Biomet® Knee System
29 catalogue numbers from 148032, listed by Biomet Orthopedics, United States, under Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive. 8 manufacturers in China are registered for this product code.
8manufacturers in China registered for this device type
29catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (4), Shanghai (2), Zhejiang (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| b-ONE Medical (Beijing) Co., Ltd. | Beijing | Beijing | Contract manufacturer | 7 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Biomet Orthopedics, United States |
|---|---|
| FDA product code | OIY |
| Device type | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3560 |
| 510(k) | K142933 |
| Record published | 2015-10-24 |
| Record revised | 2026-04-27 (version 7) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 148032 | 22 MM 200 MM | In distribution |
| 141236 | 83 mm | In distribution |
| 141517 | 87 mm | In distribution |
| 141796 | RM/LL 16 mm 83 mm | In distribution |
| 141516 | 83 mm | In distribution |
| 141233 | 71 mm | In distribution |
| 141511 | 63 mm | In distribution |
| 11-150852 | Small 31 mm | In distribution |
| 141486 | 83 MM | In distribution |
| 11-150830 | 37 mm 10 mm | In distribution |
| 185186 | 23 mm | In distribution |
| 141232 | 67 mm | In distribution |
| 11-150820 | Small 31 mm | In distribution |
| CP102888 | 34 mm | In distribution |
| 141212 | 67 mm | In distribution |
| 141266 | 83 mm | In distribution |
| 11-150826 | 31 mm 8 mm | In distribution |
| 141223 | 71 mm | In distribution |
| 11-150822 | Medium 34 mm | In distribution |
| 141320 | 80 mm Ø15 mm Post | In distribution |
| 141210 | 59 mm | In distribution |
| 141222 | 67 mm | In distribution |
| 141265 | 79 mm | In distribution |
| 141515 | 79 mm | In distribution |
| 141316 | 80 mm Ø10 mm Post | In distribution |
| 141213 | 71 mm | In distribution |
| 141221 | 63 mm | In distribution |
| 11-150818 | X-Small 28 mm | In distribution |
| 11-150838 | 28 mm 8 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Persona® | Zimmer, Inc. | 552 |
| DJO Surgical | Encore Medical, L.P. | 415 |
| Genflex2 Total Knee System | Globus Medical, Inc. | 389 |
| Persona® Vivacit-E® | Zimmer, Inc. | 332 |
| Truliant, Activit-E | Exactech, Inc. | 272 |
| TriVerse Meniscal Insert PS | Signature Orthopaedics PTY Limited | 220 |
| U2™ Knee | United Orthopedic Corp. | 195 |
| BKS E-Vitalize | Ortho Development Corp. | 193 |
| Vanguard XP Instrumentation | Biomet Orthopedics | 169 |
| Attune | Depuy (Ireland) | 161 |
| Vanguard Complete Knee System | Biomet Orthopedics | 153 |
| EXp Tibial Inserts and Patellar Components | Globus Medical, Inc. | 144 |
Showing 12 of 102. All products under Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
Recalls Naming This Product
21 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 |
|---|---|---|---|---|---|---|---|
| Biomet, Inc. | 510(k) number | 2022-12-29 | Class II | Labeling Change Control | Components Incorrectly labeled as either smaller or larger and incorrect side (right/left). | 157 units | |
| Biomet, Inc. | 510(k) number | 2022-12-29 | Class II | Labeling Change Control | Components Incorrectly labeled as either smaller or larger and incorrect side (right/left). | 91 units | |
| Biomet, Inc. | 510(k) number | 2020-04-17 | Class II | Process control | Potential presence of elevated endotoxin levels that exceed the specification limit | 54 units | 2021-06-25 |
| Biomet, Inc. | 510(k) number | 2018-12-21 | Class II | Under Investigation by firm | Vanguard Knee System Series-A Standard Patella a potential commingle that could result in the size of the implant not matching the size on the label. | 90 units | 2020-05-13 |
| Biomet, Inc. | 510(k) number | 2018-10-22 | Class II | Labeling mix-ups | Label on the outer carton or the patient labels does not match label on the inner sterile packaging | 8 units | 2019-12-11 |
| Biomet, Inc. | 510(k) number | 2018-10-22 | Class II | Labeling mix-ups | Label on the outer carton or the patient labels does not match label on the inner sterile packaging | 8 units | 2019-12-11 |
| Biomet, Inc. | 510(k) number | 2018-05-24 | Class II | Under Investigation by firm | Two lots of tibial bearings were commingled. There is a possibility that a 14mm tibial bearing is packaged in a box labeled as 12 mm tibial bearing and vice versa. This may lead to extension of surgery to find another implant. | 48 | 2020-04-07 |
| Biomet, Inc. | 510(k) number | 2018-05-18 | Class II | Under Investigation by firm | One lot of 75mm tibial tray is potentially etched and labeled as a 79 mm tibial tray. This may lead to delay in surgery, or immediate revision surgery to remove an incorrectly sized tibial component after it has been cemented. | 16 | 2020-03-31 |
| Biomet, Inc. | 510(k) number | 2018-05-11 | Class II | Under Investigation by firm | The label master file was errantly set up as a 63/37mm instead of a 63/67mm. There is no 63/37 size offered, and the product is laser marked with the correct size. | 169 | 2019-11-21 |
| Biomet, Inc. | 510(k) number | 2017-10-03 | Class II | Error in labeling | The affected products are labeled as a 62.5mm LEFT Femur; however, the contents are a Vanguard 70mm RIGHT Femur. | 8 | 2018-08-23 |
| Biomet, Inc. | 510(k) number | 2017-08-25 | Class II | Process change control | The affected AGC 2000 LP Patella products were over-molded leaving the outside diameter nonconforming to the print dimension. | 28 devices | 2018-08-09 |
| Biomet, Inc. | 510(k) number | 2017-08-25 | Class II | Process change control | The affected AGC 2000 LP Patella products were over-molded leaving the outside diameter nonconforming to the print dimension. | 11 devices | 2018-08-09 |
| Biomet, Inc. | 510(k) number | 2016-12-15 | Class II | Material/Component Contamination | Zimmer Biomet is conducting a medical device recall for ARCOS & TPRLC broaches and rasps due to potential alumina inclusions in the raw material batch used to produce the affected products. Inclusions contained within the finished product c | 26 | 2018-06-29 |
| Biomet, Inc. | 510(k) number | 2015-04-16 | Class III | Labeling mix-ups | Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes. | 1315 | 2016-05-16 |
| Biomet, Inc. | 510(k) number | 2012-11-15 | Class II | Employee error | Biomet investigation identified that the square end of the offset tibial tray adaptor locking insert is oversized and may not engage insert tool screwdriver. This could cause a possible delay in surgery greater than 30 minutes, potentiall | 200 | 2013-11-08 |
| Biomet, Inc. | 510(k) number | 2011-03-03 | Not classified | Packaging process control | The firm is recalling the product due to the product’s packaging being labeled “I-Beam 75mm. Tibial Plate”, but the package actually contains the “Interlok 67mm. CR Tibial Plate”. | 8 | 2011-07-27 |
| Biomet, Inc. | 510(k) number | 2007-12-12 | Not classified | Packaging process control | Mislabeled as to size: Package labeled as containing a 67 mm tray actually contains a 75 mm tray and vice versa. | 8 | 2008-06-11 |
| Biomet, Inc. | 510(k) number | 2007-12-12 | Not classified | Packaging process control | Mislabeled as to size: Package labeled as containing a 67 mm tray actually contains a 75 mm tray and vice versa. | 8 | 2008-06-11 |
| Biomet, Inc. | 510(k) number | 2007-09-18 | Not classified | Labeling mix-ups | Mislabeled as to size: the package actaully contained a 71 mm tray. | 7 | 2008-06-04 |
| Biomet, Inc. | 510(k) number | 2007-07-24 | Not classified | Labeling mix-ups | Incorrect Product — Mislabeled as to size; a 18 mm x 65 mm tibula implant is enclosed in a package labeled as 12 mm x 80 mm. | 4 | 2008-07-24 |
| Biomet, Inc. | 510(k) number | 2007-07-24 | Not classified | Labeling mix-ups | Incorrect Product — Mislabeled as to size; a 18 mm x 65 mm tibula implant is enclosed in a package labeled as 12 mm x 80 mm. | 1 | 2008-07-24 |
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.