Instruments
Specialty Triathlon CR Femoral Trial With EPI Line
21manufacturers in China registered for this device type
16catalogue numbers in this listing
4recalls on this code
Who Else Makes It
Concentrated in Jiangsu (10), Shanghai (3), Zhejiang (2). 11 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| Suzhou AND Science & Technology Development Corp. | Zhangjiagang | Jiangsu | Contract manufacturer | 5 |
| Guangzhou Clean Medical Products Manufacturing Corp | Guangzhou | Guangdong | Contract manufacturer | 5 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
Showing 12 of 21. All 21 manufacturers in China registered for Template
Record
| Listed by | Howmedica Osteonics Corp, United States |
|---|---|
| FDA product code | HWT |
| Device type | Template |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4800 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-10-10 |
| Record revised | 2022-03-22 (version 2) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| I-K4226T102 | Side: RIGHT | In distribution |
| I-K4226T301 | Side: LEFT | In distribution |
| I-K4226T701 | Size: 7 | In distribution |
| I-K4226T302 | Size: 3 | In distribution |
| I-K4226T101 | Side: LEFT | In distribution |
| I-K4226T702 | Side: RIGHT | In distribution |
| I-K4226T502 | Size: 5 | In distribution |
| I-K4226T202 | Size: 2 | In distribution |
| I-K4226T601 | Size: 6 | In distribution |
| I-K4226T501 | Side: LEFT | In distribution |
| I-K4226T602 | Size: 6 | In distribution |
| I-K4226T402 | Side: RIGHT | In distribution |
| I-K4226T201 | Size: 2 | In distribution |
| I-K4226T802 | Size: 8 | In distribution |
| I-K4226T401 | Side: LEFT | In distribution |
| I-K4226T801 | Size: 8 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Attune | Depuy (Ireland) | 1,385 |
| Template | Exactech, Inc. | 1,277 |
| 4WEB Medical | 4WEB Inc. | 991 |
| Evolution® | Microport Orthopedics Inc. | 966 |
| Template | Zimmer, Inc. | 792 |
| Advance® | Microport Orthopedics Inc. | 644 |
| Apex Knee System | Omni Life Science, Inc. | 635 |
| Profemur® | Microport Orthopedics Inc. | 591 |
| Link Instruments – Trial implants and size gauges | Waldemar Link GmbH & Co. KG | 549 |
| Template | Synthes Gmbh | 516 |
| Optetrak Logic | Exactech, Inc. | 512 |
| Template | Depuy Spine, Inc. | 451 |
Showing 12 of 2,940. All products under Template
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 |
|---|---|---|---|---|---|
| 2008-05-14 | Not classified | Process control | Triathlon TS Stems Trails may crack, potentially causing fragments of the plastic handle to fragment and break off completely. | Catalog 5566 T-009 to 025: 2625 US, 239 international | 2010-01-26 |
| 2008-05-14 | Not classified | Process control | Triathlon TS Stems Trails may crack, potentially causing fragments of the plastic handle to fragment and break off completely. | Catalog Number 5565 T-009 to 025: 2629 US, 238 international | 2010-01-26 |
| 2005-03-09 | Not classified | Process control | The OmniFit HFx Templates were produced without a warning statement indicating a potential function of fit issue when using -3mm and -5mm heads or sleeves on certain stems. | 865 units | 2008-09-24 |
| 2005-03-09 | Not classified | Process control | The OmniFit HFx Templates were produced without a warning statement indicating a potential function of fit issue when using -3mm and -5mm heads or sleeves on certain stems. | Sell sheets: 1919, Cutting Edge Advantage Brochure: 810 | 2008-09-24 |
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.