Emperion
Emperion 11 Sleeve Inserter Cone
22manufacturers in China registered for this device type
6catalogue numbers in this listing
37510(k) clearances naming this product code
15recalls on this code
Who Else Makes It
Concentrated in Jiangsu (10), Shanghai (4), Zhejiang (3). 12 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| 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 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Kingj Medical Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
| Hangzhou Sino-MIM Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 6 |
| Suzhou AND Science & Technology Development Corp. | Zhangjiagang | Jiangsu | Contract manufacturer | 5 |
| Beijing AK Medical Co., Ltd. | Changping District | Beijing | Contract manufacturer | 3 |
Showing 12 of 22. All 22 manufacturers in China registered for Plate, Fixation, Bone
Record
| Listed by | Smith & Nephew, Inc., United States |
|---|---|
| FDA product code | HRS |
| Device type | Plate, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K123055 |
| Record published | 2015-09-28 |
| Record revised | 2023-09-07 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2018-03-29 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 71361267 | Withdrawn | |
| 71361269 | Withdrawn | |
| 71361268 | Withdrawn | |
| 71361271 | Withdrawn | |
| 71361266 | Withdrawn | |
| 71361270 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pectus System | Biomet Microfixation | 4,662 |
| Arthrex® | Arthrex, Inc. | 3,031 |
| Evos | Smith & Nephew, Inc. | 2,235 |
| Peri-Loc | Smith & Nephew, Inc. | 2,196 |
| OsteoMed | Osteomed | 1,961 |
| VariAx | Stryker GmbH | 1,934 |
| Aptus | Medartis Inc. | 1,688 |
| TC-100 | Smith & Nephew, Inc. | 1,639 |
| Plate, Fixation, Bone | Synthes Gmbh | 1,613 |
| Anthem | Globus Medical, Inc. | 1,551 |
| Acumed | Acumed LLC | 1,360 |
| Signex | Osteonic Co., Ltd. | 1,310 |
Showing 12 of 3,530. All products under Plate, Fixation, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K241666 | 2025-02-19 |
| K240487 | 2024-09-03 |
| K223762 | 2023-05-30 |
| K213123 | 2022-10-18 |
| K210837 | 2021-06-29 |
| K203405 | 2021-01-27 |
| K201918 | 2020-11-16 |
| K201527 | 2020-07-22 |
| K190253 | 2019-03-11 |
| K181533 | 2018-08-09 |
| K173293 | 2018-01-08 |
| K172262 | 2017-08-23 |
| K170457 | 2017-06-14 |
| K170887 | 2017-04-24 |
| K163086 | 2016-12-21 |
| K162078 | 2016-11-18 |
| K161665 | 2016-11-15 |
| K152976 | 2015-11-12 |
| K143050 | 2014-12-18 |
| K140814 | 2014-05-07 |
| K132886 | 2014-02-04 |
| K132296 | 2014-01-07 |
| K123055 | 2013-01-25 |
| K120667 | 2012-04-04 |
| K112406 | 2011-11-14 |
| K110670 | 2011-07-12 |
| K092015 | 2009-07-30 |
| K090675 | 2009-06-04 |
| K083032 | 2009-01-07 |
| K081106 | 2008-06-18 |
| K072818 | 2007-11-19 |
| K071563 | 2007-08-08 |
| K062216 | 2006-09-15 |
| K061352 | 2006-06-08 |
| K051735 | 2005-07-19 |
| K033669 | 2003-12-10 |
| K993106 | 1999-12-09 |
Recalls
14 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 |
|---|---|---|---|---|---|
| 2022-01-04 | Class II | Process control | The affected screwdrivers are out of specification and may not mate with the Surfix Alpha Lock screw | 8 units (US) | |
| 2021-11-01 | Class II | Under Investigation by firm | Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was incorporated in the released IFU 81110294 EVOS Large Fragment Plating System. | 35 units | 2026-06-15 |
| 2021-11-01 | Class II | Under Investigation by firm | Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was incorporated in the released IFU 81110294 EVOS Large Fragment Plating System. | 38 units | 2026-06-15 |
| 2021-11-01 | Class II | Under Investigation by firm | Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was incorporated in the released IFU 81110294 EVOS Large Fragment Plating System. | 35 units | 2026-06-15 |
| 2021-11-01 | Class II | Under Investigation by firm | Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was incorporated in the released IFU 81110294 EVOS Large Fragment Plating System. | 41 units | 2026-06-15 |
| 2021-10-25 | Class II | Error in labeling | The labels on the packages of screws were switched. | 224 units | |
| 2020-08-24 | Class II | Error in labeling | Multiple or incorrect expiration dates were provided on the affected designation labels. | 71 units | 2022-07-11 |
| 2017-12-11 | Class II | Mixed-up of materials/components | Devices, incorrectly labeled as a VLP MINI-MOD 2.0MM STRAIGHT PLATE 8 HOLE, contained a VLP MINI-MOD 2.0MM STOUT PLATE 8 HOLE and vice versa | 2 units | 2018-06-22 |
| 2017-12-11 | Class II | Mixed-up of materials/components | Devices, incorrectly labeled as a VLP MINI-MOD 2.0MM STRAIGHT PLATE 8 HOLE, contained a VLP MINI-MOD 2.0MM STOUT PLATE 8 HOLE and vice versa | 2 units | 2018-06-22 |
| 2017-11-29 | Class II | Employee error | One lot of EVOS 2.4MM Flex Plate 6 Hole packaging contained templates. | 12 | 2020-09-01 |
| 2017-03-22 | Class II | Mixed-up of materials/components | This lot of left plates were laser etched and packaged as right plates. | 12 units | 2022-06-03 |
| 2017-03-09 | Class II | Labeling Change Control | The expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the labeling. | 1 unit | 2019-08-21 |
| 2015-10-20 | Class II | Employee error | The devices were packaged and laser marked anatomically incorrect. The Left plates were laser marked and packaged as Right plates and the Right plates were laser marked and packaged as Left plates. | 9 units | 2016-09-21 |
| 2015-10-20 | Class II | Employee error | The devices were packaged and laser marked anatomically incorrect. The Left plates were laser marked and packaged as Right plates and the Right plates were laser marked and packaged as Left plates. | 9 units | 2016-09-21 |
| 2010-07-20 | Not classified | Packaging | Inner packaging of sterile product was not sealed. Lack of sterility assurance. | 10 units | 2011-11-17 |
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.