Segmental Plating System
Segmental Plating System is an anterior cervical plate-and-screw construct. Titanium-alloy plates with two to four holes accept 3.5 or 4.0 mm screws to stabilize the cervical spine. The…
Segmental Plating System is an anterior cervical plate-and-screw construct. Titanium-alloy plates with two to four holes accept 3.5 or 4.0 mm screws to stabilize the cervical spine.
The plate incorporates an anti-backout mechanism for the screws. Dedicated instruments support delivery and assembly of the plate and screw construct.
Listed Item
SPS FA Self-Drill Screw, 4.0 x 21 mm
Preparation and Anatomical Scope
The implants are supplied nonsterile and require steam sterilization by the user. The system is intended for anterior cervical fixation from C2 to T1. It is a distinct fixation system from the separately described IdentiTi and Transcend SPS interbody spacers.
14manufacturers in China registered for this device type
131catalogue numbers in this listing
9510(k) clearances naming this product code
32recalls on this code
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (3), Zhejiang (2). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| 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 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
Showing 12 of 14. All 14 manufacturers in China registered for Appliance, Fixation, Spinal Intervertebral Body
Record
| Listed by | Alphatec Spine, Inc., United States |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K233640 |
| Record published | 2024-06-28 |
| Record revised | 2024-09-11 (version 2) |
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 12 to 24 mm; outer diameter 3.5 to 4 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 338-1-44021 | Outer Diameter 4.0 mm | In distribution |
| 338-0217 | Length 17 mm | In distribution |
| 338-1-34024 | Outer Diameter 4.0 mm | In distribution |
| 338-1-23513 | Length 13 mm | In distribution |
| 338-1-24024 | Outer Diameter 4.0 mm | In distribution |
| 338-1-43522 | Outer Diameter 3.5 mm | In distribution |
| 338-0317 | Length 17 mm | In distribution |
| 338-1-34013 | Length 13 mm | In distribution |
| 338-1-14021 | Length 21 mm | In distribution |
| 338-0321 | Length 21 mm | In distribution |
| 338-1-23512 | Outer Diameter 3.5 mm | In distribution |
| 338-1-44019 | Length 19 mm | In distribution |
| 338-1-13513 | Outer Diameter 3.5 mm | In distribution |
| 338-1-14018 | Outer Diameter 4.0 mm | In distribution |
| 338-1-23519 | Outer Diameter 3.5 mm | In distribution |
| 338-0322 | Length 22 mm | In distribution |
| 338-0419 | Length 19 mm | In distribution |
| 338-1-24018 | Outer Diameter 4.0 mm | In distribution |
| 338-1-13515 | Length 15 mm | In distribution |
| 338-1-24015 | Length 15 mm | In distribution |
| 338-0416 | Length 16 mm | In distribution |
| 338-1-44016 | Length 16 mm | In distribution |
| 338-1-33519 | Length 19 mm | In distribution |
| 338-1-43516 | Outer Diameter 3.5 mm | In distribution |
| 338-1-23523 | Outer Diameter 3.5 mm | In distribution |
| 338-1-13521 | Length 21 mm | In distribution |
| 338-1-13524 | Outer Diameter 3.5 mm | In distribution |
| 338-1-23518 | Outer Diameter 3.5 mm | In distribution |
| 338-0421 | Length 21 mm | In distribution |
| 338-0422 | Length 22 mm | In distribution |
| 338-1-24014 | Length 14 mm | In distribution |
| 338-0221 | Length 21 mm | In distribution |
| 338-1-24013 | Length 13 mm | In distribution |
| 338-1-13520 | Outer Diameter 3.5 mm | In distribution |
| 338-1-13518 | Outer Diameter 3.5 mm | In distribution |
| 338-1-43517 | Outer Diameter 3.5 mm | In distribution |
| 338-1-33522 | Length 22 mm | In distribution |
| 338-0320 | Length 20 mm | In distribution |
| 338-1-23520 | Outer Diameter 3.5 mm | In distribution |
| 338-0415 | Length 15 mm | In distribution |
| 338-1-33520 | Outer Diameter 3.5 mm | In distribution |
| 338-1-43513 | Outer Diameter 3.5 mm | In distribution |
| 338-1-14017 | Length 17 mm | In distribution |
| 338-1-43518 | Length 18 mm | In distribution |
| 338-1-43519 | Length 19 mm | In distribution |
| 338-1-33521 | Outer Diameter 3.5 mm | In distribution |
| 338-1-34015 | Outer Diameter 4.0 mm | In distribution |
| 338-1-14023 | Outer Diameter 4.0 mm | In distribution |
| 338-1-13516 | Length 16 mm | In distribution |
| 338-0216 | Length 16 mm | In distribution |
| 338-1-24023 | Outer Diameter 4.0 mm | In distribution |
| 338-1-34022 | Outer Diameter 4.0 mm | In distribution |
| 338-1-24017 | Outer Diameter 4.0 mm | In distribution |
| 338-1-43524 | Outer Diameter 3.5 mm | In distribution |
| 338-0215 | Length 15 mm | In distribution |
| 338-0315 | Length 15 mm | In distribution |
| 338-1-43521 | Outer Diameter 3.5 mm | In distribution |
| 338-1-23521 | Outer Diameter 3.5 mm | In distribution |
| 338-1-33524 | Outer Diameter 3.5 mm | In distribution |
| 338-1-44020 | Outer Diameter 4.0 mm | In distribution |
| 338-1-13517 | Outer Diameter 3.5 mm | In distribution |
| 338-1-13519 | Outer Diameter 3.5 mm | In distribution |
| 338-1-23514 | Outer Diameter 3.5 mm | In distribution |
| 338-1-44013 | Outer Diameter 4.0 mm | In distribution |
| 338-1-33523 | Length 23 mm | In distribution |
| 338-1-33516 | Outer Diameter 3.5 mm | In distribution |
| 338-1-44015 | Length 15 mm | In distribution |
| 338-1-23524 | Length 24 mm | In distribution |
| 338-0219 | Length 19 mm | In distribution |
| 338-1-43514 | Outer Diameter 3.5 mm | In distribution |
| 338-1-14013 | Length 13 mm | In distribution |
| 338-1-14020 | Length 20 mm | In distribution |
| 338-1-34019 | Outer Diameter 4.0 mm | In distribution |
| 338-1-14014 | Outer Diameter 4.0 mm | In distribution |
| 338-1-34017 | Outer Diameter 4.0 mm | In distribution |
| 338-1-33518 | Length 18 mm | In distribution |
| 338-1-34021 | Outer Diameter 4.0 mm | In distribution |
| 338-1-24022 | Length 22 mm | In distribution |
| 338-1-23517 | Outer Diameter 3.5 mm | In distribution |
| 338-1-44024 | Length 24 mm | In distribution |
| 338-1-43515 | Outer Diameter 3.5 mm | In distribution |
| 338-1-14012 | Length 12 mm | In distribution |
| 338-1-34014 | Length 14 mm | In distribution |
| 338-0417 | Length 17 mm | In distribution |
| 338-0319 | Length 19 mm | In distribution |
| 338-1-14024 | Outer Diameter 4.0 mm | In distribution |
| 338-1-34016 | Outer Diameter 4.0 mm | In distribution |
| 338-1-33513 | Outer Diameter 3.5 mm | In distribution |
| 338-0214 | Length 14 mm | In distribution |
| 338-0316 | Length 16 mm | In distribution |
| 338-1-24021 | Outer Diameter 4.0 mm | In distribution |
| 338-1-33514 | Length 14 mm | In distribution |
| 338-1-43523 | Length 23 mm | In distribution |
| 338-1-23522 | Outer Diameter 3.5 mm | In distribution |
| 338-1-33512 | Length 12 mm | In distribution |
| 338-0314 | Length 14 mm | In distribution |
| 338-1-34018 | Outer Diameter 4.0 mm | In distribution |
| 338-0414 | Length 14 mm | In distribution |
| 338-1-44023 | Length 23 mm | In distribution |
| 338-0218 | Length 18 mm | In distribution |
| 338-1-33515 | Outer Diameter 3.5 mm | In distribution |
| 338-1-24020 | Outer Diameter 4.0 mm | In distribution |
| 338-1-13512 | Length 12 mm | In distribution |
| 338-0318 | Length 18 mm | In distribution |
| 338-0222 | Length 22 mm | In distribution |
| 338-1-34012 | Outer Diameter 4.0 mm | In distribution |
| 338-1-44022 | Outer Diameter 4.0 mm | In distribution |
| 338-1-44012 | Outer Diameter 4.0 mm | In distribution |
| 338-0220 | Length 20 mm | In distribution |
| 338-1-24012 | Outer Diameter 4.0 mm | In distribution |
| 338-1-44017 | Length 17 mm | In distribution |
| 338-1-13514 | Outer Diameter 3.5 mm | In distribution |
| 338-1-13523 | Outer Diameter 3.5 mm | In distribution |
| 338-1-13522 | Outer Diameter 3.5 mm | In distribution |
| 338-1-24019 | Outer Diameter 4.0 mm | In distribution |
| 338-1-14016 | Length 16 mm | In distribution |
| 338-1-14015 | Outer Diameter 4.0 mm | In distribution |
| 338-1-14022 | Length 22 mm | In distribution |
| 338-1-23516 | Outer Diameter 3.5 mm | In distribution |
| 338-1-34023 | Outer Diameter 4.0 mm | In distribution |
| 338-1-44018 | Outer Diameter 4.0 mm | In distribution |
| 338-0418 | Length 18 mm | In distribution |
| 338-1-23515 | Outer Diameter 3.5 mm | In distribution |
| 338-1-34020 | Length 20 mm | In distribution |
| 338-1-43520 | Outer Diameter 3.5 mm | In distribution |
| 338-1-33517 | Outer Diameter 3.5 mm | In distribution |
| 338-1-43512 | Length 12 mm | In distribution |
| 338-1-44014 | Outer Diameter 4.0 mm | In distribution |
| 338-1-14019 | Outer Diameter 4.0 mm | In distribution |
| 338-1-24016 | Outer Diameter 4.0 mm | In distribution |
| 338-0420 | Length 20 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ReLine | Nuvasive, Inc. | 2,998 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 2,568 |
| Creo | Globus Medical, Inc. | 1,765 |
| AccelFix Spinal Fixation System | L&K Biomed Co., Ltd. | 1,755 |
| Ozark Cervical Plate System | VB Spine LLC | 1,460 |
| Sirion | Astura Medical | 1,246 |
| Apex Spine System | Spinecraft LLC | 1,187 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 986 |
| Astra Spine System | Spinecraft LLC | 970 |
| Zavation | Zavation | 966 |
| ACP | Nuvasive, Inc. | 918 |
| Polaris™ 5.5 Spinal System | Biomet Spine | 877 |
Showing 12 of 855. All products under Appliance, Fixation, Spinal Intervertebral Body
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251965 | 2025-08-28 |
| K233640 | 2024-02-22 |
| K230721 | 2023-05-09 |
| K213443 | 2021-12-15 |
| K200995 | 2020-05-21 |
| K182808 | 2018-11-09 |
| K102820 | 2010-11-05 |
| K101255 | 2010-07-21 |
| K070681 | 2007-05-04 |
Recalls
31 of these are 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 |
|---|---|---|---|---|---|
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 10 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 2 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 8 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 8 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 1 unit | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 7 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 3 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 7 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 3 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 5 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 6 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 1 unit | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 8 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 6 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 1 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 18 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 1 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 19 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 3 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 5 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 14 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 4 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 7 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 3 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 26 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 1 unit | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 7 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 2022-11-17 | |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 13 units | 2022-11-17 |
| 2015-04-10 | Class II | Employee error | During a field audit it was discovered by an employee that a 16mm Trestle Luxe Screw has been both laser marked and labeled as a 14mm Trestle Luxe Screw (4.0mm Variable Angle, Self-Drilling Hexalobe Screw, 14mm). As a result the firm recal | (244 units in US and 61 units OUS) | 2015-07-10 |
| 2012-05-29 | Class II | Device Design | On May 9th 2012 Alphatec Spine received a complaint which reported that the distal tip of the Trestle Luxe Slide Alignment Tool (Part Number 71721), does not properly fit into the hexalobe screw on the Trestle Luxe Plate. | 38 | 2012-09-04 |
| 2009-08-25 | Not classified | Labeling mix-ups | The recall was initiated after the firm discovered that the affected lot was labeled incorrectly in that the packaging label indicates that the part number of the lot is 61002-026, which corresponds to a two-level Trestle Anterior Cervical | 13 units | 2010-06-07 |
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.