Atlas FDA

LinkSymphoKnee System

FDA 510(k) clearance K202924 · decided 2021-05-13

Clearance details

K-number
K202924
Device name
LinkSymphoKnee System
Applicant
Waldemar Link GmbH & Co. KG
Decision
Substantially Equivalent
Date received
2020-09-29
Decision date
2021-05-13
Days to decision
226 days
Clearance type
Traditional
Product code
JWH
Device class
2
Regulation number
888.3560
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Norderstedt, DE
Third-party review
No
Expedited review
No

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Freedom Total Knee System (E-Poly Tibial Liners) (K261563)Maxx Orthopedics, Inc.2026-08-07
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Materialise TKA Guide System (K253793)Materialise NV2026-01-06
EMPOWR Knee (K252974)Encore Medical L.P.2025-12-19
ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors (K253197)Depuy Ireland UC2025-11-19
Freedom Infinia™ Total Knee System (K253314)Maxx Orthopedics, Inc.2025-10-29
Freedom® Total Knee System – Titan PCK Components (K253144)Maxx Orthopedics, Inc.2025-10-22
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Recalls involving this device

RecordFirmDate
LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented recall (Z-2541-2025)Waldemar Link GmbH & Co. KG (Mfg Site)2025-09-08
Distal Femoral Augment; Item Numbers: (1) 880-300/11 (Sz. 0 - cemented sm), (2) 880-300/21 recall (Z-1699-2025)Waldemar Link GmbH & Co. KG (Mfg Site)2025-04-30
Posterior Femoral Augment; Item Numbers: (1) 880-310/11 (Sz. 0 - cemented sm), (2) 880-310 recall (Z-1700-2025)Waldemar Link GmbH & Co. KG (Mfg Site)2025-04-30
L-Shaped Femoral Augment; Item Numbers: (1) 880-320/12 (Sz. 0 - cemented sm), (2) 880-320/ recall (Z-1701-2025)Waldemar Link GmbH & Co. KG (Mfg Site)2025-04-30
Tibial Augment; Item Numbers: (1) 880-331/11 (Sz. 1-2 - cemented x-sm), (2) 880-331/12 (Sz recall (Z-1702-2025)Waldemar Link GmbH & Co. KG (Mfg Site)2025-04-30
Modular Stem cylindrical, Tilastan, press-fit cementless, L= 80 mm, DIA = 11 mm, Product C recall (Z-1372-2025)Waldemar Link GmbH & Co. KG (Mfg Site)2025-03-17
Modular Stem cylindrical, Tilastan, press-fit cementless, L= 80 mm, DIA = 12 mm, Product C recall (Z-1373-2025)Waldemar Link GmbH & Co. KG (Mfg Site)2025-03-17
Modular Stem cylindrical, Tilastan, press-fit cementless, L= 80 mm, DIA = 13 mm, Product C recall (Z-1374-2025)Waldemar Link GmbH & Co. KG (Mfg Site)2025-03-17
LinkSymphoKnee Distal Femoral Augment - Tilastan - Size 7-8, Medial-Right/Lateral Left, 5m recall (Z-2066-2023)Waldemar Link GmbH & Co. KG (Mfg Site)2023-07-03
LinkSymphoKnee Distal Femoral Augment - Tilastan - Size. 7-8, Lateral-Right/Medial-Left, 5 recall (Z-2067-2023)Waldemar Link GmbH & Co. KG (Mfg Site)2023-07-03
LINK SymphoKnee System L-Shaped Femoral Augment, Medial-Right/Lateral-Left, Sz 5-6 Tilasta recall (Z-1674-2023)Linkbio Corp.2023-06-01