Chrysalis Intelligence · Product Codes · KWI

KWI · Prosthesis, Elbow, Hemi-, Radial, Polymer

Orthopedic · 6 clearances · 5 unique sponsors

Device class
Class II
Regulation 888.3170
Total clearances
6
2020-01-07 → 2026-07-30
Last 12 months
1
Unique sponsors
5
Medical specialty
Orthopedic
Review panel
OR
Regulation number
888.3170
Implant
Y
Life-sustain / support
N
GMP exempt
N
Third-party review
N
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
In2bones USA, LLC 2 0 2021-12-17
BioPoly, LLC 1 0 2024-03-13
DePuy Synthes 1 0 2022-03-18
Skeletal Dynamics, Inc. 1 0 2023-09-28
Arthrex, Inc. 1 1 2026-07-30
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
24360 CPT High Standard CPT for elbow prosthesis implantation
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-07-30 K260624 Arthrex, Inc. Arthrex Radial Head Replacement System
2024-03-13 K233592 BioPoly, LLC BioPoly Radial Head Implant
2023-09-28 K231188 Skeletal Dynamics, Inc. ALIGN Radial Head System
2022-03-18 K213563 DePuy Synthes DePuy Synthes Radial Head Replacement System
2021-12-17 K212872 In2bones USA, LLC Avenger Radial Head System
2020-01-07 K192754 In2bones USA, LLC Avenger Radial Head System