Chrysalis Intelligence · Product Codes · KWY

KWY · Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented

Orthopedic · 7 clearances · 7 unique sponsors

Device class
Class II
Regulation 888.3390
Total clearances
7
2020-04-17 → 2026-04-13
Last 12 months
1
Unique sponsors
7
Medical specialty
Orthopedic
Review panel
OR
Regulation number
888.3390
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
Depuy Ireland UC 1 0 2023-12-19
Waldemar Link GmbH & Co. KG 1 0 2022-07-20
G21, S.R.L. 1 0 2023-03-23
Kyocera Medical Technologies, Inc. 1 0 2020-04-17
B-One Ortho, Corp. 1 1 2026-04-13
Heraeus Medical GmbH 1 0 2022-03-23
Maxx Orthopedics, Inc. 1 0 2025-08-25
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
27125 CPT High Standard CPT for hip prosthesis hemi-implantation, femoral
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-04-13 K253357 B-One Ortho, Corp. b-ONE® Bipolar Head
2025-08-25 K243634 Maxx Orthopedics, Inc. Maxx Libertas Bipolar Hip Head (Bipolar Hip)
2023-12-19 K231526 Depuy Ireland UC CORAIL Cemented Femoral Stem
2023-03-23 K223441 G21, S.R.L. SpaceFlex Acetabular Cup
2022-07-20 K221794 Waldemar Link GmbH & Co. KG Vario-Cup System
2022-03-23 K220492 Heraeus Medical GmbH COPAL exchange G hip spacer
2020-04-17 K200709 Kyocera Medical Technologies, Inc. Kyocera Bipolar Hip System