Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2242737

FEI Number

3001548076

Entity Name

KEN-MAR MACHINE MFG CORP

City/State/Country

Paterson, NJ, US

Establishment Address

477 East 30th Street, Paterson, NJ 07504, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Ken-Mar Machine Mfg Corp (Owner Number: 10043498)

Owner / Operator Contact Address

477 East 30th Street, Paterson, NJ 07504, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2013-02-22
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2013-02-22
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2013-02-22
JDL	Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)	Orthopedic	Class 3	888.3320	2013-02-26
JDC	Prosthesis, Elbow, Constrained, Cemented	Orthopedic	Class 2	888.3150	2013-02-22
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2013-02-22
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2013-02-22
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3520	2013-02-22
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2013-02-26
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2013-02-22
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2013-02-22
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2013-02-22
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2013-02-22
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2013-02-22
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2013-02-22
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2013-02-25
OQG	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	Orthopedic	Class 2	888.3358	2013-02-25
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2013-02-25
OQH	Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented	Orthopedic	Class 2	888.3350	2013-02-25
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2013-02-22
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2013-02-22
HRY	Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3530	2013-02-21
HXB	Probe	Orthopedic	Class 1	888.4540	2013-02-25
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2013-02-22
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2013-02-22
NPJ	Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2013-02-22
KRR	Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3540	2013-02-22
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3520	2013-02-22
HRY	Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3530	2013-02-22
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2013-02-22
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2013-02-22
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3520	2013-02-22
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2013-02-22
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2013-02-22
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2013-02-22
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2013-02-22
LZN	Cement Obturator	General, Plastic Surgery	Class 2	878.3300	2013-02-26
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2013-02-22
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2013-02-22
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2013-02-22
JDK	Prosthesis, Hip, Cement Restrictor	General, Plastic Surgery	Class 2	878.3300	2013-02-22
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2013-02-21
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2013-02-22
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2013-02-21
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2013-02-22
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2013-02-22
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2013-02-22
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2013-02-22
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2013-02-22
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2013-02-22
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2013-02-21
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2013-02-22

Official Correspondent

Rudy Schloesser

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Ken-Mar Machine Mfg Corp

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
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
K122985	Aesculap Implant System, Inc.	COLUMBUS REVISION KNEE SYSTEM	2012-10-26

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 2242737. Last updated year: 2026. Please use registration number 2242737 when referencing this establishment in official correspondence.