Chrysalis Intelligence · Product Codes · MEH

MEH · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

Orthopedic · 23 clearances · 15 unique sponsors

Device class
Class II
Regulation 888.3353
Total clearances
23
2020-02-04 → 2026-08-10
Last 12 months
2
Unique sponsors
15
Medical specialty
Orthopedic
Review panel
OR
Regulation number
888.3353
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
Signature Orthopaedics Pty, Ltd. 6 0 2024-11-25
Ortho Development Corp. 2 0 2025-05-22
Depuy Ireland UC 2 0 2024-01-19
Conformis, Inc. 2 0 2023-05-23
Medacta International S.A. 1 0 2025-06-13
Stryker Orthopaedics 1 0 2021-08-16
Nextstep Arthropedix 1 0 2024-09-13
Implantcast GmbH 1 0 2020-10-16
Corin, Ltd. 1 1 2026-08-10
DePuy Orthopaedics, Inc. 1 0 2020-02-04
Stryker 1 0 2022-08-11
Waldemar Link GmbH & Co. KG 1 1 2025-11-05
Exactech, Inc. 1 0 2025-03-10
United Orthopedic Corporation 1 0 2025-05-01
Corin U.S.A. Limited 1 0 2024-10-03
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
27130 CPT High CPT for total hip arthroplasty with prosthesis; standard code for hip prosthesis including non-porous variants
L5250 HCPCS Hip disarticulation, canadian type; molded socket, hip joint, single axis constant friction knee, shin, sach foot ✓ CMS-verified description Medium HCPCS prosthetic hip component code, alternative billing approach
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-08-10 K261576 Corin, Ltd. Icona Hip Stem
2025-11-05 K250375 Waldemar Link GmbH & Co. KG Allure Hip Stem and Intramedullary Plugs
2025-06-13 K251166 Medacta International S.A. Mfinity Femoral System
2025-05-22 K251052 Ortho Development Corp. Trivicta® Hip Stem
2025-05-01 K242315 United Orthopedic Corporation Resolve Modular Revision Hip Stem
2025-03-10 K243839 Exactech, Inc. Alteon® HA Femoral Stems
2024-11-25 K243162 Signature Orthopaedics Pty, Ltd. World Liner
2024-10-03 K241472 Corin U.S.A. Limited Icona Hip Stem
2024-09-13 K241875 Nextstep Arthropedix TheRay Collared and Collarless Femoral Stem
2024-08-01 K241690 Signature Orthopaedics Pty, Ltd. Logical Liner; World Liner; World Knee Patella
2024-03-08 K233758 Ortho Development Corp. Trivicta™ Hip Stem
2024-01-19 K231873 Depuy Ireland UC DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis – MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT Basic Press-Fit Hip Prosthesis – MR Conditional
2023-05-23 K231178 Conformis, Inc. ACTERA™ hip system
2023-01-13 K220495 Signature Orthopaedics Pty, Ltd. SignaSure Dual Mobility System
2022-08-11 K220731 Stryker Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem
2022-08-04 K221104 Conformis, Inc. Actera™ hip system
2022-01-07 K211742 Signature Orthopaedics Pty, Ltd. SignaSure Dual Mobility System
2021-09-24 K211505 Signature Orthopaedics Pty, Ltd. Encore Hip Stem
2021-08-16 K211703 Stryker Orthopaedics Insignia Hip Stem
2021-05-20 K210581 Depuy Ireland UC Actis DuoFix Hip Prosthesis- Collarless
2020-10-16 K200045 Implantcast GmbH MUTARS Cemented Femoral Stems
2020-09-21 K201278 Signature Orthopaedics Pty, Ltd. World Hip Stem, World Cup, World Liner
2020-02-04 K193398 DePuy Orthopaedics, Inc. Summit DuoFix HA Coating