Proven Gen-Flex CR Knee System
112 catalogue numbers from SC2038-4, listed by Globus Medical, 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
112catalogue numbers in this listing
2510(k) clearances naming this product code
9recalls 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 | Globus Medical, 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 | Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2015-02-16 |
| Record revised | 2020-12-11 (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 |
| Distribution end date | 2018-01-16 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SC2038-4 | In distribution | |
| SC2039-6 | In distribution | |
| SC2039-5 | In distribution | |
| SC2039-3.5 | In distribution | |
| SC2039-3 | In distribution | |
| SC2038-3 | In distribution | |
| SC2038-6 | In distribution | |
| SC2038-1 | In distribution | |
| SC2038-2 | In distribution | |
| SC2038-2.5 | In distribution | |
| SC2038-3.5 | In distribution | |
| SC2039-1 | In distribution | |
| SC2039-4 | In distribution | |
| SC2039-2.5 | In distribution | |
| SC2038-5 | In distribution | |
| SC2039-2 | In distribution | |
| SC2044-2-20 | Withdrawn | |
| SC2045-3-26 | Withdrawn | |
| SC2044-6-14 | Withdrawn | |
| SC2045-3-14 | Withdrawn | |
| SC2045-2-17 | Withdrawn | |
| SC2045-2-12 | Withdrawn | |
| SC2045-4-17 | Withdrawn | |
| SC2045-5-10 | Withdrawn | |
| SC2045-5-30 | Withdrawn | |
| SC2044-6-20 | Withdrawn | |
| SC2045-4-20 | Withdrawn | |
| SC2045-2-20 | Withdrawn | |
| SC2045-1-14 | Withdrawn | |
| SC2044-5-17 | Withdrawn | |
| SC2045-1-10 | Withdrawn | |
| SC2045-6-30 | Withdrawn | |
| SC2045-3-17 | Withdrawn | |
| SC2045-1-30 | Withdrawn | |
| SC2045-2-10 | Withdrawn | |
| SC2045-4-14 | Withdrawn | |
| SC2045-6-14 | Withdrawn | |
| SC2045-6-23 | Withdrawn | |
| SC2044-5-26 | Withdrawn | |
| SC2044-6-17 | Withdrawn | |
| SC2045-4-30 | Withdrawn | |
| SC2044-1-26 | Withdrawn | |
| SC2045-6-17 | Withdrawn | |
| SC2044-5-20 | Withdrawn | |
| SC2045-1-17 | Withdrawn | |
| SC2044-2-17 | Withdrawn | |
| SC2045-1-26 | Withdrawn | |
| SC2044-2-23 | Withdrawn | |
| SC2044-6-30 | Withdrawn | |
| SC2044-1-12 | Withdrawn | |
| SC2045-6-10 | Withdrawn | |
| SC2044-4-30 | Withdrawn | |
| SC2044-2-30 | Withdrawn | |
| SC2045-6-20 | Withdrawn | |
| SC2044-5-23 | Withdrawn | |
| SC2044-5-12 | Withdrawn | |
| SC2044-3-23 | Withdrawn | |
| SC2045-2-14 | Withdrawn | |
| SC2044-2-14 | Withdrawn | |
| SC2044-1-23 | Withdrawn | |
| SC2045-5-23 | Withdrawn | |
| SC2044-2-10 | Withdrawn | |
| SC2044-6-26 | Withdrawn | |
| SC2045-1-20 | Withdrawn | |
| SC2045-3-30 | Withdrawn | |
| SC2044-1-14 | Withdrawn | |
| SC2044-2-12 | Withdrawn | |
| SC2044-3-30 | Withdrawn | |
| SC2044-3-20 | Withdrawn | |
| SC2045-2-26 | Withdrawn | |
| SC2044-3-14 | Withdrawn | |
| SC2045-1-23 | Withdrawn | |
| SC2044-4-14 | Withdrawn | |
| SC2045-2-30 | Withdrawn | |
| SC2044-3-10 | Withdrawn | |
| SC2044-2-26 | Withdrawn | |
| SC2044-4-17 | Withdrawn | |
| SC2044-5-14 | Withdrawn | |
| SC2045-6-26 | Withdrawn | |
| SC2044-4-23 | Withdrawn | |
| SC2044-5-10 | Withdrawn | |
| SC2044-4-10 | Withdrawn | |
| SC2045-3-12 | Withdrawn | |
| SC2045-3-10 | Withdrawn | |
| SC2045-4-10 | Withdrawn | |
| SC2045-5-20 | Withdrawn | |
| SC2044-6-10 | Withdrawn | |
| SC2045-5-26 | Withdrawn | |
| SC2044-1-10 | Withdrawn | |
| SC2045-6-12 | Withdrawn | |
| SC2044-4-26 | Withdrawn | |
| SC2045-1-12 | Withdrawn | |
| SC2045-3-20 | Withdrawn | |
| SC2044-4-20 | Withdrawn | |
| SC2045-5-17 | Withdrawn | |
| SC2045-5-14 | Withdrawn | |
| SC2044-6-23 | Withdrawn | |
| SC2044-1-30 | Withdrawn | |
| SC2044-4-12 | Withdrawn | |
| SC2044-6-12 | Withdrawn | |
| SC2044-3-26 | Withdrawn | |
| SC2045-3-23 | Withdrawn | |
| SC2044-1-17 | Withdrawn | |
| SC2044-3-12 | Withdrawn | |
| SC2044-3-17 | Withdrawn | |
| SC2044-1-20 | Withdrawn | |
| SC2044-5-30 | Withdrawn | |
| SC2045-4-26 | Withdrawn | |
| SC2045-4-23 | Withdrawn | |
| SC2045-4-12 | Withdrawn | |
| SC2045-2-23 | Withdrawn | |
| SC2045-5-12 | Withdrawn |
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 |
|---|---|
| K262251 | 2026-07-31 |
| K240669 | 2024-06-20 |
Recalls
2 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 |
|---|---|---|---|---|---|
| 2014-12-01 | Class II | Process design | Difficulty locking EXp tibial inserts into tibial trays, caused by a manufacturing condition where a lead in radius on the anterior locking tab is not present on certain insert lots. The absence of this lead in may prevent or make assembly | 553 | 2015-05-06 |
| 2013-06-24 | Class II | Process control | The firm became aware of an incident relating to a breach of sterility in the sterility barrier packaging of SC2316, Distal Femoral Augment with Screw. | 11 | 2014-10-08 |
| 2008-09-03 | Not classified | Employee error | Five (5) Three Peg Patella SC1591-29 were packaged in containers labeled for SC1591-38 sharing the same lot number. | 5 units | 2008-12-04 |
| 2007-10-05 | Not classified | Device Design | The screws may fracture | 34 units | 2008-01-23 |
| 2007-10-05 | Not classified | Device Design | The screws may fracture | 38 units | 2008-01-23 |
| 2007-10-05 | Not classified | Device Design | The screws may fracture | 46 units | 2008-01-23 |
| 2007-10-05 | Not classified | Device Design | The screws may fracture | 41 units | 2008-01-23 |
| 2007-10-05 | Not classified | Device Design | The screws may fracture | 48 units | 2008-01-23 |
| 2004-09-24 | Not classified | Other | Sterility may be compromised. The inner pouch of the implant packaging was sticking out beyond the seal of the outer pouch | 105 units | 2005-02-07 |
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.