Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005751028

FEI Number

3005751028

Entity Name

Zimmer Trabecular Metal Technology, Inc.

City/State/Country

Parsippany, NJ, US

Establishment Address

10 POMEROY RD., Parsippany, NJ 07054, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ZIMMER, INC. (Owner Number: 1822565)

Owner / Operator Contact Address

345 E. Main Street, --, Warsaw, IN 46580, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K050101

PMA Number

N/A

All Registered Proprietary Names

CERVICAL BONE IMPACTOR BAYONET IMPACTOR HANDLE trabecular metal (tm) vertebral body replacement trabecular metal vertebral body replacement TM Ardis Interbody Fusion Device-Solid TM-400 Lateral Grasping Inserter (Specialty Instrument based off of TM-400 Insert-K120203)- CE Marked for Export Only TM-300 Specialty Inserter (Specialty Instrument based off of TLIF Inserter-K120203)- CE Marked for Export Only TRABECULAR METAL K MUSCULOSKELETAL COMPRESSOR RONGUER STRAIGHT trabecular metal vertebral body replacement Persona Revision Knee System SCREW DEPTH GAUGE SOFT GRAFT TAMP WIRE TAMP trabecular metal tibial cone augments TM-S Fusion Device and Mergence-S Instrumentation TM-S PLE CROSS LINKED POLYETHYLENE ACETABULAR COMPONENTS MODEL XX-YY-ZZZZZZ TM Ardis Inserter Persona Revision Knee System EXTRAMEDEDULLARY TI HARRINGTON PROTRACTOR Osteotome BOX OSTEOTOME Ratcheting Deflection Beam Wrench Derotator zimmer tmt trabecular metal vertebral hedrocel trabecular metal vertebral body replacement, mod Vista-S Device trabecular metal vertebral body replacement CONTINUUM KNEE SYSTEM (CKS) BONE HARVESTER Ultra battery powerd system, accessories, and attachments Battery Powered System, accessories, and attachments PSN Valgus Alignment Guide TM-400 and associated instrumentation hedrocel trabecular metal vertebral body replacement Trabecular Metal Glenoid B/F Comple trabecular metal acetabular augments trabecular metal acetabular augments explant osteonecrosis intervention impl RETRACTOR ZIMMER BRACE Positioner, Socket Universal Sterilization Case RETRACTOR CASE Various Trays LABELING FOR MYO/WIRE II STERNOTOMY SUTURES TRABECULAR METAL OSTEONEC

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HWA	Impactor	Orthopedic	Class 1	888.4540	2006-05-26
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2011-05-12
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2006-05-26
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2011-05-12
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2011-05-12
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2011-05-12
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2012-04-20
KTZ	Caliper	Orthopedic	Class 1	888.4150	2006-05-26
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2006-05-26
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2006-05-26
HWT	Template	Orthopedic	Class 1	888.4800	2006-05-26
HXZ	Cutter, Wire	Orthopedic	Class 1	888.4540	2006-05-26
HWN	Instrument, Compression	Orthopedic	Class 1	888.4540	2006-05-26
HXB	Probe	Orthopedic	Class 1	888.4540	2006-05-26
HTZ	Instrument, Cutting, Orthopedic	General, Plastic Surgery	Class 1	878.4800	2007-01-24
HTX	Rongeur	Orthopedic	Class 1	888.4540	2006-05-26
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2011-05-12
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2018-10-26
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2018-10-26
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2018-10-26
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2006-05-26
HXG	Tamp	Orthopedic	Class 1	888.4540	2006-05-26
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2011-05-12
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2011-05-12
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2011-01-13
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2011-05-12
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2012-04-20
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2011-05-12
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2011-05-12
HWR	Driver, Prosthesis	Orthopedic	Class 1	888.4540	2006-05-26
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2013-04-22
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2019-09-09
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2019-09-09
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2019-09-09
HTH	Protractor	Orthopedic	Class 1	888.4600	2006-05-26
HWJ	Awl	Orthopedic	Class 1	888.4540	2006-05-26
HWM	Osteotome	General, Plastic Surgery	Class 1	878.4800	2006-05-26
HXC	Wrench	Orthopedic	Class 1	888.4540	2006-05-26
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2011-05-12
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2011-05-12
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2012-05-09
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2012-05-09
HWB	Extractor	Orthopedic	Class 1	888.4540	2006-05-26
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2011-05-12
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2006-05-26
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	1999-05-20
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2012-09-06
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2012-09-06
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2011-05-12
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2008-12-22
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2008-12-22
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2011-05-12
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2011-05-12
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2011-05-12
HXP	Instrument, Bending Or Contouring	Orthopedic	Class 1	888.4540	2007-01-24
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2011-05-12
HTO	Reamer	Orthopedic	Class 1	888.4540	2006-05-26
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2011-05-12
HXO	Pusher, Socket	Orthopedic	Class 1	888.4540	2006-05-26
HXY	Brace, Drill	Orthopedic	Class 1	888.4540	2006-05-26
KIL	Positioner, Socket	Orthopedic	Class 1	888.4540	2006-05-26
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	1999-05-20
GAO	Suture, Nonabsorbable	General, Plastic Surgery	Class 2	878.4495	2026-02-13
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2006-08-04

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ZIMMER, INC.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
8031000	ZIMMER SURGICAL SA	1228 Plan Les Ouates Geneve, CH
3020393263	Zimmer U.S., Inc. Connected Health	Grand Rapids, MI, US
1526350	ZIMMER SURGICAL, INC.	Dover, OH, US
3012392319	Zimmer Biomet Canada DFE	Mississauga Ontario, CA
2648920	ZIMMER MANUFACTURING B.V.	MERCEDITA, PR, US

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-0010-2008	N/A	1	EPIK KNEE SYSTEM Angled Insert Impactor RM/LL; Part #801-03-052 Rev. A; non-sterile; knee prosthesis instrument. Distributed by Encore Medical, L.P., Austin, TX 78758.
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005751028. Last updated year: 2026. Please use registration number 3005751028 when referencing this establishment in official correspondence.