Equinoxe
Catalogue number 02-012-50-9015, listed by Exactech, Inc., United States, under Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer. 21 manufacturers in China are registered for this product code.
21manufacturers in China registered for this device type
1catalogue number
32510(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 | Exactech, 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 | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K150890 |
| Record published | 2015-11-16 |
| Record revised | 2023-02-03 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | expiry date, serial number |
| Sizes | Length 15 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 02-012-50-9015 | Length 15 mm | 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 |
|---|---|
| K223252 | 2023-07-17 |
| K171045 | 2017-04-28 |
| K170240 | 2017-02-23 |
| K153595 | 2016-03-25 |
| K160484 | 2016-03-18 |
| K152170 | 2015-09-03 |
| K150890 | 2015-05-29 |
| K132161 | 2013-10-11 |
| K123687 | 2013-03-20 |
| K123342 | 2013-01-10 |
| K121307 | 2012-05-31 |
| K111400 | 2011-07-28 |
| K101981 | 2010-08-02 |
| K093360 | 2010-01-11 |
| K082022 | 2008-09-02 |
| K071738 | 2007-08-15 |
| K032522 | 2004-05-28 |
| K033883 | 2004-02-13 |
| K032606 | 2003-09-23 |
| K030686 | 2003-04-02 |
| K023186 | 2002-10-17 |
| K012251 | 2001-07-31 |
| K011976 | 2001-07-16 |
| K010434 | 2001-03-13 |
| K954208 | 1996-02-26 |
| K933494 | 1995-03-10 |
| K932690 | 1995-02-09 |
| K933610 | 1995-01-17 |
| K935773 | 1994-12-09 |
| K932776 | 1994-10-20 |
| K935726 | 1994-10-20 |
| K936079 | 1994-09-07 |
Recalls Naming This Product
4 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 |
|---|---|---|---|---|---|---|---|
| Exactech, Inc. | 510(k) number | 2023-11-21 | Class II | Packaging change control | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. | ||
| Exactech, Inc. | 510(k) number | 2020-01-27 | Class II | Labeling mix-ups | These Truliant Splined Stem Extension, 18mm x 120mm were found to have a labeling error. The upper right corner of the label incorrectly identifies the implant size as 17mm x 80mm when the implant size is 18mm x 120mm. | 4 units | |
| Exactech, Inc. | 510(k) number | 2018-05-08 | Class II | Under Investigation by firm | Potentially have non-conforming internal threads. | 1 | |
| Exactech, Inc. | 510(k) number | 2017-04-07 | Class II | Process control | Missing Screw in carton. Nine (9) serial numbers were identified as being inadvertently packaged as one per carton when two per carton are required. | 9 devices | 2020-08-04 |
Recalls
37 of these are Class II. 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 |
|---|---|---|---|---|---|
| 2024-04-18 | Class II | Under Investigation by firm | Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags. | ||
| 2024-04-18 | Class II | Under Investigation by firm | Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags. | ||
| 2024-04-18 | Class II | Under Investigation by firm | Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags. | ||
| 2024-04-18 | Class II | Under Investigation by firm | Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags. | ||
| 2023-11-21 | Class II | Packaging change control | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. | ||
| 2023-11-21 | Class II | Packaging change control | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. | ||
| 2023-11-21 | Class II | Packaging change control | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. | ||
| 2023-11-21 | Class II | Packaging change control | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. | ||
| 2021-08-30 | Class II | Process control | Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. | 33,103 devices | |
| 2021-08-30 | Class II | Process control | Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. | 242,397 devices | |
| 2021-08-30 | Class II | Process control | Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. | 12 devices | |
| 2021-08-30 | Class II | Process control | Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. | 31,201 devices | |
| 2021-08-30 | Class II | Process control | Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. | 109,787 devices | |
| 2021-08-30 | Class II | Process control | Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. | 8,985 devices | |
| 2021-08-30 | Class II | Process control | Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. | 41 devices | |
| 2019-03-13 | Class II | Under Investigation by firm | 2.5 Truliant Fit Trays were mismarked as 3 | 18 units | 2021-04-22 |
| 2017-09-19 | Class II | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. | 665 devices | 2021-06-21 |
| 2017-09-19 | Class II | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. | 801 devices | 2021-06-21 |
| 2017-09-19 | Class II | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. | 198 devices | 2021-06-21 |
| 2017-09-19 | Class II | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. | 678 devices | 2021-06-21 |
| 2017-09-19 | Class II | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. | 411 devices | 2021-06-21 |
| 2017-09-19 | Class II | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. | 889 devices | 2021-06-21 |
| 2017-09-19 | Class II | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. | 606 devices | 2021-06-21 |
| 2017-09-19 | Class II | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. | 311 devices | 2021-06-21 |
| 2017-09-19 | Class II | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. | 386 devices | 2021-06-21 |
| 2017-09-19 | Class II | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. | 333 devices | 2021-06-21 |
| 2017-09-19 | Class II | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. | 733 devices | 2021-06-21 |
| 2017-09-19 | Class II | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. | 207 devices | 2021-06-21 |
| 2017-09-19 | Class II | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. | 527 devices | 2021-06-21 |
| 2017-09-19 | Class II | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. | 575 devices | 2021-06-21 |
| 2017-09-19 | Class II | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. | 643 devices | 2021-06-21 |
| 2017-09-19 | Class II | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. | 109 devices | 2021-06-21 |
| 2017-09-19 | Class II | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. | 547 devices | 2021-06-21 |
| 2017-09-19 | Class II | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. | 656 devices | 2021-06-21 |
| 2017-09-19 | Class II | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. | 953 devices | 2021-06-21 |
| 2017-09-19 | Class II | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. | 893 devices | 2021-06-21 |
| 2017-09-19 | Class II | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. | 114 devices | 2021-06-21 |
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.