ClearanceBrief
Panels › Orthopedic › Product code KRO · Class 2

Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer

Regulation 888.3510

2510(k)s in 12 months (87 all time)
28recalls in 12 months (124 all time)
121recalls that name a 510(k)
Get daily alerts for KROSample briefCSV

Top companies in KRO

DateFirm and productCodeLinked 510(k)
Mar 13, 2014DePuy Orthopaedics, Inc.
REF 623401 R, S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right, Medium, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there
Terminated
KROK896048
Mar 13, 2014DePuy Orthopaedics, Inc.
REF 623401 L S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left, medium, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there i
Terminated
KROK896048
Jan 17, 2014Zimmer, Inc.
Zimmer Segmental Systems; Polyethylene Inserts, Size C. Knee replacement.
Terminated
KROK070978
Jan 17, 2014Zimmer, Inc.
Zimmer Segmental Systems; Polyethylene Inserts, Size B. Designed to address significant bone loss resulting from oncology, trauma, and/or salvage of previously failed arthroplasty.
Terminated
KROK070978
Apr 19, 2012Biomet, Inc.
REF. CP113456, MAK OSS No Head Lock Pin, NO HEAD / WITH PLUG CO-CR-MO ALLOY/ARCOM UHMWPE STERILE, R, Biomet Orthopedics Warsaw, IN 46581. The MAK OSS No Head Metal Lock Pin is to be inserted into
Terminated
KROK083779
Jan 11, 2012Biomet, Inc.
OSS INTERLOK BOWED IM STEM W/SCREW 14 MM X 150 MM TI 6AL 4V ALLOY. Hip and knee joint replacement prostheses intended for primary and revision joint arthroplasty for use in cemented applications.
Terminated
KROK002757
Sep 29, 2010Stryker Howmedica Osteonics Corp.
GMRS Extension Piece, 60 mm; Sterile Stryker Howmedica Osteonics; Howmedica Internation S. de. R.L. Limerick, Ireland. The Global Modular Replacement System is intended to be used with the components
Terminated
KROK023087
Jun 29, 2009Biomet, Inc.
Biomet OSS Elliptical Proximal Femoral Trial 7 cm left provisional, stainless steel, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-472125. A non-powered, orthopedic manual surgical instrument for use
Terminated
KROK002757
K043547
Jun 29, 2009Biomet, Inc.
Biomet OSS Elliptical Proximal Femoral Trial 7 cm, right provisional, stainless steel, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-472124. A non-powered, orthopedic manual surgical instrument for us
Terminated
KROK002757
K043547
Jun 29, 2009Biomet, Inc.
Biomet OSS Letson Proximal Femoral Trial 7 cm resection/left, stainless steel, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-472089. A non-powered, orthopedic manual surgical instrument for use with o
Terminated
KROK002757
K043547
Jun 29, 2009Biomet, Inc.
Biomet OSS Letson Proximal Femoral Trial 7 cm resection/right, stainless steel, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-472088. A non-powered, orthopedic manual surgical instrument for use with
Terminated
KROK002757
K043547
Jun 29, 2009Biomet, Inc.
Biomet OSS FINN Proximal Femoral Trial 7 cm resection/left, stainless steel, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-472087. A non-powered, orthopedic manual surgical instrument for use with oth
Terminated
KROK002757
K043547
Jun 29, 2009Biomet, Inc.
Biomet OSS FINN Proximal Femoral Trial 7 cm resection/right, stainless steel, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-472086. A non-powered, orthopedic manual surgical instrument for use with ot
Terminated
KROK002757
K043547
Apr 17, 2009Stryker Howmedica Osteonics Corp.
Modular Replacement System (MRS) Cemented Stems, Sterile, Catalog Numbers: 6485-3-000, 6485-3-008, 6485-3-009, 6485-3-010, 6485-3-018, 6485-3-019, 6485-3-300, 6485-3-308, 6485-3-309, 6485-3-310, 6485-
Terminated
KROK040749
Mar 9, 2009Zimmer Inc.
Zimmer Most Hinged Tibia Baseplate Spacer, size 1, 6 mm, sterile, Zimmer, Warsaw, IN; REF 5020-06-001. Component used to augment uni- and bi-compartmental defects and is manufactured from Ti-6A1-4V A
Terminated
KROK013031
Sep 17, 2008Biomet, Inc.
OSS (Orthopedic Salvage System) RS Non-Modular Long Tibial Base, Porous Coated, 71mm x 10 x 160mm, Co-CR-MO/Ti-6AL-4V alloy, sterile; Part 161043. Implant is part of a system used to replace the tibi
Terminated
KROK052685
Sep 11, 2008Biomet, Inc.
Biomet OSS Interlok IM Stem w/Screw, straight collar, 15 mm x 225 mm, TI6AL4V alloy, sterile, Biomet Orthopedics, Inc., Warsaw, IN; REF 150492. Orthopedic implant intended as part of a replacement kn
Terminated
KROK002757
Sep 11, 2008Biomet, Inc.
Biomet OSS Interlok IM Stem w/Screw, straight collar, 13 mm x 225 mm, TI6AL4V alloy, sterile, Biomet Orthopedics, Inc., Warsaw, IN; REF 150491. Orthopedic implant intended as part of a replacement kn
Terminated
KROK002757
Sep 11, 2008Biomet, Inc.
Biomet OSS Interlok IM Stem w/Screw, straight collar, 11 mm x 225 mm, TI6AL4V alloy, sterile, Biomet Orthopedics, Inc., Warsaw, IN; REF 150490. Orthopedic implant intended as part of a replacement kn
Terminated
KROK002757
Feb 15, 2005Zimmer Austin, Inc
MOST Options System Porous and Non-Porous Revision Stem Adapters, manufactured and distributed by Zimmer Austin, Inc., Austin, Texas 78717
Terminated
KROK013031
Dec 14, 2004Smith & Nephew Inc
Tibial Base Plates
Terminated
KROK912735
Sep 14, 2004Zimmer Inc.
Zimmer brand NEXGEN Complete Knee Solution Rotating Hinge Knee Tibial Component, precoat, nonmodular, size 3, sterile, for cemented use only; Cat. No. 5880-03-02.
Terminated
KROK013385
Sep 14, 2004Zimmer Inc.
Zimmer brand NEXGEN Complete Knee Solution Rotating Hinge Knee Tibial Component, precoat, nonmodular, size 2, sterile, for cemented use only; Cat. No. 5880-02-02.
Terminated
KROK013385
Nov 13, 2003Plus Orthopedics
17 mm thickness only of a polyethelene insert, which sits on the top of a metal component tibial implant. Part of the ''RT/RT Modular'' total knee replacement.
Terminated
KRONone listed

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.