Data / Medical devices / Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer (MBH): 168 FDA-registered makers in 20 countries

Name: FDA-registered makers of Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

168 establishments in 20 countries are registered with the FDA to make Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer (product code MBH, Class 2, 21 CFR 888.3565). 49 of them have a 510(k) clearance or PMA approval on file and 8 have a recall event. The FDA has issued 146 510(k) clearances under this code, the latest on September 17, 2026, and lists 44 recall events (3 Class I). FDA data exported November 2, 2026.

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Product code: MBH
Device class: 2
Regulation: 888.3565
Medical specialty: Orthopedic
Implant: Yes

Makers by country

Country	Makers
United States	103
Ireland	12
China	10
Italy	7
Switzerland	6
Malaysia	6
Germany	5
Canada	4
Taiwan	3
United Kingdom	2
Belgium	1
Ukraine	1
Costa Rica	1
Australia	1
South Korea	1
San Marino	1
France	1
Colombia	1
Indonesia	1
Mexico	1

Makers of Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

Maker	Location	Role	510(k) clearances	Latest clearance	Recall events	Class I	Source
Zimmer, Inc.	Warsaw, IN, United States	Contract manufacturer, Manufacturer	21	May 28, 2026	8	0	api.fda.gov
Howmedica Osteonics Corp	Mahwah, NJ, United States	Contract manufacturer, Contract sterilizer, Manufacturer, Specification developer	16	February 18, 2026	14	1	api.fda.gov
Microport Orthopedics Inc.	Arlington, TN, United States	Manufacturer	13	January 18, 2024	2	1	api.fda.gov
Howmedica International S. De R.L.	LIMERICK Munster, Ireland	Manufacturer	12	October 24, 2025	0	0	api.fda.gov
Biomet, Inc.	Warsaw, IN, United States	Manufacturer	10	May 10, 2016	6	0	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	10	September 8, 2026	4	0	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	10	September 8, 2026	0	0	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	9	October 1, 2021	0	0	api.fda.gov
Depuy Orthopaedics, Inc.	Warsaw, IN, United States	Manufacturer, Specification developer	8	June 18, 2024	3	1	api.fda.gov
Stryker Ireland Osteonics	County Cork, Ireland	Manufacturer, Specification developer	8	August 15, 2019	0	0	api.fda.gov
Depuy Ireland UC	Co. Cork Munster, Ireland	Manufacturer, Specification developer	6	June 18, 2024	0	0	api.fda.gov
Zimmer Orthopedics Manufacturing Limited-Galway	Oranmore Galway(County), Ireland	Manufacturer	6	October 29, 2024	0	0	api.fda.gov
Zimmer Trabecular Metal Technology, Inc.	Parsippany, NJ, United States	Manufacturer	6	June 29, 2012	2	0	api.fda.gov
Encore Medical, L.P.	Austin, TX, United States	Manufacturer	4	January 20, 2022	4	0	api.fda.gov
Exactech, Inc.	Gainesville, FL, United States	Manufacturer	4	October 3, 2024	0	0	api.fda.gov
Limacorporate S.p.A.	Villanova di San Daniele Udine, Italy	Manufacturer	4	May 22, 2025	0	0	api.fda.gov
United Orthopedic Corp.	Kaohsiung, Taiwan	Exporter to the US, Manufacturer	4	July 31, 2025	0	0	api.fda.gov
United Orthopedic Corporation	Hsinchu Hsinchu(County), Taiwan	Exporter to the US, Manufacturer	4	July 31, 2025	0	0	api.fda.gov
UOC USA Inc.	Irvine, CA, United States	Manufacturer, Manufacturer for export	4	July 31, 2025	0	0	api.fda.gov
Zimmer Orthopedic Mfg Ltd	Shannon Clare, Ireland	Manufacturer	4	May 17, 2018	0	0	api.fda.gov
Arthrex, Inc.	Naples, FL, United States	Specification developer	3	November 7, 2017	0	0	api.fda.gov
Maxx Orthopedics Inc.	Norristown, PA, United States	Complaint file establishment, Manufacturer, Specification developer	3	October 31, 2025	0	0	api.fda.gov
Medacta International SA	Castel San Pietro Ticino, Switzerland	Complaint file establishment, Manufacturer	3	February 26, 2026	0	0	api.fda.gov
Medacta International SA	Rancate Ticino, Switzerland	Complaint file establishment, Manufacturer	3	February 26, 2026	0	0	api.fda.gov
Optimotion Implants, LLC	Orlando, FL, United States	Complaint file establishment, Specification developer	3	June 27, 2024	0	0	api.fda.gov
Zhejiang Biomet Medical Products Co., Ltd.	Jinhua Zhejiang, China	Contract manufacturer, Manufacturer	3	July 30, 2014	0	0	api.fda.gov
Arthrex Manufacturing Inc.	Pendleton, SC, United States	Contract manufacturer, Contract sterilizer, Manufacturer	2	February 19, 2016	0	0	api.fda.gov
Changzhou Biomet Medical Devices Co., Ltd.	Changzhou City Jiangsu, China	Contract manufacturer, Manufacturer	2	December 11, 2013	0	0	api.fda.gov
ConforMIS, Inc.	Wilmington, MA, United States	Manufacturer	2	March 27, 2025	0	0	api.fda.gov
Depuy (ireland)	CO. CORK Munster, Ireland	Manufacturer, Specification developer	2	February 13, 2015	0	0	api.fda.gov
Materialise N.V.	LEUVEN Vlaams Brabant, Belgium	Manufacturer	2	April 2, 2014	0	0	api.fda.gov
Materialise Sdn Bhd	Petaling Jaya Selangor, Malaysia	Manufacturer	2	April 2, 2014	0	0	api.fda.gov
Materialise USA, LLC.	Plymouth, MI, United States	Manufacturer	2	April 2, 2014	0	0	api.fda.gov
Materialise Ukraine, Rep. office	Kyiv Kyyiv, Misto, Ukraine	Manufacturer	2	April 2, 2014	0	0	api.fda.gov
Microport Orthopedics, S.A.	Sabana Norte San Jose, Costa Rica	Specification developer	2	January 5, 2022	0	0	api.fda.gov
Shalby Advanced Technologies, Inc.	El Dorado Hills, CA, United States	Contract manufacturer, Contract sterilizer, Manufacturer	2	June 27, 2011	0	0	api.fda.gov
Smith & Nephew Inc.	Oklahoma City, OK, United States	Manufacturer	2	September 8, 2026	0	0	api.fda.gov
Waldemar Link GmbH & Co. KG	Norderstedt Schleswig-Holstein, Germany	Manufacturer	2	July 17, 2020	0	0	api.fda.gov
Zimmer Manufacturing B.V.	Mercedita, PR, United States	Manufacturer	2	May 17, 2018	0	0	api.fda.gov
Aesculap AG	TUTTLINGEN, DONAU Baden-Wurttemberg, Germany	Manufacturer	1	January 15, 2004	0	0	api.fda.gov
Depuy Intl., Ltd.	Leeds, United Kingdom	Specification developer	1	February 13, 2015	0	0	api.fda.gov
Exactech Sarasota	Sarasota, FL, United States	Manufacturer	1	November 26, 2018	0	0	api.fda.gov
OMNIlifeScience, Inc.	Raynham, MA, United States	Manufacturer, Specification developer	1	May 23, 2008	0	0	api.fda.gov
Ortho Development Corp.	Draper, UT, United States	Manufacturer	1	December 19, 2025	0	0	api.fda.gov
Signature Orthopaedics Pty Limited	Sydney New South Wales, Australia	Manufacturer	1	December 23, 2025	0	0	api.fda.gov
Signature Orthopaedics Europe Ltd	Athlone Westmeath, Ireland	Manufacturer	1	December 23, 2025	0	0	api.fda.gov
Total Joint Orthopedics, Inc.	Salt Lake City, UT, United States	Complaint file establishment, Specification developer	1	October 27, 2016	0	0	api.fda.gov
Unik Orthopedics, Inc	San Jose, CA, United States	Manufacturer	1	August 12, 2020	0	0	api.fda.gov
restor3d, inc.	Durham, NC, United States	Complaint file establishment, Manufacturer	1	March 27, 2025	0	0	api.fda.gov
Adler Ortho S.P.A.	Cormano Milano, Italy	Manufacturer	0		0	0	api.fda.gov
Advanced Concept Innovations LLC	Lakeland, FL, United States	Contract manufacturer	0		0	0	api.fda.gov
Almark Tool & Manufacturing Company, Inc.	Garwood, NJ, United States	Contract manufacturer	0		0	0	api.fda.gov
Aps Materials, Inc.	Dayton, OH, United States	Contract manufacturer	0		0	0	api.fda.gov
ARCH - Quakertown	Quakertown, PA, United States	Contract manufacturer	0		0	0	api.fda.gov
Arch Medical Solutions - Philadelphia, LLC Dba Jade Precision Medical Components	Huntingdon Valley, PA, United States	Contract manufacturer	0		0	0	api.fda.gov
ARCH Medical Solutions - Memphis	Bartlett, TN, United States	Contract manufacturer	0		0	0	api.fda.gov
ARCH Medical Solutions - Memphis	Lexington, TN, United States	Contract manufacturer	0		0	0	api.fda.gov
ARCH Medical Solutions - Seabrook	Seabrook, NH, United States	Contract manufacturer	0		0	0	api.fda.gov
ARCH-MedTorque	Kenosha, WI, United States	Contract manufacturer	0		0	0	api.fda.gov
Autocam Medical	Kentwood, MI, United States	Contract manufacturer	0		0	0	api.fda.gov
Adler Ortho SpA	Mezzolombardo Trento, Italy	Contract manufacturer	0		0	0	api.fda.gov
Advanced Machine, Inc.	Winchester, TN, United States	Contract manufacturer	0		0	0	api.fda.gov
Arthrex, Inc.	Ave Maria, FL, United States	Contract manufacturer, Contract sterilizer	0		0	0	api.fda.gov
Autocam Medical	Murfreesboro, TN, United States	Contract manufacturer	0		0	0	api.fda.gov
Avalign Delivery Systems Division	Greenwood, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Baechler Feintech AG	Hoelstein Basel-Landschaft, Switzerland	Contract manufacturer	0		0	0	api.fda.gov
Blue Belt Technologies, Inc.	Pittsburgh, PA, United States	Manufacturer	0		0	0	api.fda.gov
Canwell Medical Co., Ltd.	Jinhua Zhejiang, China	Contract manufacturer	0		0	0	api.fda.gov
Caragh Precision	Galway Galway(County), Ireland	Contract manufacturer	0		0	0	api.fda.gov
Centex Machining, Inc.	Round Rock, TX, United States	Contract manufacturer	0		0	0	api.fda.gov
Cep Bio-Coat, LLC	Farmington Hills, MI, United States	Contract manufacturer	0		0	0	api.fda.gov
Corentec Co., Ltd.	Cheonan Si, Chungnam, South Korea	Exporter to the US, Manufacturer	0		0	0	api.fda.gov
CREATEC GmbH & CO. KG	FRIEDRICHSHAFEN Baden-Wurttemberg, Germany	Contract manufacturer, Exporter to the US	0		0	0	api.fda.gov
Complexus Medical	Mishawaka, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Depuy Orthopaedics, Inc.	Raynham, MA, United States	Manufacturer	0		0	0	api.fda.gov
Depuy Synthes (suzhou) Medical Devices Co., Ltd.	SUZHOU Jiangsu, China	Manufacturer	0		0	0	api.fda.gov
Donson Machine Company	Alsip, IL, United States	Contract manufacturer	0		0	0	api.fda.gov
Dot America, Inc.	Columbia City, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Eddi Bressan S.R.L.	CORMONS Gorizia, Italy	Contract manufacturer	0		0	0	api.fda.gov
Eptam Plastics, Ltd	Northfield, NH, United States	Contract manufacturer	0		0	0	api.fda.gov
Engineered Medical Systems, LLC	Bartlett, TN, United States	Contract manufacturer	0		0	0	api.fda.gov
Globus Medical, Inc.	Audubon, PA, United States	Manufacturer	0		0	0	api.fda.gov
Globus Medical, Inc.	Memphis, TN, United States	Manufacturer	0		0	0	api.fda.gov
Guangzhou Aquila Precise Tools Limited	Guangzhou City Guangdong, China	Contract manufacturer	0		0	0	api.fda.gov
Hammill MFG. Co.	Maumee, OH, United States	Contract manufacturer	0		0	0	api.fda.gov
HONER Medizin-Technik GmbH & Co. KG	SPAICHINGEN Baden-Wurttemberg, Germany	Contract manufacturer	0		0	0	api.fda.gov
Hoosier, Inc.	Corona, CA, United States	Contract manufacturer	0		0	0	api.fda.gov
Hipp Medical AG	Renquishausen Baden-Wurttemberg, Germany	Contract manufacturer	0		0	0	api.fda.gov
Incipio Devices	Huntington, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Instru-Med Technologies	Warsaw, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Intai Technology Corp. Implants Business Unit	Taichung City, Taiwan	Contract manufacturer	0		0	0	api.fda.gov
Ken-Mar Machine MFG Corp	Paterson, NJ, United States	Contract manufacturer	0		0	0	api.fda.gov
LH Medical Corporation	Fort Wayne, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
LSM-MED S.r.l.	Serravalle San Marino Citta, San Marino	Contract manufacturer	0		0	0	api.fda.gov
Limacorporate S.p.A.	Calatafimi Segesta (TP) Sicilia, Italy	Contract manufacturer	0		0	0	api.fda.gov
Lincotek Medical LLC	Vandalia, OH, United States	Contract manufacturer	0		0	0	api.fda.gov
Mach Medical	Columbia City, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Mack Molding Company	Arlington, VT, United States	Contract manufacturer	0		0	0	api.fda.gov
Maitland Engineering	South Bend, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Mako Surgical Corp.	Weston, FL, United States	Specification developer	0		0	0	api.fda.gov
Medical Conteneur SAS	SAINT-SOUPPLETS Seine-et-Marne, France	Contract manufacturer	0		0	0	api.fda.gov
Medtech LLC	Millington, TN, United States	Contract manufacturer	0		0	0	api.fda.gov
Millstone Medical Outsourcing LLC.	Fall River, MA, United States	Contract manufacturer	0		0	0	api.fda.gov
Moebius Precision Corp	Lansing, MI, United States	Contract manufacturer	0		0	0	api.fda.gov
Mack Proto	Gardner, MA, United States	Contract manufacturer	0		0	0	api.fda.gov
Materialise Colombia S.A.S	Medellin Antioquia, Colombia	Manufacturer	0		0	0	api.fda.gov
Metal Craft Machine & Engineering, Inc.	Elk River, MN, United States	Contract manufacturer	0		0	0	api.fda.gov
MicroPort Orthopedics Global Supply Center Limited	Shanghai, China	Contract manufacturer	0		0	0	api.fda.gov
Micron Solutions, Inc.	Fitchburg, MA, United States	Contract manufacturer	0		0	0	api.fda.gov
Millstone Medical Outsourcing LLC	Olive Branch, MS, United States	Contract manufacturer	0		0	0	api.fda.gov
NGInstruments, Inc dba Avalign Cutting Instruments	Warsaw, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Norwood Medical LLC	Dayton, OH, United States	Contract manufacturer	0		0	0	api.fda.gov
Nse-Automatech	Granby Quebec, Canada	Contract manufacturer	0		0	0	api.fda.gov
Nelipak Healthcare Packaging	CLARA, Offaly, Ireland	Contract manufacturer	0		0	0	api.fda.gov
Oberg Medical Products Company	Sarver, PA, United States	Contract manufacturer	0		0	0	api.fda.gov
Oeb S.R.L.	Camposanto Modena, Italy	Contract manufacturer	0		0	0	api.fda.gov
Onyx Medical LLC	Memphis, TN, United States	Contract manufacturer	0		0	0	api.fda.gov
Orchid Orthopedic Solutions Lansing	Holt, MI, United States	Contract manufacturer	0		0	0	api.fda.gov
Orchid Orthopedic Solutions Oregon, Inc.	Oregon City, OR, United States	Contract manufacturer	0		0	0	api.fda.gov
Orchid Orthopedics-Chelsea	Chelsea, MI, United States	Contract manufacturer	0		0	0	api.fda.gov
Orchid Unique	Bridgeport, MI, United States	Contract manufacturer	0		0	0	api.fda.gov
Orthoplastics Ltd	Bacup Lancashire, United Kingdom	Contract manufacturer	0		0	0	api.fda.gov
Oberg Medical - Finishing Solutions	Wallingford, CT, United States	Contract manufacturer	0		0	0	api.fda.gov
Orchid Orthopedic Solutions Alabama LLC	Arab, AL, United States	Contract manufacturer	0		0	0	api.fda.gov
Paragon Medical, Inc.	Pierceton, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Perryman Company	Houston, PA, United States	Contract manufacturer	0		0	0	api.fda.gov
PPD Meditech, Div. Of Industries PPD Inc.	Waterville Quebec, Canada	Contract manufacturer	0		0	0	api.fda.gov
Precision Adm	Winnipeg Manitoba, Canada	Contract manufacturer	0		0	0	api.fda.gov
Precision Edge Surgical Products Company	Sault Sainte Marie, MI, United States	Contract manufacturer	0		0	0	api.fda.gov
PT. Team Metal Indonesia	BATAM Riau, Indonesia	Contract manufacturer	0		0	0	api.fda.gov
Paragon Medical - Dayton	Dayton, OH, United States	Contract manufacturer	0		0	0	api.fda.gov
Paragon Medical Device (Changzhou) Co., Ltd.	Changzhou Jiangsu, China	Contract manufacturer	0		0	0	api.fda.gov
Paragon Medical Inc.	Smithfield, UT, United States	Contract manufacturer	0		0	0	api.fda.gov
Phillips Precision Inc	Elmwood Park, NJ, United States	Contract manufacturer	0		0	0	api.fda.gov
Quality Tech Services, LLC	Bloomington, MN, United States	Contract manufacturer	0		0	0	api.fda.gov
Rayco Steel Process, Inc.	Warsaw, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Restoration Medical Polymers	Columbia City, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Riverside Machine & Engineering, Inc.	Eau Claire, WI, United States	Contract manufacturer	0		0	0	api.fda.gov
RMS Co.	Minneapolis, MN, United States	Contract manufacturer	0		0	0	api.fda.gov
SCT, Inc.	Franklin Lakes, NJ, United States	Contract manufacturer	0		0	0	api.fda.gov
Single Source Medical LLC	Churubusco, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
SMB Medical SA	Sant'Antonino Ticino, Switzerland	Contract manufacturer	0		0	0	api.fda.gov
Smith & Nephew Inc.	Mansfield, MA, United States	Manufacturer	0		0	0	api.fda.gov
Smith & Nephew Orthopaedics AG	AARAU Aargau, Switzerland	Manufacturer	0		0	0	api.fda.gov
Steripack Usa (limited) LLC	Lakeland, FL, United States	Contract manufacturer	0		0	0	api.fda.gov
Sti Lualdi S.R.L.	Casiacco Pordenone, Italy	Contract manufacturer	0		0	0	api.fda.gov
Straits Orthopaedics (MFG) Sdn Bhd	Simpang Ampat Pulau Pinang, Malaysia	Contract manufacturer	0		0	0	api.fda.gov
Straits Orthopaedics (MFG) Sdn Bhd	Perai Pulau Pinang, Malaysia	Contract manufacturer	0		0	0	api.fda.gov
Straits Orthopaedics (MFG) Sdn Bhd	Bandar Cassia Pulau Pinang, Malaysia	Contract manufacturer	0		0	0	api.fda.gov
Symmetry Medical Ireland Limited	Midleton, Cork Munster, Ireland	Contract manufacturer	0		0	0	api.fda.gov
Symmetry Medical Manufacturing Inc	Claypool, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Symmetry Medical Manufacturing Inc.	Warsaw, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Sites Medical, LLC	Columbia City, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Smith and Nephew Operations Sdn. Bhd	Penang Pulau Pinang, Malaysia	Manufacturer	0		0	0	api.fda.gov
Stryker (Suzhou) Medical Technology Co.,Ltd.	Suzhou Jiangsu, China	Contract manufacturer	0		0	0	api.fda.gov
Stryker Anngrove	Cork Munster, Ireland	Contract manufacturer	0		0	0	api.fda.gov
Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd.	Changzhou, Jiangsu, China	Contract manufacturer	0		0	0	api.fda.gov
Summit Orthopedic Technologies Inc.	Naples, FL, United States	Contract manufacturer	0		0	0	api.fda.gov
Suzhou Elite Precision Machinery Co., Ltd.	Kunshan Jiangsu, China	Contract manufacturer, Manufacturer	0		0	0	api.fda.gov
Symmetry Medical Malaysia Sdn Bhd (758243-M)	Bayan Lepas Pulau Pinang, Malaysia	Contract manufacturer	0		0	0	api.fda.gov
T & L Sharpening, Inc.	Indiana Beach, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Takumi Precision Engineering Ltd	Limerick Limerick(County), Ireland	Contract manufacturer	0		0	0	api.fda.gov
Velcromex, S.A. De C.V.	AGUA PRIETA Sonora, Mexico	Contract manufacturer	0		0	0	api.fda.gov
Viant AS&O Holdings, LLC	Indianapolis, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Viant Medical, LLC	Fort Wayne, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Zimmer Cas	Montreal, Quebec, Canada	Manufacturer	0		0	0	api.fda.gov
Zimmer GMBH	WINTERTHUR Zurich, Switzerland	Contract manufacturer, Manufacturer	0		0	0	api.fda.gov
rms Surgical	Anoka, MN, United States	Contract manufacturer	0		0	0	api.fda.gov

Updated September 17, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.