HTN · Washer, Bolt Nut · Chrysalis Intelligence

Device class

Class II

Regulation 888.3030

Total clearances

2020-04-06 → 2026-06-10

Last 12 months

Unique sponsors

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.	6	1	2025-12-22
Acumed, LLC	2	0	2025-01-23
Vilex, LLC	2	0	2024-11-27
TriMed, Inc.	2	0	2025-07-11
GM Dos Reis Industria e Comercio Ltda.	2	0	2024-11-01
In2bones USA, LLC	1	0	2022-03-31
Fusion Orthopedics	1	0	2024-12-23
Cc-Instruments, Inc.	1	0	2023-12-18
Wright Medical Technology, Inc. (Stryker Corporation)	1	1	2025-10-29
Orthopaedic Implant Company	1	0	2024-02-02
Globus Medical, Inc.	1	0	2024-06-03
Movmedix S.A.S.	1	1	2026-06-10
Akros Medical	1	0	2020-04-06
Lincotek Medical	1	1	2026-03-27
Medline Industries, Inc.	1	0	2021-12-10

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
C1713	HCPCS	Anchor/screw for opposing bone-to-bone or soft tissue-to-bone (implantable) ✓ CMS-verified description	Low	Generic fastener, component of fixation systems

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-06-10	K253115	Movmedix S.A.S.	LARS ACJ
2026-03-27	K252081	Lincotek Medical	SportLinc Syndesmosis Device
2025-12-22	K253727	Arthrex, Inc.	Syndesmosis TightRope PRO
2025-10-29	K251643	Wright Medical Technology, Inc. (Stryker Corporation)	Synchfix EVT
2025-07-11	K251134	TriMed, Inc.	RipCord
2025-01-23	K243624	Acumed, LLC	Acu-Sinch Knotless Mini
2024-12-23	K242091	Fusion Orthopedics	Bolo Button System
2024-11-27	K243408	Vilex, LLC	TACTIX Vector Syndesmosis System
2024-11-01	K242311	GM Dos Reis Industria e Comercio Ltda.	EXPERT - Flexible Joint Fixation System
2024-08-01	K240035	Vilex, LLC	TACTIX Vector Syndesmosis System
2024-06-03	K240947	Globus Medical, Inc.	TENSOR® Suture Button System
2024-02-02	K233531	Orthopaedic Implant Company	OIC FLEX-FIX System
2023-12-18	K232780	Cc-Instruments, Inc.	CC-Clip® Implant System
2023-10-06	K232755	Arthrex, Inc.	Arthrex FiberTape and TigerTape Cerclage Sutures
2022-08-22	K221485	Arthrex, Inc.	Arthrex FiberTape and TigerTape Cerclage Sutures
2022-06-06	K220947	Arthrex, Inc.	Arthrex Knotless AC Repair Devices
2022-06-01	K220650	TriMed, Inc.	TriMed Ripcord Device
2022-03-31	K220260	In2bones USA, LLC	Hercules Syndesmosis Implant System
2022-01-07	K212990	Acumed, LLC	Acumed Ankle Syndesmosis Repair System
2021-12-17	K213644	Arthrex, Inc.	Arthrex Knotless Mini TightRopes
2021-12-10	K211612	Medline Industries, Inc.	Medline UNITE REFLEX Dynamic Discs
2020-10-29	K200332	GM Dos Reis Industria e Comercio Ltda.	EXPERT - Joint Fixation System
2020-09-03	K201522	Arthrex, Inc.	Arthrex Syndesmosis TightRope XP Buttress Plate Implant System
2020-04-06	K200361	Akros Medical	Akros Scruture Anchor LisFranc Repair Kit