Atlas FDA

AVL HINGE KNEE SYSTEM

FDA 510(k) clearance K051570 · decided 2005-08-05

Clearance details

K-number
K051570
Device name
AVL HINGE KNEE SYSTEM
Applicant
Biomet, Inc.
Decision
Substantially Equivalent
Date received
2005-06-14
Decision date
2005-08-05
Days to decision
52 days
Clearance type
Traditional
Product code
KRO
Device class
2
Regulation number
888.3510
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Warsaw, IN, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System (K261898)Howmedica Osteonics Corp. dba Stryker Orthopaedics2026-08-06
Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge Bumper (K252898)Howmedica Osteonics Corp., Dba Stryker Orthopaedics2025-12-15
Stem Extension Line (USTAR II System) (K252303)United Orthopedic Corporation2025-08-22
Triathlon® Hinge Knee System (K251665)Howmedica Osteonics Corp., Dba Stryker Orthopaedics2025-07-25
ATTUNE™ Revision Hinge Knee (K242871)Depuy Ireland UC2024-11-21
EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS™ Limb Salvage System;EVOLUTION® MP Total Knee System; EVOLUTION® MP Total Knee System; EVOLUTION® MP Adaptive CS Insert; EVOLUTION® MP Adaptive PS Tibial Insert; EVOLUTION® MP CS/CR Porous Femur/EVOLUTION® Adaptive CS and PS Inserts; EVOLUTION® Revision CCK System; ADVANCE® Double High Insert; ADVANCE® A-CLASS® Tibial Insert; ADVANCE® Knee System; ADVANCE® Ultra-Congruent Tibial Inse (K240043)Microport Orthopedics, Inc.2024-04-01
ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System (K233980)Depuy Ireland UC2024-03-21
EVOLUTION® Hinge Knee System (K230563)Microport Orthopedics, Inc.2023-09-27
Triathlon® Hinge Knee System; Triathlon® Revision Insert X3® (K230416)Stryker2023-05-19
Modular Rotating Hinge Knee Systems and Compatible Components (K223069)Howmedica Osteonics Corp., Dba Stryker Orthopaedics2023-04-21
Triathlon® Hinge Knee System (K223528)Howmedica Osteonics Corp., Dba Stryker Orthopaedics2023-01-20
LINK Endo-Model EVO Knee System (K220628)Waldemar Link GmbH & Co. KG2022-05-03

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
C2A-TAPER ACETABULAR HIP SYSTEM (P050009/S009)Biomet, Inc.2011-02-11
C2A-TAPER ACETABULAR SYSTEM (P050009/S004)Biomet, Inc.2009-04-17
C2A TAPER ACETABULAR SYSTEM (P050009/S007)Biomet, Inc.2009-03-13
C2-A TAPER ACETABULAR SYSTEM (P050009/S005)Biomet, Inc.2007-11-30
C2A-TAPER ACETABULAR SYSTEM (P050009/S002)Biomet, Inc.2006-06-16
C2A-TAPER ACETABULAR SYSTEM (P050009/S001)Biomet, Inc.2006-02-01
C2 A-TAPER ACETABULAR SYSTEM (P050009)Biomet, Inc.2005-12-16