Gorilla Plating System
Precision Guide Lapidus, Medial Wall-Step-Off, 1 mm Step Plate, Right (1.4mm thick)
22manufacturers in China registered for this device type
188catalogue numbers in this listing
8510(k) clearances naming this product code
1recall
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 | Paragon 28, 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) | K140397 |
| Record published | 2016-09-24 |
| Record revised | 2025-04-22 (version 5) |
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 |
| Sizes | Length 10 to 35 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| P53-106-L001 | Lapidus, Medial Wall – Standard, Left (1.3mm thick) w/ compression | In distribution |
| P53-109-R011 | Gorilla, Plate, Med Col Arch, TN-NC, 1.5mm Thk, Right, Sm, TiA | In distribution |
| P53-106-L003 | Lapidus, Medial Wall – Graft Spanning Medium, Left (1.6mm thk) | In distribution |
| P53-110-R000 | Slanted-T Plate: 3-Hole w/ Compression, Right | In distribution |
| P53-151-1002 | Length 15 mm | In distribution |
| P53-154-0001 | Teddy Bear Plate, Small | In distribution |
| P53-103-L103 | MTP, 10 degree, Long Plate, Left | In distribution |
| P53-109-L003 | Gorilla, Plate, Med Col Arch, 1.5mm Thk, Left, Lg, TiA | In distribution |
| P53-109-L103 | Gorilla, Plate, Med Col Arch, 2.0mm Thk, Left, Lg, TiA | In distribution |
| P53-110-L201 | 4-Corner Plates: 1ST & 2ND, Small, Left | In distribution |
| P53-103-R002 | MTP, 0 degree, Medium Plate, Right | In distribution |
| P53-109-R111 | Gorilla, Plate, Med Col Arch NC-1st Met, 2.0mm Thk, Right, Sm, TiA | In distribution |
| P53-152-0001 | 4-Hole T-Plate w/ Compression | In distribution |
| P53-101-2022 | 28 Plate, 20 mm, 2-Hole Locking | In distribution |
| P53-106-R003 | Lapidus, Medial Wall – Graft Spanning Medium, Right (1.6mm thk) | In distribution |
| P53-103-L001 | MTP, 0 degree, Short Plate, Left | In distribution |
| P53-110-L302 | Clover Plate: 6-Hole w/ Compression, Left | In distribution |
| P53-106-L202 | Precision Guide Lapidus, Medial Wall-Step-Off, 2 mm Step Plate, Left (1.4mm) | In distribution |
| P53-103-R102 | MTP, 10 degree, Medium Plate, Right | In distribution |
| P53-110-R102 | Slanted Straight Plate: 5-Hole Slant, Right | In distribution |
| P53-101-2012 | 28 Plate, 20 mm, 2-Hole Locking | In distribution |
| P53-109-L013 | Gorilla, Plate, Med Col Arch, TN-NC, 1.5mm Thk, Left, Lg, TiA | In distribution |
| P53-153-0003 | Trap Plate, Long | In distribution |
| P53-109-1109 | Gorilla, Plate, Med Col Rescue, 2.0mm Thk, 9-Hole, TiA | In distribution |
| P53-101-1023 | Length 25 mm | In distribution |
| P53-103-R151 | MTP, 5 degree, Revision Plate, Short, Right | In distribution |
| P53-109-L101 | Gorilla, Plate, Med Col Arch, 2.0mm Thk, Left, Sm, TiA | In distribution |
| P53-103-R153 | MTP, 5 degree, Revision Plate, Long, Right | In distribution |
| P53-109-L113 | Gorilla, Plate, Med Col Arch NC-1st Met, 2.0mm Thk, Left, Lg, TiA | In distribution |
| P53-154-0003 | Teddy Bear Plate, Large | In distribution |
| P53-110-L000 | Slanted-T Plate: 3-Hole w/ Compression, Left | In distribution |
| P53-109-R103 | Gorilla, Plate, Med Col Arch, 2.0mm Thk, Right, Lg, TiA | In distribution |
| P53-104-0210 | BOW & Arrow, Evans Plate, 10mm Wedge | In distribution |
| P53-103-R051 | MTP, 5 degree, Short Plate, Right | In distribution |
| P53-104-0000 | BOW & Arrow, Base Wedge Plate, 0.0mm Wedge | In distribution |
| P53-109-R112 | Gorilla, Plate, Med Col Arch NC-1st Met, 2.0mm Thk, Right, Md, TiA | In distribution |
| P53-109-L111 | Gorilla, Plate, Med Col Arch NC-1st Met, 2.0mm Thk, Left, Sm, TiA | In distribution |
| P53-103-L153 | MTP, 5 degree, Revision Plate, Long, Left | In distribution |
| P53-103-L152 | MTP, 5 degree, Revision Plate, Medium, Left | In distribution |
| P53-101-2011 | 28 Plate, 15 mm, 2-Hole Locking | In distribution |
| P53-103-L051 | MTP, 5 degree, Short Plate, Left | In distribution |
| P53-103-R152 | MTP, 5 degree, Revision Plate, Medium, Right | In distribution |
| P53-106-L002 | Lapidus, Medial Wall – Graft Spanning Small, Left (1.6mm thk) w/ compression | In distribution |
| P53-203-L013 | Gorilla, Ankle Fx, Anatomical Fibular Plate L, 13-Hole | In distribution |
| P53-110-L001 | Slanted-T Plate: 4-Hole w/ Compression, Left | In distribution |
| P53-201-0010 | Gorilla, Ankle Fx, Fibular, Plate, Straight, 10-Hole | In distribution |
| P53-153-0002 | Trap Plate, Medium | In distribution |
| P53-105-L003 | HEvans Plate, Long, 24mm, Left | In distribution |
| P53-104-0030 | BOW & Arrow, Base Wedge Plate, 3.0mm Wedge | In distribution |
| P53-104-0150 | BOW & Arrow Cotton Plate, 5mm Wedge | In distribution |
| P53-104-0160 | BOW & Arrow Cotton Plate, 6mm Wedge | In distribution |
| P53-110-L301 | Clover Plate: 5-Hole w/ Compression, Left | In distribution |
| P53-109-R113 | Gorilla, Plate, Med Col Arch NC-1st Met, 2.0mm Thk, Right, Lg, TiA | In distribution |
| P53-151-0002 | Length 15 mm | In distribution |
| P53-103-R003 | MTP, 0 degree, Long Plate, Right | In distribution |
| P53-151-0001 | Length 10 mm | In distribution |
| P53-203-L011 | Gorilla, Ankle Fx, Anatomical Fibular Plate L, 11-Hole | In distribution |
| P53-101-2021 | 28 Plate, 15 mm, 2-Hole Locking | In distribution |
| P53-201-0007 | Gorilla, Ankle Fx, Fibular, Plate, Straight, 07-Hole | In distribution |
| P53-153-0001 | Trap Plate, Small | In distribution |
| P53-109-R001 | Gorilla, Plate, Med Col Arch, 1.5mm Thk, Right, Sm, TiA | In distribution |
| P53-105-L001 | HEvans Plate, Small, 16mm, Left | In distribution |
| P53-103-R001 | MTP, 0 degree, Short Plate, Right | In distribution |
| P53-106-R005 | Lapidus, Medial Wall – Graft Spanning Large, Right (1.6mm thk) | In distribution |
| P53-110-R212 | 4-Corner Plates: 2ND & 3RD, Medium, Right | In distribution |
| P53-110-R203 | 4-Corner Plates: 1ST & 2ND, Large, Right | In distribution |
| P53-110-R213 | 4-Corner Plates: 2ND & 3RD, Large, Right | In distribution |
| P53-103-L151 | MTP, 5 degree, Revision Plate, Short, Left | In distribution |
| P53-102-R001 | Calcaneal Fracture Plate, Small, Right | In distribution |
| P53-104-0170 | BOW & Arrow Cotton Plate, 7mm Wedge | In distribution |
| P53-103-L102 | MTP, 10 degree, Medium Plate, Left | In distribution |
| P53-153-0004 | Trap Plate, X-Long | In distribution |
| P53-104-0206 | BOW & Arrow, Evans Plate, 6mm Wedge | In distribution |
| P53-110-L002 | Slanted-T Plate: 5-Hole w/ Compression, Left | In distribution |
| P53-109-1111 | Gorilla, Plate, Med Col Rescue, 2.0mm Thk, 11-Hole, TiA | In distribution |
| P53-110-R201 | 4-Corner Plates: 1ST & 2ND, Small, Right | In distribution |
| P53-109-R101 | Gorilla, Plate, Med Col Arch, 2.0mm Thk, Right, Sm, TiA | In distribution |
| P53-109-L002 | Gorilla, Plate, Med Col Arch, 1.5mm Thk, Left, Md, TiA | In distribution |
| P53-101-3022 | Length 30 mm | In distribution |
| P53-151-1003 | Universal Plate Dog Bone, Slanted, 20mm | In distribution |
| P53-109-L012 | Gorilla, Plate, Med Col Arch, TN-NC, 1.5mm Thk, Left, Md, TiA | In distribution |
| P53-151-0003 | 20 mm Dogbone Plate w/ Compression | In distribution |
| P53-106-R204 | Lapidus, Medial Wall-Step-Off, 4 mm Step Plate, Right (1.4mm thick) | In distribution |
| P53-109-1115 | Gorilla, Plate, Med Col Rescue, 2.0mm Thk, 15-Hole, TiA | In distribution |
| P53-102-L002 | Calcaneal Fracture Plate, Medium, Left | In distribution |
| P53-102-L001 | Calcaneal Fracture Plate, Small, Left | In distribution |
| P53-104-0040 | BOW & Arrow, Base Wedge Plate, 4.0mm Wedge | In distribution |
| P53-104-0208 | BOW & Arrow, Evans Plate, 8mm Wedge | In distribution |
| P53-104-0035 | BOW & Arrow, Base Wedge Plate, 3.5mm Wedge | In distribution |
| P53-201-0006 | Gorilla, Ankle Fx, Fibular, Plate, Straight, 06-Hole | In distribution |
| P53-203-L007 | Gorilla, Ankle Fx, Anatomical Fibular Plate L, 07-Hole | In distribution |
| P53-110-L212 | 4-Corner Plates: 2ND & 3RD, Medium, Left | In distribution |
| P53-103-R103 | MTP, 10 degree, Long Plate, Right | In distribution |
| P53-103-R252 | MTP, 5 degree, Graft Spanning Plate, Right | In distribution |
| P53-110-R302 | Clover Plate: 6-Hole w/ Compression, Right | In distribution |
| P53-110-L202 | 4-Corner Plates: 1ST & 2ND, Medium, Left | In distribution |
| P53-105-R001 | HEvans Plate, Small, 16mm, Right | In distribution |
| P53-203-R015 | Gorilla, Ankle Fx, Anatomical Fibular Plate R, 15-Hole | In distribution |
| P53-109-R003 | Gorilla, Plate, Med Col Arch, 1.5mm Thk, Right, Lg, TiA | In distribution |
| P53-101-3011 | Length 25 mm | In distribution |
| P53-201-0009 | Gorilla, Ankle Fx, Fibular, Plate, Straight, 09-Hole | In distribution |
| P53-203-L017 | Gorilla, Ankle Fx, Anatomical Fibular Plate L, 17-Hole | In distribution |
| P53-105-L002 | HEvans Plate, Medium, 20mm, Left | In distribution |
| P53-104-0020 | BOW & Arrow, Base Wedge Plate, 2.0mm Wedge | In distribution |
| P53-109-1009 | Gorilla, Plate, Med Col Rescue, 1.5mm Thk, 9-Hole, TiA | In distribution |
| P53-109-L001 | Gorilla, Plate, Med Col Arch, 1.5mm Thk, Left, Sm, TiA | In distribution |
| P53-107-2015 | In distribution | |
| P53-104-0180 | BOW & Arrow Cotton Plate, 8mm Wedge | In distribution |
| P53-201-0012 | Gorilla, Ankle Fx, Fibular, Plate, Straight, 12-Hole | In distribution |
| P53-104-0025 | BOW & Arrow, Base Wedge Plate, 2.5mm Wedge | In distribution |
| P53-203-L009 | Gorilla, Ankle Fx, Anatomical Fibular Plate L, 09-Hole | In distribution |
| P53-106-L203 | Precision Guide Lapidus, Medial Wall-Step-Off, 3 mm Step Plate, Left (1.4mm) | In distribution |
| P53-110-L213 | 4-Corner Plates: 2ND & 3RD, Large, Left | In distribution |
| P53-102-R002 | Calcaneal Fracture Plate, Medium, Right | In distribution |
| P53-103-R052 | MTP, 5 degree, Medium Plate, Right | In distribution |
| P53-101-1012 | 28 Plate, 20 mm, 2-Hole Compression | In distribution |
| P53-109-1011 | Gorilla, Plate, Med Col Rescue, 1.5mm Thk, 11-Hole, TiA | In distribution |
| P53-210-0007 | Gorilla, Ankle Fx, Medial Malleolus Plate, 07-Hole | In distribution |
| P53-105-R002 | HEvans Plate, Medium, 20mm, Right | In distribution |
| P53-101-4021 | 28 Plate, 4-Hole Straight w/ Compression | In distribution |
| P53-110-R202 | 4-Corner Plates: 1ST & 2ND, Medium, Right | In distribution |
| P53-101-2013 | 28 Plate, 25 mm, 2-Hole Locking | In distribution |
| P53-106-L205 | Lapidus, Medial Wall-Step-Off, 5 mm Step Plate, Left (1.4mm thick) | In distribution |
| P53-201-0008 | Gorilla, Ankle Fx, Fibular, Plate, Straight, 08-Hole | In distribution |
| P53-103-L252 | MTP, 5 degree, Graft Spanning Plate, Left | In distribution |
| P53-152-0002 | 5-Hole T-Plate w/ Compression | In distribution |
| P53-201-0014 | Gorilla, Ankle Fx, Fibular, Plate, Straight, 14-Hole | In distribution |
| P53-109-L112 | Gorilla, Plate, Med Col Arch NC-1st Met, 2.0mm Thk, Left, Md, TiA | In distribution |
| P53-201-0005 | Gorilla, Ankle Fx, Fibular, Plate, Straight, 05-Hole | In distribution |
| P53-110-R301 | Clover Plate: 5-Hole w/ Compression, Right | In distribution |
| P53-203-R009 | Gorilla, Ankle Fx, Anatomical Fibular Plate R, 09-Hole | In distribution |
| P53-110-L101 | Slanted Straight Plate: 4-Hole Slant, Left | In distribution |
| P53-109-R102 | Gorilla, Plate, Med Col Arch, 2.0mm Thk, Right, Md, TiA | In distribution |
| P53-110-R100 | Slanted Straight Plate: 3-Hole Slant, Right | In distribution |
| P53-203-R011 | Gorilla, Ankle Fx, Anatomical Fibular Plate R, 11-Hole | In distribution |
| P53-101-1022 | 28 Plate, 20 mm, 2-Hole Compression | In distribution |
| P53-103-R101 | MTP, 10 degree, Short Plate, Right | In distribution |
| P53-106-L005 | Lapidus, Medial Wall – Graft Spanning Large, Left (1.6mm thk) | In distribution |
| P53-101-3023 | Length 35 mm | In distribution |
| P53-203-L015 | Gorilla, Ankle Fx, Anatomical Fibular Plate L, 15-Hole | In distribution |
| P53-106-R001 | Lapidus, Medial Wall – Standard, Right (1.3mm thick) w/ compression | In distribution |
| P53-109-L011 | Gorilla, Plate, Med Col Arch, TN-NC, 1.5mm Thk, Left, Sm, TiA | In distribution |
| P53-203-R013 | Gorilla, Ankle Fx, Anatomical Fibular Plate R, 13-Hole | In distribution |
| P53-105-R003 | HEvans Plate, Long, 24mm, Right | In distribution |
| P53-110-L102 | Slanted Straight Plate: 5-Hole Slant, Left | In distribution |
| P53-101-3021 | 28 Plate, 25 mm, 3-Hole Compression | In distribution |
| P53-110-R101 | Slanted Straight Plate: 4-Hole Slant, Right | In distribution |
| P53-101-2023 | 28 Plate, 25 mm, 2-Hole Locking | In distribution |
| P53-110-L211 | 4-Corner Plates: 2ND & 3RD, Small, Left | In distribution |
| P53-104-0212 | BOW & Arrow, Evans Plate, 12mm Wedge | In distribution |
| P53-103-L052 | MTP, 5 degree, Medium Plate, Left | In distribution |
| P53-109-1015 | Gorilla, Plate, Med Col Rescue, 1.5mm Thk, 15-Hole, TiA | In distribution |
| P53-103-L101 | MTP, 10 degree, Short Plate, Left | In distribution |
| P53-151-0005 | Length 30 mm | In distribution |
| P53-101-5021 | 28 Plate, 5-Hole Straight w/ Compression | In distribution |
| P53-103-L003 | MTP, 0 degree, Long Plate, Left | In distribution |
| P53-109-R012 | Gorilla, Plate, Med Col Arch, TN-NC, 1.5mm Thk, Right, Md, TiA | In distribution |
| P53-154-0002 | Teddy Bear Plate, Medium | In distribution |
| P53-106-L201 | Precision Guide Lapidus, Medial Wall-Step-Off, 1 mm Step Plate, Left (1.4) | In distribution |
| P53-102-L003 | Calcaneal Fracture Plate, Large, Left | In distribution |
| P53-106-R002 | Lapidus, Medial Wall – Graft Spanning Small, Right (1.6mm thk) w/ compression | In distribution |
| P53-201-0016 | Gorilla, Ankle Fx, Fibular, Plate, Straight, 16-Hole | In distribution |
| P53-110-R211 | 4-Corner Plates: 2ND & 3RD, Small, Right | In distribution |
| P53-103-L053 | MTP, 5 degree, Long Plate, Left | In distribution |
| P53-151-1004 | Length 25 mm | In distribution |
| P53-109-L102 | Gorilla, Plate, Med Col Arch, 2.0mm Thk, Left, Md, TiA | In distribution |
| P53-203-R007 | Gorilla, Ankle Fx, Anatomical Fibular Plate R, 07-Hole | In distribution |
| P53-101-3012 | 28 Plate, 30 mm, 3-Hole Compression | In distribution |
| P53-103-L002 | MTP, 0 degree, Medium Plate, Left | In distribution |
| P53-106-R201 | Precision Guide Lapidus, Medial Wall-Step-Off, 1 mm Step Plate, Right (1.4mm thick) | In distribution |
| P53-110-L100 | Slanted Straight Plate: 3-Hole Slant, Left | In distribution |
| P53-109-R002 | Gorilla, Plate, Med Col Arch, 1.5mm Thk, Right, Md, TiA | In distribution |
| P53-110-R002 | Slanted-T Plate: 5-Hole w/ Compression, Right | In distribution |
| P53-106-R203 | Precision Guide Lapidus, Medial Wall-Step-Off, 3 mm Step Plate, Right (1.4mm thick) | In distribution |
| P53-102-R003 | Calcaneal Fracture Plate, Large, Right | In distribution |
| P53-201-0004 | Gorilla, Ankle Fx, Fibular, Plate, Straight, 04-Hole | In distribution |
| P53-109-R013 | Gorilla, Plate, Med Col Arch, TN-NC, 1.5mm Thk, Right, Lg, TiA | In distribution |
| P53-201-0003 | Gorilla, Ankle Fx, Fibular, Plate, Straight, 03-Hole | In distribution |
| P53-104-0045 | BOW & Arrow, Base Wedge Plate, 4.5mm Wedge | In distribution |
| P53-110-R001 | Slanted-T Plate: 4-Hole w/ Compression, Right | In distribution |
| P53-101-1021 | 28 Plate, 15 mm, 2-Hole Compression | In distribution |
| P53-103-R053 | MTP, 5 degree, Long Plate, Right | In distribution |
| P53-106-R202 | Precision Guide Lapidus, Medial Wall-Step-Off, 2 mm Step Plate, Right (1.4mm thick) | In distribution |
| P53-106-R205 | Lapidus, Medial Wall-Step-Off, 5 mm Step Plate, Right (1.4mm thick) | In distribution |
| P53-106-L204 | Lapidus, Medial Wall-Step-Off, 4 mm Step Plate, Left (1.4mm thick) | In distribution |
| P53-201-R017 | Gorilla, Ankle Fx, Anatomical Fibular Plate R, 17-Hole | In distribution |
| P53-151-0004 | 25 mm Dogbone Plate w/ Compression | In distribution |
| P53-110-L203 | 4-Corner Plates: 1ST & 2ND, Large, Left | 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 |
|---|---|
| K250952 | 2025-07-18 |
| K241262 | 2024-06-05 |
| K222194 | 2022-08-19 |
| K221465 | 2022-06-17 |
| K203511 | 2020-12-29 |
| K190365 | 2019-04-12 |
| K172886 | 2017-12-20 |
| K140397 | 2014-04-17 |
Recalls
1 of these is 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 |
|---|---|---|---|---|
| 2022-05-18 | Class II | Under Investigation by firm | Incorrect labeling; There is potential that the drill packaging contains the incorrect part number. | 3 units |
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.