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TrabecuLink Tibial Cone

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 15-3991/02Model Femoral cone, uncemented, Ti6Al4V - 3D-printed, 3-zonesRef 15-2991/01Model Tibial cone, uncemented, Ti6Al4V - 3D-printed, fullRef 15-3997/01Ref 15-2994/02Model Tibial cone, uncemented, Ti6Al4V - 3D-printed, right halfRef 15-3994/04Model Femoral cone, uncemented, Ti6Al4V - 3D-printed, 2-zonesRef 15-3992/05Ref 15-2992/04Model Tibial cone, uncemented, Ti6Al4V - 3D-printed, halfRef 15-2991/03Model Tibial cone, uncemented, Ti6Al4V - 3D-printed, left halfRef 15-3993/02Ref 15-2993/01Ref 15-3994/01Ref 15-2994/04Ref 15-3994/05Ref 15-3992/06Ref 15-3992/07Model Femoral cone, uncemented, Ti6Al4V - 3D-printed, proximalRef 15-2993/02Ref 15-3991/03Ref 15-2993/03Ref 15-2992/03Ref 15-3994/07Ref 15-3995/02Ref 15-3996/02Ref 15-3994/02Ref 15-2994/01Ref 15-3998/01Ref 15-3992/03Ref 15-3994/06Ref 15-3992/01Ref 15-2993/04

by WALDEMAR LINK GmbH & Co. KG

Identity

Trade Name
TrabecuLink Tibial Cone FDA UDI
TrabecuLink Femoral and Tibial Cone - Instruments FDA UDI
TrabecuLink Femoral Cones FDA UDI
Generic Name
Knee arthroplasty wedge FDA UDI
Orthopaedic fixation implant alignment tool FDA UDI
Device Name
TrabecuLink Femoral and Tibial Cones EUDAMED
TrabecuLink Tibial Cone / right half FDA UDI
Orthopaedic implant aiming/guiding block, reusable - TrabecuLink Femoral and Tibial Cone FDA UDI
TrabecuLink Tibial Cone / left half FDA UDI
TrabecuLink Femoral Cones / 3-zones right FDA UDI
TrabecuLink Femoral Cones / 3-zones left FDA UDI
TrabecuLink Femoral Cones / 2-zones FDA UDI
TrabecuLink Tibial Cone / full FDA UDI
TrabecuLink Tibial Cone / half FDA UDI
TrabecuLink Femoral Cones / Proximal FDA UDI
Model / Reference
15-2993/02 EUDAMEDFDA UDI
15-2992/03 EUDAMEDFDA UDI
15-2991/03 EUDAMEDFDA UDI
15-3995/02 EUDAMEDFDA UDI
15-3991/02 EUDAMEDFDA UDI
15-3996/02 EUDAMEDFDA UDI
15-3994/02 EUDAMEDFDA UDI
15-3992/01 EUDAMEDFDA UDI
15-3994/06 EUDAMEDFDA UDI
15-2994/02 EUDAMEDFDA UDI
15-3994/04 EUDAMEDFDA UDI
15-3992/06 EUDAMEDFDA UDI
15-3993/02 EUDAMEDFDA UDI
15-2993/01 EUDAMEDFDA UDI
15-3998/01 EUDAMEDFDA UDI
15-2991/01 EUDAMEDFDA UDI
15-2993/04 EUDAMEDFDA UDI
15-3992/05 EUDAMEDFDA UDI
15-3991/03 EUDAMEDFDA UDI
15-3994/07 EUDAMEDFDA UDI
15-2993/03 EUDAMEDFDA UDI
15-3992/07 EUDAMEDFDA UDI
15-3994/05 EUDAMEDFDA UDI
15-3992/03 EUDAMEDFDA UDI
15-2994/04 EUDAMEDFDA UDI
15-3994/01 EUDAMEDFDA UDI
15-3997/01 EUDAMEDFDA UDI
15-2992/04 EUDAMEDFDA UDI
15-2994/01 EUDAMEDFDA UDI
Femoral cone, uncemented, Ti6Al4V - 3D-printed, 3-zones EUDAMED
Tibial cone, uncemented, Ti6Al4V - 3D-printed, full EUDAMED
Tibial cone, uncemented, Ti6Al4V - 3D-printed, right half EUDAMED
Femoral cone, uncemented, Ti6Al4V - 3D-printed, 2-zones EUDAMED
Tibial cone, uncemented, Ti6Al4V - 3D-printed, half EUDAMED
Tibial cone, uncemented, Ti6Al4V - 3D-printed, left half EUDAMED
Femoral cone, uncemented, Ti6Al4V - 3D-printed, proximal EUDAMED
15-6151/14 FDA UDI
Description
TrabecuLink Tibial Cone / right half FDA UDI
Orthopaedic implant aiming/guiding block, reusable - TrabecuLink Femoral and Tibial Cone FDA UDI
TrabecuLink Tibial Cone / left half FDA UDI
TrabecuLink Femoral Cones / 3-zones right FDA UDI
TrabecuLink Femoral Cones / 3-zones left FDA UDI
TrabecuLink Femoral Cones / 2-zones FDA UDI
TrabecuLink Tibial Cone / full FDA UDI
TrabecuLink Tibial Cone / half FDA UDI
TrabecuLink Femoral Cones / Proximal FDA UDI

Identifiers

Catalog Number
15-2993/02 FDA UDI
15-2992/03 FDA UDI
15-2991/03 FDA UDI
15-3995/02 FDA UDI
15-3991/02 FDA UDI
15-3996/02 FDA UDI
15-3994/02 FDA UDI
15-3992/01 FDA UDI
15-3994/06 FDA UDI
15-2994/02 FDA UDI
15-3994/04 FDA UDI
15-3992/06 FDA UDI
15-3993/02 FDA UDI
15-2993/01 FDA UDI
15-3998/01 FDA UDI
15-2991/01 FDA UDI
15-2993/04 FDA UDI
15-3992/05 FDA UDI
15-3991/03 FDA UDI
15-3994/07 FDA UDI
15-2993/03 FDA UDI
15-3992/07 FDA UDI
15-3994/05 FDA UDI
15-3992/03 FDA UDI
15-2994/04 FDA UDI
15-3994/01 FDA UDI
15-3997/01 FDA UDI
15-2992/04 FDA UDI
15-2994/01 FDA UDI
Primary DI / UDI-DI
04026575192472 EUDAMEDFDA UDI
04026575192441 EUDAMEDFDA UDI
04026575192403 EUDAMEDFDA UDI
04026575265244 EUDAMEDFDA UDI
04026575265206 EUDAMEDFDA UDI
04026575265251 EUDAMEDFDA UDI
04026575265237 EUDAMEDFDA UDI
04026575265114 EUDAMEDFDA UDI
04026575182466 EUDAMEDFDA UDI
04026575192540 EUDAMEDFDA UDI
04026575182442 EUDAMEDFDA UDI
04026575182480 EUDAMEDFDA UDI
04026575265220 EUDAMEDFDA UDI
04026575192465 EUDAMEDFDA UDI
04026575265190 EUDAMEDFDA UDI
04026575076536 EUDAMEDFDA UDI
04026575192588 EUDAMEDFDA UDI
04026575182428 EUDAMEDFDA UDI
04026575265305 EUDAMEDFDA UDI
04026575182473 EUDAMEDFDA UDI
04026575192489 EUDAMEDFDA UDI
04026575182435 EUDAMEDFDA UDI
04026575182459 EUDAMEDFDA UDI
04026575265312 EUDAMEDFDA UDI
04026575192571 EUDAMEDFDA UDI
04026575265138 EUDAMEDFDA UDI
04026575265183 EUDAMEDFDA UDI
04026575192458 EUDAMEDFDA UDI
04026575192526 EUDAMEDFDA UDI
04026575274444 FDA UDI
Basic UDI-DI
4026575-1-KNR-252005-YK EUDAMED
4026575-1-KNR-252001-Y7 EUDAMED
4026575-1-KNR-252002-YA EUDAMED
4026575-1-KNR-252006-YN EUDAMED
4026575-1-KNR-252004-YG EUDAMED
4026575-1-KNR-252003-YD EUDAMED
4026575-1-KNR-252007-YR EUDAMED
510(k) Number
K200113 FDA UDI
K201364 FDA UDI
FDA Product Code
MBH FDA UDI
FZX FDA UDI
EMDN Code
P09098002 KNEE PROSTHESES ADAPTERS (INCLUDING CONES AND SLEEVES) EUDAMED
GMDN Term
Knee arthroplasty wedge FDA UDI
Orthopaedic fixation implant alignment tool FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Class I FDA UDI
Regulation Number
888.3565 FDA UDI
878.4800 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDIFDA UDI

Single Use

No

FDA UDI

Implantable

Yes

EUDAMEDFDA UDIFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Sutures

No

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 UDIFDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Knee arthroplasty wedge

TrabecuLink Tibial Cone by WALDEMAR LINK GmbH & Co. KG — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Knee arthroplasty wedge.

Cleared under the same submission

K200113 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
WALDEMAR LINK GmbH & Co. KG

Sources (59)

  • FDA UDI 5328090b-ff73-4e4d-9569-a65f2a066bb6 35 fields · synced Sep 18, 2026
  • FDA UDI b9222f9d-5ef2-4fff-bc7a-1521bb361d1f 33 fields · synced May 25, 2026
  • FDA UDI f51adcf5-3e5a-4264-8652-9277c769b0a4 35 fields · synced May 29, 2026
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  • FDA UDI ff9a6380-b12e-495a-96f2-a08a3ec2db1a 35 fields · synced May 29, 2026
  • FDA UDI 615726f2-1419-4476-a083-3645c5218bfb 35 fields · synced May 29, 2026
  • FDA UDI 2f65c704-bf18-403e-b1a8-1eec7a208fff 35 fields · synced May 29, 2026
  • FDA UDI c4f66693-1176-41fb-b668-150b2085f4a4 35 fields · synced May 30, 2026
  • FDA UDI 21330856-0a49-49ec-84ad-10c8a5c3f177 35 fields · synced May 30, 2026
  • FDA UDI 7208e553-891a-4526-89e0-086bb43cee10 35 fields · synced May 30, 2026
  • FDA UDI a8a10b06-1cd7-4a9a-ae7e-fa041285883a 35 fields · synced May 30, 2026
  • FDA UDI 23067ca7-ae65-43ec-9389-c77c710df7bb 35 fields · synced May 30, 2026
  • FDA UDI a5ec5a64-8215-4cb6-bd88-c9f819d07dc4 35 fields · synced May 30, 2026
  • FDA UDI 0cf482f5-79d2-4e07-b032-1297d22d7e7f 35 fields · synced May 30, 2026
  • FDA UDI 9d2fa1b1-46be-46e4-83f3-bed46f80a5cb 35 fields · synced May 30, 2026
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  • FDA UDI b3c4ed4d-2e96-4f6e-be69-20559c1f09ca 35 fields · synced May 30, 2026
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  • FDA UDI e84ea1f9-77e2-426c-acb0-39bb0b20a6ce 35 fields · synced May 30, 2026
  • FDA UDI eaca39fc-2009-48c1-aca1-28696c75eee5 35 fields · synced May 30, 2026
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  • FDA UDI 48534f71-40ba-429c-a576-53f726080671 35 fields · synced May 30, 2026
  • EUDAMED e31a82a3-f7b1-40b9-b4c8-306e2883dbbe 61 fields · synced Jul 9, 2026
  • EUDAMED a752d9bc-b4ef-4e91-8418-7ff16dd7aabd 61 fields · synced Jul 9, 2026
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  • EUDAMED 864ddc69-5912-4046-ac36-da1308f80134 61 fields · synced Jul 13, 2026
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  • EUDAMED 2527a18c-02ce-4dbb-94c3-a9284ae45755 61 fields · synced Jul 15, 2026
  • EUDAMED 305ce088-0c42-4178-b099-18d6aa22ff67 61 fields · synced Jul 16, 2026
  • EUDAMED 517890da-ce0e-4be1-a7c5-2a961b7a99b2 61 fields · synced Jul 17, 2026
  • EUDAMED 193167db-2452-424e-854c-b8b189160bae 61 fields · synced Jul 19, 2026
  • EUDAMED 9d7d007e-5328-43b8-9627-e7efb11473f7 61 fields · synced Jul 19, 2026
  • EUDAMED b67e5be9-6030-4fa2-8de1-510ea66c0f03 61 fields · synced Jul 24, 2026
  • EUDAMED 16457d35-9fc4-405a-9271-6639e3d6869c 61 fields · synced Jul 27, 2026
  • EUDAMED 92eb8ff0-e6ca-4103-91f7-c6afc37165d7 61 fields · synced Jul 28, 2026
  • EUDAMED 0f0cd3b0-e876-42d9-983d-d72f8c874a4b 61 fields · synced Jul 28, 2026
  • EUDAMED e3a38a77-93ba-4315-93fb-f7a312dda85f 61 fields · synced Jul 28, 2026
  • EUDAMED 29f11dca-2067-4638-8d53-a0ac7150913f 61 fields · synced Jul 29, 2026
  • EUDAMED 2f4c252b-29f5-47ed-a6ec-b6b834e2c75d 61 fields · synced Jul 30, 2026
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  • EUDAMED ef0eff0a-3cb8-4f57-b3e7-60be1b4e8396 61 fields · synced Aug 4, 2026
  • EUDAMED 81d0e79e-3b44-42c0-9c63-914ad330c38f 61 fields · synced Aug 4, 2026
  • EUDAMED 620a2862-cd3f-4c27-bfe0-c2e1508d57a7 61 fields · synced Aug 4, 2026
  • EUDAMED 72cdedee-0a5c-468f-8593-199c683610b0 61 fields · synced Sep 18, 2026