P.F.C.
P.F.C. NON-POROUS KEEL TIBIAL TRAY SZ 1 58mm M/L 38mm A/P
21manufacturers in China registered for this device type
92catalogue numbers in this listing
16510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Concentrated in Jiangsu (10), Shanghai (4), Beijing (3). 13 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| b-ONE Medical (Beijing) Co., Ltd. | Beijing | Beijing | Contract manufacturer | 7 |
| Changzhou Wastonortho Medical Appliance Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 5 |
Showing 12 of 21. All 21 manufacturers in China registered for Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Record
| Listed by | Depuy Orthopaedics, Inc., United States |
|---|---|
| FDA product code | JWH |
| Device type | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3560 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K884796 |
| Record published | 2015-09-24 |
| Record revised | 2019-12-11 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 98-4199 | In distribution | |
| 98-4031 | In distribution | |
| 98-6096 | In distribution | |
| 98-4144 | In distribution | |
| 98-6054 | In distribution | |
| 98-6073 | In distribution | |
| 98-6080 | In distribution | |
| 98-4393 | In distribution | |
| 98-6066 | In distribution | |
| 98-6076 | In distribution | |
| 98-6041 | In distribution | |
| 98-4030 | In distribution | |
| 98-4154 | In distribution | |
| 98-4395 | In distribution | |
| 98-4160 | In distribution | |
| 98-6086 | In distribution | |
| 98-6064 | In distribution | |
| 98-6077 | In distribution | |
| 98-6017 | In distribution | |
| 98-4684 | In distribution | |
| 98-4143 | In distribution | |
| 98-6043 | In distribution | |
| 98-4198 | In distribution | |
| 98-6011 | In distribution | |
| 98-4155 | In distribution | |
| 98-4390 | In distribution | |
| 98-4142 | In distribution | |
| 98-6015 | In distribution | |
| 98-6082 | In distribution | |
| 98-6051 | In distribution | |
| 98-4146 | In distribution | |
| 98-6072 | In distribution | |
| 98-6067 | In distribution | |
| 98-6092 | In distribution | |
| 98-4197 | In distribution | |
| 98-4148 | In distribution | |
| 98-4153 | In distribution | |
| 98-6060 | In distribution | |
| 98-6094 | In distribution | |
| 98-6071 | In distribution | |
| 98-4394 | In distribution | |
| 98-6056 | In distribution | |
| 98-6074 | In distribution | |
| 98-6055 | In distribution | |
| 98-6083 | In distribution | |
| 98-4150 | In distribution | |
| 98-4190 | In distribution | |
| 98-6012 | In distribution | |
| 98-4152 | In distribution | |
| 98-6050 | In distribution | |
| 98-4149 | In distribution | |
| 98-6013 | In distribution | |
| 98-4157 | In distribution | |
| 98-6040 | In distribution | |
| 98-6063 | In distribution | |
| 98-6065 | In distribution | |
| 98-6097 | In distribution | |
| 98-6081 | In distribution | |
| 98-6093 | In distribution | |
| 98-6087 | In distribution | |
| 98-4196 | In distribution | |
| 98-4195 | In distribution | |
| 98-6010 | In distribution | |
| 98-4159 | In distribution | |
| 98-4158 | In distribution | |
| 98-6091 | In distribution | |
| 98-6084 | In distribution | |
| 86-4006 | In distribution | |
| 98-4682 | In distribution | |
| 98-4681 | In distribution | |
| 98-4683 | In distribution | |
| 98-6057 | In distribution | |
| 98-6014 | In distribution | |
| 98-4156 | In distribution | |
| 98-4392 | In distribution | |
| 98-6016 | In distribution | |
| 98-4033 | In distribution | |
| 98-6052 | In distribution | |
| 98-6062 | In distribution | |
| 98-6042 | In distribution | |
| 98-4145 | In distribution | |
| 98-6070 | In distribution | |
| 98-6090 | In distribution | |
| 98-6061 | In distribution | |
| 98-6075 | In distribution | |
| 98-4032 | In distribution | |
| 98-6053 | In distribution | |
| 98-6085 | In distribution | |
| 98-6095 | In distribution | |
| 98-4151 | In distribution | |
| 98-4391 | In distribution | |
| 98-4147 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Prophecy® | Microport Orthopedics Inc. | 4,423 |
| Exult Knee Replacement System | Corentec Co., Ltd. | 1,770 |
| Freedom | Maxx Orthopedics Inc. | 1,693 |
| Legion | Smith & Nephew, Inc. | 1,534 |
| MyKnee | Medacta International SA | 1,466 |
| Journey | Smith & Nephew, Inc. | 1,339 |
| Persona® | Zimmer, Inc. | 1,254 |
| DJO Surgical | Encore Medical, L.P. | 1,131 |
| U2 Total Knee System | United Orthopedic Corp. | 1,078 |
| CKS Plus | Shalby Advanced Technologies, Inc. | 1,024 |
| Lospa Modular Knee System | Corentec Co., Ltd. | 1,020 |
| Natural-Knee® | Zimmer, Inc. | 980 |
Showing 12 of 1,175. All products under Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K262130 | 2026-09-04 |
| K193540 | 2020-06-16 |
| K182301 | 2019-11-08 |
| K110397 | 2011-08-16 |
| K100391 | 2010-09-29 |
| K082500 | 2008-11-18 |
| K073529 | 2008-01-24 |
| K063686 | 2007-12-20 |
| K063633 | 2007-03-02 |
| K060515 | 2006-03-23 |
| K040281 | 2004-07-09 |
| K040166 | 2004-02-23 |
| K033272 | 2004-02-05 |
| K003026 | 2001-06-19 |
| K991106 | 1999-06-09 |
| K982585 | 1998-10-05 |
Recalls Naming This Product
16 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Depuy Orthopaedics, Inc. | 510(k) number | 2011-06-28 | Not classified | Employee error | DePuy initiated a voluntary recall effective immediately, for one lot of P.F.C. SIGMA RD Dome Patella 3 Peg (38mm) due to packaging labels that did not correctly reflect the size of the enclosed patellar component. In the recalled lot, the | 29 | 2013-08-28 |
| Depuy Orthopaedics, Inc. | 510(k) number | 2005-05-26 | Not classified | Other | An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant. | 5 | 2005-12-02 |
| Depuy Orthopaedics, Inc. | 510(k) number | 2005-05-26 | Not classified | Other | An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant. | 10 | 2005-12-02 |
| Depuy Orthopaedics, Inc. | 510(k) number | 2005-05-26 | Not classified | Other | An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant. | 10 | 2005-12-02 |
| Depuy Orthopaedics, Inc. | 510(k) number | 2005-05-26 | Not classified | Other | An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant. | 9 | 2005-12-02 |
| Depuy Orthopaedics, Inc. | 510(k) number | 2005-05-26 | Not classified | Other | An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant. | 10 | 2005-12-02 |
| Depuy Orthopaedics, Inc. | 510(k) number | 2005-05-26 | Not classified | Other | An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant. | 10 | 2005-12-02 |
| Depuy Orthopaedics, Inc. | 510(k) number | 2005-05-26 | Not classified | Other | An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant. | 5 | 2005-12-02 |
| Depuy Orthopaedics, Inc. | 510(k) number | 2005-05-26 | Not classified | Other | An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant. | 10 | 2005-12-02 |
| Depuy Orthopaedics, Inc. | 510(k) number | 2005-05-26 | Not classified | Other | An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant. | 5 | 2005-12-02 |
| Depuy Orthopaedics, Inc. | 510(k) number | 2005-05-26 | Not classified | Other | An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant. | 5 | 2005-12-02 |
| Depuy Orthopaedics, Inc. | 510(k) number | 2005-05-26 | Not classified | Other | An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant. | 5 | 2005-12-02 |
| Depuy Orthopaedics, Inc. | 510(k) number | 2005-05-26 | Not classified | Other | An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant. | 5 | 2005-12-02 |
| Depuy Orthopaedics, Inc. | 510(k) number | 2005-05-26 | Not classified | Other | An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant. | 10 | 2005-12-02 |
| Depuy Orthopaedics, Inc. | 510(k) number | 2005-05-26 | Not classified | Other | An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant. | 5 | 2005-12-02 |
| Depuy Orthopaedics, Inc. | 510(k) number | 2005-05-26 | Not classified | Other | An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant. | 5 | 2005-12-02 |
Recalls
1 of these is Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2022-01-05 | Class II | Nonconforming Material/Component | May have adhesive residue on the posterior surface of the femoral augment, if undetected prior to implantation, soft tissue irritation and/or infection may occur. | 6 units | 2023-12-22 |
| 2022-01-05 | Class II | Nonconforming Material/Component | May have adhesive residue on the posterior surface of the femoral augment, if undetected prior to implantation, soft tissue irritation and/or infection may occur. | 3 units | 2023-12-22 |
| 2021-09-09 | Class II | Under Investigation by firm | Packaging may include screws that are not intended to be used with the 5mm augments, may cause delay in surgery | 10 units | 2023-08-09 |
| 2021-07-01 | Class II | Process change control | Package labeled as 16mm x 80mm contained a 16mm x 130mm stem instead and result in obtaining a replacement | 7 units | 2023-02-01 |
| 2021-02-22 | Class II | Packaging change control | Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to potential damaged packaging. These implant components are utilized in Total Knee Arthroplasty. The affected tibial bases are designed to be use | 102 units total (Domestic: 6 units, Foreign: 86 units) | 2023-10-11 |
| 2021-01-08 | Class II | Nonconforming Material/Component | The taper dimensions may be out of specification due to a production issue during the manufacturing of these lots. | 60 sleeves | 2024-01-17 |
| 2018-07-18 | Class II | Employee error | This unit may be missing the screw/collet Assembly | 1 | 2019-04-17 |
| 2018-04-16 | Class II | Process control | There may be burrs on the extraction hole threads. | 1 unit | 2019-04-02 |
| 2018-04-16 | Class II | Process control | There may be burrs on the extraction hole threads. | 2 units | 2019-04-02 |
| 2014-02-24 | Class II | Packaging | DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for S-ROM Noiles Rotating Hinge Femur with Pin devices. The outer carton and shrink wrap are intact. | 130 | 2015-03-03 |
| 2014-02-24 | Class II | Packaging | DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for S-ROM Noiles Rotating Hinge Femur with Pin devices. The outer carton and shrink wrap are intact. | 132 | 2015-03-03 |
| 2013-12-09 | Class II | Process design | Knee implant femoral devices were found to have anomalous microstructure. Porosity and the presence of blocky carbides, within the cobalt chrome part, can decrease the overall fatigue strength. This decrease in strength could cause implants | 2 | 2014-06-10 |
| 2013-11-18 | Class II | Device Design | DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient. | 29,235 units in total / 2008 through November 2013 | 2015-02-24 |
| 2013-11-18 | Class II | Device Design | DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient. | 29,235 units in total / 2008 through November 2013 | 2015-02-24 |
| 2013-11-18 | Class II | Device Design | DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient. | 29,235 units in total / 2008 through November 2013 | 2015-02-24 |
| 2013-11-18 | Class II | Device Design | DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient. | 29,235 units in total / 2008 through November 2013 | 2015-02-24 |
| 2013-11-18 | Class II | Device Design | DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient. | 29,235 units in total / 2008 through November 2013 | 2015-02-24 |
| 2013-11-18 | Class II | Device Design | DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient. | 29,235 units in total / 2008 through November 2013 | 2015-02-24 |
| 2013-11-18 | Class II | Device Design | DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient. | 29,235 units in total / 2008 through November 2013 | 2015-02-24 |
| 2013-11-18 | Class II | Device Design | DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient. | 29,235 units in total / 2008 through November 2013 | 2015-02-24 |
| 2013-11-18 | Class II | Device Design | DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient. | 29,235 units in total / 2008 through November 2013 | 2015-02-24 |
| 2013-11-18 | Class II | Device Design | DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient. | 29,235 units in total / 2008 through November 2013 | 2015-02-24 |
| 2013-07-11 | Class I | Device Design | The LPS Lower Extremity Dovetail Intercalary component has the potential for fracture of the female component when exposed to certain physiological loads. | 58 U.S. / 39 OUS | 2014-07-10 |
| 2009-05-07 | Not classified | Process control | There may be a crack on the lateral side of the condyle in the posterior chamfer region. The device is used as a Orthopedic knee implant. | 260 | 2010-10-25 |
| 2006-09-14 | Not classified | Other | Mislabeled: units containing a size 32 mm. patella were labeled as a 38 mm patella. | 9 | 2007-04-26 |
| 2005-05-26 | Not classified | Other | An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant. | 11 | 2005-12-02 |
| 2005-05-26 | Not classified | Other | An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant. | 18 | 2005-12-02 |
| 2005-05-26 | Not classified | Other | An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant. | 6 | 2005-12-02 |
| 2005-05-26 | Not classified | Other | An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant. | 12 | 2005-12-02 |
| 2005-05-26 | Not classified | Other | An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant. | 12 | 2005-12-02 |
| 2005-05-26 | Not classified | Other | An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant. | 21 | 2005-12-02 |
| 2005-05-26 | Not classified | Other | An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant. | 12 | 2005-12-02 |
| 2005-05-26 | Not classified | Other | An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant. | 5 | 2005-12-02 |
| 2005-05-26 | Not classified | Other | An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant. | 2005-12-02 | |
| 2005-05-26 | Not classified | Other | An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant. | 30 | 2005-12-02 |
| 2005-05-26 | Not classified | Other | An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant. | 11 | 2005-12-02 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA.
Records are records: nothing here is an offer of sale.