Plate, Fixation, Bone
2.7MM TI Cortex Screw SLF-Tpng With T8 Stardrive Recess 26MM
22manufacturers in China registered for this device type
1,613catalogue numbers in this listing
9510(k) clearances naming this product code
8recalls 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 | Synthes Gmbh, Switzerland |
|---|---|
| FDA product code | HRS |
| Device type | Plate, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K071264 |
| Record published | 2015-09-14 |
| Record revised | 2025-11-20 (version 12) |
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, expiry date |
| Distribution end date | 2024-07-10 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 02.100.022S | In distribution | ||
| 04.205.255 | In distribution | ||
| 206.024 | In distribution | ||
| 04.501.336 | In distribution | ||
| 02.130.110 | In distribution | ||
| 04.211.404 | In distribution | ||
| 207.018 | In distribution | ||
| 447.232 | In distribution | ||
| 212.818 | In distribution | ||
| 201.624 | In distribution | ||
| 02.221.114S | In distribution | ||
| 04.210.136 | In distribution | ||
| 201.362.97 | In distribution | ||
| 400.504 | 5 | In distribution | |
| 207.075 | In distribution | ||
| 245.023 | In distribution | ||
| 02.214.012 | In distribution | ||
| 04.205.260 | In distribution | ||
| 04.112.811S | In distribution | ||
| 04.112.912 | In distribution | ||
| 04.112.814S | In distribution | ||
| 02.210.124TS | In distribution | ||
| 04.501.324 | In distribution | ||
| 402.886 | In distribution | ||
| 02.221.091S | In distribution | ||
| 04.211.412 | In distribution | ||
| 02.200.070 | In distribution | ||
| 02.112.911S | In distribution | ||
| 02.100.114 | In distribution | ||
| 402.870 | In distribution | ||
| 02.221.101 | In distribution | ||
| 02.130.354S | In distribution | ||
| 400.507E | In distribution | ||
| 401.375.97 | In distribution | ||
| 02.211.404 | In distribution | ||
| 04.501.116.05 | 5 | In distribution | |
| 04.124.410S | In distribution | ||
| 04.211.032 | In distribution | ||
| 02.112.913 | In distribution | ||
| 04.211.403 | In distribution | ||
| 02.100.215 | In distribution | ||
| 02.231.305S | In distribution | ||
| 447.706S | In distribution | ||
| 02.130.005 | In distribution | ||
| 02.130.262S | In distribution | ||
| 02.112.630 | In distribution | ||
| 02.130.152S | In distribution | ||
| 04.205.290 | In distribution | ||
| 202.260 | In distribution | ||
| 04.112.812S | In distribution | ||
| 422.308 | In distribution | ||
| 04.130.312 | In distribution | ||
| 241.34 | In distribution | ||
| 02.221.090S | In distribution | ||
| 02.164.004S | In distribution | ||
| 02.214.116 | In distribution | ||
| 04.501.318 | In distribution | ||
| 497.697 | 5 | In distribution | |
| 02.118.552 | In distribution | ||
| 406.480 | In distribution | ||
| 200.530 | In distribution | ||
| 201.824 | In distribution | ||
| 04.211.221S | In distribution | ||
| 04.210.956 | In distribution | ||
| 422.348 | In distribution | ||
| 02.112.611 | In distribution | ||
| 201.762 | In distribution | ||
| 420.40 | In distribution | ||
| 02.207.270 | In distribution | ||
| 02.112.614 | In distribution | ||
| 401.768TS | In distribution | ||
| 241.33 | In distribution | ||
| 02.221.112 | In distribution | ||
| 204.720 | In distribution | ||
| 04.214.108 | In distribution | ||
| 02.130.353 | In distribution | ||
| 04.205.050 | In distribution | ||
| 420.05 | In distribution | ||
| 422.578 | In distribution | ||
| 02.130.211 | In distribution | ||
| 249.919 | In distribution | ||
| 208.090 | In distribution | ||
| 201.894 | In distribution | ||
| 412.830 | In distribution | ||
| 02.205.245 | In distribution | ||
| 02.100.116 | In distribution | ||
| 414.866 | In distribution | ||
| 02.112.820 | In distribution | ||
| 02.210.132 | In distribution | ||
| 04.210.124 | In distribution | ||
| 60.501.129 | In distribution | ||
| 402.876 | In distribution | ||
| 212.224 | In distribution | ||
| 02.221.174S | In distribution | ||
| 04.210.114 | In distribution | ||
| 447.233 | In distribution | ||
| 02.127.185TS | In distribution | ||
| 04.130.252 | In distribution | ||
| 02.221.153S | In distribution | ||
| 02.100.103 | In distribution | ||
| 402.828 | In distribution | ||
| 04.214.107 | In distribution | ||
| 406.470 | In distribution | ||
| 02.130.362 | In distribution | ||
| 447.711S | In distribution | ||
| 241.010 | In distribution | ||
| 02.130.152 | In distribution | ||
| 04.118.542 | In distribution | ||
| 202.882 | In distribution | ||
| 02.221.125 | In distribution | ||
| 02.210.122 | In distribution | ||
| 04.130.315 | In distribution | ||
| 401.876 | In distribution | ||
| 02.112.815 | In distribution | ||
| 400.607E | In distribution | ||
| 02.205.280 | In distribution | ||
| 04.112.614S | In distribution | ||
| 02.204.026 | In distribution | ||
| 03.111.042 | In distribution | ||
| 212.212 | In distribution | ||
| 04.211.400 | In distribution | ||
| 420.02 | In distribution | ||
| 02.130.009 | In distribution | ||
| 02.130.264S | In distribution | ||
| 02.118.556 | In distribution | ||
| 02.100.104 | In distribution | ||
| 201.782 | In distribution | ||
| 02.127.175 | In distribution | ||
| 200.689 | In distribution | ||
| 201.766TS | In distribution | ||
| 401.877 | In distribution | ||
| 406.448 | In distribution | ||
| 420.62 | In distribution | ||
| 04.124.413 | In distribution | ||
| 04.501.304 | In distribution | ||
| 402.232 | In distribution | ||
| 02.120.604 | In distribution | ||
| 245.032 | In distribution | ||
| 202.230 | In distribution | ||
| 02.211.052 | In distribution | ||
| 02.130.258 | In distribution | ||
| 201.808 | In distribution | ||
| 202.898 | In distribution | ||
| 02.118.508 | In distribution | ||
| 02.130.156S | In distribution | ||
| 400.605E | In distribution | ||
| 02.221.150 | In distribution | ||
| 400.509 | 5 | In distribution | |
| 02.214.118 | In distribution | ||
| 02.221.088S | In distribution | ||
| 401.374.97 | In distribution | ||
| 02.200.030 | In distribution | ||
| 420.81 | In distribution | ||
| 02.130.330S | In distribution | ||
| 201.646 | In distribution | ||
| 212.816 | In distribution | ||
| 04.112.620S | In distribution | ||
| 02.210.126TS | In distribution | ||
| 02.221.154S | In distribution | ||
| 223.508 | In distribution | ||
| 04.118.556 | In distribution | ||
| 401.900 | In distribution | ||
| 423.508 | In distribution | ||
| 02.221.123S | In distribution | ||
| 04.501.320 | In distribution | ||
| 02.200.145 | In distribution | ||
| 202.962 | In distribution | ||
| 04.112.623 | In distribution | ||
| 204.885 | In distribution | ||
| 02.231.016S | In distribution | ||
| 443.61.96 | In distribution | ||
| 02.120.606 | In distribution | ||
| 420.45 | In distribution | ||
| 204.028 | In distribution | ||
| 04.200.018 | In distribution | ||
| 02.100.020S | In distribution | ||
| 02.112.615 | In distribution | ||
| 201.900 | In distribution | ||
| 400.505E | In distribution | ||
| 04.130.150S | In distribution | ||
| 201.370.97 | In distribution | ||
| 02.112.814S | In distribution | ||
| 243.62 | In distribution | ||
| 02.100.113 | In distribution | ||
| 04.205.070 | In distribution | ||
| 204.026 | In distribution | ||
| 02.207.075 | In distribution | ||
| 04.205.250 | In distribution | ||
| 04.112.815 | In distribution | ||
| 412.810 | In distribution | ||
| 241.40 | In distribution | ||
| 02.214.112 | In distribution | ||
| 04.210.130TS | In distribution | ||
| 02.100.302 | In distribution | ||
| 04.120.606 | In distribution | ||
| 201.768 | In distribution | ||
| 02.100.206 | In distribution | ||
| 420.63 | In distribution | ||
| 392.178 | 10 | In distribution | |
| 04.210.150 | In distribution | ||
| 204.842 | In distribution | ||
| 447.704 | In distribution | ||
| 04.210.952 | In distribution | ||
| 04.112.624S | In distribution | ||
| 243.091 | In distribution | ||
| 401.358.97 | In distribution | ||
| 02.211.030 | In distribution | ||
| 04.118.580S | In distribution | ||
| 245.924 | In distribution | ||
| 497.695 | 5 | In distribution | |
| 04.211.402 | In distribution | ||
| 04.118.532 | In distribution | ||
| 04.112.911S | In distribution | ||
| 201.772TS | In distribution | ||
| 02.112.614S | In distribution | ||
| 204.038 | In distribution | ||
| 02.100.118 | In distribution | ||
| 402.228 | In distribution | ||
| 206.075 | In distribution | ||
| 249.914 | In distribution | ||
| SD03.127.008 | In distribution | ||
| 02.100.367 | In distribution | ||
| 02.111.903.01 | In distribution | ||
| 04.210.120 | In distribution | ||
| 400.604E | In distribution | ||
| 04.100.020S | In distribution | ||
| 400.510 | 5 | In distribution | |
| 04.100.020 | In distribution | ||
| 02.137.001S | In distribution | ||
| 201.880 | In distribution | ||
| 401.380.97 | In distribution | ||
| 04.210.154 | In distribution | ||
| 02.221.174 | In distribution | ||
| 02.130.010 | In distribution | ||
| 02.210.130 | In distribution | ||
| 02.231.018 | In distribution | ||
| 420.304 | In distribution | ||
| 201.641 | In distribution | ||
| 02.112.823 | In distribution | ||
| 02.130.154 | In distribution | ||
| 401.376.97 | In distribution | ||
| 441.42 | In distribution | ||
| 02.127.128 | In distribution | ||
| 02.231.710S | In distribution | ||
| 423.516 | In distribution | ||
| 447.031 | In distribution | ||
| 04.211.411 | In distribution | ||
| 02.211.222S | In distribution | ||
| 04.205.090 | In distribution | ||
| 401.761 | 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 |
| Anthem | Globus Medical, Inc. | 1,551 |
| Acumed | Acumed LLC | 1,360 |
| 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 |
|---|---|
| K254093 | 2026-03-10 |
| K260069 | 2026-03-09 |
| K254054 | 2026-03-02 |
| K233994 | 2024-07-26 |
| K233967 | 2024-05-09 |
| K112689 | 2011-10-26 |
| K093772 | 2010-03-29 |
| K020602 | 2002-05-20 |
| K982732 | 1998-10-08 |
Recalls Naming This Product
19 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 |
|---|---|---|---|---|---|---|---|
| Synthes (USA) Products LLC | 510(k) number | 2024-01-24 | Class II | Process control | Products not sterilized, sterility cannot be confirmed | 47 units | |
| Synthes Gmbh | 510(k) number | 2019-12-16 | Class II | Under Investigation by firm | There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube remains in the outer tube. In both instances this could prevent the screw from being removed and used causing a surgical delay. The | 25 total | 2020-06-08 |
| Synthes Gmbh | 510(k) number | 2019-12-16 | Class II | Under Investigation by firm | There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube remains in the outer tube. In both instances this could prevent the screw from being removed and used causing a surgical delay. The | 25 total | 2020-06-08 |
| Synthes Gmbh | 510(k) number | 2019-12-16 | Class II | Under Investigation by firm | There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube remains in the outer tube. In both instances this could prevent the screw from being removed and used causing a surgical delay. The | 25 total | 2020-06-08 |
| Synthes Gmbh | 510(k) number | 2019-12-16 | Class II | Under Investigation by firm | There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube remains in the outer tube. In both instances this could prevent the screw from being removed and used causing a surgical delay. The | 25 total | 2020-06-08 |
| Synthes Gmbh | 510(k) number | 2019-12-16 | Class II | Under Investigation by firm | There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube remains in the outer tube. In both instances this could prevent the screw from being removed and used causing a surgical delay. The | 25 total | 2020-06-08 |
| Synthes (USA) Products LLC | 510(k) number | 2016-06-28 | Class II | Nonconforming Material/Component | It was reported that the specified lots of the 2.4mm Titanium Locking Screw Self-Tapping with Stardrive Recess 12mm can break between the head and the shaft. This resulted from the neck feature being too close to the StarDrive feature leav | 41 units | 2017-02-02 |
| Synthes (USA) Products LLC | 510(k) number | 2015-11-02 | Class II | Process control | It was discovered that the above part number and lot of 2.4mm Locking Screws may contain the incorrect package insert (GP2613, VA-LCP Distal Radius System). The correct package insert for the above part is GP2615 (Modular Mini Fragment LCP | 229 | 2016-07-15 |
| Synthes (USA) Products LLC | 510(k) number | 2015-10-06 | Class II | Packaging | Specific lots of the SS 2.7mm locking screw have been mislabeled as SS 2.4mm locking screw. | 98 | 2016-07-15 |
| Synthes (USA) Products LLC | 510(k) number | 2015-09-28 | Class II | Labeling mix-ups | The 2.7MM/3.5MM VA-LCP Humerus Plates were found to be labeled incorrectly. Part number 02.117.410S was incorrectly etched with part number 02.117.610S | 36 | 2016-12-06 |
| Synthes Gmbh | 510(k) number | 2014-02-05 | Class II | Employee error | Labeling correction: The package insert in one 5.0mm Variable Locking Screw package was a GP0006 (Anterior Cervical Vertebrae Plate System) insert, which should have been a GP2848 (4.5mm VA-LCP Curved Condylar Plate System insert). | 45 | 2015-08-31 |
| Synthes Gmbh | 510(k) number | 2014-01-07 | Class II | Component design/selection | The Drill Template and the Saw Guide for the Ulna Osteotomy System may exhibit jamming, bending, or breaking of the screw connecting the Saw Guide to the Drill Template or jamming, bending, or breaking of the K-wire during fixation of the D | 343 | 2015-09-10 |
| Synthes USA (HQ), Inc. | 510(k) number | 2013-07-31 | Class II | Labeling mix-ups | Specific lots of the SS 2.4mm and SS 2.7mm Locking Screw (self-tapping) due to a mislabeling issue. The SS 2.7mm Screw was labeled as SS 2.4 mm Screw. | 98 | 2016-08-18 |
| Synthes (USA) Products LLC | 510(k) number | 2013-07-30 | Class II | Labeling mix-ups | A complaint was reported regarding a screw being found in a package labeled for 2.4 mm LC-DCP Plate. | 13 | 2015-08-17 |
| Synthes (USA) Products LLC | 510(k) number | 2013-05-31 | Class II | Device Design | The firm is initiating a Field Safety Correction for the labeling of the 2.4mm VA-LCP Two Column Volar Distal Radius Plate and 1.2 Nm Torque Limiting Attachment. The US Technique guide lists 1.2Nm TLA as an option for use with the 2.4mm Var | 119, 891 | 2015-09-21 |
| Synthes USA (HQ), Inc. | 510(k) number | 2013-05-29 | Class II | Employee error | A plate was inadvertently released to a sales consultant that was restricted for sale. | 1 | 2015-05-21 |
| Synthes USA (HQ), Inc. | 510(k) number | 2013-03-08 | Class II | Labeling mix-ups | Recall is being initiated due to the part being mislabeled (Part Number 241.267 was mislabeled with Part Number 241.276). | 2 | 2015-05-21 |
| Synthes USA (HQ), Inc. | 510(k) number | 2013-01-11 | Class II | Labeling mix-ups | It was discovered that one of the VA-LCP Dorsal Distal Radius Plates was incorrectly etched as Part Number 02.115.431 (110 degree) instead of the correct Part Number 02.115.231 (90 degree). | 4 | 2015-08-31 |
| Synthes Gmbh | 510(k) number | 2006-12-05 | Not classified | Other | Hole is malformed, leading to reduced construct strength. | 11 units | 2007-02-13 |
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 | Closed |
|---|---|---|---|---|---|
| 2014-01-27 | Class II | Labeling design | Certain modules containing the Synthes Small Notch Titanium Reconstructive Plate set was distributed by Spine sales consultants although it was contraindicated for certain spine applications. | 18747 | 2016-08-26 |
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.