LPH · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Device class

Class II

Regulation 888.3358

Total clearances

2020-05-14 → 2026-09-23

Last 12 months

Unique sponsors

Classification details

Medical specialty

Orthopedic

Review panel

Regulation number

888.3358

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
Depuy Ireland UC	6	0	2025-01-22
Medacta International S.A.	6	2	2026-08-28
Howmedica Osteonics Corp., Dba Stryker Orthopaedics	5	1	2026-07-10
Smith & Nephew, Inc.	5	0	2024-10-07
Globus Medical, Inc.	4	1	2026-08-04
Corentec Co., Ltd.	4	0	2023-02-27
Waldemar Link GmbH & Co. KG	3	0	2024-11-08
Lima Corporate S.P.A.	2	0	2025-08-29
Microport Orthopedics	2	0	2024-04-18
Encore Medical L.P.	2	1	2025-11-12
Zimmer GmbH	2	1	2026-02-04
Onkos Surgical	2	0	2023-01-30
Howmedica Osteonics Corp (Dba Stryker Orthopaedics)	1	0	2025-07-25
United Orthopedic Corporation	1	0	2022-11-04
DePuy Orthopaedics, Inc.	1	0	2020-10-21
Zimmer Biomet	1	1	2026-09-23
Kyocera Medical Technologies, Inc.	1	0	2025-04-10
Meril Healthcare Pvt. , Ltd.	1	0	2023-05-09
Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics	1	0	2021-04-22
Signature Orthopaedics Pty, Ltd.	1	0	2020-08-14
Restor3D, Inc.	1	1	2025-12-05
Howmedica Osteonics Corp. (Aka Stryker Orthopaedics)	1	0	2020-05-27
Nextstep Arthopedix, LLC	1	1	2026-06-05
Ortho Development Corp.	1	0	2024-10-11
Beijing Keyi Medical Device Technology Co., Ltd.	1	0	2020-05-14

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
27130	CPT	—	High	Total hip arthroplasty; semi-constrained metal/polymer prosthesis
S2348	HCPCS	Decompression procedure, percutaneous, of nucleus pulposus of intervertebral disc, using radiofrequency energy, single or multiple levels, lumbar ✓ CMS-verified description	Medium	Uncemented hip prosthesis; alternative payment modifier

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-09-23	K261453	Zimmer Biomet	G7® Acetabular System
2026-08-28	K253630	Medacta International S.A.	Mpact 3D Metal Foam
2026-08-04	K254043	Globus Medical, Inc.	TRIVANCE Hip Stem
2026-07-10	K261624	Howmedica Osteonics Corp., Dba Stryker Orthopaedics	Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar Component
2026-06-05	K243192	Nextstep Arthopedix, LLC	iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating
2026-05-19	K251270	Biomet, Inc.	Taperloc® Complete Hip Stem
2026-02-04	K252623	Zimmer, Inc.	G7® Revision Acetabular System
2026-01-28	K251043	Medacta International S.A.	Mpact 3D Metal Implants Extension DMLS Technology
2025-12-05	K252067	Restor3D, Inc.	Velora Acetabular System
2025-11-20	K252846	Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics	TaperSet Hip System
2025-11-12	K251833	Encore Medical L.P.	EMPOWR Acetabular® Liner Extension
2025-08-29	K251718	Lima Corporate S.P.A.	ArTT Augments and Buttresses and Bone Screws
2025-07-25	K250989	Howmedica Osteonics Corp (Dba Stryker Orthopaedics)	Stryker and Serf hip devices
2025-06-06	K243456	Globus Medical, Inc.	ONVOY Acetabular System
2025-06-05	K242744	Corin U.S.A. Limited	Trinity EVO Acetabular Shell
2025-04-23	K242232	Medacta International S.A.	Mpact 3D Metal Augments II
2025-04-10	K242045	Kyocera Medical Technologies, Inc.	Initia T3 Acetabular Hemispherical Shell System
2025-02-06	K243784	Howmedica Osteonics Corp., Dba Stryker Orthopaedics	Stryker Orthopaedics Hip Devices Labeling Update
2025-01-22	K243977	Depuy Ireland UC	EMPHASYS Acetabular System
2025-01-13	K241059	Adler Ortho S.P.A	Pantheon Proximal Femur Reconstruction (PFR) System
2024-11-08	K241636	Waldemar Link GmbH & Co. KG	MobileLink Acetabular Cup System - Line Extension (Multiple)
2024-10-11	K242833	Ortho Development Corp.	Legend® Acetabular Shell
2024-10-07	K242375	Smith & Nephew, Inc.	OR3O Dual Mobility System
2024-10-07	K242084	Depuy Ireland UC	EMPHASYS Acetabular Shell with RapiTite HA
2024-04-18	K240046	Microport Orthopedics	Ethylene Oxide Sterilization Supplier Change for MPO Hips