Product Code: KRR FDA class 2 21 CFR 888.3540

Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer

Orthopedic

This device is a semi-constrained cemented patello-femoral knee prosthesis made from metal and polymer, used in knee arthroplasty to resurface the patellofemoral joint while allowing some degree of rotation, applied in cases of isolated patellofemoral arthritis or as part of total knee reconstruction. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is KRR, regulated under 21 CFR 888.3540 within the Orthopedic specialty. This device is designated as an implant.

View on FDA

510(k)s

FEI Numbers

117

Registration Numbers

117

Unique Applicants

Years Active

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Basic Information

Product Code: KRR
Device Class: FDA class 2
Regulation Number: 888.3540
Medical Specialty: Orthopedic
Review Panel: OR
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✓

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 27 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K231253	Overture Orthopaedics Patellofemoral System	Jul 07, 2023	Substantially Equivalent	Overture Resurfacing, Inc.
K221048	Episealer Patellofemoral System	Dec 23, 2022	Substantially Equivalent	Episurf Medical, Inc.
K211303	Avon Patello-femoral Joint Prosthesis	Jun 04, 2021	Substantially Equivalent	Howmedica Osteonics Corp., Dba Stryker Orthopaedics
K200122	MOTO PFJ System	Apr 20, 2020	Substantially Equivalent	Medacta International S.A.
K181280	Patello-Femoral Wave (Kahuna) Arthroplasty System	Jun 14, 2018	Substantially Equivalent	Arthrosurface, Inc.
K160461	Arthrex iBalance BiCompartmental Arthroplasty System	Apr 12, 2016	Substantially Equivalent	Arthrex, Inc.
K143543	Prelude PF Patellae	Jan 30, 2015	Substantially Equivalent	Biomet, Inc.
K123907	PRELUDE PF FEMORAL COMPONENTS (MIM COCRMO), PRELUDE PF FEMORAL COMPONENTS (CAST COCRMO), PRELUDE PF PATELLA COMPONENTS,	Sep 03, 2013	Substantially Equivalent	Biomet Manufacturing Corp
K111970	KNEETEC PFJ&HLS KNEETEC PATELLAR COMPONENT	Feb 23, 2012	Substantially Equivalent	Tornier
K082088	MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM II	Oct 22, 2008	Substantially Equivalent	Mako Surgical Corp.
K080029	MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM	May 16, 2008	Substantially Equivalent	Mako Surgical Corp.
K073120	ACCIN PATELLOFEMORAL SYSTEM	Feb 29, 2008	Substantially Equivalent	Accelerated Innovation, LLC
K071413	HEMICAP PATELLO-FEMORAL RESURFACING SYSTEM	Nov 09, 2007	Substantially Equivalent	Arthrosurface, Inc.
K070695	ZIMMER PATELLOFEMORAL JOINT PROSTHESIS	Jun 07, 2007	Substantially Equivalent	Zimmer, Inc.
K060127	HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS	Mar 16, 2006	Substantially Equivalent	Arthrosurface, Inc.
K050473	RBK PATELLA FEMORAL KNEE	Nov 14, 2005	Substantially Equivalent	Global Orthopaedic Technology, USA, Inc.
K051948	AVON PATELLO-FEMORAL JOINT PROSTHESIS	Oct 21, 2005	Substantially Equivalent	Howmedica Osteonics Corp.
K051086	SMITH & NEPHEW PATELLO-FEMORAL IMPLANT	May 31, 2005	Substantially Equivalent	Smith & Nephew, Inc.
K041160	AVON EXTRA-SMALL PATELLO-FEMORAL REPLACEMENT	May 27, 2004	Substantially Equivalent	Howmedica Osteonics Corp.
K013982	KINEMATCH PATELLO-FEMORAL RESURFACING IMPALANT	May 21, 2002	Substantially Equivalent	Kinamed, Inc.
K020841	AVON PATELLAR COMPONENT	Apr 11, 2002	Substantially Equivalent	Howmedica Osteonics Corp.
K010100	AVON PATELLO-FEMORAL JOINT PROSTHESIS	Apr 06, 2001	Substantially Equivalent	Howmedica Osteonics Corp.
K002356	NATURAL-KNEE II PATELLOFEMORAL JOINT PROSTHESIS	Oct 30, 2000	Substantially Equivalent	Sulzer Orthopedics, Inc.
K001374	PATIENT MATCHED COBALT ALLOY TROCHLEA REPLACEMENT	Jul 27, 2000	Substantially Equivalent	Biomet Manufacturing, Inc.
K001350	PATIENT MATCHED TITANIUM ALLOY TROCHLEA	Jul 26, 2000	Substantially Equivalent	Biomet, Inc.
K000827	UNICOMPARTMENTAL PATELLOFEMORAL PROSTHESIS (UPP) CEMENTED	Jun 23, 2000	Substantially Equivalent	Walter Abendschein, M.D.
K962190	PATELLOFEMORAL JOINT PROSTHESIS	Oct 28, 1996	Substantially Equivalent	Intermedics Orthopedics