Chrysalis Intelligence · Product Codes · KTT

KTT · Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Orthopedic · 48 clearances · 27 unique sponsors

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Device class

Class II

Regulation 888.3030

Total clearances

2020-07-29 → 2026-06-11

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
Paragon 28, Inc.	6	1	2025-12-19
Vilex, LLC	4	1	2026-04-17
Smith & Nephew, Inc.	3	0	2021-07-29
OrthoPediatrics Corp.	3	0	2025-03-07
Wishbone Medical, Inc.	3	0	2023-06-16
Stryker GmbH	3	1	2025-12-19
Response Ortho Solutions, LLC	2	1	2025-11-20
Synthes (USA) Products, LLC	2	1	2026-06-11
S.H.Pitkar Orthotools Pvt. , Ltd.	2	0	2020-10-06
Orthofix Srl	2	0	2024-12-03
Extremity Medical, LLC	2	0	2025-05-07
New Standard Device Dba Metalogix	1	0	2024-05-30
Orthonovis, Inc.	1	0	2022-08-25
Auxein Medical Private Limited	1	0	2023-11-30
Aike (Shanghai) Medical Instrument Co., Ltd.	1	0	2021-01-05
Metric Medical Devices, Inc.	1	0	2024-05-29
Medusa Orthopedics, LLC	1	1	2025-11-25
Glw Medical Innovation	1	0	2020-09-14
Arrowhead De, LLC	1	0	2020-09-22
Sequel Medical, Inc.	1	0	2021-01-19
DePuy Synthes	1	0	2023-07-26
Orthospin, Ltd.	1	0	2021-01-06
Amdt Holdings, Inc.	1	0	2025-08-08
Arthrex, Inc.	1	0	2023-10-18
Orthopaedic Implant Company	1	0	2021-05-05

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 with multiplane fixation
20680	CPT	—	Medium	CPT for adjustment or revision of external fixation device

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-06-11	K254087	Synthes (USA) Products, LLC	MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction System
2026-04-17	K260900	Vilex, LLC	DYNEX® External Fixation Systems
2026-03-23	K260112	Stabiliz Orthopaedics, Inc.	QuikFix External Fixator: Knee-Spanning Pack
2026-01-20	K253291	Blue Ocean Global	Excelsior System
2025-12-19	K253613	Paragon 28, Inc.	Monkey Rings External Ring Fixation System
2025-12-19	K253202	Stryker GmbH	Hoffmann LRF System
2025-11-25	K252555	Medusa Orthopedics, LLC	Medusa Orthopedics Boa External Fixation System
2025-11-20	K252625	Response Ortho Solutions, LLC	The Response Ortho Smart Fixator - Hexapod System
2025-09-30	K252106	Paragon 28, Inc.	External Fixation Mini Rail System
2025-08-11	K251862	Paragon 28, Inc.	External Fixation Bone Distractor
2025-08-08	K250472	Amdt Holdings, Inc.	SixFix Hexapod Fixator and Deformity Analysis and Correction Software (DACS)
2025-05-07	K251128	Extremity Medical, LLC	Extremity Medical External Fixation System
2025-03-07	K243798	OrthoPediatrics Corp.	Orthex External Fixation System
2025-02-21	K241563	Extremity Medical, LLC	Extremity Medical External Fixation System
2024-12-03	K242861	Orthofix Srl	TrueLok Elevate
2024-11-01	K242452	Paragon 28, Inc.	Monkey Bars Pin to Bar External Fixation System
2024-09-18	K241769	Response Ortho Solutions, LLC	Response Ortho Metaphyseal Hinge Fixator System
2024-05-30	K233025	New Standard Device Dba Metalogix	Revolution External Plating System
2024-05-29	K240049	Metric Medical Devices, Inc.	LINK(TM) External Fixator
2023-12-21	K233741	Stryker GmbH	Hoffmann LRF System
2023-11-30	K221787	Auxein Medical Private Limited	Auxein's DHS/DCS Plate System
2023-10-18	K232897	Arthrex, Inc.	Arthrex Small External Fixation System
2023-10-12	K232838	Paragon 28, Inc.	Monkey RingsTM External Fixation System
2023-07-26	K231922	DePuy Synthes	DEPUY SYNTHES MAXFRAME AUTOSTRUT System
2023-06-16	K231461	Wishbone Medical, Inc.	Smart Correction System (HA Half Pins)