Pilot Spinal System
PILOT is a posterior pedicle-screw fixation system for the non-cervical spine. It combines rods, screws and side-loading bodies to stabilize spinal segments while fusion develops. The…
PILOT is a posterior pedicle-screw fixation system for the non-cervical spine. It combines rods, screws and side-loading bodies to stabilize spinal segments while fusion develops.
The side-loading bodies accept either 5.5 or 6.35 mm rods. Rod options are straight or pre-lordosed, allowing the connected construct to follow the treated spinal alignment.
Listed Item
Rod, Pre-Lordosed, Ø5.5 x 55mm long (Bulleted End Cap)
Materials and Use
The implants are Ti-6Al-4V ELI titanium alloy, supplied nonsterile for single use. Components are specified for use within the PILOT system, without mixing other systems or manufacturers. The construct is intended to maintain alignment during healing as an adjunct to thoracic or lumbar fusion.
15manufacturers in China registered for this device type
230catalogue numbers in this listing
22510(k) clearances naming this product 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 | Life Spine, United States |
|---|---|
| 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) | K111729 |
| Record published | 2019-11-07 |
| Record revised | 2025-11-20 (version 5) |
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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 800-039M55 | In distribution | |
| 114-014-A | In distribution | |
| 8400-090 | In distribution | |
| 8500-070B | In distribution | |
| 1075-501 | In distribution | |
| 8402-100B | In distribution | |
| 114-449-2 | In distribution | |
| 8402-110B | In distribution | |
| 865-301 | In distribution | |
| 8400-050 | In distribution | |
| 8402-095B | In distribution | |
| 113-322 | In distribution | |
| 114-014-1 | In distribution | |
| 8400-105B | In distribution | |
| 113-494 | In distribution | |
| 655-351 | In distribution | |
| 4552-055 | In distribution | |
| 1065-351 | In distribution | |
| 1175-501 | In distribution | |
| 8400-045B | In distribution | |
| 800-096 | In distribution | |
| 1065-301 | In distribution | |
| 8402-100 | In distribution | |
| 113-385 | In distribution | |
| 2012-0086 | In distribution | |
| 114-448-2 | In distribution | |
| 113-1103 | In distribution | |
| 8402-075B | In distribution | |
| 113-359-8 | In distribution | |
| 8402-120 | In distribution | |
| 1055-351 | In distribution | |
| 665-401 | In distribution | |
| 8400-095B | In distribution | |
| 1165-351 | In distribution | |
| 8400-115B | In distribution | |
| 885-351 | In distribution | |
| 8400-120B | In distribution | |
| 113-340 | In distribution | |
| 865-451 | In distribution | |
| 1155-401 | In distribution | |
| 8675-401 | In distribution | |
| 113-1102 | In distribution | |
| 8402-070B | In distribution | |
| 113-460 | In distribution | |
| 8402-080B | In distribution | |
| 675-551 | In distribution | |
| 4552-085 | In distribution | |
| 114-080-1 | In distribution | |
| 875-351 | In distribution | |
| 800-039S55 | In distribution | |
| 1165-501 | In distribution | |
| 8675-451 | In distribution | |
| 8500-065B | In distribution | |
| 655-501 | In distribution | |
| 8400-030 | In distribution | |
| 8400-070 | In distribution | |
| 855-401 | In distribution | |
| 8500-075B | In distribution | |
| 8400-090B | In distribution | |
| 1155-301 | In distribution | |
| 8402-090 | In distribution | |
| 114-080-2 | In distribution | |
| 2012-0063 | In distribution | |
| 8400-045 | In distribution | |
| 1165-401 | In distribution | |
| 1085-451 | In distribution | |
| 8400-140B | In distribution | |
| 1165-301 | In distribution | |
| 8400-040B | In distribution | |
| 8400-070B | In distribution | |
| 8402-115 | In distribution | |
| 113-300 | In distribution | |
| 8400-150B | In distribution | |
| 8400-035S | In distribution | |
| 113-459 | In distribution | |
| 885-301 | In distribution | |
| 8402-085B | In distribution | |
| 855-351 | In distribution | |
| 8400-105 | In distribution | |
| 8500-090B | In distribution | |
| 655-301 | In distribution | |
| 8402-065 | In distribution | |
| 8400-050B | In distribution | |
| 8400-080 | In distribution | |
| 1065-551 | In distribution | |
| 885-551 | In distribution | |
| 8400-075 | In distribution | |
| 4552-075 | In distribution | |
| 8402-120B | In distribution | |
| 113-471 | In distribution | |
| 8400-085 | In distribution | |
| 665-451 | In distribution | |
| 116-412 | In distribution | |
| 665-501 | In distribution | |
| 113-349 | In distribution | |
| 1085-551 | In distribution | |
| 8400-060B | In distribution | |
| 113-306-X | In distribution | |
| 800-046 | In distribution | |
| 114-448-1 | In distribution | |
| 1065-401 | In distribution | |
| 114-448-4 | In distribution | |
| 1085-351 | In distribution | |
| 114-448-3 | In distribution | |
| 2012-0026 | In distribution | |
| 8400-110 | In distribution | |
| 114-006 | In distribution | |
| 8400-100 | In distribution | |
| 114-448-5 | In distribution | |
| 113-1100 | In distribution | |
| 8400-130B | In distribution | |
| 1075-451 | In distribution | |
| 8402-070 | In distribution | |
| 4552-065 | In distribution | |
| 116-413 | In distribution | |
| 1155-451 | In distribution | |
| 1075-551 | In distribution | |
| 1165-551 | In distribution | |
| 8400-150 | In distribution | |
| 875-451 | In distribution | |
| 545-351 | In distribution | |
| 8402-085 | In distribution | |
| 1055-451 | In distribution | |
| 4552-080 | In distribution | |
| 114-014-2 | In distribution | |
| 675-301 | In distribution | |
| 8400-065 | In distribution | |
| 4552-045 | In distribution | |
| 8402-090B | In distribution | |
| 8400-120 | In distribution | |
| 4552-090 | In distribution | |
| 113-333-1 | In distribution | |
| 8402-105B | In distribution | |
| 8402-065B | In distribution | |
| 113-492 | In distribution | |
| 8400-085B | In distribution | |
| 113-301 | In distribution | |
| 2012-0029 | In distribution | |
| 8665-401 | In distribution | |
| 885-501 | In distribution | |
| 1075-301 | In distribution | |
| 1055-401 | In distribution | |
| 113-1104 | In distribution | |
| 1055-501 | In distribution | |
| 1085-401 | In distribution | |
| 8400-110B | In distribution | |
| 2012-0124 | In distribution | |
| 113-320 | In distribution | |
| 1155-351 | In distribution | |
| 800-097 | In distribution | |
| 655-401 | In distribution | |
| 8400-040 | In distribution | |
| 113-321 | In distribution | |
| 1175-551 | In distribution | |
| 8402-105 | In distribution | |
| 665-301 | In distribution | |
| 2013-0057 | In distribution | |
| 1075-401 | In distribution | |
| 114-450 | In distribution | |
| 114-449-3 | In distribution | |
| 1085-501 | In distribution | |
| 1165-451 | In distribution | |
| 113-478 | In distribution | |
| FMC6663 | In distribution | |
| 113-474 | In distribution | |
| 116-200 | In distribution | |
| 113-323 | In distribution | |
| 665-551 | In distribution | |
| 114-014-B | In distribution | |
| 1065-501 | In distribution | |
| 113-360 | In distribution | |
| 885-401 | In distribution | |
| 675-501 | In distribution | |
| 113-473 | In distribution | |
| 8500-080B | In distribution | |
| 1175-351 | In distribution | |
| 8402-095 | In distribution | |
| 800-048 | In distribution | |
| 1175-451 | In distribution | |
| 800-047 | In distribution | |
| 113-458 | In distribution | |
| 1075-351 | In distribution | |
| 675-401 | In distribution | |
| 1085-301 | In distribution | |
| 113-361 | In distribution | |
| 113-351 | In distribution | |
| 8402-075 | In distribution | |
| 8400-115 | In distribution | |
| 116-451 | In distribution | |
| 1175-401 | In distribution | |
| 8400-140 | In distribution | |
| 2010-0022 | In distribution | |
| 1055-301 | In distribution | |
| 8402-110 | In distribution | |
| 114-449-1 | In distribution | |
| 8400-075B | In distribution | |
| 8400-160 | In distribution | |
| 8400-065B | In distribution | |
| 8400-055 | In distribution | |
| 8400-130 | In distribution | |
| 113-456 | In distribution | |
| 875-401 | In distribution | |
| 885-451 | In distribution | |
| 1155-501 | In distribution | |
| 4552-050 | In distribution | |
| 865-401 | In distribution | |
| 1175-301 | In distribution | |
| 1065-451 | In distribution | |
| 800-222 | In distribution | |
| 113-479 | In distribution | |
| 113-457 | In distribution | |
| 8665-451 | In distribution | |
| 675-351 | In distribution | |
| 855-451 | In distribution | |
| 113-1101 | In distribution | |
| 665-351 | In distribution | |
| 8400-055B | In distribution | |
| 8400-080B | In distribution | |
| 8400-100B | In distribution | |
| 8400-095 | In distribution | |
| 8400-035 | In distribution | |
| 8500-085B | In distribution | |
| 8400-060 | In distribution | |
| 800-095 | In distribution | |
| 8402-080 | In distribution | |
| 2012-0077 | In distribution | |
| 675-451 | In distribution | |
| 865-351 | In distribution | |
| 8402-115B | In distribution | |
| 655-451 | 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 |
|---|---|
| K254274 | 2026-04-16 |
| K233455 | 2023-12-12 |
| K220341 | 2022-05-02 |
| K220025 | 2022-03-31 |
| K210549 | 2021-04-22 |
| K203163 | 2020-12-17 |
| K200070 | 2020-04-23 |
| K191575 | 2019-08-08 |
| K183430 | 2019-03-13 |
| K151196 | 2015-07-14 |
| K150390 | 2015-03-16 |
| K141222 | 2015-02-12 |
| K140457 | 2014-03-25 |
| K133564 | 2014-02-19 |
| K132866 | 2013-10-28 |
| K132760 | 2013-10-03 |
| K123373 | 2013-03-06 |
| K111953 | 2012-08-07 |
| K111729 | 2011-09-07 |
| K090320 | 2009-07-22 |
| K073480 | 2008-01-04 |
| K070995 | 2007-06-22 |
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.