Orthex
Pear Wire, Sharp Bayonet, 400mm x 1.5mm, HA Coated (Sterile)
17manufacturers in China registered for this device type
231catalogue numbers in this listing
3510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (4), Zhejiang (3). 13 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| 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 Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Hangzhou Sino-MIM Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 6 |
| Suzhou AND Science & Technology Development Corp. | Zhangjiagang | Jiangsu | Contract manufacturer | 5 |
Showing 12 of 17. All 17 manufacturers in China registered for Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Record
| Listed by | Orthopediatrics, Corp, United States |
|---|---|
| FDA product code | KTT |
| Device type | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K151881 |
| Record published | 2020-02-28 |
| Record revised | 2026-06-24 (version 9) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2021-09-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| C320-095 | In distribution | |
| R050-155 | In distribution | |
| R320-230 | In distribution | |
| C915-90-07 | In distribution | |
| R635-04-R | In distribution | |
| R050-180 | In distribution | |
| C660 | In distribution | |
| CS-12-2 | In distribution | |
| C650T | In distribution | |
| K400-18PSA | In distribution | |
| C604-08 | In distribution | |
| R100-130 | In distribution | |
| C420-FF | In distribution | |
| K250-12BN | In distribution | |
| R050-205 | In distribution | |
| C025-095 | In distribution | |
| C420-FS | In distribution | |
| C100-110 | In distribution | |
| 350-M4-03 | In distribution | |
| C350T-M4-04 | In distribution | |
| C915-CW-07 | In distribution | |
| 611-06N | In distribution | |
| C320-110S | In distribution | |
| 350-M4-01 | In distribution | |
| C410-S4 | In distribution | |
| C065-130 | In distribution | |
| R320-130S | In distribution | |
| C450-04-50 | In distribution | |
| R025-205 | In distribution | |
| C350T-M4-06 | In distribution | |
| R065-130 | In distribution | |
| R635-02-R | In distribution | |
| C025-130 | In distribution | |
| AS137-295 | In distribution | |
| 350-M6-02 | In distribution | |
| C605-F | In distribution | |
| C620-07 | In distribution | |
| AS-12-5 | In distribution | |
| C650LT | In distribution | |
| K300-15BN | In distribution | |
| K300-15BNP | In distribution | |
| R065-180 | In distribution | |
| K400-15PA | In distribution | |
| 390-135 | In distribution | |
| K370-18BNPA | In distribution | |
| 350T-M6-03 | In distribution | |
| R050-230 | In distribution | |
| R320-105S | In distribution | |
| R410-S4 | In distribution | |
| CS145-245 | In distribution | |
| C450-04-30 | In distribution | |
| AS093-170 | In distribution | |
| AS070-105 | In distribution | |
| R065-205 | In distribution | |
| CS-12-1 | In distribution | |
| C050-130 | In distribution | |
| CS-12-3 | In distribution | |
| R025-155 | In distribution | |
| AS-12-3 | In distribution | |
| CS-19-5 | In distribution | |
| 350T-M6-05 | In distribution | |
| R635-04-SQ | In distribution | |
| C410-S5 | In distribution | |
| C420-M1 | In distribution | |
| R650 | In distribution | |
| R635-01-SQ | In distribution | |
| C670-40 | In distribution | |
| C450-04-80 | In distribution | |
| AS-12-1 | In distribution | |
| C420-F2 | In distribution | |
| K400-15PSA | In distribution | |
| 350-M6-04 | In distribution | |
| K400-18BNP | In distribution | |
| CS-12-6 | In distribution | |
| C320-130S | In distribution | |
| R065-255 | In distribution | |
| C050-095 | In distribution | |
| R050-280 | In distribution | |
| R065-230 | In distribution | |
| CS55-80 | In distribution | |
| K250-18BNA | In distribution | |
| C635-01 | In distribution | |
| C065-095 | In distribution | |
| K400-18BN | In distribution | |
| C450-04-100 | In distribution | |
| C025-110 | In distribution | |
| 390-70 | In distribution | |
| R320-130 | In distribution | |
| C350-M4-02 | In distribution | |
| CS-19-1 | In distribution | |
| C610-075 | In distribution | |
| 350-M6-05 | In distribution | |
| K370-18BN | In distribution | |
| C320-075 | In distribution | |
| C410-S3 | In distribution | |
| K400-18BA | In distribution | |
| 611-06 | In distribution | |
| C650 | In distribution | |
| 611-04T | In distribution | |
| C350-M4-01 | In distribution | |
| C100-130 | In distribution | |
| AS-17 | In distribution | |
| C640-11 | In distribution | |
| R410-S2 | In distribution | |
| CS75-105 | In distribution | |
| C420-M4 | In distribution | |
| K300-15BNPA | In distribution | |
| C320-060 | In distribution | |
| R100-255 | In distribution | |
| 350T-M6-02 | In distribution | |
| 350-M4-02 | In distribution | |
| CS-17 | In distribution | |
| AS-12-6 | In distribution | |
| CS-19-6 | In distribution | |
| K400-18BNPA | In distribution | |
| R100-280 | In distribution | |
| C351-M4-05 | In distribution | |
| C351-M4-04 | In distribution | |
| 350-M6-B | In distribution | |
| CS-12-5 | In distribution | |
| C320-060S | In distribution | |
| C320-130 | In distribution | |
| C350-M4-04 | In distribution | |
| R635-02-SQ | In distribution | |
| R050-255 | In distribution | |
| C350T-M4-01 | In distribution | |
| C050-110 | In distribution | |
| K400-15BNP | In distribution | |
| R320-155 | In distribution | |
| 611-04N | In distribution | |
| K250-18BN | In distribution | |
| C050-075 | In distribution | |
| C050-060 | In distribution | |
| CS-19-4 | In distribution | |
| C-Ball | In distribution | |
| C350-M4-05 | In distribution | |
| C600-16 | In distribution | |
| 600-08 | In distribution | |
| C350-M4-03 | In distribution | |
| AS-12-4 | In distribution | |
| R100-105 | In distribution | |
| R410-S1 | In distribution | |
| 390-95 | In distribution | |
| C100-095 | In distribution | |
| K400-15BNPA | In distribution | |
| R635-01-R | In distribution | |
| C604-10 | In distribution | |
| 670-18 | In distribution | |
| 390-260 | In distribution | |
| C065-110 | In distribution | |
| R025-130 | In distribution | |
| R065-280 | In distribution | |
| 350T-M6-01 | In distribution | |
| AS-12-2 | In distribution | |
| C604-16 | In distribution | |
| R650T | In distribution | |
| K400-18BNA | In distribution | |
| 611-06T | In distribution | |
| C351-M4-02 | In distribution | |
| 350-M6-01 | In distribution | |
| C025-060 | In distribution | |
| R025-230 | In distribution | |
| 350T-M6-06 | In distribution | |
| C450-04-120 | In distribution | |
| R410-S3 | In distribution | |
| R320-155S | In distribution | |
| R320-230S | In distribution | |
| CS100-155 | In distribution | |
| R025-180 | In distribution | |
| C320-110 | In distribution | |
| C430-90 | In distribution | |
| C420-M3 | In distribution | |
| C420-M2 | In distribution | |
| C100-060 | In distribution | |
| 390-050 | In distribution | |
| C320-075S | In distribution | |
| R605-F | In distribution | |
| K400-15BA | In distribution | |
| K400-15BNA | In distribution | |
| C100-075 | In distribution | |
| C604-20 | In distribution | |
| C351-M4-01 | In distribution | |
| R100-230 | In distribution | |
| C350-M4-B | In distribution | |
| C604-12 | In distribution | |
| R-Ball | In distribution | |
| R650LT | In distribution | |
| K400-18BPA | In distribution | |
| C025-075 | In distribution | |
| 350-M6-03 | In distribution | |
| R100-205 | In distribution | |
| CS-19-3 | In distribution | |
| R320-180S | In distribution | |
| R320-105 | In distribution | |
| C430-50 | In distribution | |
| C410-S2 | In distribution | |
| R065-105 | In distribution | |
| C420-F1 | In distribution | |
| 611-04 | In distribution | |
| R100-180 | In distribution | |
| R320-205S | In distribution | |
| K400-15BN | In distribution | |
| K400-15BPA | In distribution | |
| R100-155 | In distribution | |
| C320-095S | In distribution | |
| C610-07 | In distribution | |
| R065-155 | In distribution | |
| C420-F4 | In distribution | |
| K400-18PA | In distribution | |
| R050-105 | In distribution | |
| C351-M4-03 | In distribution | |
| C065-075 | In distribution | |
| R050-130 | In distribution | |
| 350T-M6-04 | In distribution | |
| R025-105 | In distribution | |
| C420-F3 | In distribution | |
| C350T-M4-03 | In distribution | |
| C350T-M4-02 | In distribution | |
| C350T-M4-05 | In distribution | |
| K370-18BNP | In distribution | |
| K200-20BN | In distribution | |
| C605-F4 | In distribution | |
| C065-060 | In distribution | |
| R320-180 | In distribution | |
| CS-19-2 | In distribution | |
| 350-M4-04 | In distribution | |
| C610-07N | In distribution | |
| R320-205 | In distribution | |
| CS-12-4 | In distribution | |
| 390-045-Q | In distribution | |
| C605-C | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Smart Correction | Wishbone Medical Inc. | 1,534 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Synthes Gmbh | 880 |
| LCP | Synthes Gmbh | 355 |
| Orthex External Fixation System | Orthopediatrics, Corp | 353 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Sterilmed, Inc. | 325 |
| CHS | Smith & Nephew, Inc. | 321 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Stryker Sustainability Solutions | 277 |
| Hoffmann | Stryker GmbH | 239 |
| Orthex | Vilex IN Tennessee, Inc. | 221 |
| Omega | Stryker GmbH | 212 |
| eZ-Fix | Orthopediatrics, Corp | 207 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Smith & Nephew, Inc. | 204 |
Showing 12 of 530. All products under Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K243798 | 2025-03-07 |
| K223786 | 2023-02-10 |
| K220809 | 2022-04-08 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Orthopediatrics, Corp | UDI-DI | 2022-09-12 | Class II | Under Investigation by firm | Bolt breakage on the head or threaded portion, which may cause loss of strut continuity with frame. This may cause loss of deformity correction and/or disruption of bone regeneration. | 1354 (594 US) |
| Orthopediatrics, Corp | 510(k) number | 2022-06-29 | Class II | Process change control | Manufacturing variance near transition of tip is increasing the likelihood the wire tip may fracture. The fractured tip may be retained in the patient. Retrieval attempts may be made which could result in a delay of surgery and potentially | 640 units |
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.