Pass LP Spinal System
PASS LP is a spinal fixation family for correction and stabilization of the thoracic, lumbar and sacral spine. Screws, hooks, rods and connecting components assemble into constructs…
PASS LP is a spinal fixation family for correction and stabilization of the thoracic, lumbar and sacral spine. Screws, hooks, rods and connecting components assemble into constructs spanning one or several levels.
The range includes pedicle and iliac screws, sacral plates, clamps, nuts, rod plates and crosslinks. A listed connector clamp is one connection component in this broader system. Materials across the range include titanium alloy and cobalt-chromium-molybdenum alloy.
Listed Item
Connector Clamp B02236001 6.0MM Standard
Construct Configurations
Components can be rigidly locked in different configurations. Adult constructs act as an adjunct to fusion, while a defined subset supports posterior pedicle-screw fixation in pediatric patients. Rod plates are excluded from the pediatric indication. Material and configuration therefore depend on the selected components.
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 | Medicrea International, France |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K141398 |
| Record published | 2024-07-24 |
| Record revised | 2025-11-20 (version 4) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| B02250020 | In distribution | |
| B02257240 | In distribution | |
| B02236001 | In distribution | |
| B02219570 | In distribution | |
| B02125540 | In distribution | |
| B02217580 | In distribution | |
| B02236052 | In distribution | |
| B02176006 | In distribution | |
| B02235545 | In distribution | |
| B02218570 | In distribution | |
| B02216540 | In distribution | |
| B02256540 | In distribution | |
| B02214545 | In distribution | |
| B02235570 | In distribution | |
| B02211070 | In distribution | |
| B02250010 | In distribution | |
| B02215535 | In distribution | |
| B02217535 | In distribution | |
| B02236010 | In distribution | |
| B02217510 | In distribution | |
| B02236030 | In distribution | |
| B02235530 | In distribution | |
| B02241104 | In distribution | |
| B02214535 | In distribution | |
| B02241106 | In distribution | |
| B02215530 | In distribution | |
| B02175504 | In distribution | |
| B02126045 | In distribution | |
| B02236092 | In distribution | |
| B02216530 | In distribution | |
| B02125524 | In distribution | |
| B02218580 | In distribution | |
| B02236051 | In distribution | |
| B02126024 | In distribution | |
| B02265510 | In distribution | |
| B02156535 | In distribution | |
| B02175503 | In distribution | |
| B02217570 | In distribution | |
| B02236385 | In distribution | |
| B02219540 | In distribution | |
| B02175507 | In distribution | |
| B02219580 | In distribution | |
| B02236020 | In distribution | |
| B02219590 | In distribution | |
| B02158080 | In distribution | |
| B02158075 | In distribution | |
| B02157240 | In distribution | |
| B02175505 | In distribution | |
| B02176008 | In distribution | |
| B02266010 | In distribution | |
| B02236098 | In distribution | |
| B02175510 | In distribution | |
| B02236055 | In distribution | |
| B02156545 | In distribution | |
| B02257245 | In distribution | |
| B02175509 | In distribution | |
| B02175506 | In distribution | |
| B02236050 | In distribution | |
| B02158070 | In distribution | |
| B02216550 | In distribution | |
| B02158090 | In distribution | |
| B02226026 | In distribution | |
| B02176007 | In distribution | |
| B02176010 | In distribution | |
| B02211010 | In distribution | |
| B02236040 | In distribution | |
| B02211090 | In distribution | |
| B02235540 | In distribution | |
| B02175508 | In distribution | |
| B02157250 | In distribution | |
| B02215550 | In distribution | |
| B02266000 | In distribution | |
| B02236027 | In distribution | |
| B02176003 | In distribution | |
| B02156555 | In distribution | |
| B02266020 | In distribution | |
| B02215545 | In distribution | |
| B02241114 | In distribution | |
| B02123626 | In distribution | |
| B02265520 | In distribution | |
| B02157245 | In distribution | |
| B02219510 | In distribution | |
| B02245308 | In distribution | |
| B02242407 | In distribution | |
| B02214525 | In distribution | |
| B02217590 | In distribution | |
| B02223626 | In distribution | |
| B02216545 | In distribution | |
| B02219545 | In distribution | |
| B02158065 | In distribution | |
| B02236070 | In distribution | |
| B02236099 | In distribution | |
| B02216535 | In distribution | |
| B02176005 | In distribution | |
| B02156550 | In distribution | |
| B02236023 | In distribution | |
| B02214530 | In distribution | |
| B02236054 | In distribution | |
| B02157235 | In distribution | |
| B02236094 | In distribution | |
| B02223645 | In distribution | |
| B02130005 | In distribution | |
| B02236045 | In distribution | |
| B02176009 | In distribution | |
| B02123645 | In distribution | |
| B02218510 | In distribution | |
| B02218590 | In distribution | |
| B02217545 | In distribution | |
| B02126012 | In distribution | |
| B02256545 | In distribution | |
| B02126003 | In distribution | |
| B02156530 | In distribution | |
| B02176004 | In distribution | |
| B02157230 | In distribution | |
| B02125545 | In distribution | |
| B02126006 | In distribution | |
| B02235510 | In distribution | |
| B02126040 | In distribution | |
| B02215540 | In distribution | |
| B02214540 | In distribution | |
| B02125512 | In distribution | |
| B02242308 | In distribution | |
| B02217540 | In distribution | |
| B02158085 | In distribution | |
| B02236053 | In distribution | |
| B02219550 | In distribution | |
| B02226045 | In distribution | |
| B02241116 | In distribution | |
| B02158095 | In distribution | |
| B02156540 | In distribution | |
| B02235501 | In distribution | |
| B02150000 | In distribution | |
| B02245407 | In distribution | |
| B02236097 | In distribution |
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 |
|---|---|
| K220724 | 2022-04-08 |
| K213281 | 2022-01-05 |
| K190376 | 2019-05-02 |
| K182240 | 2018-10-17 |
| K162786 | 2017-01-25 |
| K160640 | 2016-09-23 |
| K161627 | 2016-07-29 |
| K153413 | 2016-04-22 |
| K141398 | 2015-01-09 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Medicrea International | 510(k) number | 2019-06-27 | Class II | Employee error | It has been determined that some Pedicle system screw identified as 45mm long have an actual length of 50mm. Pedicle screws with a diameter of 7.5 mm or more are reserved for the sacrum area. As a result, a screw that is too long could com | 210 Pedicle Screws | 2020-11-19 |
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 |
|---|---|---|---|---|---|
| 2019-11-11 | Class II | Device Design | Incompatible universal counter torque (A22020500) with the nut driver T30 (A22020220) | 3 units | 2020-10-14 |
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.