TPS
TPS Footswitch , Two-Pedal
21manufacturers in China registered for this device type
1catalogue number
12510(k) clearances naming this product code
19recalls on this code
Who Else Makes It
Concentrated in Shanghai (7), Jiangsu (6), Guangdong (5). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Dongguan BAO Kang Dian ZI KE JI Limited | Dongguan | Guangdong | Contract manufacturer | 24 |
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
| Peter’s Technology (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 9 |
| Jiangsu Shenli Medical Production Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 6 |
| PAN-International Precision Electronic Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| Goals Sterilization Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 26 |
Showing 12 of 21. All 21 manufacturers in China registered for Arthroscope
Record
| Listed by | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | HRX |
| Device type | Arthroscope |
| Device class | Class 2 |
| Regulation | 21 CFR 888.1100 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K941333 |
| Record published | 2016-09-23 |
| Record revised | 2019-09-30 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Distribution end date | 2019-09-29 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0275701400 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Surgical Direct | Surgical Direct, Inc. | 299 |
| Arthroscope | Karl Storz GmbH & Co. KG | 278 |
| Conmed/Linvatec | Provision | 265 |
| Arthroscope | Smith & Nephew, Inc. | 255 |
| Medline | Medline Industries, Inc. | 205 |
| Arthroscope | Sterilmed, Inc. | 184 |
| Sustainable Technologies | Provision | 150 |
| Medline Renewal | Medline Industries, Inc. | 123 |
| Stryker | Provision | 113 |
| Arthrex® | Arthrex, Inc. | 109 |
| Arthrex | Provision | 109 |
| Eberle | Eberle GmbH & Co. KG | 92 |
Showing 12 of 567. All products under Arthroscope
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K202659 | 2020-12-01 |
| K191259 | 2019-07-12 |
| K183470 | 2019-01-07 |
| K181752 | 2018-12-21 |
| K172116 | 2018-01-25 |
| K162062 | 2016-11-01 |
| K151932 | 2016-03-31 |
| K130430 | 2013-05-23 |
| K943323 | 1994-11-28 |
| K910858 | 1991-05-23 |
| K811861 | 1981-07-16 |
| K771200 | 1977-07-21 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Stryker Endoscopy | 510(k) number | 2014-05-19 | Class II | Nonconforming Material/Component | STERRAD 100S parameters provided in the Shaver Handpiece reprocessing guide (P10299 Revision A) did not fully consider all worst-case scenarios during validation testing. | 1992 trays | 2015-05-07 |
Recalls
17 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 |
|---|---|---|---|---|---|
| 2019-07-25 | Class II | Packaging | The seal integrity of the sterile bag containing the kits may be compromised. | 53 | 2020-09-24 |
| 2019-07-25 | Class II | Packaging | The seal integrity of the sterile bag containing the kits may be compromised. | 94 | 2020-09-24 |
| 2019-07-25 | Class II | Packaging | The seal integrity of the sterile bag containing the kits may be compromised. | 21 | 2020-09-24 |
| 2019-07-25 | Class II | Packaging | The seal integrity of the sterile bag containing the kits may be compromised. | 2248 | 2020-09-24 |
| 2019-07-25 | Class II | Packaging | The seal integrity of the sterile bag containing the kits may be compromised. | 259 | 2020-09-24 |
| 2019-07-25 | Class II | Packaging | The seal integrity of the sterile bag containing the kits may be compromised. | 110 | 2020-09-24 |
| 2019-07-25 | Class II | Packaging | The seal integrity of the sterile bag containing the kits may be compromised. | 1959 | 2020-09-24 |
| 2019-07-25 | Class II | Packaging | The seal integrity of the sterile bag containing the kits may be compromised. | 251 | 2020-09-24 |
| 2019-07-25 | Class II | Packaging | The seal integrity of the sterile bag containing the kits may be compromised. | 35 | 2020-09-24 |
| 2019-07-25 | Class II | Packaging | The seal integrity of the sterile bag containing the kits may be compromised. | 76 | 2020-09-24 |
| 2019-07-25 | Class II | Packaging | The seal integrity of the sterile bag containing the kits may be compromised. | 476 | 2020-09-24 |
| 2019-07-25 | Class II | Packaging | The seal integrity of the sterile bag containing the kits may be compromised. | 1533 | 2020-09-24 |
| 2019-07-25 | Class II | Packaging | The seal integrity of the sterile bag containing the kits may be compromised. | 28 | 2020-09-24 |
| 2019-04-30 | Class II | Under Investigation by firm | The seal integrity of the sterile bag containing the kits may be compromised. | 1600 | 2020-09-18 |
| 2019-04-30 | Class II | Under Investigation by firm | The seal integrity of the sterile bag containing the kits may be compromised. | 447 | 2020-09-18 |
| 2017-11-09 | Class II | Environmental control | Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates. | 504 | 2019-04-16 |
| 2013-11-04 | Class II | Device Design | Stryker has identified a potential for the auger and/or cannula to fracture when the Dekompressor is used contrary to the warnings in the Instructions For Use (IFU). Specifically, manually bending the cannula can weaken the device and may r | 20,385 total distributed since 2004 | 2014-04-29 |
| 2011-02-03 | Not classified | Other | The firm received five complaints that the stylet did not fit down the cannula. The investigation revealed that the incorrect probe assembly was packaged for two DeKompressor part numbers with the lot number of 10214012. | 44 units both products | 2011-06-01 |
| 2011-02-03 | Not classified | Other | The firm received five complaints that the stylet did not fit down the cannula. The investigation revealed that the incorrect probe assembly was packaged for two DeKompressor part numbers with the lot number of 10214012. | 44 units both products | 2011-06-01 |
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.