Pass LP
PASS LP is a modular system for posterior stabilization of the thoracic, lumbar and sacral spine. Its components include pedicle screws, hooks, rods, sacral plates, iliac screws, clamps,…
PASS LP is a modular system for posterior stabilization of the thoracic, lumbar and sacral spine. Its components include pedicle screws, hooks, rods, sacral plates, iliac screws, clamps, nuts, rod plates and crosslinks.
The titanium-alloy components lock into configurations assembled for single-level or multilevel fixation. Listed hook components form part of this wider construct, alongside screws and connecting components.
Listed Item
RIGHT POLYAXIAL TP HOOK, LARGE OFFSET 11mm LONG LUMBAR LAMINAR COUNTERHOOK
Fusion and Component Selection
The system provides stabilization as an adjunct to fusion. A defined subset is also intended for pediatric posterior pedicle-screw fixation with autograft and/or allograft. Pediatric use depends on the component and indication; rod plates and caps for sacral plates are excluded from that pediatric indication.
15manufacturers in China registered for this device type
2,111catalogue numbers in this listing
9510(k) clearances naming this product code
2recalls on this code
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) | K190376 |
| Record published | 2015-10-23 |
| Record revised | 2025-10-30 (version 10) |
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 |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Distribution end date | 2025-10-29 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| B02217580 | In distribution | |
| B02256540 | In distribution | |
| B02200010L | In distribution | |
| B02241106S | In distribution | |
| B02176010S | In distribution | |
| B02514535S | In distribution | |
| B02126040S | In distribution | |
| B02416535 | In distribution | |
| B02236001S | In distribution | |
| B02256550S | In distribution | |
| B02265520 | In distribution | |
| B02236054 | In distribution | |
| B02465520S | In distribution | |
| B02235540S | In distribution | |
| B02265510S | In distribution | |
| B02250060R | In distribution | |
| B02266020 | In distribution | |
| B02214530 | In distribution | |
| B02242407S | In distribution | |
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| B02125540S | In distribution | |
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| B02235510S | In distribution | |
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| B02416545 | In distribution | |
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| B02156540 | In distribution | |
| B02256555S | In distribution | |
| B02235501 | In distribution | |
| B02515530S | In distribution | |
| B02123645 | In distribution | |
| B02236385 | In distribution | |
| B02218590S | In distribution | |
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| B02126006S | In distribution | |
| B02236030S | In distribution | |
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| B02235570S | In distribution | |
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| B02516555S | In distribution | |
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| B02465510S | In distribution | |
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| B02157235 | In distribution | |
| B02218570 | In distribution | |
| B02217590 | In distribution | |
| B02245407 | In distribution | |
| B02218510 | In distribution | |
| B02257245S | In distribution | |
| B02236051 | In distribution | |
| B02517535S | In distribution | |
| B02241116 | In distribution | |
| B02514530S | In distribution | |
| B02126012S | In distribution | |
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| B02235530S | In distribution | |
| B02214545 | In distribution | |
| B02256530S | In distribution | |
| B02250020 | In distribution | |
| B02215550 | In distribution | |
| B02465515 | In distribution | |
| B02126045 | In distribution | |
| B02175506 | In distribution | |
| B02176003S | In distribution | |
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| B02515535S | In distribution | |
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| B02466015 | In distribution | |
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| B02211070 | In distribution | |
| B02126004S | In distribution | |
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| B02216555S | Withdrawn | |
| B02223618 | Withdrawn | |
| B36020590 | Withdrawn | |
| B02211010S | Withdrawn |
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 |
|---|---|
| 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
2 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Medicrea International | UDI-DI | 2023-07-12 | Class II | Under Investigation by firm | There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch. | 963 units | |
| Medicrea International | 510(k) number | 2019-11-11 | Class II | Device Design | Incompatible universal counter torque (A22020500) with the nut driver T30 (A22020220) | 3 units | 2020-10-14 |
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 |
|---|---|---|---|---|---|
| 2019-06-27 | 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 |
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.