HammerTube System
HammerTube System Peek Implant, Ø2.75mm x 14mm, 10°, Sterile
12manufacturers in China registered for this device type
26catalogue numbers in this listing
3510(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 | Paragon 28, United States |
|---|---|
| FDA product code | HTY |
| Device type | Pin, Fixation, Smooth |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K171715 |
| Record published | 2019-10-17 |
| Record revised | 2025-04-22 (version 4) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| P40-002-0350-S | In distribution | ||
| P40-002-0275-S | In distribution | ||
| P40-900-2300 | In distribution | ||
| P40-900-3500 | In distribution | ||
| P40-001-0350-SK | In distribution | ||
| P40-002-0275-S | In distribution | ||
| P40-002-0275-SK | In distribution | ||
| P40-001-0275-SK | In distribution | ||
| P40-002-0275-S | In distribution | ||
| P40-900-2800 | In distribution | ||
| P40-002-0350-SK | In distribution | ||
| P40-001-0350-SK | In distribution | ||
| P40-900-2750 | In distribution | ||
| P40-002-0275-SK | In distribution | ||
| P40-001-0275-S | In distribution | ||
| P40-002-0350-S | In distribution | ||
| P40-002-0350-S | In distribution | ||
| P99-292-1615 | 10 | In distribution | |
| P40-001-0350-S | In distribution | ||
| P40-001-0350-S | In distribution | ||
| P40-001-0275-S | In distribution | ||
| P40-001-0350-S | In distribution | ||
| P40-001-0275-SK | In distribution | ||
| P99-292-1415 | 10 | In distribution | |
| P40-001-0275-S | In distribution | ||
| P40-002-0350-SK | In distribution |
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 |
|---|---|
| K262722 | 2026-08-28 |
| K183228 | 2019-01-25 |
| K171715 | 2018-03-05 |
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 |
|---|---|---|---|---|---|---|
| Paragon 28 | 510(k) number | 2022-05-26 | Class II | Under Investigation by firm | Due to Titanium plasma coating not present implant. | 9 implants |
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.