← Back to catalogue

VariAx 2 MIS Calcaneus

FDA 510(k)FDA UDIEUDAMED

Class II (US FDA 510(k))

510(k) K221346Ref 52-23616EModel 08858251004355T8Ref 58-23008Ref 40-27650Ref 614832Ref 58-23011SModel 08858251004356TARef 58-17014Ref 52-23018ERef 40-35900Model 08858251004363T7Ref 53-23212ERef 58-23024SRef 40-27026Ref 40-27608SRef 53-27122ERef 614846SRef 40-35665SRef 40-35622Ref 53-23024SRef 662624Model 08858251003258T2Ref 657330Ref 663740Ref 614728Ref 662508SModel 08858251003259T4Ref 703919Model 08858251028114U2

by Stryker GmbH

Identity

Trade Name
VariAx EUDAMEDFDA UDI
VARIAX® EUDAMED
VARIAX® 2 EUDAMED
VariAx®2 EUDAMED
Generic Name
Orthopaedic bone screw (non-sliding) FDA UDI
Implantable bone washer FDA UDI
Device Name
VARIAX SCREWS - SCREW - TITANIUM ALLOY - CLASS IIB - NON-STERILE EUDAMED
VARIAX SCREWS - SCREW - TITANIUM ALLOY - CLASS IIB - STERILE EUDAMED
VARIAX SCREWS - WASHER - TITANIUM ALLOY - CLASS IIB - NON-STERILE EUDAMED
VARIAX 2 SCREWS - SCREW - TITANIUM ALLOY - CLASS IIB - NON STERILE EUDAMED
VARIAX 2 SCREWS - SCREW - TITANIUM ALLOY - CLASS IIB - STERILE EUDAMED
VARIAX 2 INSTRUMENTS - TORQUE LIMITERS - CLASS I - NON STERILE EUDAMED
LOCKING SCREW, T10 FDA UDI
LOCKING SCREW, T7 FDA UDI
BONE SCREW, T7 FDA UDI
Bone Screw FDA UDI
PARTIALLY THREADED BONE SCREW, T7 FDA UDI
LOCKING SCREWS,CROSS-PIN,SELF-T FDA UDI
Locking Screw, T6 FDA UDI
BONE SCREW, CROSS-PIN, SELF-TAPPING FDA UDI
BONE SCREWS, CROSS-PIN FDA UDI
LOCKING SCREWS, CROSS-PIN FDA UDI
Bone Screw, T5 FDA UDI
WASHER FOR 3.5MM BONE SCREW FDA UDI
Locking Screw FDA UDI
Locking Screw, T5 FDA UDI
Model / Reference
40-35665S EUDAMEDFDA UDI
40-27608S EUDAMEDFDA UDI
40-27026 EUDAMEDFDA UDI
614832 EUDAMEDFDA UDI
40-27650 EUDAMEDFDA UDI
53-27122E EUDAMEDFDA UDI
40-35622 EUDAMEDFDA UDI
53-23024S EUDAMEDFDA UDI
663740 EUDAMEDFDA UDI
53-23212E EUDAMEDFDA UDI
58-23024S EUDAMEDFDA UDI
58-17014 EUDAMEDFDA UDI
52-23018E EUDAMEDFDA UDI
52-23616E EUDAMEDFDA UDI
662624 EUDAMEDFDA UDI
40-35900 EUDAMEDFDA UDI
657330 EUDAMEDFDA UDI
614728 EUDAMEDFDA UDI
58-23008 EUDAMEDFDA UDI
58-23011S EUDAMEDFDA UDI
662508S EUDAMEDFDA UDI
08858251004355T8 EUDAMED
08858251004356TA EUDAMED
08858251004363T7 EUDAMED
614846S EUDAMED
08858251003258T2 EUDAMED
08858251003259T4 EUDAMED
08858251028114U2 EUDAMED
703919 EUDAMED
Description
LOCKING SCREW, T10 FDA UDI
LOCKING SCREW, T7 FDA UDI
BONE SCREW, T7 FDA UDI
Bone Screw FDA UDI
PARTIALLY THREADED BONE SCREW, T7 FDA UDI
LOCKING SCREWS,CROSS-PIN,SELF-T FDA UDI
Locking Screw, T6 FDA UDI
BONE SCREW, CROSS-PIN, SELF-TAPPING FDA UDI
BONE SCREWS, CROSS-PIN FDA UDI
LOCKING SCREWS, CROSS-PIN FDA UDI
Bone Screw, T5 FDA UDI
WASHER FOR 3.5MM BONE SCREW FDA UDI
Locking Screw FDA UDI
Locking Screw, T5 FDA UDI

Identifiers

Catalog Number
40-35665S FDA UDI
40-27608S FDA UDI
40-27026 FDA UDI
614832 FDA UDI
40-27650 FDA UDI
53-27122E FDA UDI
40-35622 FDA UDI
53-23024S FDA UDI
663740 FDA UDI
53-23212E FDA UDI
58-23024S FDA UDI
58-17014 FDA UDI
52-23018E FDA UDI
52-23616E FDA UDI
662624 FDA UDI
40-35900 FDA UDI
657330 FDA UDI
614728 FDA UDI
58-23008 FDA UDI
58-23011S FDA UDI
662508S FDA UDI
Primary DI / UDI-DI
04546540539625 EUDAMEDFDA UDI
04546540538949 EUDAMEDFDA UDI
07613154628131 EUDAMEDFDA UDI
07613154970360 EUDAMEDFDA UDI
07613154628407 EUDAMEDFDA UDI
07613154913947 EUDAMEDFDA UDI
07613154628728 EUDAMEDFDA UDI
04546540541369 EUDAMEDFDA UDI
07613327378597 EUDAMEDFDA UDI
07613154913633 EUDAMEDFDA UDI
04546540542878 EUDAMEDFDA UDI
37613154496885 EUDAMEDFDA UDI
07613154576401 EUDAMEDFDA UDI
07613154576548 EUDAMEDFDA UDI
07613327378870 EUDAMEDFDA UDI
07613154629008 EUDAMEDFDA UDI
07613327087079 EUDAMEDFDA UDI
07613154970087 EUDAMEDFDA UDI
37613154497004 EUDAMEDFDA UDI
04546540542786 EUDAMEDFDA UDI
07613327378535 EUDAMEDFDA UDI
04546540597533 EUDAMED
07613327648355 EUDAMED
Basic UDI-DI
08858251004355T8 EUDAMED
08858251004356TA EUDAMED
08858251004363T7 EUDAMED
08858251003258T2 EUDAMED
08858251003259T4 EUDAMED
08858251028114U2 EUDAMED
Unit of Use DI
07613154497003 EUDAMED
07613154496884 EUDAMED
Direct Marketing DI
07613327648355 EUDAMED
510(k) Number
K221346 FDA 510(k)
K180500 FDA UDI
FDA Product Code
HRS FDA 510(k)FDA UDI
HWC FDA UDI
EMDN Code
P09120601 CORTICAL SCREWS EUDAMED
P09120699 BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER EUDAMED
P091280 OSTEOSYNTHESIS DEVICES, DEVICES FOR TENDON AND LIGAMENT SYNTHESIS - ACCESSORIES EUDAMED
GMDN Term
Orthopaedic bone screw (non-sliding) FDA UDI
Implantable bone washer FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class I 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
Market of Registration
Netherlands EUDAMED
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
Not in Commercial Distribution FDA UDI
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDIEUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

EUDAMEDFDA UDIEUDAMED

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

Yes

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 — 65.0 Millimeter FDA UDI
Length — 8.0 Millimeter FDA UDI
Length — 26.0 Millimeter FDA UDI
Length — 32.0 Millimeter FDA UDI
Length — 50.0 Millimeter FDA UDI
Length — 22.0 Millimeter FDA UDI
Length — 24.0 Millimeter FDA UDI
Length — 40.0 Millimeter FDA UDI
Length — 12.0 Millimeter FDA UDI
Length — 14.0 Millimeter FDA UDI
Length — 18.0 Millimeter FDA UDI
Length — 16.0 Millimeter FDA UDI
Length — 30.0 Millimeter FDA UDI
Length — 28.0 Millimeter FDA UDI
Length — 11.0 Millimeter FDA UDI

The VariAx 2 MIS Calcaneus is a minimally invasive surgical (MIS) orthopedic device designed for calcaneus (heel bone) procedures. It is classified as a bone screw system intended for internal fixation of calcaneal fractures, enabling stable bone alignment and facilitating bone healing through precise, minimally invasive techniques.

This device is supplied sterile and intended for single-use, adhering to FDA 510(k) clearance under the traditional review pathway (K221346). It is manufactured by Stryker GmbH and complies with EU MDR regulations. The system is intended for use in orthopedic surgical settings, with no MRI safety restrictions specified. Storage and handling follow standard sterile surgical instrument 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: Stryker Leibinger GmbH & Co. KG (Freiburg im Breisgau) im Ranking …

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Stryker GmbH

Sources (45)

  • FDA 510(k) K221346 24 fields · synced Sep 18, 2026
  • FDA UDI c42422b4-d55e-47fc-915f-a610f8a3db6e 36 fields · synced May 27, 2026
  • FDA UDI 76ce150a-1323-4558-99d7-955b372831fa 36 fields · synced May 27, 2026
  • FDA UDI e4d18512-9f82-47ee-8b47-6cca2cfb98af 36 fields · synced May 29, 2026
  • FDA UDI bbee6f5f-f6c2-4b9a-9058-4d259b277d09 35 fields · synced May 29, 2026
  • FDA UDI 6f9ea394-d0b9-479a-9333-051c8d636dcd 36 fields · synced May 29, 2026
  • FDA UDI 6cb7fec4-b48e-4308-8df7-41f7a245aa44 36 fields · synced May 30, 2026
  • FDA UDI 37cced9b-960a-42d4-82e3-7dd3cf99f394 36 fields · synced May 30, 2026
  • FDA UDI 6b5b3e83-2884-4830-8743-97e27d3db13a 35 fields · synced May 30, 2026
  • FDA UDI 7ab94415-3a10-43e9-ab47-b778cfa1b875 36 fields · synced May 30, 2026
  • FDA UDI 9b1c56b9-12ce-42d6-8567-dfff329e36cc 36 fields · synced May 30, 2026
  • FDA UDI c7a83064-efa6-4286-9f6f-95bcd7a8d507 35 fields · synced May 30, 2026
  • FDA UDI b2663214-20e1-4b8e-bed8-f9faaa5555e4 35 fields · synced May 30, 2026
  • FDA UDI 453de122-c04f-4afc-9ae5-bb5abc3d6983 36 fields · synced May 30, 2026
  • FDA UDI 2d9f6713-84e9-40c4-b38b-7196334ab59a 36 fields · synced May 30, 2026
  • FDA UDI c735989e-0997-415d-aa2a-c021f293654e 36 fields · synced May 30, 2026
  • FDA UDI 84f948cd-3423-4db9-bba6-a82b4851bd2d 36 fields · synced May 30, 2026
  • FDA UDI 85593e75-db44-4f4a-8565-0379756b353d 36 fields · synced May 30, 2026
  • FDA UDI 07ba553b-453e-4cab-98ef-3a0451e8368f 35 fields · synced May 30, 2026
  • FDA UDI 2f3cafa8-3803-4a93-95e7-17bebc664e27 35 fields · synced May 30, 2026
  • FDA UDI f8c74c83-55c5-4d77-bd16-73510efb4619 35 fields · synced May 30, 2026
  • FDA UDI 11baf65d-982b-4cf8-aaaa-a4ad088464ce 36 fields · synced May 30, 2026
  • EUDAMED 45a0180a-0b19-4e6a-a3e8-033ffa60daa7 61 fields · synced Jul 8, 2026
  • EUDAMED 7b4dc2f6-e23a-4d57-abc5-08642b71acee 61 fields · synced Jul 8, 2026
  • EUDAMED c4457682-c705-45dc-ae49-a36a625901d3 61 fields · synced Jul 8, 2026
  • EUDAMED 727343b0-0f94-47f3-b174-a340b0d8d0e5 61 fields · synced Jul 8, 2026
  • EUDAMED 70796736-799b-4e66-bc68-98bc21aa8cdd 61 fields · synced Jul 8, 2026
  • EUDAMED b50632cc-f85b-4c9e-8ce5-1d858f7199a2 61 fields · synced Jul 8, 2026
  • EUDAMED d3e347ca-1dd3-46ee-b8c2-2dbbba64e9f0 61 fields · synced Jul 8, 2026
  • EUDAMED 23ef3b98-f0ec-4937-9788-fa7cbc82af46 61 fields · synced Jul 8, 2026
  • EUDAMED 46469885-a07c-4799-929b-f14d1d39b827 61 fields · synced Jul 8, 2026
  • EUDAMED 357b3485-21e7-422d-ae92-2963d3bbd54b 61 fields · synced Jul 8, 2026
  • EUDAMED d1a68153-9b00-489a-827e-c89aaab7bf68 61 fields · synced Jul 8, 2026
  • EUDAMED f42f6461-6db6-4bd1-9a28-971d35ba083c 61 fields · synced Jul 8, 2026
  • EUDAMED b68c26a0-8255-4362-9808-32b5706f49a0 61 fields · synced Jul 8, 2026
  • EUDAMED 9bc5cbbc-ae4b-409d-8d35-c20eb1346823 61 fields · synced Jul 8, 2026
  • EUDAMED db5eae6d-f084-4bc6-9d57-859c959ef757 61 fields · synced Jul 8, 2026
  • EUDAMED 04f879c6-96c8-4739-b912-d504b0eb7671 61 fields · synced Jul 8, 2026
  • EUDAMED 279e21b4-bda4-4d5a-8717-1e42b1b34ff5 61 fields · synced Aug 1, 2026
  • EUDAMED 2eb5c8a7-7203-4f26-af51-35c913cec2f5 61 fields · synced Aug 1, 2026
  • EUDAMED d06c99ff-d21e-4844-89e8-41ce42c268b0 61 fields · synced Aug 1, 2026
  • EUDAMED cc52dea1-a530-44d2-b0e8-1ee99ed947e8 61 fields · synced Aug 1, 2026
  • EUDAMED a6dabbf3-cf10-4901-b337-87fa0c55d49b 61 fields · synced Aug 1, 2026
  • EUDAMED b33276cb-441e-42aa-9ba6-9307ef7ac917 61 fields · synced Aug 1, 2026
  • EUDAMED 6791153e-9fb7-42de-9e76-efe047dd18e9 61 fields · synced Sep 17, 2026