NKB · Thoracolumbosacral Pedicle Screw System

Device class

Class II

Regulation 888.3070

Total clearances

242

2020-01-10 → 2026-07-24

Last 12 months

Unique sponsors

128

Definition

What is Thoracolumbosacral Pedicle Screw System

Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.

Classification details

Medical specialty

Orthopedic

Review panel

Regulation number

888.3070

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Medtronic Sofamor Danek USA, Inc.	11	3	2026-04-21
CarboFix Orthopedics , Ltd.	10	0	2024-11-05
S.M.A.I.O	9	4	2026-07-01
L&K BIOMED Co., Ltd.	8	1	2026-05-05
Alphatec Spine, Inc.	7	1	2026-07-14
Life Spine, Inc.	7	1	2026-04-16
Medos International SARL	6	1	2025-10-21
SeaSpine Orthopedics Corporation	6	0	2025-06-18
Zavation Medical Products, LLC	5	1	2026-07-24
Medacta International S.A.	5	1	2026-04-28
Spine Wave, Inc.	4	0	2025-06-06
Medtronic	4	0	2023-01-23
Innovative Surgical Designs, Inc.	4	0	2022-09-16
Spineart	4	0	2022-01-21
Nexus Spine	3	1	2025-10-14
Shanghai Sanyou Medical Co, Ltd.	3	0	2023-10-10
Icotec AG	3	0	2025-02-27
Astura Medical	3	1	2025-10-21
Altus Partners, LLC	3	0	2022-09-16
Republic Spine, LLC	2	0	2023-05-26
Zimmer Biomet Spine, Inc.	2	0	2021-04-02
CG Bio Co., Ltd.	2	0	2025-05-08
Vy Spine, LLC	2	0	2023-10-13
Integrity Implants, Inc.	2	0	2023-08-07
Spinal Elements, Inc.	2	0	2025-02-21

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
22612	CPT	—	High	Arthrodesis, lumbar; with instrumentation (pedicle screw systems)
C1713	HCPCS	Anchor/screw for opposing bone-to-bone or soft tissue-to-bone (implantable) ✓ CMS-verified description	High	Pedicle screw system for spinal fixation

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-07-24	K260362	MANTIZ Co., Ltd.	QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)
2026-07-24	K253943	Zavation Medical Products, LLC	Tiger 2 System
2026-07-14	K261284	Alphatec Spine, Inc.	Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System
2026-07-01	K253802	S.M.A.I.O	KHEIRON® Spinal Fixation System, including patient specific K-ROD
2026-06-17	K253045	Socko Medical Co., Ltd.	Socko Vimax Spinal Fixation System
2026-06-09	K251251	Chanpin Medtak Co., Ltd.	ChanPin Pedicle Screw Spinal System
2026-05-15	K260989	Kyocera Medical Technologies Inc. (KMTI)	Varion Thoracolumbar Fixation System
2026-05-07	K253739	Globus Medical, Inc.	SCRIPT Rods, CREO Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline System
2026-05-05	K261130	L&K BIOMED Co., Ltd.	AccelFix Spinal Fixation System
2026-05-01	K253966	Spineart SA	PERLA® TL Posterior Thoraco-lumbar Fixation System
2026-04-29	K252542	ZheJiang Decans Medical Devices Co., Ltd.	LEO Spinal System
2026-04-28	K253940	Medacta International S.A.	M.U.S.T. Pedicle Screw System - Extension
2026-04-21	K260216	Medtronic Sofamor Danek USA, Inc.	CD Horizon ModuLeX Fenestrated Screw Set; CD Horizon ModuLeX Spinal System
2026-04-16	K254274	Life Spine, Inc.	ARx® SAI Implant System
2026-04-03	K260786	S.M.A.I.O	KHEIRON® Spinal Fixation System, including patient specific K-ROD
2026-02-24	K254247	Osteomni, Inc.	OSTEOMNI SPINAL FIXATION SYSTEM
2026-02-23	K253169	Box Spine, LLC	Duet Spinal Fixation System
2026-02-10	K253545	K2m, Inc.	Vulcan Spinal System
2026-01-13	K252461	Spinal Resources, Inc.	Swedge Pedicle Screw Fixation System Bezier Rod
2026-01-07	K253990	S.M.A.I.O	KHEIRON® Spinal Fixation System, including patient specific K-ROD
2026-01-07	K253941	Medtronic Sofamor Danek USA, Inc.	CD Horizon ModuLeX Spinal System (LigaMAS Head Assembly)
2025-12-17	K253721	S.M.A.I.O	KHEIRON® Spinal Fixation System, including patient specific K-ROD
2025-12-17	K253093	Highridge Medical, LLC	Vital Spinal Fixation System
2025-11-18	K252729	Double Medical Technology, Inc.	Universal Spinal System
2025-10-24	K253335	Medtronic Sofamor Danek USA, Inc.	CD Horizon Spinal System