Genesis II
GENESIS II HYRDOXYAPATITE POROUS Posterior Stabilized FEMORALS SIZE 5 RIGHT
12manufacturers in China registered for this device type
74catalogue numbers in this listing
11510(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 | Smith & Nephew, Inc., 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, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K121393 |
| Record published | 2016-06-10 |
| Record revised | 2023-09-07 (version 8) |
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 |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2022-03-17 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| E0015106-1 | In distribution | |
| 71931638 | In distribution | |
| 71422040 | In distribution | |
| 71422036 | In distribution | |
| 71430921 | In distribution | |
| 71422028 | In distribution | |
| 71422084 | In distribution | |
| 71422090 | In distribution | |
| 71422082 | In distribution | |
| 71430926 | In distribution | |
| 71430923 | In distribution | |
| E0014737-2 | In distribution | |
| 71422074 | In distribution | |
| 71931644 | In distribution | |
| E0014966-2 | In distribution | |
| 71441432 | In distribution | |
| 71422044 | In distribution | |
| 71430925 | In distribution | |
| 71931643 | In distribution | |
| 71422062 | In distribution | |
| 71430913 | In distribution | |
| 71422070 | In distribution | |
| E0014966-4 | In distribution | |
| XK000552-3 | In distribution | |
| 71422024 | In distribution | |
| 71422052 | In distribution | |
| 71931645 | In distribution | |
| 71422064 | In distribution | |
| E0014737-1 | In distribution | |
| 71931640 | In distribution | |
| 71931636 | In distribution | |
| E0014950-2 | In distribution | |
| 71440046 | In distribution | |
| 71931637 | In distribution | |
| 71931646 | In distribution | |
| 71422068 | In distribution | |
| E0015106-2 | In distribution | |
| 71422034 | In distribution | |
| 71931642 | In distribution | |
| E0014883-1 | In distribution | |
| 71931641 | In distribution | |
| 71422086 | In distribution | |
| 71422078 | In distribution | |
| 71422042 | In distribution | |
| 71422050 | In distribution | |
| E0014966-5 | In distribution | |
| 71422080 | In distribution | |
| 71441438 | In distribution | |
| E0014966-1 | In distribution | |
| 71430912 | In distribution | |
| E0014966-3 | In distribution | |
| 71422066 | In distribution | |
| 71430915 | In distribution | |
| E0014966-6 | In distribution | |
| E0014950-1 | In distribution | |
| 71931639 | In distribution | |
| 71422072 | In distribution | |
| 71422046 | In distribution | |
| 71422026 | In distribution | |
| 71422088 | In distribution | |
| 71931647 | In distribution | |
| 71422032 | In distribution | |
| 71422030 | In distribution | |
| 71422048 | In distribution | |
| 71441422 | Withdrawn | |
| 71430922 | Withdrawn | |
| E0014913-1 | Withdrawn | |
| E0014965-1 | Withdrawn | |
| E0014579-2 | Withdrawn | |
| E0014883 | Withdrawn | |
| E0014913 | Withdrawn | |
| E0014832-1 | Withdrawn | |
| E0014965-2 | Withdrawn | |
| E0014579-1 | Withdrawn |
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 |
| DJO Surgical | Encore Medical, L.P. | 191 |
| Vanguard XP Instrumentation | Biomet Orthopedics | 150 |
| Truliant® | Exactech, Inc. | 142 |
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 |
|---|---|
| K211221 | 2021-10-01 |
| K211246 | 2021-05-24 |
| K210566 | 2021-03-25 |
| K121393 | 2012-08-07 |
| K100897 | 2010-05-13 |
| K091543 | 2009-12-21 |
| K073325 | 2007-12-20 |
| K071790 | 2007-08-17 |
| K032683 | 2003-10-15 |
| K030612 | 2003-05-27 |
| K030623 | 2003-05-22 |
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 |
|---|---|---|---|---|---|---|---|
| Smith & Nephew, Inc. | 510(k) number | 2019-12-16 | Class II | Process change control | Multiple lots of LEGION AP Femoral Cutting Blocks were manufactured with an oversize green plunger hole and therefore do not meet their design specifications. | 59 units | |
| Smith & Nephew, Inc. | 510(k) number | 2018-09-18 | Class II | Process control | One lot of the Legion AP femoral cutting block, size 6, was manufactured with an oversized spring. | 6 units | 2019-05-08 |
| Smith & Nephew, Inc. | 510(k) number | 2018-05-04 | Class II | Error in labeling | One lot of GENESIS II 13 mm tibial punches are 2 mm smaller than specification. | 5 units | 2019-02-22 |
| Smith & Nephew, Inc. | 510(k) number | 2018-04-09 | Class II | Process control | A single lot of GENESIS II FEMORAL FIVE DEGREE VALGUS BUSHING due to a laser mark labeling error. The left valgus bushing was incorrectly laser marked as right and vice versa. | 18 units | 2019-02-22 |
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.