Pin, Fixation, Smooth
68 catalogue numbers from 186-60, listed by Zimmer, Inc., United States, under Pin, Fixation, Smooth. 12 manufacturers in China are registered for this product code.
12manufacturers in China registered for this device type
68catalogue numbers in this listing
2510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (3), Zhejiang (2). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Kingj Medical Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
| Aplus (Guangzhou) Medical Technology Company | Guangzhou | Guangdong | Contract manufacturer | 6 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
Record
| Listed by | Zimmer, Inc., United States |
|---|---|
| FDA product code | HTY |
| Device type | Pin, Fixation, Smooth |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K143618 |
| Record published | 2015-09-24 |
| Record revised | 2025-07-14 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Length 4 to 20 in; length 70 to 150 mm |
| Distribution end date | 2016-03-10 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 186-60 | Length 6 in | 6 | In distribution |
| 47-262-03-04 | Length 9 in | 5 | In distribution |
| 47-187-07-59 | Length 9 in | 5 | In distribution |
| 47-2620-13 | Length 9 in | 5 | In distribution |
| 801-01-10 | Length 17 in | In distribution | |
| 47-187-03-59 | Length 9 in | 5 | In distribution |
| 801-01-15 | 1/4 Inch, Diameter, 19 1/4 Inch, Length | In distribution | |
| 801-01-11 | 1/4 Inch, Diameter, 9 1/2 Inch, Length | In distribution | |
| 802-01-15 | 3/16 Inch, Diameter | In distribution | |
| 47-186-04-15 | Length 5 in | 5 | In distribution |
| 802-01-10 | Length 14 in | In distribution | |
| 806-01-14 | 3/32 Inch, Diameter | In distribution | |
| 802-01-09 | 3/16 Inch, Diameter, 13-1/4 Inch, Length | In distribution | |
| 47-186-02-69 | Length 9 in | 5 | In distribution |
| 4901-06-07 | 0.6 mm Diameter | 10 | In distribution |
| 186-27-20 | .079 Inch, Diameter | 6 | In distribution |
| 47-186-86 | Length 4 in | 5 | In distribution |
| 801-01-08 | 1/4 Inch, Diameter, 15 1/2 Inch, Length | In distribution | |
| 47-262-06-04 | Length 9 in | 5 | In distribution |
| 262-02-04 | Length 9 in | 6 | In distribution |
| 47-186-01-79 | Length 9 in | 5 | In distribution |
| 802-01-16 | 3/16 Inch, Diameter, 17 3/4 Inch, Length | In distribution | |
| 47-186-04-14 | Length 4 in | 5 | In distribution |
| 47-262-11 | Length 9 in | 5 | In distribution |
| 186-62 | Length 9 in | 6 | In distribution |
| 801-01-13 | 1/4 Inch, Diameter, 17 3/4 Inch, Length | In distribution | |
| 803-01-12 | Length 9 in | In distribution | |
| 186-54 | Length 4 in | 6 | In distribution |
| 806-01-13 | 3/32 Inch, Diameter, 9-1/2 Inch, Length | In distribution | |
| 262-01-04 | Length 9 in | 6 | In distribution |
| 804-01-13 | 3/32 Inch, Diameter, 3-3/4 Inch, Length | In distribution | |
| 186-90 | Length 6 in | 6 | In distribution |
| 802-01-12 | 3/16 Inch, Diameter, 14 3/4 Inch, Length | In distribution | |
| 47-187-01-59 | Length 9 in | 5 | In distribution |
| 804-01-14 | Length 4 in | In distribution | |
| 804-01-12 | 3/32 Inch, Diameter, 3-1/2 Inch, Length | In distribution | |
| 186-44 | Length 6 in | 6 | In distribution |
| 187-05-59 | 9/64 Inch, Diameter | 6 | In distribution |
| 803-01-14 | 1/8 Inch, Diameter | In distribution | |
| 801-01-12 | 1/4 Inch, Diameter, 10 1/4 Inch, Length | In distribution | |
| 47-2620-25 | Length 9 in | 5 | In distribution |
| 802-01-14 | 3/16 Inch, Diameter, 16 1/4 Inch, Length | In distribution | |
| 801-01-14 | 1/4 Inch, Diameter, 18 1/2 Inch, Length | In distribution | |
| 47-187-02-59 | Length 9 in | 5 | In distribution |
| 802-01-13 | 3/16 Inch, Diameter, 15 1/2 Inch, Length | In distribution | |
| 186-86 | Length 4 in | 6 | In distribution |
| 801-01-16 | Length 20 in | In distribution | |
| 806-01-12 | 3/32 Inch, Diameter | In distribution | |
| 802-01-08 | 3/16 Inch, Diameter, 12-1/2 Inch, Length | In distribution | |
| 186-70 | Length 4 in | 6 | In distribution |
| 4901-10-15 | Length 150 mm | 10 | In distribution |
| 47-2620-17 | Length 9 in | 5 | In distribution |
| 47-187-06-59 | Length 9 in | 5 | In distribution |
| 47-186-03-69 | Length 9 in | 5 | In distribution |
| 47-262-13 | Length 9 in | 5 | In distribution |
| 47-186-70 | Length 4 in | 5 | In distribution |
| 801-01-09 | 1/4 Inch, Diameter, 16 1/4 Inch, Length | In distribution | |
| 47-186-76 | Length 6 in | 5 | In distribution |
| 803-01-13 | 1/8 Inch, Diameter, 9-1/2 Inch, Length | In distribution | |
| 47-186-62 | Length 9 in | 5 | In distribution |
| 802-01-11 | 3/16 Inch, Diameter, 7 1/4 Inch, Length | In distribution | |
| 8503-730-04 | Length 9 in | Withdrawn | |
| 8503-728 | Length 9 in | Withdrawn | |
| 8503-730-01 | Length 9 in | Withdrawn | |
| 8503-729 | Length 9 in | Withdrawn | |
| 8503-730-05 | Length 12 in | Withdrawn | |
| 8503-730-03 | Length 12 in | Withdrawn | |
| 8503-730-02 | Length 10 in | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Rondo’ | Citieffe SRL | 265 |
| HNM Medical | HNM Stainless, LLC. | 232 |
| Kmedic | Teleflex Medical LLC | 227 |
| gSource | Gsource, LLC. | 221 |
| MicroAire® | Microaire Surgical Instruments LLC | 213 |
| Orthomed | Ortho-MED, Inc. | 163 |
| mahe medical GmbH | Mahe Intl., Inc. | 160 |
| Pin, Fixation, Smooth | Key Surgical, LLC | 134 |
| Pin, Fixation, Smooth | Stryker GmbH | 134 |
| Aptus | Medartis Inc. | 134 |
| Key Surgical K-Wires and Steinmann Pins | Key Surgical, LLC | 126 |
| PedFlex Flexible Nailing System | Orthopediatrics, Corp | 119 |
Showing 12 of 682. All products under Pin, Fixation, Smooth
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K150626 | 2015-05-01 |
| K143618 | 2015-02-06 |
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 |
|---|---|---|---|---|---|
| 2009-05-01 | Not classified | Packaging process control | The package contains pins with an incorrect diameter. | 37 | 2009-11-12 |
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.