Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013186738

FEI Number

3013186738

Entity Name

Heraeus Medical LLC

City/State/Country

Yardley, PA, US

Establishment Address

Township Line Road 770, Suite 300, Yardley, PA 19067, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Heraeus Medical GmbH (Owner Number: 10048423)

Owner / Operator Contact Address

Philipp-Reis-Str. 8/13, Wehrheim, DE-HE 61273, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PALACOS® R+G pro PALACOS® R+G Palacos G OSTEOPAL V Palamed® G PALACOS® MV+G PALACOS® R pro PALACOS® MV+G pro PALACOS® R+G pro PALACOS® fast R+G Palacos® R COPAL® exchange G PALACOS® MV pro PALAMIX Cement Gun PALAMIX Nozzle Slim PALAMIX Nozzle Medium pro nozzle medium pro nozzle short with knee pressuriser

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KIH	Dispenser, Cement	Orthopedic	Class 1	888.4200	2015-01-13
MBB	Bone Cement, Antibiotic	Orthopedic	Class 2	888.3027	2015-01-13
JDZ	Mixer, Cement, For Clinical Use	Orthopedic	Class 1	888.4210	2015-01-13
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2015-01-13
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2024-05-06
MBB	Bone Cement, Antibiotic	Orthopedic	Class 2	888.3027	2024-05-06
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2024-05-06
MBB	Bone Cement, Antibiotic	Orthopedic	Class 2	888.3027	2015-01-13
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2015-01-13
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2025-01-15
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2025-01-15
MBB	Bone Cement, Antibiotic	Orthopedic	Class 2	888.3027	2015-01-12
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2015-01-12
JDZ	Mixer, Cement, For Clinical Use	Orthopedic	Class 1	888.4210	2021-07-12
KIH	Dispenser, Cement	Orthopedic	Class 1	888.4200	2021-07-12
MBB	Bone Cement, Antibiotic	Orthopedic	Class 2	888.3027	2021-07-12
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2021-07-12
MBB	Bone Cement, Antibiotic	Orthopedic	Class 2	888.3027	2019-06-03
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2019-06-03
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2015-01-12
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2019-11-22
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2019-11-22
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2019-11-22
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2022-02-03
KIH	Dispenser, Cement	Orthopedic	Class 1	888.4200	2022-02-03
JDZ	Mixer, Cement, For Clinical Use	Orthopedic	Class 1	888.4210	2022-02-03
KIH	Dispenser, Cement	Orthopedic	Class 1	888.4200	2017-11-20

Official Correspondent

Benjamin Hagedorn

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Heraeus Medical GmbH

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3006406161	Heraeus Medical GmbH	WEHRHEIM Hesse, DE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K823482	Intermedics Orthopedics	101 UNIVERSAL ENDOPROSTHESIS	1983-02-07
K901338	Kirschner Medical Corp.	KIRSCHNER MODULAR TCIV TOTAL KNEE SYSTEM	1990-05-22
K030577	Stelkast Company	PROVEN MODULAR TIBIAL TRAY	2003-03-25
K153310	Total Joint Orthopedics, Inc.	Klassic Knee System	2015-12-17
K102380	Wrightmedicaltechnologyinc	EVOLUTION MP TOTAL KNEE SYSTEM	2011-01-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2019	Smith & Nephew, Inc.	2	Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, 74021214, 74021215, 74021216, 74021217, 74021218, 74021219, 74021220, 74021221, 74021222, 74021223, 74021224, 74021225, 74021226, 74021227, 74021228, 74021229
Z-0002-2019	Smith & Nephew, Inc.	2	JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112, 74021113, 74021114, 74021115, 74021116, 74021117, 74021118, 74021119, 74021120, 74021121, 74021122, 74021123, 74021124, 74021125, 74021126, 74021127, 74021128, 74021129, 74021130, 74021131, 74021132, 74021133, 74021134, 74021135, 74021136, 74021137, 74021138, 74021139, 74021140, 74021141, 74021142, 74021143, 74021144, 74021145, 74021146, 74021147, 74021148, 74021149
Z-0003-2017	Zimmer Biomet, Inc.	2	Vanguard 360 Revision Knee System Knee prostheses
Z-0003-2019	Smith & Nephew, Inc.	2	JOURNEY BCS Knee Conventional Polyethylene Inserts: 74023111, 74023112, 74023113, 74023114, 74023115, 74023116, 74023117, 74023118, 74023121, 74023122, 74023123, 74023124, 74023125, 74023126, 74023127, 74023128, 74023131, 74023132, 74023133, 74023134, 74023135, 74023136, 74023137, 74023138, 74023141, 74023142, 74023143, 74023144, 74023145, 74023146, 74023147, 74023148, 74023211, 74023212, 74023213, 74023214, 74023215, 74023216, 74023217, 74023218, 74023221, 74023222, 74023223, 74023224, 74023225, 74023226, 74023227, 74023228, 74023231, 74023232, 74023233, 74023234, 74023235, 74023236, 74023237, 74023238, 74023241, 74023242, 74023243, 74023244, 74023245, 74023246, 74023247, 74023248, 74023251, 74023252, 74023253, 74023254, 74023255, 74023256, 74023257, 74023258, 74023261, 74023262, 74023263, 74023264, 74023265, 74023266, 74023267, 74023268, 74023271, 74023272, 74023273, 74023274, 74023275, 74023276, 74023277, 74023278, 74023281, 74023282, 74023283, 74023284, 74023285, 74023286, 74023287, 74023288, 74023311, 74023312, 74023313, 74023314, 74023315, 74023316, 74023317, 74023318, 74023321, 74023322, 74023323, 74023324, 74023325, 74023326, 74023327, 74023328, 74023331, 74023332, 74023333, 74023334, 74023335, 74023336, 74023337, 74023338, 74023341, 74023342, 74023343, 74023344, 74023345, 74023346, 74023347, 74023348, 74023411, 74023412, 74023413, 74023414, 74023415, 74023416, 74023417, 74023418, 74023421, 74023422, 74023423, 74023424, 74023425, 74023426, 74023427, 74023428, 74023431, 74023432, 74023433, 74023434, 74023435, 74023436, 74023437, 74023438, 74023441, 74023442, 74023443, 74023444, 74023445, 74023446, 74023447, 74023448, 74023451, 74023452, 74023453, 74023454, 74023455, 74023456, 74023457, 74023458, 74023461, 74023462, 74023463, 74023464, 74023465, 74023466, 74023467, 74023468, 74023471, 74023472, 74023473, 74023474, 74023475, 74023476, 74023477, 74023478, 74023481, 74023482, 74023483, 74023484, 74023485, 74023486, 74023487, 74023488, 74023648, 74203326
Z-0013-06	Plus Orthopedics USA	2	TC-PLUS Tibial Insert Ultra-Congruent Size 10 ; 9 mm, Model 25456

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013186738. Last updated year: 2026. Please use registration number 3013186738 when referencing this establishment in official correspondence.