HRS · Plate, Fixation, Bone · Chrysalis Intelligence

Device class

Class II

Regulation 888.3030

Total clearances

329

2020-01-05 → 2026-09-23

Last 12 months

Unique sponsors

115

Classification details

Medical specialty

Orthopedic

Review panel

Regulation number

888.3030

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
Arthrex, Inc.	16	3	2026-03-03
TriMed, Inc.	16	2	2026-07-16
Medartis AG	13	2	2026-06-05
Skeletal Dynamics, Inc.	11	2	2026-03-23
Tyber Medical, LLC	11	1	2026-06-12
Newclip Technics	10	4	2026-07-28
Bonebridge AG	10	3	2026-06-26
In2bones USA, LLC	9	0	2024-08-13
Jeil Medical Corporation	9	0	2025-05-30
GM Dos Reis Industria e Comercio Ltda.	9	3	2026-08-19
Stryker GmbH	9	0	2024-10-06
Smith & Nephew, Inc.	8	0	2025-02-19
DePuy Synthes	6	0	2024-03-21
Nvision Biomedical Technologies, Inc.	6	4	2026-09-18
Treace Medical Concepts, Inc.	6	1	2026-09-15
KLS-Martin L.P.	6	3	2026-02-20
Bodycad Laboratories, Inc.	6	1	2025-10-28
Acumed, LLC	5	0	2025-08-21
Biomet Microfixation	5	1	2026-06-02
Globus Medical, Inc.	5	1	2026-02-26
Paragon 28, Inc.	5	0	2025-07-18
Synthes GmbH	4	2	2026-03-09
Auxein Medical Private Limited	4	0	2023-01-27
Vilex, LLC	4	0	2024-08-28
Aap Implantate AG	4	1	2026-03-24

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
20670	CPT	—	High	Standard CPT for application of external fixation device
C1713	HCPCS	Anchor/screw for opposing bone-to-bone or soft tissue-to-bone (implantable) ✓ CMS-verified description	Medium	Bone fixation device, metallic

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-09-23	K261892	Costa Surgical, Inc.	ProRib Fixation System
2026-09-18	K262098	Nvision Biomedical Technologies	EnHAnce PEEK Bunion System
2026-09-15	K262963	Treace Medical Concepts, Inc.	TMC Implant Fixation System
2026-09-03	K261647	Pace Surgical	Tempo Plating System; Ultra Compression Screw System
2026-08-28	K261830	Ortler Global Tibbi Gerecler Anonim Sirketi	FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog)
2026-08-19	K262537	GM Dos Reis Industria e Comercio Ltda.	Versalock Sterile Plating System
2026-08-13	K260277	Mikron Makina San. ve Tic. Ltd. Sti.	MIKRON TRAUMA BONE PLATE& SCREW SYSTEM
2026-07-28	K261511	Newclip Technics	Xpert Ankle
2026-07-21	K261406	GM Dos Reis Industria e Comercio Ltda.	Versalock Proximal Tibial Plating System
2026-07-16	K262032	TriMed, Inc.	TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB )
2026-07-08	K261191	Newclip Technics	Alians Elbow S
2026-07-01	K261054	Stryker Leibinger GmbH & Co KG	RibPlate System
2026-06-26	K261351	Bonebridge AG	SALGINA 2.5mm Distal Radius System
2026-06-16	K260958	I.T.S. GmbH	I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular Stability; I.T.S. Humeral Head Plate with Angular Stability; I.T.S. FR.O.H. Calcaneus Repair System; I.T.S. Pilonplate with Angular Stability; I.T.S. Olecranonplate with Angular Stability; I.T.S. Straight Plate with Angular Stability; I.T.S. Screw System; I.T.S. PRS Sacral Rod System; I.T.S. Fibula Plate PROlock with Angular Stability; I.T.S. Distal Humeral Plates with Angular Stability; I.T.S. LRS (L
2026-06-12	K261207	Tyber Medical, LLC	Exalta Proximal Tibia Plating System
2026-06-05	K260761	Medartis AG	APTUS Clavicle System 2.8
2026-06-02	K261002	Biomet Microfixation	Pectus Blu System
2026-05-29	K261038	Newclip Technics	Xpert PFP
2026-05-09	K261145	Avanti Orthopaedics, LLC	Avanti Distal Elbow ORIF System
2026-04-30	K260323	OrthoPediatrics Corp.	OrthoPediatrics® Locking Cannulated Blade Plate System
2026-04-24	K260411	Chest Wall Innovations, Inc.	PC Fix System
2026-04-24	K260228	Bonebridge AG	POYA 3.5mm Medial Proximal Tibia System
2026-04-24	K260054	I.T.S. GmbH	I.T.S. PRS Phoenix II
2026-04-10	K260090	Actis Medical Pty., Ltd.	SMART Osteotomy System
2026-04-01	K253718	Nvision Biomedical Technologies, Inc.	enHAnce PEEK Bunion System