Acumed
2.3mm X 20mm Non-Toggling Cortical Screw
31manufacturers in China registered for this device type
3,187catalogue numbers in this listing
5510(k) clearances naming this product code
35recalls 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 | Acumed 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, Manufacturer |
| 510(k) | K141383 |
| Record published | 2023-07-29 |
| Record revised | 2025-03-27 (version 8) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| 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, manufacturing date |
| Storage | Storage environment temperature up to 120 °F |
| Sizes | Length 10 to 16 mm |
| Distribution end date | 2022-10-05 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3050-20028 | In distribution | |
| HCA-5140 | In distribution | |
| 3012-23005-S | In distribution | |
| 30-0544 | In distribution | |
| 3005-65090 | In distribution | |
| 30-0319-S | In distribution | |
| 30-0899 | In distribution | |
| FA-CO3560-S | In distribution | |
| 3005-50068 | In distribution | |
| CO-3180-S | In distribution | |
| 30-0259 | In distribution | |
| 30-0303-S | In distribution | |
| 80-0655 | In distribution | |
| 3006-40028-S | In distribution | |
| AT-1200 | In distribution | |
| 3007-50024 | In distribution | |
| COL-2360 | In distribution | |
| 3006-40030-S | In distribution | |
| FA-0160 | In distribution | |
| 3005-73070 | In distribution | |
| 3005-65060 | In distribution | |
| 80-1628 | In distribution | |
| 30-0508 | In distribution | |
| 3006-73055 | In distribution | |
| CA-4260 | In distribution | |
| 27-0220 | In distribution | |
| 3005-40034 | In distribution | |
| AM-0040 | In distribution | |
| 3013-27026 | In distribution | |
| AP-67120-S | In distribution | |
| 3011-43052 | In distribution | |
| 3005-45076 | In distribution | |
| 3007-35022 | In distribution | |
| CO-3280-S | In distribution | |
| 30-0261-S | In distribution | |
| 30-0306 | In distribution | |
| 3007-50032 | In distribution | |
| 30-0228 | In distribution | |
| 3015-40045-S | In distribution | |
| 3051-25026-S | In distribution | |
| 20-0455-S | In distribution | |
| CO-N2320 | In distribution | |
| FA-CO2750-S | In distribution | |
| 3013-35034 | In distribution | |
| 3005-50030 | In distribution | |
| 3006-30034 | In distribution | |
| 3007-73050 | In distribution | |
| 3006-73120-S | In distribution | |
| 20-0152 | In distribution | |
| AT2-C13-S | In distribution | |
| FA-CO2750 | In distribution | |
| HCA-L5345-S | In distribution | |
| COL-3140-S | In distribution | |
| LAG-4350-S | In distribution | |
| 3004-23022-S | In distribution | |
| 3005-30048 | In distribution | |
| 3004-23009 | In distribution | |
| 3004-23006 | In distribution | |
| FA-CO2755 | In distribution | |
| 30-0031 | In distribution | |
| 30-0292 | In distribution | |
| 3018-47050-S | In distribution | |
| 3053-40022-S | In distribution | |
| 3007-65120 | In distribution | |
| 30-0645 | In distribution | |
| 30-0901-S | In distribution | |
| 3006-73130 | In distribution | |
| CA-4350 | In distribution | |
| 20-0556-S | In distribution | |
| 30-0326-S | In distribution | |
| 3018-47032 | In distribution | |
| AI-0012-S | In distribution | |
| 3052-35060 | In distribution | |
| 30170008-S | In distribution | |
| 3006-73080 | In distribution | |
| 3011-43014 | In distribution | |
| 3013-27046 | In distribution | |
| 3005-73095 | In distribution | |
| 30-0878 | In distribution | |
| HCO3250-S | In distribution | |
| 30-2842 | In distribution | |
| HCA-5120 | In distribution | |
| 3053-40056 | In distribution | |
| 30-0353-S | In distribution | |
| 3007-35044 | In distribution | |
| 3007-45064 | In distribution | |
| CO-3260-S | In distribution | |
| 3053-40056-S | In distribution | |
| 3007-50026 | In distribution | |
| CO-N2346 | In distribution | |
| AI-0020-S | In distribution | |
| FA-CO2760-S | In distribution | |
| 20-0163 | In distribution | |
| 3017-10007-S | In distribution | |
| CO-3060-S | In distribution | |
| 30-0906-S | In distribution | |
| ATF-140 | In distribution | |
| FA-0140-S | In distribution | |
| 3007-45044 | In distribution | |
| 30-0293 | In distribution | |
| CO-3500 | In distribution | |
| HCA-5150 | In distribution | |
| 3007-65120-S | In distribution | |
| COL-3140 | In distribution | |
| 3005-65110-S | In distribution | |
| 30-0365-S | In distribution | |
| 20-0465-S | In distribution | |
| 3004-15010-S | In distribution | |
| 3051-25048-S | In distribution | |
| 30-0327-S | In distribution | |
| 3005-40020 | In distribution | |
| 30-0886-S | In distribution | |
| CA-4225-S | In distribution | |
| 30170011-S | In distribution | |
| 3040-23010-S | In distribution | |
| 30-0295-S | In distribution | |
| CO-3200-S | In distribution | |
| 3006-65140 | In distribution | |
| 3040-23012-S | In distribution | |
| AI-0026-S | In distribution | |
| AT2-S26-S | In distribution | |
| CO-T2344 | In distribution | |
| 3006-73045-S | In distribution | |
| 30100059 | In distribution | |
| 3004-15006-S | In distribution | |
| 3012-15009 | In distribution | |
| CO-T2308 | In distribution | |
| FA-4036-S | In distribution | |
| 3012-15013-S | In distribution | |
| 30-0514 | In distribution | |
| 30-2330-S | In distribution | |
| CO-N2324 | In distribution | |
| 3006-40024-S | In distribution | |
| 3005-65150-S | In distribution | |
| 3004-15010 | In distribution | |
| 20-0447 | In distribution | |
| 30-0356-S | In distribution | |
| 30-0239 | In distribution | |
| 30-0349-S | In distribution | |
| COL-2180 | In distribution | |
| 3005-40036-S | In distribution | |
| FA-CO2736 | In distribution | |
| CA-4220-S | In distribution | |
| 20-0572 | In distribution | |
| 30-0883-S | In distribution | |
| FA-CO2718 | In distribution | |
| COL-3500-S | In distribution | |
| 3004-15007 | In distribution | |
| 20-0451 | In distribution | |
| 30-0264 | In distribution | |
| CO-T2338 | In distribution | |
| 30-0606 | In distribution | |
| 30-0030-S | In distribution | |
| 3053-40020-S | In distribution | |
| 3006-40034 | In distribution | |
| CO-T2330-S | In distribution | |
| 3015-40026 | In distribution | |
| 20-0189-S | In distribution | |
| 3005-30050 | In distribution | |
| CO-T2328 | In distribution | |
| 3005-30044 | In distribution | |
| 3005-40044 | In distribution | |
| 30-0898-S | In distribution | |
| 3011-43042-S | In distribution | |
| 80-0614 | In distribution | |
| 3006-40038-S | In distribution | |
| COL-2280-S | In distribution | |
| 30-0131 | In distribution | |
| 30-0310 | In distribution | |
| CO-F2722-S | In distribution | |
| 3016-40018 | In distribution | |
| AT2-C28 | In distribution | |
| 30-0162 | In distribution | |
| 20-0168-S | In distribution | |
| 20-0463 | In distribution | |
| 3006-73090 | In distribution | |
| 20-0198 | In distribution | |
| 3006-73125 | In distribution | |
| CO-F2710-S | In distribution | |
| 3006-73045 | In distribution | |
| 30100009 | In distribution | |
| 3052-35050 | In distribution | |
| HCA-L5320-S | In distribution | |
| 30-0446-S | In distribution | |
| CO-2722 | In distribution | |
| 3011-43012-S | In distribution | |
| 3052-35028 | In distribution | |
| FA-CO2738 | In distribution | |
| 3005-40040-S | In distribution | |
| ATF-370-S | In distribution | |
| FA-CO3530 | In distribution | |
| HCA5475-S | In distribution | |
| 30-0315 | In distribution | |
| 3041-23013 | In distribution | |
| 3005-65075-S | In distribution | |
| 3005-73105 | In distribution | |
| 40-0146-S | In distribution | |
| 30-2338-S | In distribution | |
| CO-2720-S | In distribution | |
| 30-0363 | In distribution | |
| AT2-C24-S | In distribution | |
| CO-2720 | In distribution | |
| HCA-L5352-S | In distribution | |
| RBP1202 | In distribution | |
| FA-CO2726-S | In distribution | |
| 3051-25024 | In distribution | |
| CA-4160-S | In distribution | |
| 3006-40058-S | In distribution | |
| 3018-47034-S | In distribution | |
| 30-0324 | In distribution | |
| 3005-73075 | In distribution | |
| 3018-47012-S | In distribution | |
| MS-4500 | In distribution | |
| 30-0264-S | In distribution | |
| 3003-43052-S | In distribution | |
| CO-27275-S | In distribution | |
| LAG-5054-S | In distribution | |
| AP-0040 | In distribution | |
| CO-T2312 | In distribution | |
| LAG-4300-S | In distribution | |
| 3005-73035 | In distribution | |
| 3011-43058-S | In distribution | |
| 3005-73035-S | In distribution | |
| HCA5375-S | In distribution | |
| 80-0054 | In distribution | |
| CO-F2110-S | In distribution | |
| CO-S2110 | In distribution | |
| 30-0309-S | In distribution | |
| EXINN921525 | In distribution | |
| 3065-20028 | In distribution | |
| 3006-73110 | In distribution | |
| CO-27375 | In distribution | |
| 30-0231-S | In distribution | |
| CA-4180-S | In distribution | |
| 27-0120 | In distribution | |
| 3004-15016 | In distribution | |
| 3040-23012 | In distribution | |
| FA-CO2720-S | In distribution | |
| 3005-65075 | In distribution | |
| CO-3275 | In distribution | |
| 30-0304-S | In distribution | |
| FA-4030-S | In distribution | |
| FA-0260-S | In distribution | |
| FA-CO3518 | In distribution | |
| RBP1212 | In distribution | |
| 20-0462 | In distribution | |
| COL-2550 | In distribution | |
| 46-0005-S | In distribution | |
| ATM-160 | In distribution | |
| FA-0200 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Screw, Fixation, Bone | Synthes Gmbh | 3,975 |
| Aptus | Medartis Inc. | 3,623 |
| 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 |
| Volt | Synthes Gmbh | 1,444 |
Showing 12 of 5,775. All products under Screw, Fixation, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K230744 | 2023-06-09 |
| K221333 | 2022-12-29 |
| K123890 | 2013-03-18 |
| K111608 | 2011-08-29 |
| K033639 | 2004-01-15 |
Recalls Naming This Product
6 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 | Closed |
|---|---|---|---|---|---|---|---|
| Acumed LLC | UDI-DI | 2026-05-28 | Class II | Device Design | Due to manufacturing error, hexalobe screws used with wrist fixation system may break during use. | 5,272 units | |
| Acumed LLC | 510(k) number | 2022-03-09 | Class II | Device Design | Cannulated Screws 4.0mm x 10mm and 4.0mm x 12mm may not have sufficient axial pullout strength for the indicated use. Remote possibility of resulting in a mal or nonunion of the bone fragments, iatrogenic fracture, joint impingement or dam | 537 units | |
| Acumed LLC | 510(k) number | 2022-03-09 | Class II | Device Design | Cannulated Screws 4.0mm x 10mm and 4.0mm x 12mm may not have sufficient axial pullout strength for the indicated use. Remote possibility of resulting in a mal or nonunion of the bone fragments, iatrogenic fracture, joint impingement or dam | 506 unit | |
| Acumed LLC | 510(k) number | 2009-05-19 | Not classified | Employee error | Mix-up of parts – Product labeled cortical bone screw actually contains Acutract fixation screw | 83 | 2010-05-17 |
| Acumed LLC | 510(k) number | 2007-07-09 | Not classified | Packaging process control | Product mislabeled. The inner sticky labels for the patient identified the product incorrectly as a Cortical screw (non-locking). The product package was labeled correctly. | 400 screws | 2010-02-03 |
| Acumed LLC | 510(k) number | 2005-12-27 | Not classified | Process change control | Package of 3.5mm X 32.5mm cortical screw may contain 3.5mm X 22.5mm cortical screw. | 112 pieces | 2010-02-03 |
Recalls
4 of these are Class II. Class II means a temporary or reversible health consequence. 4 are recorded with the root cause “No Marketing Application”: the device was distributed without the premarket submission its class requires, a compliance finding rather than a defect. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2022-11-29 | Class II | No Marketing Application | Distribution without Pre-Market Clearance | Total 306,934 units (Acutrak 239,611 units and Mini Acutrak | |
| 2022-11-29 | Class II | No Marketing Application | Distribution without Pre-Market Clearance | 80,805 units | |
| 2022-11-29 | Class II | No Marketing Application | Distribution without Pre-Market Clearance | 7,498 units | |
| 2022-11-29 | Class II | No Marketing Application | Distribution without Pre-Market Clearance | 1,681,860 units (Acutrak 2 286,026; Micro Acutrak 2 524,566; | |
| 2009-08-21 | Not classified | Pending | Labeling may contain 2 lot numbers and 2 model numbers. It was observed that the box top label (30170060-S, W67391) does not match the two side labels (3010320-S, W67385). The part and patient labeling inside the box match the side labels | 125 | 2010-11-06 |
| 2008-02-14 | Not classified | Packaging process control | Product sterility may be compromised. | 3 pcs | 2010-02-03 |
| 2008-02-14 | Not classified | Packaging process control | Product sterility may be compromised. | 10 pcs | 2010-02-03 |
| 2008-02-14 | Not classified | Packaging process control | Product sterility may be compromised. | 10 pcs | 2010-02-03 |
| 2008-02-14 | Not classified | Packaging process control | Product sterility may be compromised. | 10 pcs | 2010-02-03 |
| 2008-02-14 | Not classified | Packaging process control | Product sterility may be compromised. | 3 pcs | 2010-02-03 |
| 2008-02-14 | Not classified | Packaging process control | Product sterility may be compromised. | 31 pcs | 2010-02-03 |
| 2008-02-14 | Not classified | Packaging process control | Product sterility may be compromised. | 3 pcs | 2010-02-03 |
| 2008-02-14 | Not classified | Packaging process control | Product sterility may be compromised. | 3 pcs | 2010-02-03 |
| 2008-02-14 | Not classified | Packaging process control | Product sterility may be compromised. | 10 pcs | 2010-02-03 |
| 2008-02-14 | Not classified | Packaging process control | Product sterility may be compromised. | 20 pcs | 2010-02-03 |
| 2008-02-14 | Not classified | Packaging process control | Product sterility may be compromised. | 20 pcs | 2010-02-03 |
| 2008-02-14 | Not classified | Packaging process control | Product sterility may be compromised. | 20 pcs | 2010-02-03 |
| 2008-02-14 | Not classified | Packaging process control | Product sterility may be compromised. | 10 pcs | 2010-02-03 |
| 2008-02-14 | Not classified | Packaging process control | Product sterility may be compromised. | 20 pcs | 2010-02-03 |
| 2008-02-14 | Not classified | Packaging process control | Product sterility may be compromised. | 3 pcs | 2010-02-03 |
| 2008-02-14 | Not classified | Packaging process control | Product sterility may be compromised. | 10 pcs | 2010-02-03 |
| 2008-02-14 | Not classified | Packaging process control | Product sterility may be compromised. | 3 pcs | 2010-02-03 |
| 2008-02-14 | Not classified | Packaging process control | Product sterility may be compromised. | 3 pcs | 2010-02-03 |
| 2008-02-14 | Not classified | Packaging process control | Product sterility may be compromised. | 7 pcs | 2010-02-03 |
| 2008-02-14 | Not classified | Packaging process control | Product sterility may be compromised. | 3 pcs | 2010-02-03 |
| 2008-02-14 | Not classified | Packaging process control | Product sterility may be compromised. | 20 pcs | 2010-02-03 |
| 2008-02-14 | Not classified | Packaging process control | Product sterility may be compromised. | 3 pcs | 2010-02-03 |
| 2008-02-14 | Not classified | Packaging process control | Product sterility may be compromised. | 10 pcs | 2010-02-03 |
| 2008-02-14 | Not classified | Packaging process control | Product sterility may be compromised. | 30 pcs | 2010-02-03 |
| 2008-02-14 | Not classified | Packaging process control | Product sterility may be compromised. | 3 pcs | 2010-02-03 |
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.