Acumed
TRIAL Post-Lat Dist Humerus Pl 11Hole RT
22manufacturers in China registered for this device type
1,360catalogue numbers in this listing
20510(k) clearances naming this product code
6recalls on this code
Who Else Makes It
Concentrated in Jiangsu (10), Shanghai (4), Zhejiang (3). 12 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 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Kingj Medical Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
| Hangzhou Sino-MIM Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 6 |
| Suzhou AND Science & Technology Development Corp. | Zhangjiagang | Jiangsu | Contract manufacturer | 5 |
| Beijing AK Medical Co., Ltd. | Changping District | Beijing | Contract manufacturer | 3 |
Showing 12 of 22. All 22 manufacturers in China registered for Plate, Fixation, Bone
Record
| Listed by | Acumed LLC, United States |
|---|---|
| FDA product code | HRS |
| Device type | Plate, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K122538 |
| Record published | 2015-10-24 |
| Record revised | 2025-11-20 (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, manufacturing date |
| Distribution end date | 2017-12-12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 70-0451-S | In distribution | |
| PL-MCPL-S | In distribution | |
| PLT-LEM9L | In distribution | |
| 70T-0069 | In distribution | |
| 71-0379 | In distribution | |
| 7005-08006 | In distribution | |
| 71-0415 | In distribution | |
| 71-0445 | In distribution | |
| 70-0324 | In distribution | |
| PL-DR50L-S | In distribution | |
| PL-PHSL | In distribution | |
| 7007-0109L | In distribution | |
| 5002-0304N-S | In distribution | |
| PL-WF60 | In distribution | |
| 7014-0912R-S | In distribution | |
| 7007-0303R | In distribution | |
| 70-0388-S | In distribution | |
| 71-0307 | In distribution | |
| 70-0074-S | In distribution | |
| 70-0430 | In distribution | |
| 71-0330 | In distribution | |
| PL-LEM8 | In distribution | |
| 70-0055 | In distribution | |
| 70-0047-S | In distribution | |
| 70-0442 | In distribution | |
| PL-SA07L-S | In distribution | |
| 7001-0415 | In distribution | |
| 7008-0112-S | In distribution | |
| PL-FIB11-S | In distribution | |
| PL-PHXGL | In distribution | |
| 71-0149 | In distribution | |
| PL-DCP10-S | In distribution | |
| PL-ELOXR-S | In distribution | |
| 7014-0716R-S | In distribution | |
| 7006-3302N | In distribution | |
| 71-0019 | In distribution | |
| 7007-0105R-S | In distribution | |
| PLT-MTPRR | In distribution | |
| 71-0447 | In distribution | |
| 7007-0204R-S | In distribution | |
| 70-0016-S | In distribution | |
| 7001-0106R-S | In distribution | |
| 71-0373 | In distribution | |
| 7014-0612L | In distribution | |
| 70-0075-S | In distribution | |
| 70-0389-S | In distribution | |
| PL-MTPL | In distribution | |
| 70-0049 | In distribution | |
| 7007-0504-S | In distribution | |
| PLT-SLB10L | In distribution | |
| 70-0396 | In distribution | |
| PL-PHSL-S | In distribution | |
| 7007-0109R | In distribution | |
| 70-0011-S | In distribution | |
| 70-0074 | In distribution | |
| PL-LEM7-S | In distribution | |
| 7005-08003 | In distribution | |
| 70-0066-S | In distribution | |
| 70-0313-S | In distribution | |
| 7006-3402R | In distribution | |
| 70-0389 | In distribution | |
| 7001-0206R | In distribution | |
| PL-BSWDR | In distribution | |
| 71-0377 | In distribution | |
| 7014-0620L | In distribution | |
| 7007-0104R | In distribution | |
| PL-ELMX-S | In distribution | |
| PL-CL9JR | In distribution | |
| PLT-CL10LR | In distribution | |
| 71-0416 | In distribution | |
| PL-CL9JL-S | In distribution | |
| 7002-0416R | In distribution | |
| 70-0467 | In distribution | |
| 71-0227 | In distribution | |
| PLT-SMB09L | In distribution | |
| 70-0368 | In distribution | |
| 71-0378 | In distribution | |
| 70-0069-S | In distribution | |
| 70-0368-S | In distribution | |
| 71-0368 | In distribution | |
| 7007-0205R | In distribution | |
| 3014-23046 | In distribution | |
| PL-SG04L-S | In distribution | |
| 71-0414 | In distribution | |
| 80-4021 | In distribution | |
| 7001-0106L-S | In distribution | |
| PL-MPJL-S | In distribution | |
| 7002-0416R-S | In distribution | |
| 70-0395-S | In distribution | |
| 7014-0712L-S | In distribution | |
| 70-0433 | In distribution | |
| 70-0035 | In distribution | |
| 70-0009-S | In distribution | |
| E-70-0078 | In distribution | |
| 70-0292-S | In distribution | |
| 71-0360 | In distribution | |
| 7007-0109R-S | In distribution | |
| 70-0017 | In distribution | |
| 70-0397-S | In distribution | |
| 7005-13002-S | In distribution | |
| 7006-3104L | In distribution | |
| 80-4020 | In distribution | |
| 70-0023 | In distribution | |
| 70-0325 | In distribution | |
| 71-0326 | In distribution | |
| PL-ELCLR | In distribution | |
| PL-LEL20R-S | In distribution | |
| 70-0227-S | In distribution | |
| 71-0145 | In distribution | |
| 7005-13010-S | In distribution | |
| 7006-3103R | In distribution | |
| 80-4019 | In distribution | |
| 70-0297 | In distribution | |
| PL-LEO13E | In distribution | |
| PL-DR30L | In distribution | |
| 70-0231 | In distribution | |
| PL-ELMS | In distribution | |
| 70-0439 | In distribution | |
| 70-0406 | In distribution | |
| 71-0310 | In distribution | |
| 70-0298 | In distribution | |
| 70-0440 | In distribution | |
| 70-0073 | In distribution | |
| 7005-1303L | In distribution | |
| 7005-08001-S | In distribution | |
| PL-ELOXL | In distribution | |
| 70-0315 | In distribution | |
| 70-0406-S | In distribution | |
| 70-0374-S | In distribution | |
| 70-0294 | In distribution | |
| 70-0314-S | In distribution | |
| 3025-35046 | In distribution | |
| 71-0013 | In distribution | |
| 70-0464 | In distribution | |
| PL-LEL6L-S | In distribution | |
| 7007-0204L | In distribution | |
| 71-0372 | In distribution | |
| PL-PHXGR | In distribution | |
| PLT-CL6SL | In distribution | |
| E-70-0022 | In distribution | |
| 71-0334 | In distribution | |
| 7008-0102 | In distribution | |
| 7007-0603-S | In distribution | |
| 7005-13006-S | In distribution | |
| 70-0459 | In distribution | |
| 75-0057 | In distribution | |
| 70T-0076 | In distribution | |
| PLT-DR30R | In distribution | |
| 7105-13010 | In distribution | |
| PL-CL10LL | In distribution | |
| 70-0322 | In distribution | |
| 70-0052 | In distribution | |
| PL-MTPLR-S | In distribution | |
| PL-CL8JR | In distribution | |
| 70-0446-S | In distribution | |
| 70-0365-S | In distribution | |
| PL-MCPL | In distribution | |
| 70-0116 | In distribution | |
| 70-0382 | In distribution | |
| PL-GLD3-S | In distribution | |
| PL-TIBAM-S | In distribution | |
| 70-0096 | In distribution | |
| 70-0356 | In distribution | |
| 70-0448-S | In distribution | |
| E-70-0024 | In distribution | |
| 3025-35020 | In distribution | |
| 71-0458 | In distribution | |
| PL-ELOM-S | In distribution | |
| 70-0314 | In distribution | |
| 7014-0720L | In distribution | |
| 7007-0107L | In distribution | |
| 70-0076 | In distribution | |
| 70-0379 | In distribution | |
| PLT-CL8JL | In distribution | |
| PL-ELML-S | In distribution | |
| PLT-CL8SR | In distribution | |
| 70-0077-S | In distribution | |
| 70-0326-S | In distribution | |
| 70-0035-S | In distribution | |
| 70-0118 | In distribution | |
| PL-SMB13R-S | In distribution | |
| 70-0388 | In distribution | |
| PL-LEM9L-S | In distribution | |
| PL-TIBMM-S | In distribution | |
| 70-0053 | In distribution | |
| 70-0123-S | In distribution | |
| 70-0443 | In distribution | |
| 70-0416 | In distribution | |
| 70-0336-S | In distribution | |
| PL-TMT14-S | In distribution | |
| 70-0068-S | In distribution | |
| 7010-0107R | In distribution | |
| PL-WF33-S | In distribution | |
| PLT-CL9JR | In distribution | |
| 70-0307 | In distribution | |
| 70-0289-S | In distribution | |
| PL-ELLSR | In distribution | |
| 7105-08004 | In distribution | |
| 7014-0916R-S | In distribution | |
| 71-0327 | In distribution | |
| 70-0058-S | In distribution | |
| PLT-DR70L | In distribution | |
| 70-0078 | In distribution | |
| 70-0327 | In distribution | |
| 70-0381 | In distribution | |
| 71-0338 | In distribution | |
| 70-0025 | In distribution | |
| 70-0312-S | In distribution | |
| 7007-0113L | In distribution | |
| 7005-08007-S | In distribution | |
| 70-0245-S | In distribution | |
| PL-WF60-S | In distribution | |
| 7007-0104R-S | In distribution | |
| PLT-DR65L | In distribution | |
| 7014-0712L | In distribution | |
| 7007-0702 | In distribution | |
| PLT-CL8LR | In distribution | |
| 7014-0516R | In distribution | |
| 7006-3103L | In distribution | |
| 70-0331-S | In distribution | |
| PL-ELCLL | In distribution | |
| PLT-ELCOL | In distribution | |
| 70-0037-S | In distribution | |
| PL-GLD7-S | In distribution | |
| 70-0010 | In distribution | |
| 70-0438 | In distribution | |
| 7007-0206R-S | In distribution | |
| 7001-0114L-S | In distribution | |
| 3025-35022 | In distribution | |
| 3025-35044 | In distribution | |
| 70-0057 | In distribution | |
| 3025-35032 | In distribution | |
| PL-CL6SR | In distribution | |
| 7105-13005 | In distribution | |
| 70-0125 | In distribution | |
| 71-0009 | In distribution | |
| 75-0058 | In distribution | |
| 70-0371-S | In distribution | |
| PL-SMB13L | In distribution | |
| 3025-35052 | In distribution | |
| 70-0364 | In distribution | |
| 71-0382 | In distribution | |
| 7008-0108 | In distribution | |
| 70-0009 | In distribution | |
| 71-0037 | In distribution | |
| PLT-SLB10R | In distribution | |
| 70-0108 | In distribution | |
| 70T-0075 | In distribution | |
| 7008-0102-S | In distribution | |
| 70-0051 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pectus System | Biomet Microfixation | 4,662 |
| Arthrex® | Arthrex, Inc. | 3,031 |
| Evos | Smith & Nephew, Inc. | 2,235 |
| Peri-Loc | Smith & Nephew, Inc. | 2,196 |
| OsteoMed | Osteomed | 1,961 |
| VariAx | Stryker GmbH | 1,934 |
| Aptus | Medartis Inc. | 1,688 |
| TC-100 | Smith & Nephew, Inc. | 1,639 |
| Plate, Fixation, Bone | Synthes Gmbh | 1,613 |
| Anthem | Globus Medical, Inc. | 1,551 |
| Signex | Osteonic Co., Ltd. | 1,310 |
| LCP | Synthes Gmbh | 1,295 |
Showing 12 of 3,530. All products under Plate, Fixation, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252356 | 2025-08-21 |
| K251132 | 2025-07-14 |
| K251296 | 2025-06-18 |
| K233311 | 2024-04-22 |
| K210750 | 2021-07-15 |
| K151886 | 2015-10-30 |
| K143385 | 2015-04-06 |
| K143394 | 2015-01-23 |
| K141383 | 2014-06-13 |
| K132769 | 2014-01-06 |
| K131764 | 2013-09-05 |
| K131380 | 2013-06-10 |
| K122538 | 2012-11-19 |
| K120903 | 2012-07-13 |
| K102998 | 2011-01-04 |
| K100123 | 2010-10-06 |
| K071715 | 2007-07-18 |
| K063460 | 2006-12-07 |
| K051410 | 2005-07-21 |
| K051083 | 2005-05-12 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Acumed LLC | 510(k) number | 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 | 2017-01-19 | Class II | Mixed-up of materials/components | The 6-hole Pubic Symphysis plate (PN 70-0451) is specified to be made of Commercially Pure Titanium (ASTM F67 – CP Grade 4). However, batch 383813 was manufactured out of Titanium Alloy (Ti-6Al- 4V ELI per ASTM F135 Ti alloy) and was distr | 15 units | 2017-05-08 |
| Acute Innovations, LLC | 510(k) number | 2013-10-30 | Class II | Under Investigation by firm | The ACUTE Innovations Ribloc U plus Rib Fracture Plating System is recalled because it has the potential to malfunction during installation in a surgery. | 176 units | 2014-03-13 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. 1 is 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 |
|---|---|---|---|---|---|
| 2023-12-19 | Class II | No Marketing Application | Distribution without Pre-Market Clearance | 2,952,121 units | |
| 2014-03-26 | Class II | Component change control | Certain lots of Acumed Tension Band Pins are being recalled because the implantable product was manufactured with a grade of stainless steel that is not within specifications. | 2544 unit in the US and 3584 units outside the US | 2015-02-04 |
| 2010-04-14 | Not classified | Other | The saw blades may not cut aggressively enough for their intended application therefore creating a risk that the saw could generate excessive heat, which may contribute to bone necrosis and/or non-union. | 718 units | 2010-06-28 |
| 2007-06-29 | Not classified | Process control | Plates are incorrectly laser marked. The PL-DR50L plates are incorrectly laser marked with PL-DR70L. | 51 pieces | 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.