Atlas FDA

Prelude PF Patellae

FDA 510(k) clearance K143543 · decided 2015-01-30

Clearance details

K-number
K143543
Device name
Prelude PF Patellae
Applicant
Biomet, Inc.
Decision
Substantially Equivalent
Date received
2014-12-15
Decision date
2015-01-30
Days to decision
46 days
Clearance type
Traditional
Product code
KRR
Device class
2
Regulation number
888.3540
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Warsaw, IN, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Biomet

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

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
Avon Patello-femoral Joint Prosthesis (K211303)Howmedica Osteonics Corp., Dba Stryker Orthopaedics2021-06-04
MOTO PFJ System (K200122)Medacta International S.A.2020-04-20
Patello-Femoral Wave (Kahuna) Arthroplasty System (K181280)Arthrosurface, Inc.2018-06-14
Arthrex iBalance BiCompartmental Arthroplasty System (K160461)Arthrex, Inc.2016-04-12
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
All instrumentation associated with the Prelude PF Resurfacing Knee System. recall (Z-1318-2016)Biomet, Inc.2016-04-04

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