CastleLoc Pectus Bar System
CastleLoc Pectus Bar System supports correction of anterior chest-wall deformity, including pectus excavatum. An implanted bar elevates and supports the ribs and sternum as part of a…
CastleLoc Pectus Bar System supports correction of anterior chest-wall deformity, including pectus excavatum. An implanted bar elevates and supports the ribs and sternum as part of a minimally invasive repair.
The system combines a pectus bar with stabilizers, nuts and claw fixators that hold the bar. These components are Ti-6Al-4V titanium alloy.
Listed Item
CastleLoc Pectus Gently Curved Rectangular Bar, L17.5 inchxW12.8 mm, T2.8 mm
Bar Configurations
Straight and curved bars are available in different lengths and curvatures for varying body sizes. A listed gently curved bar is one configuration within the range. The system is intended for children, adolescents and adults.
22manufacturers in China registered for this device type
167catalogue numbers in this listing
3510(k) clearances naming this product 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 | L&K Biomed Co., Ltd., South Korea |
|---|---|
| FDA product code | HRS |
| Device type | Plate, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K260448 |
| Record published | 2026-05-27 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PB30-1200 | In distribution | |
| OB28-0060 | In distribution | |
| PB12-1007 | In distribution | |
| PB28-3100 | In distribution | |
| LB12-2007 | In distribution | |
| PB28-0200 | In distribution | |
| PB28-0175 | In distribution | |
| PB28-1150 | In distribution | |
| PB12-0005 | In distribution | |
| OB28-0135 | In distribution | |
| LB12-2016 | In distribution | |
| PB30-2180 | In distribution | |
| PB28-3195 | In distribution | |
| PB30-2185 | In distribution | |
| PB12-1009 | In distribution | |
| PB28-1125 | In distribution | |
| BC05-0176 | In distribution | |
| PB06-3045 | In distribution | |
| PB06-3060 | In distribution | |
| LB12-2012 | In distribution | |
| PB28-2135 | In distribution | |
| PB28-2100 | In distribution | |
| PB12-0019 | In distribution | |
| PB28-0190 | In distribution | |
| PB28-1090 | In distribution | |
| PB30-3185 | In distribution | |
| PB28-1200 | In distribution | |
| PB30-3195 | In distribution | |
| PB28-1175 | In distribution | |
| PB28-1110 | In distribution | |
| PB10-0002 | In distribution | |
| LB12-2011 | In distribution | |
| PB28-2185 | In distribution | |
| PB30-0195 | In distribution | |
| PB12-0015 | In distribution | |
| PB30-1175 | In distribution | |
| PB28-3190 | In distribution | |
| PB28-1160 | In distribution | |
| PB28-3135 | In distribution | |
| LB10-2004 | In distribution | |
| PB06-3055 | In distribution | |
| LB12-2020 | In distribution | |
| PB28-1140 | In distribution | |
| OB28-0115 | In distribution | |
| PB28-1190 | In distribution | |
| PB28-3150 | In distribution | |
| PB28-1130 | In distribution | |
| PB25-E190 | In distribution | |
| PB28-1195 | In distribution | |
| PB28-1135 | In distribution | |
| PB28-0195 | In distribution | |
| PB28-1180 | In distribution | |
| PB28-2195 | In distribution | |
| PB28-0060 | In distribution | |
| PB12-0017 | In distribution | |
| PB28-0180 | In distribution | |
| PB12-1015 | In distribution | |
| PB12-0008 | In distribution | |
| PB28-3115 | In distribution | |
| PB30-1185 | In distribution | |
| PB28-2160 | In distribution | |
| OB28-0110 | In distribution | |
| PB25-E185 | In distribution | |
| LB12-2014 | In distribution | |
| PB25-E195 | In distribution | |
| OB28-0085 | In distribution | |
| LB12-2010 | In distribution | |
| PB28-1120 | In distribution | |
| OB28-0125 | In distribution | |
| PB28-2110 | In distribution | |
| PB06-3065 | In distribution | |
| PB28-0150 | In distribution | |
| PB30-1190 | In distribution | |
| PB30-3175 | In distribution | |
| PB30-2175 | In distribution | |
| OB28-0070 | In distribution | |
| LB12-2013 | In distribution | |
| PC05-0175 | In distribution | |
| PB28-3180 | In distribution | |
| PB28-3110 | In distribution | |
| PB28-0185 | In distribution | |
| PB28-1115 | In distribution | |
| PB28-2190 | In distribution | |
| PB28-0125 | In distribution | |
| PB30-0175 | In distribution | |
| PB28-0130 | In distribution | |
| PB28-0115 | In distribution | |
| LB12-2018 | In distribution | |
| PB12-0009 | In distribution | |
| PB28-2125 | In distribution | |
| PB28-1105 | In distribution | |
| PC05-1216 | In distribution | |
| PB28-2175 | In distribution | |
| PB28-3120 | In distribution | |
| PB12-0002 | In distribution | |
| PB12-0010 | In distribution | |
| PB10-0005 | In distribution | |
| PB28-2150 | In distribution | |
| PB28-0110 | In distribution | |
| PB12-1017 | In distribution | |
| LB12-2004 | In distribution | |
| PB30-3200 | In distribution | |
| PB28-0100 | In distribution | |
| LB12-2019 | In distribution | |
| PB12-0011 | In distribution | |
| PB10-0004 | In distribution | |
| OB28-0120 | In distribution | |
| PC05-1016 | In distribution | |
| LB12-2009 | In distribution | |
| PB30-0190 | In distribution | |
| PB30-3190 | In distribution | |
| OB28-0130 | In distribution | |
| PC05-0176 | In distribution | |
| PB28-3160 | In distribution | |
| PB12-1010 | In distribution | |
| PB06-3040 | In distribution | |
| PB12-0013 | In distribution | |
| PB06-3050 | In distribution | |
| PB28-3185 | In distribution | |
| PB12-1019 | In distribution | |
| PB28-0140 | In distribution | |
| PB28-0135 | In distribution | |
| OB28-0065 | In distribution | |
| PB28-2130 | In distribution | |
| OB28-0055 | In distribution | |
| PB28-1100 | In distribution | |
| LB10-2003 | In distribution | |
| PB28-3140 | In distribution | |
| PB30-1180 | In distribution | |
| PB28-3200 | In distribution | |
| PB30-2190 | In distribution | |
| PB30-2195 | In distribution | |
| OB28-0095 | In distribution | |
| OB28-0075 | In distribution | |
| PB28-2180 | In distribution | |
| PB28-2120 | In distribution | |
| PB30-3180 | In distribution | |
| PB28-1145 | In distribution | |
| PB28-2200 | In distribution | |
| PB12-1011 | In distribution | |
| PB30-0200 | In distribution | |
| PB30-1195 | In distribution | |
| PB28-3125 | In distribution | |
| PB28-2115 | In distribution | |
| PB06-3070 | In distribution | |
| PN03-0007 | In distribution | |
| PB30-2200 | In distribution | |
| PB12-0007 | In distribution | |
| PB28-2140 | In distribution | |
| PB28-1185 | In distribution | |
| LB12-2017 | In distribution | |
| PB12-0004 | In distribution | |
| OB28-0080 | In distribution | |
| OB28-0090 | In distribution | |
| PB30-0185 | In distribution | |
| PB28-3130 | In distribution | |
| PB25-E180 | In distribution | |
| LB12-2008 | In distribution | |
| PB25-E175 | In distribution | |
| PB28-3175 | In distribution | |
| PB25-E200 | In distribution | |
| PB12-1013 | In distribution | |
| OB28-0050 | In distribution | |
| LB12-2015 | In distribution | |
| PB12-1008 | In distribution | |
| LB12-2003 | In distribution | |
| PB28-0120 | 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 |
|---|---|
| K260448 | 2026-03-19 |
| K250892 | 2025-04-25 |
| K243357 | 2025-02-27 |
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.