SPS
One-Third Tubular Plate; with Collar
22manufacturers in China registered for this device type
251catalogue numbers in this listing
25510(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 | Stryker GmbH, Switzerland |
|---|---|
| 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) | K012162 |
| Record published | 2015-09-24 |
| Record revised | 2026-02-23 (version 13) |
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 |
| Sizes | Length 25 to 400 mm |
| Distribution end date | 2024-02-28 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 621576S | Length 117.0 mm | In distribution |
| 621465 | Screw Holes: 5.0 Holes | In distribution |
| 432166 | Length 292.0 mm | In distribution |
| 432215 | Screw Holes: 15.0 Holes | In distribution |
| 432207 | Screw Holes: 7.0 Holes | In distribution |
| 620704 | Length 83.0 mm | In distribution |
| 621131 | Length 142.0 mm | In distribution |
| 430213 | Screw Holes: 13.0 Holes | In distribution |
| 431004 | Screw Holes: 4.0 Holes | In distribution |
| 620415 | Screw Holes: 5.0 Holes | In distribution |
| 620311 | Length 202.0 mm | In distribution |
| 620310 | Length 184.0 mm | In distribution |
| 433103 | Screw Holes: 3.0 Holes | In distribution |
| 432206 | Screw Holes: 6.0 Holes | In distribution |
| 433155 | Screw Holes: 5.0 Holes | In distribution |
| 432002 | Screw Holes: 2.0 Holes | In distribution |
| 430010 | Length 130.0 mm | In distribution |
| 620216 | Length 290.0 mm | In distribution |
| 431024 | Length 48.7 mm | In distribution |
| 432115 | Length 274.0 mm | In distribution |
| 621574S | Screw Holes: 4.0 Holes | In distribution |
| 432011 | Screw Holes: 11.0 Holes | In distribution |
| 621132 | Length 155.0 mm | In distribution |
| 432110 | Length 184.0 mm | In distribution |
| 430002 | Length 26.0 mm | In distribution |
| 430203 | Length 38.0 mm | In distribution |
| 620204 | Length 74.0 mm | In distribution |
| 620706 | Length 115.0 mm | In distribution |
| 621133 | Screw Holes: 13.0 Holes | In distribution |
| 432013 | Length 236.0 mm | In distribution |
| 621443 | Length 66.0 mm | In distribution |
| 620203 | Screw Holes: 3.0 Holes | In distribution |
| 621468 | Screw Holes: 8.0 Holes | In distribution |
| 432161 | Length 202.0 mm | In distribution |
| 432059 | Length 164.0 mm | In distribution |
| 620208 | Length 146.0 mm | In distribution |
| 433006 | Length 115.0 mm | In distribution |
| 620306 | Length 112.0 mm | In distribution |
| 621142 | Length 26.0 mm | In distribution |
| 432109 | Screw Holes: 9.0 Holes | In distribution |
| 433104 | Screw Holes: 4.0 Holes | In distribution |
| 432210 | Screw Holes: 10.0 Holes | In distribution |
| 433156 | Screw Holes: 6.0 Holes | In distribution |
| 621148 | Length 104.0 mm | In distribution |
| 430207S | Length 90.0 mm | In distribution |
| 621122 | Length 25.0 mm | In distribution |
| 620756 | Length 115.0 mm | In distribution |
| 620212 | Screw Holes: 12.0 Holes | In distribution |
| 432012 | Length 218.0 mm | In distribution |
| 620314 | Length 256.0 mm | In distribution |
| 620755 | Length 99.0 mm | In distribution |
| 431025 | Screw Holes: 5.0 Holes | In distribution |
| 432007 | Length 128.0 mm | In distribution |
| 432164 | Screw Holes: 14.0 Holes | In distribution |
| 432014 | Screw Holes: 14.0 Holes | In distribution |
| 620418 | Length 143.0 mm | In distribution |
| 432158 | Screw Holes: 8.0 Holes | In distribution |
| 432054 | Length 74.0 mm | In distribution |
| 621144 | Screw Holes: 4.0 Holes | In distribution |
| 621445 | Length 94.0 mm | In distribution |
| 432212 | Screw Holes: 12.0 Holes | In distribution |
| 620316 | Screw Holes: 16.0 Holes | In distribution |
| 432157 | Length 130.0 mm | In distribution |
| 432208 | Screw Holes: 8.0 Holes | In distribution |
| 431005 | Length 62.0 mm | In distribution |
| 621553 | Length 60.0 mm | In distribution |
| 432113 | Screw Holes: 13.0 Holes | In distribution |
| 432111 | Length 202.0 mm | In distribution |
| 431034 | Screw Holes: 4.0 Holes | In distribution |
| 621129 | Screw Holes: 9.0 Holes | In distribution |
| 432004 | Screw Holes: 4.0 Holes | In distribution |
| 620413 | Screw Holes: 3.0 Holes | In distribution |
| 432205 | Screw Holes: 5.0 Holes | In distribution |
| 431044 | Length 80.0 mm | In distribution |
| 431103 | Length 60.0 mm | In distribution |
| 432114 | Length 256.0 mm | In distribution |
| 431036 | Screw Holes: 6.0 Holes | In distribution |
| 431050 | Length 167.0 mm | In distribution |
| 430020 | Length 260.0 mm | In distribution |
| 432062 | Length 218.0 mm | In distribution |
| 432216 | Screw Holes: 16.0 Holes | In distribution |
| 432160 | Length 184.0 mm | In distribution |
| 430005 | Length 65.0 mm | In distribution |
| 620312 | Screw Holes: 12.0 Holes | In distribution |
| 621146 | Length 78.0 mm | In distribution |
| 621555 | Length 80.0 mm | In distribution |
| 432057 | Screw Holes: 7.0 Holes | In distribution |
| 431030 | Length 99.7 mm | In distribution |
| 621154 | Screw Holes: 14.0 Holes | In distribution |
| 432116 | Length 292.0 mm | In distribution |
| 621424 | Screw Holes: 4.0 Holes | In distribution |
| 432106 | Screw Holes: 6.0 Holes | In distribution |
| 433055 | Length 99.0 mm | In distribution |
| 620309 | Screw Holes: 9.0 Holes | In distribution |
| 430016 | Screw Holes: 16.0 Holes | In distribution |
| 432112 | Screw Holes: 12.0 Holes | In distribution |
| 621423 | Screw Holes: 3.0 Holes | In distribution |
| 621448 | Length 138.0 mm | In distribution |
| 430207 | Length 90.0 mm | In distribution |
| 430007 | Screw Holes: 7.0 Holes | In distribution |
| 430006 | Screw Holes: 6.0 Holes | In distribution |
| 621128 | Length 103.0 mm | In distribution |
| 431026 | Screw Holes: 6.0 Holes | In distribution |
| 621450 | Length 167.0 mm | In distribution |
| 433005 | Screw Holes: 5.0 Holes | In distribution |
| 430206 | Screw Holes: 6.0 Holes | In distribution |
| 430116 | Screw Holes: 16.0 Holes | In distribution |
| 430205 | Length 64.0 mm | In distribution |
| 621554 | Length 70.0 mm | In distribution |
| 621446 | Screw Holes: 6.0 Holes | In distribution |
| 621426 | Length 65.7 mm | In distribution |
| 621428 | Length 82.7 mm | In distribution |
| 620206 | Length 110.0 mm | In distribution |
| 432163 | Screw Holes: 13.0 Holes | In distribution |
| 432156 | Screw Holes: 6.0 Holes | In distribution |
| 430104 | Screw Holes: 4.0 Holes | In distribution |
| 430112 | Screw Holes: 12.0 Holes | In distribution |
| 620416 | Length 111.0 mm | In distribution |
| 620211 | Screw Holes: 11.0 Holes | In distribution |
| 621577S | Screw Holes: 7.0 Holes | In distribution |
| 432063 | Length 236.0 mm | In distribution |
| 621463 | Screw Holes: 3.0 Holes | In distribution |
| 621126 | Length 77.0 mm | In distribution |
| 621430 | Screw Holes: 10.0 Holes | In distribution |
| 620414 | Length 79.0 mm | In distribution |
| 432008 | Length 146.0 mm | In distribution |
| 621130 | Screw Holes: 10.0 Holes | In distribution |
| 433008 | Length 147.0 mm | In distribution |
| 621143 | Screw Holes: 3.0 Holes | In distribution |
| 430114 | Screw Holes: 14.0 Holes | In distribution |
| 432064 | Length 254.0 mm | In distribution |
| 432056 | Length 110.0 mm | In distribution |
| 430003 | Screw Holes: 3.0 Holes | In distribution |
| 432010 | Screw Holes: 10.0 Holes | In distribution |
| 430204 | Screw Holes: 4.0 Holes | In distribution |
| 430008 | Length 104.0 mm | In distribution |
| 431046 | Length 109.0 mm | In distribution |
| 431102 | Length 50.0 mm | In distribution |
| 431045 | Screw Holes: 5.0 Holes | In distribution |
| 432015 | Length 272.0 mm | In distribution |
| 620456 | Length 113.0 mm | In distribution |
| 620210 | Length 182.0 mm | In distribution |
| 432108 | Screw Holes: 8.0 Holes | In distribution |
| 433054 | Screw Holes: 4.0 Holes | In distribution |
| 432117 | Length 310.0 mm | In distribution |
| 433004 | Length 83.0 mm | In distribution |
| 621134 | Screw Holes: 14.0 Holes | In distribution |
| 430018 | Screw Holes: 18.0 Holes | In distribution |
| 430214 | Length 181.0 mm | In distribution |
| 620209 | Screw Holes: 9.0 Holes | In distribution |
| 431008 | Length 88.0 mm | In distribution |
| 621123 | Length 38.0 mm | In distribution |
| 430210 | Screw Holes: 10.0 Holes | In distribution |
| 432159 | Length 166.0 mm | In distribution |
| 431028 | Screw Holes: 8.0 Holes | In distribution |
| 432018 | Screw Holes: 18.0 Holes | In distribution |
| 433106 | Length 111.0 mm | In distribution |
| 432203 | Length 46.0 mm | In distribution |
| 620313 | Length 238.0 mm | In distribution |
| 432118 | Length 328.0 mm | In distribution |
| 432061 | Screw Holes: 11.0 Holes | In distribution |
| 431043 | Length 66.0 mm | In distribution |
| 433058 | Screw Holes: 8.0 Holes | In distribution |
| 621466 | Length 70.0 mm | In distribution |
| 432209 | Screw Holes: 9.0 Holes | In distribution |
| 621464 | Length 53.0 mm | In distribution |
| 620213 | Screw Holes: 13.0 Holes | In distribution |
| 620307 | Screw Holes: 7.0 Holes | In distribution |
| 620214 | Length 254.0 mm | In distribution |
| 430107 | Length 84.0 mm | In distribution |
| 621149 | Screw Holes: 9.0 Holes | In distribution |
| 432213 | Screw Holes: 13.0 Holes | In distribution |
| 432006 | Screw Holes: 6.0 Holes | In distribution |
| 433108 | Length 143.0 mm | In distribution |
| 432058 | Screw Holes: 8.0 Holes | In distribution |
| 621150 | Length 130.0 mm | In distribution |
| 433158 | Screw Holes: 8.0 Holes | In distribution |
| 432055 | Length 92.0 mm | In distribution |
| 621425 | Length 57.2 mm | In distribution |
| 621147 | Screw Holes: 7.0 Holes | In distribution |
| 432003 | Length 56.0 mm | In distribution |
| 431105 | Length 80.0 mm | In distribution |
| 621152 | Length 156.0 mm | In distribution |
| 431104 | Length 70.0 mm | In distribution |
| 432214 | Screw Holes: 14.0 Holes | In distribution |
| 431006 | Screw Holes: 6.0 Holes | In distribution |
| 430122 | Screw Holes: 22.0 Holes | In distribution |
| 430202 | Length 25.0 mm | In distribution |
| 620454 | Screw Holes: 4.0 Holes | In distribution |
| 430004 | Screw Holes: 4.0 Holes | In distribution |
| 621145 | Screw Holes: 5.0 Holes | In distribution |
| 430108 | Screw Holes: 8.0 Holes | In distribution |
| 432204 | Length 62.0 mm | In distribution |
| 621125 | Screw Holes: 5.0 Holes | In distribution |
| 432060 | Length 182.0 mm | In distribution |
| 621573S | Screw Holes: 3.0 Holes | In distribution |
| 620758 | Screw Holes: 8.0 Holes | In distribution |
| 431003 | Screw Holes: 3.0 Holes | In distribution |
| 621436 | Screw Holes: 6.0 Holes | In distribution |
| 430106 | Length 72.0 mm | In distribution |
| 430105 | Length 60.0 mm | In distribution |
| 433154 | Screw Holes: 4.0 Holes | In distribution |
| 430012 | Length 156.0 mm | In distribution |
| 430011 | Screw Holes: 11.0 Holes | In distribution |
| 432065 | Screw Holes: 15.0 Holes | In distribution |
| 432162 | Screw Holes: 12.0 Holes | In distribution |
| 431023 | Screw Holes: 3.0 Holes | In distribution |
| 430118 | Length 216.0 mm | In distribution |
| 433056 | Screw Holes: 6.0 Holes | In distribution |
| 430209 | Length 116.0 mm | In distribution |
| 430212 | Screw Holes: 12.0 Holes | In distribution |
| 432107 | Screw Holes: 7.0 Holes | In distribution |
| 430120 | Screw Holes: 20.0 Holes | In distribution |
| 620458 | Length 145.0 mm | In distribution |
| 620308 | Length 148.0 mm | In distribution |
| 621127 | Length 90.0 mm | In distribution |
| 621578S | Length 141.0 mm | In distribution |
| 430110 | Screw Holes: 10.0 Holes | In distribution |
| 621552 | Length 50.0 mm | In distribution |
| 621444 | Screw Holes: 4.0 Holes | In distribution |
| 432005 | Screw Holes: 5.0 Holes | In distribution |
| 621579S | Length 153.0 mm | In distribution |
| 432009 | Length 164.0 mm | In distribution |
| 432211 | Screw Holes: 11.0 Holes | In distribution |
| 620455 | Screw Holes: 5.0 Holes | In distribution |
| 620207 | Screw Holes: 7.0 Holes | In distribution |
| 620205 | Screw Holes: 5.0 Holes | In distribution |
| 432016 | Length 290.0 mm | In distribution |
| 432165 | Screw Holes: 15.0 Holes | In distribution |
| 621434 | Length 49.3 mm | In distribution |
| 620315 | Length 274.0 mm | In distribution |
| 621575S | Screw Holes: 5.0 Holes | In distribution |
| 430009 | Screw Holes: 9.0 Holes | In distribution |
| 430211 | Length 142.0 mm | In distribution |
| 621124 | Screw Holes: 4.0 Holes | In distribution |
| 621151 | Length 143.0 mm | In distribution |
| 431048 | Length 138.0 mm | In distribution |
| 620754 | Screw Holes: 4.0 Holes | In distribution |
| 430208 | Screw Holes: 8.0 Holes | In distribution |
| 433105 | Length 95.0 mm | In distribution |
| 430014 | Screw Holes: 14.0 Holes | In distribution |
| 430109 | Screw Holes: 9.0 Holes | In distribution |
| 620222 | Screw Holes: 22.0 Holes | Withdrawn |
| 620218 | Screw Holes: 18.0 Holes | Withdrawn |
| 620322 | Length 400.0 mm | Withdrawn |
| 620202 | Length 38.0 mm | Withdrawn |
| 620317 | Length 310.0 mm | Withdrawn |
| 620318 | Screw Holes: 18.0 Holes | Withdrawn |
| 620220 | Screw Holes: 20.0 Holes | Withdrawn |
| 620215 | Length 272.0 mm | Withdrawn |
Showing 250 of 251 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 |
| 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 |
|---|---|
| K242445 | 2024-10-06 |
| K233919 | 2024-03-25 |
| K231257 | 2023-08-18 |
| K231262 | 2023-08-18 |
| K222381 | 2023-04-27 |
| K223772 | 2023-04-07 |
| K221346 | 2022-07-08 |
| K212581 | 2022-01-19 |
| K200398 | 2020-06-05 |
| K192675 | 2019-11-22 |
| K191412 | 2019-08-23 |
| K183172 | 2019-03-05 |
| K181091 | 2018-10-11 |
| K172148 | 2018-03-19 |
| K172350 | 2017-12-15 |
| K170727 | 2017-06-22 |
| K170771 | 2017-05-08 |
| K162841 | 2017-02-21 |
| K162439 | 2017-02-03 |
| K153379 | 2016-05-26 |
| K151769 | 2015-10-27 |
| K151879 | 2015-08-06 |
| K113109 | 2011-12-23 |
| K112926 | 2011-12-19 |
| K110476 | 2011-03-18 |
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 |
|---|---|---|---|---|---|
| 2019-12-05 | Class II | Under Investigation by firm | Instrument can break at the level of the thread when being exposed to high forces during nail implantation or removal which can lead to complications during nail insertion and removal. | 433 (289 units U.S. / 144 units OUS) | 2020-10-09 |
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.