Insite™ FT PEEK
7 catalogue numbers from 0846832000333, listed by Tornier Inc., United States, under Fastener, Fixation, Nondegradable, Soft Tissue. 7 manufacturers in China are registered for this product code.
7manufacturers in China registered for this device type
7catalogue numbers in this listing
7510(k) clearances naming this product code
24recalls on this code
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (2), Zhejiang (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Renolit Hansen Packaging Tech. (BJ) Ltd. | Beijing | Beijing | Contract manufacturer | 1 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| Suzhou Endophix Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 17 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Tornier Inc., United States |
|---|---|
| FDA product code | MBI |
| Device type | Fastener, Fixation, Nondegradable, Soft Tissue |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2015-10-16 |
| Record revised | 2022-05-11 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature up to 49 °C |
| Sizes | Outer diameter 2.5 to 6.5 mm |
| Distribution end date | 2017-04-10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0846832000333 | Outer Diameter 5.5 mm | In distribution |
| SMP000415 | Outer Diameter 4.5 mm | In distribution |
| 0846832000340 | Outer Diameter 6.5 mm | In distribution |
| 0846832000326 | Outer Diameter 4.5 mm | In distribution |
| SMP000515 | Outer Diameter 5.5 mm | In distribution |
| SMP000315 | Outer Diameter 3.5 mm | Withdrawn |
| SMP000215 | Outer Diameter 2.5 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arthrex® | Arthrex, Inc. | 362 |
| HNM Sports Medicine | HNM Stainless, LLC. | 150 |
| Suture Anchors – HTA Headless Titanium Anchor and Zip Anchors | GM DOS Reis Industria E Comercio Ltda | 78 |
| Juggerknot® | Biomet Orthopedics | 77 |
| Fastener, Fixation, Nondegradable, Soft Tissue | Parcus Medical, LLC | 74 |
| endophix | Suzhou Endophix Co., Ltd. | 71 |
| Titan | Medline Industries, Inc. | 68 |
| TopLock | Fusion Orthopedics, LLC | 67 |
| HNM Medical | HNM Stainless, LLC. | 59 |
| Orthobutton CL | Riverpoint Medical LLC | 55 |
| Apollo | Medline Industries, Inc. | 53 |
| JuggerKnot Soft Anchor | Riverpoint Medical LLC | 46 |
Showing 12 of 618. All products under Fastener, Fixation, Nondegradable, Soft Tissue
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K150715 | 2015-07-28 |
| K133777 | 2014-04-04 |
| K132632 | 2013-09-19 |
| K110773 | 2011-06-02 |
| K103262 | 2011-04-05 |
| K091870 | 2009-09-21 |
| K080335 | 2008-04-23 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2007-09-27 | Not classified | Package design/selection | Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging | 35 units | 2012-06-21 |
| 2007-09-27 | Not classified | Package design/selection | Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging | 904 units | 2012-06-21 |
| 2007-09-27 | Not classified | Package design/selection | Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging | 1,708 units | 2012-06-21 |
| 2007-09-27 | Not classified | Package design/selection | Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging | 338 units | 2012-06-21 |
| 2007-09-27 | Not classified | Package design/selection | Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging | 323 units | 2012-06-21 |
| 2007-09-27 | Not classified | Package design/selection | Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging | 2,217 units | 2012-06-21 |
| 2007-09-27 | Not classified | Package design/selection | Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging | 4 units | 2012-06-21 |
| 2007-09-27 | Not classified | Package design/selection | Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging | 984 units | 2012-06-21 |
| 2007-09-27 | Not classified | Package design/selection | Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging | 1,538 units | 2012-06-21 |
| 2007-09-27 | Not classified | Package design/selection | Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging | 1308 units | 2012-06-21 |
| 2007-09-27 | Not classified | Package design/selection | Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging | 59 units | 2012-06-21 |
| 2007-09-27 | Not classified | Package design/selection | Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging | 337 units | 2012-06-21 |
| 2007-09-27 | Not classified | Package design/selection | Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging | 111 units | 2012-06-21 |
| 2007-09-27 | Not classified | Package design/selection | Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging | 4,091 units | 2012-06-21 |
| 2007-09-27 | Not classified | Package design/selection | Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging | 329 units | 2012-06-21 |
| 2007-09-27 | Not classified | Package design/selection | Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging | 417 units | 2012-06-21 |
| 2007-09-27 | Not classified | Package design/selection | Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging | 292 units | 2012-06-21 |
| 2007-09-27 | Not classified | Package design/selection | Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging | 321 units | 2012-06-21 |
| 2007-09-27 | Not classified | Package design/selection | Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging | 776 units | 2012-06-21 |
| 2007-09-27 | Not classified | Package design/selection | Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging | 177 units | 2012-06-21 |
| 2007-09-27 | Not classified | Package design/selection | Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging | 361 units | 2012-06-21 |
| 2007-09-27 | Not classified | Package design/selection | Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging | 8 units | 2012-06-21 |
| 2007-09-27 | Not classified | Package design/selection | Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging | 102 units | 2012-06-21 |
| 2007-09-27 | Not classified | Package design/selection | Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging | 208 units | 2012-06-21 |
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.