DJO Surgical
Baseplate, FK 10/3D Down 12 Nonporous Stemmed, Tibia, 3D, LT
12manufacturers in China registered for this device type
191catalogue numbers in this listing
2510(k) clearances naming this product code
4recalls on this code
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (3), Zhejiang (2). 8 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 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| 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 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Encore Medical, L.P., United States |
|---|---|
| FDA product code | MBH |
| Device type | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3565 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K091956 |
| Record published | 2017-08-07 |
| Record revised | 2019-12-11 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 391-13-704 | In distribution | |
| 236-01-103 | In distribution | |
| 353-01-106 | In distribution | |
| 244-01-102 | In distribution | |
| 353-03-103 | In distribution | |
| 243-01-109 | In distribution | |
| 353-04-111 | In distribution | |
| 244-01-110 | In distribution | |
| 236-02-103 | In distribution | |
| 334-02-110 | In distribution | |
| 244-02-106 | In distribution | |
| 233-02-108 | In distribution | |
| 392-15-710 | In distribution | |
| 336-02-104 | In distribution | |
| 233-01-110 | In distribution | |
| 244-02-103 | In distribution | |
| 243-02-107 | In distribution | |
| 355-01-003 | In distribution | |
| 236-02-106 | In distribution | |
| 334-01-102 | In distribution | |
| 244-01-103 | In distribution | |
| 353-01-107 | In distribution | |
| 353-01-103 | In distribution | |
| 334-01-106 | In distribution | |
| 244-02-105 | In distribution | |
| 244-02-104 | In distribution | |
| 353-02-111 | In distribution | |
| 353-04-102 | In distribution | |
| 333-01-108 | In distribution | |
| 353-02-106 | In distribution | |
| 244-01-104 | In distribution | |
| 236-01-104 | In distribution | |
| 355-01-001 | In distribution | |
| 236-02-107 | In distribution | |
| 236-02-108 | In distribution | |
| 335-02-102 | In distribution | |
| 353-04-108 | In distribution | |
| 392-09-708 | In distribution | |
| 243-01-110 | In distribution | |
| 243-01-102 | In distribution | |
| 333-01-102 | In distribution | |
| 392-09-710 | In distribution | |
| 243-01-106 | In distribution | |
| 233-01-112 | In distribution | |
| 353-01-104 | In distribution | |
| 244-02-107 | In distribution | |
| 391-09-704 | In distribution | |
| 110-03-741 | In distribution | |
| 353-02-108 | In distribution | |
| 335-01-104 | In distribution | |
| 391-19-706 | In distribution | |
| 244-01-108 | In distribution | |
| 391-15-704 | In distribution | |
| 244-02-102 | In distribution | |
| 233-01-105 | In distribution | |
| 353-03-109 | In distribution | |
| 243-01-104 | In distribution | |
| 236-01-110 | In distribution | |
| 353-04-109 | In distribution | |
| 391-19-702 | In distribution | |
| 336-01-108 | In distribution | |
| 356-02-004 | In distribution | |
| 353-02-105 | In distribution | |
| 334-01-112 | In distribution | |
| 353-04-104 | In distribution | |
| 353-04-103 | In distribution | |
| 336-02-102 | In distribution | |
| 335-02-106 | In distribution | |
| 353-01-105 | In distribution | |
| 334-02-112 | In distribution | |
| 244-01-111 | In distribution | |
| 236-02-102 | In distribution | |
| 353-03-102 | In distribution | |
| 353-03-110 | In distribution | |
| 353-03-107 | In distribution | |
| 391-19-712 | In distribution | |
| 233-02-102 | In distribution | |
| 233-01-106 | In distribution | |
| 391-13-703 | In distribution | |
| 236-02-110 | In distribution | |
| 392-19-708 | In distribution | |
| 243-01-108 | In distribution | |
| 236-02-112 | In distribution | |
| 333-01-106 | In distribution | |
| 243-02-106 | In distribution | |
| 244-01-106 | In distribution | |
| 233-02-106 | In distribution | |
| 244-01-107 | In distribution | |
| 233-02-107 | In distribution | |
| 233-01-103 | In distribution | |
| 233-01-104 | In distribution | |
| 353-05-111 | In distribution | |
| 391-15-706 | In distribution | |
| 334-02-104 | In distribution | |
| 391-15-712 | In distribution | |
| 336-02-112 | In distribution | |
| 353-03-106 | In distribution | |
| 353-03-105 | In distribution | |
| 391-11-705 | In distribution | |
| 236-01-106 | In distribution | |
| 353-04-105 | In distribution | |
| 355-03-004 | In distribution | |
| 353-02-110 | In distribution | |
| 391-09-707 | In distribution | |
| 335-01-108 | In distribution | |
| 353-02-103 | In distribution | |
| 243-01-111 | In distribution | |
| 353-02-102 | In distribution | |
| 353-03-111 | In distribution | |
| 333-02-104 | In distribution | |
| 391-13-712 | In distribution | |
| 355-02-003 | In distribution | |
| 355-02-002 | In distribution | |
| 236-02-104 | In distribution | |
| 353-01-102 | In distribution | |
| 236-01-108 | In distribution | |
| 233-02-105 | In distribution | |
| 353-02-109 | In distribution | |
| 233-02-103 | In distribution | |
| 335-01-106 | In distribution | |
| 233-01-108 | In distribution | |
| 244-02-110 | In distribution | |
| 333-01-104 | In distribution | |
| 353-01-108 | In distribution | |
| 392-13-706 | In distribution | |
| 244-01-105 | In distribution | |
| 353-01-110 | In distribution | |
| 244-02-109 | In distribution | |
| 391-15-708 | In distribution | |
| 243-02-102 | In distribution | |
| 243-02-108 | In distribution | |
| 392-15-702 | In distribution | |
| 353-02-107 | In distribution | |
| 244-02-108 | In distribution | |
| 233-01-102 | In distribution | |
| 392-13-704 | In distribution | |
| 236-01-107 | In distribution | |
| 110-03-732 | In distribution | |
| 243-02-103 | In distribution | |
| 244-02-111 | In distribution | |
| 243-01-103 | In distribution | |
| 336-01-106 | In distribution | |
| 233-02-112 | In distribution | |
| 392-15-706 | In distribution | |
| 336-01-104 | In distribution | |
| 333-01-110 | In distribution | |
| 243-02-109 | In distribution | |
| 392-15-704 | In distribution | |
| 110-03-735 | In distribution | |
| 236-01-102 | In distribution | |
| 353-06-111 | In distribution | |
| 353-04-107 | In distribution | |
| 236-01-105 | In distribution | |
| 353-01-111 | In distribution | |
| 333-02-102 | In distribution | |
| 353-04-106 | In distribution | |
| 335-01-112 | In distribution | |
| 391-11-710 | In distribution | |
| 356-02-003 | In distribution | |
| 243-02-105 | In distribution | |
| 392-13-702 | In distribution | |
| 236-01-112 | In distribution | |
| 356-03-004 | In distribution | |
| 244-01-109 | In distribution | |
| 353-02-104 | In distribution | |
| 353-01-109 | In distribution | |
| 335-02-108 | In distribution | |
| 392-13-707 | In distribution | |
| 355-02-004 | In distribution | |
| 391-09-708 | In distribution | |
| 802-05-107 | In distribution | |
| 336-01-102 | In distribution | |
| 392-11-708 | In distribution | |
| 353-04-110 | In distribution | |
| 353-03-108 | In distribution | |
| 243-01-105 | In distribution | |
| 243-02-104 | In distribution | |
| 236-02-105 | In distribution | |
| 233-01-107 | In distribution | |
| 335-01-102 | In distribution | |
| 391-15-703 | In distribution | |
| 353-03-104 | In distribution | |
| 233-02-104 | In distribution | |
| 392-09-703 | In distribution | |
| 243-02-111 | In distribution | |
| 243-02-110 | In distribution | |
| 355-03-002 | In distribution | |
| 233-02-110 | In distribution | |
| 391-13-707 | In distribution | |
| 243-01-107 | In distribution | |
| 392-09-705 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Prophecy | Microport Orthopedics Inc. | 4,272 |
| Triathlon | Howmedica Osteonics Corp | 712 |
| Instrument | Howmedica Osteonics Corp | 709 |
| Persona® Vivacit-E® | Zimmer, Inc. | 499 |
| Arthrex® | Arthrex, Inc. | 494 |
| Persona® | Zimmer, Inc. | 441 |
| Legion | Smith & Nephew, Inc. | 397 |
| U2 Total Knee System | United Orthopedic Corp. | 286 |
| Attune | Depuy (Ireland) | 234 |
| Vanguard XP Instrumentation | Biomet Orthopedics | 150 |
| Truliant® | Exactech, Inc. | 142 |
| Vanguard Knee System | Biomet Orthopedics | 125 |
Showing 12 of 948. All products under Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K210308 | 2021-03-30 |
| K171991 | 2017-10-04 |
Recalls Naming This Product
13 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 |
|---|---|---|---|---|---|---|---|
| Encore Medical, L.P. | 510(k) number | 2023-11-10 | Class II | Labeling Change Control | Due to incorrect product/device within packaging. | 37 devices | |
| Encore Medical, L.P. | 510(k) number | 2023-09-29 | Class II | Process change control | Knee punch handle tip is breaking during surgery due to the lack of heat treatment, which may lead to a disruption in surgery. | 406 | |
| Encore Medical, L.P. | 510(k) number | 2023-02-28 | Class II | Process change control | Patella drills are marked with incorrect diameter size of 5.6mm, when they should be 5.4mm. Porous patella overdrills are marked with incorrect diameter size of 5.4 mm, when they should be 5.6 mm. If the incorrect drill is selected during s | 29 | |
| Encore Medical, L.P. | 510(k) number | 2020-08-03 | Class II | Process change control | There is a potential for the retaining pin of the tibial punch handle to become loose and fall out while impacting. If undetected, there is a potential of leaving debris in the joint space. | 190 units | |
| Encore Medical, L.P. | 510(k) number | 2017-05-31 | Class II | Packaging process control | Mis-pack. A size 6 Left 3DKnee Tibial Insert box and pouch contained a Size 8 right 3Dknee Tibial Insert. | 9 units | 2021-01-08 |
| Encore Medical, L.P. | 510(k) number | 2017-05-31 | Class II | Packaging process control | Mis-pack. A size 6 Left 3DKnee Tibial Insert box and pouch contained a Size 8 right 3Dknee Tibial Insert. | 9 units | 2021-01-08 |
| Encore Medical, L.P. | 510(k) number | 2013-04-01 | Class II | Labeling mix-ups | U.S. Agent contacted Director Commercial Logistics, notifying him of incorrect color coded labels on two packages of e+tibial inserts. There were 8 e+ tibial inserts of the same lot number in Finished Goods as the two from the agency. Thes | 5 | 2013-07-01 |
| Encore Medical, L.P. | 510(k) number | 2012-08-09 | Class II | Incorrect or no expiration date | The firm is recalling one lot of 392-09-706, 3DKnee e+ Tibial insert, 9 mm, Size 6, Right. The shelf life labeling of specific lots for a component were found to be incorrect and were found to be expired. | 7 units | 2013-01-25 |
| Encore Medical, L.P. | 510(k) number | 2010-06-28 | Not classified | Labeling mix-ups | One lot of product has an incorrect color label. The color label is a secondary visual indicator of sizing. | 18 | 2010-10-04 |
| Encore Medical, L.P. | 510(k) number | 2010-03-19 | Not classified | Packaging process control | Affected product had incorrect color label which is a secondary visual indicator for sizing. | 7 units | 2010-07-22 |
| Encore Medical, L.P. | 510(k) number | 2008-02-20 | Not classified | Error in labeling | Tibial insert trial incorrectly marked for thickness; device thickness marked correctly as 13mm on the underside of the trial, but is incorrectly marked as 15mm on the side. | 6 units. | 2008-09-02 |
| Encore Medical, L.P. | 510(k) number | 2005-11-03 | Not classified | Other | The product is mislabeled in that Size 6 right Foundation may contain size 8 right 3D knee non-porous baseplates and vice versa. Device is intended to aid surgeon in relieving knee pain and restoring knee joint function. | 14 units. | 2008-04-04 |
| Encore Medical, L.P. | 510(k) number | 2004-05-10 | Not classified | Other | Labeling is switched for the two products recalled. 3DKNEE is labeled as Foundation and Foundation is labeled as 3DKNEE | 16 | 2004-08-09 |
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.