Omni Stable AF
Solid Screw, Non-Locking, 4.0 x 42mm
31manufacturers in China registered for this device type
86catalogue numbers in this listing
16510(k) clearances naming this product code
2recalls on this code
Who Else Makes It
Concentrated in Jiangsu (15), Shanghai (5), Zhejiang (3). 19 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
Showing 12 of 31. All 31 manufacturers in China registered for Screw, Fixation, Bone
Record
| Listed by | Extremity Medical, LLC, United States |
|---|---|
| FDA product code | HWC |
| Device type | Screw, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K212297 |
| Record published | 2023-06-12 |
| Record revised | 2024-02-19 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 144-35040 | In distribution | |
| 144-35154 | In distribution | |
| 144-28156 | In distribution | |
| 155-40042 | In distribution | |
| 144-35225 | In distribution | |
| 144-35034 | In distribution | |
| 144-28136 | In distribution | |
| 144-35042 | In distribution | |
| 144-35132 | In distribution | |
| 144-28140 | In distribution | |
| 144-35265 | In distribution | |
| 144-28144 | In distribution | |
| 155-40040 | In distribution | |
| 155-40052 | In distribution | |
| 144-28148 | In distribution | |
| 144-28150 | In distribution | |
| 144-28054 | In distribution | |
| 155-40056 | In distribution | |
| 144-35054 | In distribution | |
| 144-35134 | In distribution | |
| 144-28138 | In distribution | |
| 144-28032 | In distribution | |
| 144-28152 | In distribution | |
| 144-35146 | In distribution | |
| 144-28060 | In distribution | |
| 144-28134 | In distribution | |
| 144-35046 | In distribution | |
| 144-35032 | In distribution | |
| 144-28052 | In distribution | |
| 155-40044 | In distribution | |
| 144-28108 | In distribution | |
| 144-35142 | In distribution | |
| 144-35260 | In distribution | |
| 144-28142 | In distribution | |
| 144-28042 | In distribution | |
| 155-40046 | In distribution | |
| 144-35136 | In distribution | |
| 144-28038 | In distribution | |
| 144-35170 | In distribution | |
| 144-28044 | In distribution | |
| 144-35144 | In distribution | |
| 144-35044 | In distribution | |
| 144-35036 | In distribution | |
| 144-28132 | In distribution | |
| 144-28048 | In distribution | |
| 144-35160 | In distribution | |
| 144-35270 | In distribution | |
| 144-35150 | In distribution | |
| 144-28058 | In distribution | |
| 144-35165 | In distribution | |
| 144-35235 | In distribution | |
| 144-35052 | In distribution | |
| 144-28160 | In distribution | |
| 144-28146 | In distribution | |
| 155-40054 | In distribution | |
| 144-28056 | In distribution | |
| 144-28154 | In distribution | |
| 144-28040 | In distribution | |
| 144-35220 | In distribution | |
| 144-28046 | In distribution | |
| 144-35152 | In distribution | |
| 144-35156 | In distribution | |
| 144-28008 | In distribution | |
| 144-35065 | In distribution | |
| 144-28050 | In distribution | |
| 144-35060 | In distribution | |
| 155-40050 | In distribution | |
| 144-35140 | In distribution | |
| 155-40048 | In distribution | |
| 144-35108 | In distribution | |
| 144-35070 | In distribution | |
| 144-28158 | In distribution | |
| 144-35158 | In distribution | |
| 144-28036 | In distribution | |
| 155-40058 | In distribution | |
| 144-35050 | In distribution | |
| 144-35038 | In distribution | |
| 144-35056 | In distribution | |
| 144-35138 | In distribution | |
| 144-35058 | In distribution | |
| 144-35008 | In distribution | |
| 144-35255 | In distribution | |
| 144-28034 | In distribution | |
| 155-40060 | In distribution | |
| 144-35048 | In distribution | |
| 144-35148 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Screw, Fixation, Bone | Synthes Gmbh | 3,975 |
| Aptus | Medartis Inc. | 3,623 |
| Acumed | Acumed LLC | 3,187 |
| Arthrex® | Arthrex, Inc. | 2,781 |
| OsteoMed | Osteomed | 2,764 |
| Screw, Fixation, Bone | AAP Implantate AG | 2,176 |
| Screw, Fixation, Bone | Zimmer, Inc. | 1,993 |
| Arix System Bone Screw | Jeil Medical Corporation | 1,875 |
| Cannulated Screw System + | Tyber Medical | 1,814 |
| Cannulated Compression Headless Screw | Tyber Medical | 1,621 |
| Microware Bone Plates and Bone Screws | Microware Precision Co., Ltd. | 1,601 |
| Anthem | Globus Medical, Inc. | 1,538 |
Showing 12 of 5,775. All products under Screw, Fixation, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K250536 | 2025-10-08 |
| K211261 | 2021-05-28 |
| K201556 | 2020-07-08 |
| K171018 | 2017-07-13 |
| K152710 | 2015-10-15 |
| K150309 | 2015-03-04 |
| K143402 | 2015-02-04 |
| K133636 | 2014-03-28 |
| K130120 | 2013-04-11 |
| K121349 | 2012-07-18 |
| K121417 | 2012-07-18 |
| K101700 | 2010-10-12 |
| K093770 | 2010-04-28 |
| K091577 | 2009-07-24 |
| K082934 | 2009-04-23 |
| K081934 | 2008-08-29 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2012-03-22 | Class II | Device Design | Lag screw measurement is short (approximately 5 mm) when using current screw measuring device (p/n 101-00010) per the IO FIX Surgical Technique Rev C. which can lead to possible inappropriate implant size selection (e.g. shorter screw size | 93 units | 2013-06-13 |
| 2011-04-13 | Class II | Employee error | Product Event Reports revealed that lag screw passes through washer (e.g. X-Post) intra-operatively. | 120 Units | 2013-03-21 |
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.