Chrysalis Intelligence · Product Codes · KWT

KWT · Unclassified

9 clearances · 7 unique sponsors

Device class
Regulation —
Total clearances
9
2020-07-16 → 2025-12-01
Last 12 months
2
Unique sponsors
7
Medical specialty
Review panel
Regulation number
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
Implantcast GmbH 3 0 2025-03-10
Shoulder Innovations, Inc. 1 0 2025-02-11
Biomet Orthopedics 1 0 2023-07-12
Waldemar Link GmbH & Co. KG 1 0 2021-06-21
Fx Shoulder USA, Inc. 1 0 2020-07-16
Tornier, Inc. 1 1 2025-10-30
Exactech, Inc. 1 1 2025-12-01
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.

CodeTypeDescriptionConfidenceRationale
23470 CPT High Standard CPT for shoulder prosthesis implantation, non-constrained
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2025-12-01 K250713 Exactech, Inc. Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants
2025-10-30 K251686 Tornier, Inc. Tornier Humeral Reconstruction System Max (Tornier HRS Max)
2025-03-10 K241944 Implantcast GmbH AGILON® XO Shoulder Replacement System
2025-02-11 K241817 Shoulder Innovations, Inc. InSet Total Shoulder System
2024-02-16 K231657 Implantcast GmbH AGILON® XO Shoulder Replacement System
2023-07-12 K223631 Biomet Orthopedics Comprehensive Segmental Revision System(SRS)
2022-09-28 K222482 Implantcast GmbH AGILON XO Shoulder System
2021-06-21 K210899 Waldemar Link GmbH & Co. KG LINK Embrace Shoulder System- Anatomical Configuration
2020-07-16 K191698 Fx Shoulder USA, Inc. TiN Coated Humeral Head