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)
Top companies in KRO
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 13, 2014 | DePuy 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 |
KRO | K896048 |
| Mar 13, 2014 | DePuy 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 |
KRO | K896048 |
| Jan 17, 2014 | Zimmer, Inc. Zimmer Segmental Systems; Polyethylene Inserts, Size C.
Knee replacement. Terminated |
KRO | K070978 |
| Jan 17, 2014 | Zimmer, 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 |
KRO | K070978 |
| Apr 19, 2012 | Biomet, 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 |
KRO | K083779 |
| Jan 11, 2012 | Biomet, 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 |
KRO | K002757 |
| Sep 29, 2010 | Stryker 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 |
KRO | K023087 |
| Jun 29, 2009 | Biomet, 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 |
KRO | K002757 K043547 |
| Jun 29, 2009 | Biomet, 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 |
KRO | K002757 K043547 |
| Jun 29, 2009 | Biomet, 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 |
KRO | K002757 K043547 |
| Jun 29, 2009 | Biomet, 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 |
KRO | K002757 K043547 |
| Jun 29, 2009 | Biomet, 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 |
KRO | K002757 K043547 |
| Jun 29, 2009 | Biomet, 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 |
KRO | K002757 K043547 |
| Apr 17, 2009 | Stryker 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 |
KRO | K040749 |
| Mar 9, 2009 | Zimmer 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 |
KRO | K013031 |
| Sep 17, 2008 | Biomet, 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 |
KRO | K052685 |
| Sep 11, 2008 | Biomet, 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 |
KRO | K002757 |
| Sep 11, 2008 | Biomet, 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 |
KRO | K002757 |
| Sep 11, 2008 | Biomet, 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 |
KRO | K002757 |
| Feb 15, 2005 | Zimmer Austin, Inc MOST Options System Porous and Non-Porous Revision Stem Adapters, manufactured and distributed by Zimmer Austin, Inc., Austin, Texas 78717 Terminated |
KRO | K013031 |
| Dec 14, 2004 | Smith & Nephew Inc Tibial Base Plates Terminated |
KRO | K912735 |
| Sep 14, 2004 | Zimmer 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 |
KRO | K013385 |
| Sep 14, 2004 | Zimmer 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 |
KRO | K013385 |
| Nov 13, 2003 | Plus 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 |
KRO | None listed |
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