HSB · Rod, Fixation, Intramedullary And Accessories

Device class

Class II

Regulation 888.3020

Total clearances

2020-01-31 → 2026-06-29

Last 12 months

Unique sponsors

Classification details

Medical specialty

Orthopedic

Review panel

Regulation number

888.3020

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
Stryker GmbH	9	2	2026-06-29
Nuvasive Specialized Orthopedics, Inc.	8	1	2026-06-18
Orthofix Srl	6	2	2026-05-19
Paragon 28, Inc.	6	1	2026-03-05
Arthrex, Inc.	5	2	2026-03-20
Zimmer GmbH	4	1	2026-03-12
OrthoPediatrics Corp.	3	0	2025-04-01
Flow-Fx, LLC	2	0	2024-02-05
Zimmer Switzerland Manufacturing GmbH	2	1	2025-12-12
Pega Medical, Inc.	2	0	2021-05-26
Jeil Medical Corporation	2	1	2025-12-10
Glw, Inc.	2	0	2022-10-27
Stryker Trauma GmbH	2	0	2020-07-22
Globus Medical, Inc.	2	1	2026-04-24
Flower Orthopedics Corporation Dba Conventus Flower	2	0	2022-11-21
Smith & Nephew, Inc.	2	0	2024-12-09
Adaptable Ortho Innovations, LLC	1	0	2021-03-18
Reselute, Inc.	1	1	2026-03-10
Orthoxel Dac	1	0	2024-04-04
DePuy Synthes	1	0	2024-08-01
Gm Dos Reis Industria E Comercio	1	0	2025-06-12
Ortho Development Corporation	1	0	2021-12-21
X-Bolt Orthopedics	1	0	2023-03-06
BAAT Medical Products B.V.	1	0	2020-08-27
Advanced Orthopaedic Solutions, Inc.	1	0	2020-08-28

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
20680	CPT	—	High	Standard CPT for application of intramedullary fixation device
C1719	HCPCS	Brachytherapy source, non-stranded, non-high dose rate iridium-192, per source ✓ CMS-verified description	Medium	Fixation device, intramedullary rod

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-06-29	K261481	Stryker GmbH	Pangea Femur Reconstruction System
2026-06-18	K261651	NuVasive Specialized Orthopedics	Precice Max System and Precice Ankle Salvage System
2026-06-18	K253080	Suzhou and Science & Technology Development Corp.	AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)
2026-06-17	K253155	Beijing Fule Science & Technology Development Co., Ltd.	Fule Metallic Lockable Intramedullary Nail Systems
2026-06-16	K253046	ZheJiang Decans Medical Devices Co., Ltd.	HERA Interlocking Intramedullary Nailing System
2026-05-19	K260146	Orthofix Srl	FITBONE® TRANSPORT AND LENGTHENING SYSTEM
2026-05-08	K253991	Orthofix Srl	Fitbone Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA
2026-04-24	K261043	Globus Medical, Inc.	AUTOBAHN Nailing System
2026-03-20	K252016	Arthrex, Inc.	Arthrex Humeral Nails
2026-03-18	K252961	Fusion Orthopedics USA, LLC	Fusion FibFix Nail
2026-03-12	K253566	Zimmer, Inc.	Affixus Retrograde Femoral Nailing System
2026-03-10	K253517	Reselute, Inc.	Reselute Tibial Nail
2026-03-05	K253591	Paragon 28, Inc.	Phantom® Hindfoot TTC/TC Nail System
2026-03-05	K252196	Arthrex, Inc.	Arthrex FibuLock Nail System
2026-03-04	K252025	Satori Orthopaedics, Inc.	Active Intramedullary (AIM) Tibial Nail System
2026-02-03	K253640	Stryker GmbH	T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System
2025-12-12	K253749	Zimmer Switzerland Manufacturing GmbH	Affixus® Natural Nail® Proximal Humeral System
2025-12-10	K252826	Jeil Medical Corporation	ARIX Femur Nail System
2025-10-17	K250197	Citieffe S.R.L.	Estremo Fibular Nail
2025-09-12	K250628	MedShape, Inc.	DynaNail TTC Fusion System
2025-08-20	K251400	Stryker GmbH	T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System
2025-08-13	K250163	Stryker GmbH	T2 Alpha Femur Retrograde Nailing System
2025-08-07	K250622	Ortho Solutions UK , Ltd.	Succession AFN System
2025-07-14	K251850	Paragon 28, Inc.	Phantom® Hindfoot TTC/TC Nail System
2025-06-12	K250559	Gm Dos Reis Industria E Comercio	GMReis Fibula Nail System