P.a.c.e.
P.A.C.E. is a foot and ankle plating family with bone plates, screws and associated instruments. A plate-and-screw construct holds bone segments in position during fracture fixation,…
P.A.C.E. is a foot and ankle plating family with bone plates, screws and associated instruments. A plate-and-screw construct holds bone segments in position during fracture fixation, osteotomy or fusion.
The range includes forefoot, midfoot, hindfoot and ankle configurations. Plates use titanium alloy or commercially pure titanium, while matching cortical and locking screws use titanium alloy.
Listed Item
P.A.C.E. MTP Fusion Plate 0°, narrow, Right, 2,5/2,8mm System
Forefoot Plate Choices
Forefoot forms include straight, T, Y, L and cloverleaf fracture plates, together with MTP and TMT fusion designs and revision options. Right and left versions and different lengths allow the plate geometry to correspond to the selected anatomical site.
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 | Maxxos-Medical Gmbh, Germany |
|---|---|
| FDA product code | HRS |
| Device type | Plate, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K251892 |
| Record published | 2025-12-13 |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M211117-323 | In distribution | |
| M211117-423 | In distribution | |
| M211117-417 | In distribution | |
| M211117-313 | In distribution | |
| M211117-305 | In distribution | |
| M211117-416 | In distribution | |
| M211117-223 | In distribution | |
| M211117-206 | In distribution | |
| M211117-303 | In distribution | |
| M211117-316 | In distribution | |
| M211117-203 | In distribution | |
| M211117-427 | In distribution | |
| M211117-407 | In distribution | |
| M211117-306 | In distribution | |
| M211117-123 | In distribution | |
| M211117-425 | In distribution | |
| M211117-106 | In distribution | |
| M211117-315 | In distribution | |
| M211117-213 | In distribution | |
| M211117-317 | In distribution | |
| M211117-413 | In distribution | |
| M211117-406 | In distribution | |
| M211117-415 | In distribution | |
| M211117-325 | In distribution | |
| M211117-405 | In distribution | |
| M211117-307 | In distribution | |
| M211117-403 | In distribution | |
| M211117-327 | In distribution | |
| M211117-113 | In distribution | |
| M211117-426 | In distribution | |
| M211117-326 | 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 |
|---|---|
| K251892 | 2025-09-08 |
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.