524b7f93-64e3-4a9a-a85d-a89dec2cfc85 35 fields · synced May 30, 2026
  • FDA UDI b18caa1b-2aeb-414b-a490-d39d4871fbb5 35 fields · synced May 30, 2026
  • FDA UDI 35e3b6de-b4f5-44c1-b3e1-fc1a6a423736 35 fields · synced May 30, 2026
  • FDA UDI 7c8e5500-8fae-4672-bd79-d297c430762d 35 fields · synced May 30, 2026
  • FDA UDI 2636d992-6fec-4269-ba03-894e5604dad5 35 fields · synced May 30, 2026
  • FDA UDI a820d1bc-0d47-42d5-b59b-853dc119703d 35 fields · synced May 30, 2026
  • EUDAMED f8e76986-6899-4a64-ba5c-0e4cabaaa0f9 61 fields · synced Jul 8, 2026
  • EUDAMED 43f7113d-0322-41cf-9d21-ac72bd8edbff 61 fields · synced Jul 8, 2026
  • EUDAMED 533e7c87-f48e-4b7a-8949-07680ada998d 61 fields · synced Jul 8, 2026
  • EUDAMED 8922dadf-c794-4635-9b96-bffde9cafbdb 61 fields · synced Jul 8, 2026
  • EUDAMED be5108e8-123b-4f7a-8ca6-0d0c6b9faabe 61 fields · synced Jul 8, 2026
  • EUDAMED b9373943-534b-470f-bacd-e15eb7970563 61 fields · synced Jul 8, 2026
  • EUDAMED 146b7f0a-d031-4f93-9b43-c3ad2ca8bd33 61 fields · synced Jul 8, 2026
  • EUDAMED c353cf2d-6771-48f4-ad2e-b3ff3c02c273 61 fields · synced Jul 8, 2026
  • EUDAMED a5c3cb59-276b-4411-977f-7d64b244bd35 61 fields · synced Jul 8, 2026
  • EUDAMED 7a11f471-bafe-4a38-a394-7c05358b01f9 61 fields · synced Jul 8, 2026
  • EUDAMED 4bbb052c-032c-49fd-8f47-a93748d87819 61 fields · synced Jul 8, 2026
  • EUDAMED 077edfac-4e9d-40ef-bb6b-1bf84e84cc2d 61 fields · synced Jul 8, 2026