Sterispine PS
Sterispine PS is a posterior screw-and-rod fixation system for the non-cervical spine. It immobilizes and stabilizes spinal segments as an adjunct to fusion in skeletally mature patients.…
Sterispine PS is a posterior screw-and-rod fixation system for the non-cervical spine. It immobilizes and stabilizes spinal segments as an adjunct to fusion in skeletally mature patients.
The family includes multiaxial and cannulated multiaxial screws, with or without extended heads, and straight or prebent rods. Components are supplied sterile with a sterile, single-use set of surgical instruments.
Screw and Rod Range
The screw range includes 5.5, 6.5 and 7.5 mm diameters. Earlier screw lengths of 25 to 60 mm are supplemented by lengths from 65 to 85 mm. Rod options span 30 to 380 mm in length, providing different component sizes within the fixation system.
15manufacturers in China registered for this device type
313catalogue numbers in this listing
9510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (3), Shandong (3). 6 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 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| 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 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
Showing 12 of 15. All 15 manufacturers in China registered for Thoracolumbosacral Pedicle Screw System
Record
| Listed by | Safe Orthopaedics SAS, France |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K170528 |
| Record published | 2020-09-01 |
| Record revised | 2026-03-12 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2026-03-10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| KITCLK | In distribution | |
| KITMCL765 | In distribution | |
| KITACL760 | In distribution | |
| KITMFL435 | In distribution | |
| KITMC735 | In distribution | |
| KITM780 | In distribution | |
| KITMCL430 | In distribution | |
| KITMCL580 | In distribution | |
| KITMFL430 | In distribution | |
| KITACL455 | In distribution | |
| KITM730 | In distribution | |
| KITMF445 | In distribution | |
| KITMC640 | In distribution | |
| KITACL675 | In distribution | |
| KITM550 | In distribution | |
| KITMFL730 | In distribution | |
| KITM570 | In distribution | |
| KITRMI575 | In distribution | |
| KITMC770 | In distribution | |
| KITMFL745 | In distribution | |
| KITACL740 | In distribution | |
| KITMFL550 | In distribution | |
| KITM685 | In distribution | |
| KITACL550 | In distribution | |
| KITACL565 | In distribution | |
| KITACL450 | In distribution | |
| KITMC535 | In distribution | |
| KITMFL540 | In distribution | |
| KITRMI180S | In distribution | |
| KITRMI100S | In distribution | |
| KITMF635 | In distribution | |
| KITM665 | In distribution | |
| KITRMI160S | In distribution | |
| KITMCL555 | In distribution | |
| KITM440 | In distribution | |
| KITRMI100 | In distribution | |
| KITM635 | In distribution | |
| KITMFL645 | In distribution | |
| KITMFL660 | In distribution | |
| KITMF450 | In distribution | |
| KITMCL440 | In distribution | |
| KITMF530 | In distribution | |
| KITACL485 | In distribution | |
| KITMC550 | In distribution | |
| KITRMI240S | In distribution | |
| KITMC730 | In distribution | |
| KITMCL465 | In distribution | |
| KITACL650 | In distribution | |
| KITMCL680 | In distribution | |
| KITRMI590 | In distribution | |
| KITMC435 | In distribution | |
| KITM625 | In distribution | |
| KITM735 | In distribution | |
| KITM425 | In distribution | |
| KITMC445 | In distribution | |
| KITMF645 | In distribution | |
| KITMCL640 | In distribution | |
| KITMCL455 | In distribution | |
| KITRMI210S | In distribution | |
| KITM560 | In distribution | |
| KITACL530 | In distribution | |
| KITMF735 | In distribution | |
| KITRMI595 | In distribution | |
| KITACL780 | In distribution | |
| KITMC540 | In distribution | |
| KITM725 | In distribution | |
| KITACL665 | In distribution | |
| KITRMI220S | In distribution | |
| KITMC775 | In distribution | |
| KITMF440 | In distribution | |
| KITMCL675 | In distribution | |
| KITMC465 | In distribution | |
| KITMC660 | In distribution | |
| KITRMI1380S | In distribution | |
| KITACL745 | In distribution | |
| KITMCL445 | In distribution | |
| KITMCL775 | In distribution | |
| KITMCL535 | In distribution | |
| KITMC685 | In distribution | |
| KITMFL440 | In distribution | |
| KITMCL750 | In distribution | |
| KITMC785 | In distribution | |
| KITMCL735 | In distribution | |
| KITMCL480 | In distribution | |
| KITM545 | In distribution | |
| KITM630 | In distribution | |
| KITACL750 | In distribution | |
| KITRMI530 | In distribution | |
| KITRMI300S | In distribution | |
| KITMCL660 | In distribution | |
| KITRMI150S | In distribution | |
| KITMC545 | In distribution | |
| KITMF555 | In distribution | |
| KITMFL455 | In distribution | |
| KITRMI270S | In distribution | |
| KITM445 | In distribution | |
| KITACL765 | In distribution | |
| KITMCL760 | In distribution | |
| KITMC755 | In distribution | |
| KITM525 | In distribution | |
| KITM470 | In distribution | |
| KITACL660 | In distribution | |
| KITMC650 | In distribution | |
| KITRMI555 | In distribution | |
| KITMCL585 | In distribution | |
| KITMCL635 | In distribution | |
| KITM775 | In distribution | |
| KITMFL655 | In distribution | |
| KITRMI320S | In distribution | |
| KITPSANC025 | In distribution | |
| KITMCL545 | In distribution | |
| KITM740 | In distribution | |
| KITMCL785 | In distribution | |
| KITANCMIS | In distribution | |
| KITM530 | In distribution | |
| KITRMI340S | In distribution | |
| KITMF455 | In distribution | |
| KITREDUCER | In distribution | |
| KITACL470 | In distribution | |
| KITMC440 | In distribution | |
| KITMF730 | In distribution | |
| KITACL655 | In distribution | |
| KITMFL755 | In distribution | |
| KITRMI570 | In distribution | |
| KITM785 | In distribution | |
| KITMCL685 | In distribution | |
| KITMCL570 | In distribution | |
| KITMF535 | In distribution | |
| KITRMI110S | In distribution | |
| KITMCL475 | In distribution | |
| KITMFL535 | In distribution | |
| KITMCL470 | In distribution | |
| KITACL630 | In distribution | |
| KITMF750 | In distribution | |
| KITACL670 | In distribution | |
| KITMC530 | In distribution | |
| KITMCL740 | In distribution | |
| KITMC625 | In distribution | |
| KITMC675 | In distribution | |
| KITM655 | In distribution | |
| KITACL640 | In distribution | |
| KITACL480 | In distribution | |
| KITMC470 | In distribution | |
| KITMCL670 | In distribution | |
| KITACL645 | In distribution | |
| KITMC745 | In distribution | |
| KITM675 | In distribution | |
| KITMF650 | In distribution | |
| KITMF540 | In distribution | |
| KITMFL555 | In distribution | |
| KITMF630 | In distribution | |
| KITMC455 | In distribution | |
| KITMFL445 | In distribution | |
| KITMCL645 | In distribution | |
| KITMC645 | In distribution | |
| KITACL725 | In distribution | |
| KITRMI360S | In distribution | |
| KITMCL435 | In distribution | |
| KITM535 | In distribution | |
| KITMCL755 | In distribution | |
| KITMCL665 | In distribution | |
| KITRMI290S | In distribution | |
| KITMCL565 | In distribution | |
| KITMCL540 | In distribution | |
| KITMC430 | In distribution | |
| KITRMI350S | In distribution | |
| KITRMI560 | In distribution | |
| KITMC670 | In distribution | |
| KITM580 | In distribution | |
| KITACL460 | In distribution | |
| KITMCL725 | In distribution | |
| KITMCL550 | In distribution | |
| KITMCL530 | In distribution | |
| KITM480 | In distribution | |
| KITACL580 | In distribution | |
| KITMF435 | In distribution | |
| KITACL535 | In distribution | |
| KITMFL545 | In distribution | |
| KITACL775 | In distribution | |
| KITMFL760 | In distribution | |
| KITM750 | In distribution | |
| KITACL465 | In distribution | |
| KITRMI540 | In distribution | |
| KITMFL640 | In distribution | |
| KITRMI260S | In distribution | |
| KITACL730 | In distribution | |
| KITMC630 | In distribution | |
| KITMCL770 | In distribution | |
| KITMC425 | In distribution | |
| KITACL575 | In distribution | |
| KITM650 | In distribution | |
| KITRMI190S | In distribution | |
| KITACL435 | In distribution | |
| KITACL430 | In distribution | |
| KITACL445 | In distribution | |
| KITMC740 | In distribution | |
| KITM585 | In distribution | |
| KITACL770 | In distribution | |
| KITMF560 | In distribution | |
| KITM465 | In distribution | |
| KITM680 | In distribution | |
| KITANCESS | In distribution | |
| KITMC765 | In distribution | |
| KITMCL575 | In distribution | |
| KITM670 | In distribution | |
| KITMF660 | In distribution | |
| KITMCL425 | In distribution | |
| KITM645 | In distribution | |
| KITMF740 | In distribution | |
| KITMCL625 | In distribution | |
| KITRMI310S | In distribution | |
| KITMCL780 | In distribution | |
| KITM745 | In distribution | |
| KITM435 | In distribution | |
| KITRMI280S | In distribution | |
| KITACL625 | In distribution | |
| KITMFL635 | In distribution | |
| KITACL785 | In distribution | |
| KITRMI250S | In distribution | |
| KITMFL460 | In distribution | |
| KITMF430 | In distribution | |
| KITACL475 | In distribution | |
| KITACL585 | In distribution | |
| KITRMI170S | In distribution | |
| KITM760 | In distribution | |
| KITMC575 | In distribution | |
| KITMCL485 | In distribution | |
| KITM485 | In distribution | |
| KITRMI580 | In distribution | |
| KITMF545 | In distribution | |
| KITMCL650 | In distribution | |
| KITRMI545 | In distribution | |
| KITMC655 | In distribution | |
| KITACL440 | In distribution | |
| KITMCL460 | In distribution | |
| KITACL555 | In distribution | |
| KITACL680 | In distribution | |
| KITMC460 | In distribution | |
| KITM540 | In distribution | |
| KITMC780 | In distribution | |
| KITRMI380S | In distribution | |
| KITPERCUT | In distribution | |
| KITMCL560 | In distribution | |
| KITACL635 | In distribution | |
| KITMF655 | In distribution | |
| KITMFL630 | In distribution | |
| KITRMI565 | In distribution | |
| KITM770 | In distribution | |
| KITMC580 | In distribution | |
| KITRMI330S | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| The Jasper Spinal Fixation System | Gbs Commonwealth Co., Ltd. | 32,491 |
| Invictus | Alphatec Spine, Inc. | 4,722 |
| Vital Spinal Fixation System | Highridge Medical, LLC | 4,422 |
| Innoverse Spinal System | CG MedTech Co., Ltd. | 4,240 |
| 4CIS® Chiron Spinal Fixation System | Alpha AI Co., Ltd. | 3,787 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 3,522 |
| Hedjet System | Medyssey Co., Ltd. | 3,438 |
| Anax™ 5.5 Spinal System | CG MedTech Co., Ltd. | 3,424 |
| Mega Plus MIS Spine System | BK Meditech Co., Ltd. | 3,396 |
| ReLine | Nuvasive, Inc. | 2,882 |
| Nex-D2 | Next Orthosurgical | 2,765 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 2,386 |
Showing 12 of 1,490. All products under Thoracolumbosacral Pedicle Screw System
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K201648 | 2020-07-30 |
| K170528 | 2017-03-09 |
| K151921 | 2015-10-08 |
| K151747 | 2015-10-05 |
| K150092 | 2015-02-10 |
| K140802 | 2014-06-04 |
| K130632 | 2013-05-03 |
| K121299 | 2012-07-30 |
| K112453 | 2011-11-15 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Safe Orthopaedics SAS | UDI-DI | 2022-06-03 | Class II | Labeling Change Control | The type of screw printed on the traceability record for the patient label is incorrect, but the type of screw printed on the other labeling is correct. | 8 devices |
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.