Atlas FDA

Patello-Femoral Wave (Kahuna) Arthroplasty System

FDA 510(k) clearance K181280 · decided 2018-06-14

Clearance details

K-number
K181280
Device name
Patello-Femoral Wave (Kahuna) Arthroplasty System
Applicant
Arthrosurface, Inc.
Decision
Substantially Equivalent
Date received
2018-05-15
Decision date
2018-06-14
Days to decision
30 days
Clearance type
Special
Product code
KRR
Device class
2
Regulation number
888.3540
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Franklin, MA, 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
Overture Orthopaedics Patellofemoral System (K231253)Overture Resurfacing, Inc.2023-07-07
Episealer Patellofemoral System (K221048)Episurf Medical, Inc.2022-12-23
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MOTO PFJ System (K200122)Medacta International S.A.2020-04-20
Arthrex iBalance BiCompartmental Arthroplasty System (K160461)Arthrex, Inc.2016-04-12
Prelude PF Patellae (K143543)Biomet, Inc.2015-01-30
PRELUDE PF FEMORAL COMPONENTS (MIM COCRMO), PRELUDE PF FEMORAL COMPONENTS (CAST COCRMO), PRELUDE PF PATELLA COMPONENTS, (K123907)Biomet Manufacturing Corp2013-09-03
KNEETEC PFJ&HLS KNEETEC PATELLAR COMPONENT (K111970)Tornier2012-02-23
MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM II (K082088)Mako Surgical Corp.2008-10-22
MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM (K080029)Mako Surgical Corp.2008-05-16
ACCIN PATELLOFEMORAL SYSTEM (K073120)Accelerated Innovation, LLC2008-02-29
HEMICAP PATELLO-FEMORAL RESURFACING SYSTEM (K071413)Arthrosurface, Inc.2007-11-09

Recalls involving this device

RecordFirmDate
MEDLINE UNITE FOOT & ANKLE Screw, Non-Locking, Mini T8 (2.0x8mm), REF MMSN2008 recall (Z-1045-2023)MEDLINE INDUSTRIES, LP - Northfield2023-02-01
MEDLINE UNITE FOOT & ANKLE Screw, Polyaxial Locking, Mini T8 (2.0x8mm), REF MMSL2008 recall (Z-1046-2023)MEDLINE INDUSTRIES, LP - Northfield2023-02-01
MEDLINE UNITE FOOT & ANKLE DRILL BIT, 1.3MM Solid Core, REF MPN10013 recall (Z-1047-2023)MEDLINE INDUSTRIES, LP - Northfield2023-02-01