Locking Plates
Locking Plate, Straight, 10-Hole
22manufacturers in China registered for this device type
26catalogue numbers in this listing
25510(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 | Trimed, Inc., 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, Complaint-file establishment, Manufacturer |
| 510(k) | K060041 |
| Record published | 2016-09-07 |
| Record revised | 2025-11-20 (version 8) |
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, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PS10 | In distribution | |
| PS8 | In distribution | |
| CLST-8 | In distribution | |
| CLST-12-6 | In distribution | |
| SMTP-10 | In distribution | |
| PS5 | In distribution | |
| PCA15 | In distribution | |
| SMTP-6 | In distribution | |
| CLST-10-6 | In distribution | |
| PCB15 | In distribution | |
| PS12 | In distribution | |
| PCA10 | In distribution | |
| CLST-8-6 | In distribution | |
| SMTP-8 | In distribution | |
| PC6 | In distribution | |
| PCB8 | In distribution | |
| SMTP-3 | In distribution | |
| CLST-6 | In distribution | |
| CLST-6-6 | In distribution | |
| PCB10 | In distribution | |
| PCA8 | In distribution | |
| CLST-4 | In distribution | |
| PS6 | In distribution | |
| PS15 | In distribution | |
| BRGP | In distribution | |
| BBRGP | In distribution |
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 |
| Acumed | Acumed LLC | 1,360 |
| Signex | Osteonic Co., Ltd. | 1,310 |
Showing 12 of 3,530. All products under Plate, Fixation, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K262032 | 2026-07-16 |
| K254002 | 2026-01-15 |
| K252061 | 2025-08-20 |
| K251945 | 2025-07-10 |
| K250929 | 2025-06-26 |
| K250935 | 2025-05-22 |
| K250948 | 2025-04-08 |
| K243987 | 2025-03-19 |
| K243999 | 2025-03-19 |
| K243569 | 2025-01-15 |
| K243050 | 2024-11-26 |
| K241942 | 2024-09-17 |
| K233863 | 2024-04-17 |
| K230805 | 2023-09-01 |
| K222637 | 2022-12-21 |
| K192696 | 2020-01-05 |
| K151735 | 2016-01-29 |
| K112794 | 2012-05-10 |
| K112509 | 2011-11-04 |
| K111266 | 2011-10-06 |
| K102785 | 2011-08-19 |
| K091156 | 2009-07-15 |
| K060041 | 2006-02-07 |
| K050681 | 2005-07-27 |
| K043263 | 2005-01-14 |
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 |
|---|---|---|---|---|---|---|---|
| Trimed, Inc. | 510(k) number | 2018-08-24 | Class II | Component design/selection | The bone screw is shorter than the intended design specification. | 13 screws | 2020-12-28 |
| Trimed, Inc. | 510(k) number | 2018-08-15 | Class II | Employee error | The firm has become aware that the angled-hole of certain semi-tubular design bone plates may have been modified from its specification, and the modification may not have been fully qualified. | 583 Bone Plates | |
| Trimed, Inc. | 510(k) number | 2016-08-29 | Class II | Device Design | TriMed is recalling the Semi-Tubular Plates with 10 holes (SMTP-10) because a non-locking screw passed through a hole in a SMTP-10 plate being implanted. | 30 units | 2016-11-01 |
Recalls
3 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 |
|---|---|---|---|---|---|
| 2023-11-28 | Class II | Labeling design | Plates, part of a wrist fixation system, are affixed during surgery with bearings that may pop out from distal peg holes. | 270 | |
| 2018-08-24 | Class II | Device Design | Modifications to the specification were not appropriately qualified through the company’s design control process which may result in structural integrity issues of the device. | 5 devices | 2021-04-28 |
| 2018-04-16 | Class II | Process control | Two instrument holes located on the side of the plate, which act to align the saw guide are located on the wrong side of the plate | 722 | 2021-01-28 |
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.