Data / Medical devices / Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer (JWH): 246 FDA-registered makers in 23 countries

Name: FDA-registered makers of Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

246 establishments in 23 countries are registered with the FDA to make Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer (product code JWH, Class 2, 21 CFR 888.3560). 84 of them have a 510(k) clearance or PMA approval on file and 24 have a recall event. The FDA has issued 921 510(k) clearances under this code, the latest on September 15, 2026, and lists 287 recall events (1 Class I). FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

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Product code: JWH
Device class: 2
Regulation: 888.3560
Medical specialty: Orthopedic
Implant: Yes

Makers by country

Country	Makers
United States	137
China	18
Germany	13
Ireland	12
France	11
Italy	10
United Kingdom	9
Switzerland	8
Malaysia	6
Canada	4
Taiwan	3
South Korea	3
India	2
Belgium	1
Ukraine	1
Australia	1
Colombia	1
Indonesia	1
New Zealand	1
Argentina	1
San Marino	1
Costa Rica	1
Mexico	1

Makers of Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, 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, Manufacturer for export	61	March 6, 2025	47	0	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	51	April 2, 2025	21	0	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	51	April 2, 2025	0	0	api.fda.gov
Depuy Orthopaedics, Inc.	Warsaw, IN, United States	Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer	46	August 25, 2021	17	1	api.fda.gov
Microport Orthopedics Inc.	Arlington, TN, United States	Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Repackager or relabeler, Reprocessor	44	February 18, 2025	1	0	api.fda.gov
Howmedica Osteonics Corp	Mahwah, NJ, United States	Contract manufacturer, Contract sterilizer, Manufacturer, Specification developer	43	February 6, 2025	36	0	api.fda.gov
Biomet, Inc.	Warsaw, IN, United States	Manufacturer	40	July 28, 2017	33	0	api.fda.gov
Depuy Orthopaedics, Inc.	Raynham, MA, United States	Manufacturer, Manufacturer for export	30	September 4, 2026	0	0	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	30	April 26, 2022	0	0	api.fda.gov
Exactech, Inc.	Gainesville, FL, United States	Manufacturer	29	July 17, 2023	18	0	api.fda.gov
Howmedica International S. De R.L.	LIMERICK Munster, Ireland	Manufacturer	29	December 4, 2024	0	0	api.fda.gov
Medacta International SA	Castel San Pietro Ticino, Switzerland	Complaint file establishment, Manufacturer	28	September 15, 2026	0	0	api.fda.gov
Medacta International SA	Rancate Ticino, Switzerland	Complaint file establishment, Manufacturer	28	September 15, 2026	0	0	api.fda.gov
Stryker Ireland Osteonics	County Cork, Ireland	Manufacturer, Specification developer	28	February 6, 2025	0	0	api.fda.gov
Encore Medical, L.P.	Austin, TX, United States	Complaint file establishment, Manufacturer, Specification developer	27	July 2, 2025	33	0	api.fda.gov
United Orthopedic Corp.	Kaohsiung, Taiwan	Exporter to the US, Manufacturer	20	September 25, 2025	2	0	api.fda.gov
United Orthopedic Corporation	Hsinchu Hsinchu(County), Taiwan	Exporter to the US, Manufacturer	20	September 25, 2025	0	0	api.fda.gov
UOC USA Inc.	Irvine, CA, United States	Manufacturer, Manufacturer for export	20	September 25, 2025	0	0	api.fda.gov
ConforMIS, Inc.	Wilmington, MA, United States	Complaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler, Reprocessor	18	April 27, 2023	1	0	api.fda.gov
Exactech Sarasota	Sarasota, FL, United States	Manufacturer	17	April 28, 2017	0	0	api.fda.gov
Aesculap AG	TUTTLINGEN, DONAU Baden-Wurttemberg, Germany	Complaint file establishment, Manufacturer	15	March 25, 2015	0	0	api.fda.gov
Depuy Synthes (suzhou) Medical Devices Co., Ltd.	SUZHOU Jiangsu, China	Manufacturer	15	August 25, 2021	0	0	api.fda.gov
Ortho Development Corp.	Draper, UT, United States	Complaint file establishment, Manufacturer, Specification developer	15	October 25, 2024	0	0	api.fda.gov
Total Joint Orthopedics, Inc.	Salt Lake City, UT, United States	Complaint file establishment, Specification developer	15	July 23, 2026	0	0	api.fda.gov
Globus Medical, Inc.	Audubon, PA, United States	Manufacturer	14	July 31, 2026	5	0	api.fda.gov
Depuy (ireland)	CO. CORK Munster, Ireland	Manufacturer, Repackager or relabeler, Specification developer	13	June 15, 2017	0	0	api.fda.gov
Globus Medical, Inc.	Memphis, TN, United States	Manufacturer	13	July 31, 2026	0	0	api.fda.gov
Materialise N.V.	LEUVEN Vlaams Brabant, Belgium	Manufacturer	13	January 6, 2026	2	0	api.fda.gov
Maxx Orthopedics Inc.	Norristown, PA, United States	Complaint file establishment, Manufacturer, Specification developer	13	October 22, 2025	0	0	api.fda.gov
Materialise Sdn Bhd	Petaling Jaya Selangor, Malaysia	Manufacturer	13	January 6, 2026	0	0	api.fda.gov
Materialise USA, LLC.	Plymouth, MI, United States	Manufacturer	13	January 6, 2026	3	0	api.fda.gov
Materialise Ukraine, Rep. office	Kyiv Kyyiv, Misto, Ukraine	Manufacturer	13	January 6, 2026	0	0	api.fda.gov
Shalby Advanced Technologies, Inc.	El Dorado Hills, CA, United States	Contract manufacturer, Contract sterilizer, Manufacturer	13	January 14, 2025	0	0	api.fda.gov
Corentec Co., Ltd.	Cheonan Si, Chungnam, South Korea	Exporter to the US, Manufacturer	12	April 17, 2025	1	0	api.fda.gov
OMNIlifeScience, Inc.	Raynham, MA, United States	Manufacturer, Specification developer	12	April 2, 2021	2	0	api.fda.gov
Signature Orthopaedics Pty Limited	Sydney New South Wales, Australia	Manufacturer	10	September 11, 2024	1	0	api.fda.gov
Changzhou Biomet Medical Devices Co., Ltd.	Changzhou City Jiangsu, China	Contract manufacturer, Manufacturer	9	July 28, 2017	0	0	api.fda.gov
Smith & Nephew Orthopaedics AG	AARAU Aargau, Switzerland	Manufacturer	9	May 4, 2023	0	0	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	9	August 13, 2012	4	0	api.fda.gov
Smith and Nephew Operations Sdn. Bhd	Penang Pulau Pinang, Malaysia	Manufacturer	9	May 4, 2023	0	0	api.fda.gov
Zimmer Orthopedic Mfg Ltd	Shannon Clare, Ireland	Contract manufacturer, Manufacturer	9	September 5, 2019	0	0	api.fda.gov
Zimmer Trabecular Metal Technology, Inc.	Parsippany, NJ, United States	Manufacturer	9	September 5, 2019	1	0	api.fda.gov
Depuy Ireland UC	Co. Cork Munster, Ireland	Manufacturer, Specification developer	7	September 4, 2026	0	0	api.fda.gov
Limacorporate S.p.A.	Villanova di San Daniele Udine, Italy	Manufacturer	7	January 18, 2024	1	0	api.fda.gov
Signature Orthopaedics Europe Ltd	Athlone Westmeath, Ireland	Manufacturer	7	September 11, 2024	0	0	api.fda.gov
B-One Ortho, Corp.	Cedar Knolls, NJ, United States	Manufacturer, Specification developer	6	October 6, 2022	0	0	api.fda.gov
Corin Limited	CIRENCESTER Gloucestershire, United Kingdom	Complaint file establishment, Manufacturer	6	September 23, 2024	3	0	api.fda.gov
Zhejiang Biomet Medical Products Co., Ltd.	Jinhua Zhejiang, China	Contract manufacturer, Manufacturer	6	December 23, 2014	0	0	api.fda.gov
b-ONE Ortho Corp.	Fairfield, NJ, United States	Specification developer	6	October 6, 2022	0	0	api.fda.gov
Arthrex, Inc.	Naples, FL, United States	Specification developer	5	November 12, 2015	1	0	api.fda.gov
Smith & Nephew Inc.	Oklahoma City, OK, United States	Manufacturer	5	November 16, 2017	0	0	api.fda.gov
Waldemar Link GmbH & Co. KG	Norderstedt Schleswig-Holstein, Germany	Complaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler	5	March 21, 2023	6	0	api.fda.gov
Zimmer Orthopedics Manufacturing Limited-Galway	Oranmore Galway(County), Ireland	Manufacturer	5	March 8, 2023	0	0	api.fda.gov
Arthrex Manufacturing Inc.	Pendleton, SC, United States	Contract manufacturer, Contract sterilizer, Manufacturer	4	November 19, 2014	0	0	api.fda.gov
CPM Medical Consultants, LLC.	Farmers Branch, TX, United States	Complaint file establishment, Specification developer	3	August 16, 2021	0	0	api.fda.gov
Materialise Colombia S.A.S	Medellin Antioquia, Colombia	Manufacturer	3	January 6, 2026	0	0	api.fda.gov
Osteoremedies, LLC	Memphis, TN, United States	Specification developer	3	October 2, 2024	0	0	api.fda.gov
Amplitude	Valence Drome, France	Complaint file establishment, Manufacturer	2	November 3, 2023	0	0	api.fda.gov
Biopro, Inc.	Port Huron, MI, United States	Manufacturer	2	September 21, 1993	0	0	api.fda.gov
Depuy Intl., Ltd.	Leeds, United Kingdom	Manufacturer, Specification developer	2	March 29, 1989	0	0	api.fda.gov
Mako Surgical Corp.	Weston, FL, United States	Specification developer	2	December 4, 2024	0	0	api.fda.gov
Meril Healthcare Pvt. Ltd.	Vapi Gujarat, India	Contract manufacturer, Manufacturer	2	November 16, 2021	0	0	api.fda.gov
Novosource, LLC	Morgantown, WV, United States	Complaint file establishment, Manufacturer, Specification developer	2	September 16, 2013	0	0	api.fda.gov
PT. Team Metal Indonesia	BATAM Riau, Indonesia	Contract manufacturer, Manufacturer	2	February 22, 2013	0	0	api.fda.gov
Zimmer Cas	Montreal, Quebec, Canada	Manufacturer	2	December 28, 2017	1	0	api.fda.gov
Zimmer Manufacturing B.V.	Mercedita, PR, United States	Manufacturer	2	March 29, 2018	4	0	api.fda.gov
Beijing Ak Medical Co, Ltd	Changping District Beijing, China	Complaint file establishment, Manufacturer, Specification developer	1	June 22, 2018	0	0	api.fda.gov
Beijing Ikey Medical Device Technology Co., Ltd.	Beijing, China	Manufacturer	1	April 19, 2024	0	0	api.fda.gov
CREATEC GmbH & CO. KG	FRIEDRICHSHAFEN Baden-Wurttemberg, Germany	Contract manufacturer, Exporter to the US	1	May 22, 2017	0	0	api.fda.gov
Guangzhou Aquila Precise Tools Limited	Guangzhou City Guangdong, China	Contract manufacturer, Manufacturer	1	November 9, 2012	0	0	api.fda.gov
Implanet	Martillac Nouvelle-Aquitaine, France	Manufacturer	1	October 22, 2019	0	0	api.fda.gov
Implants Intl. Ltd.	THORNABY-ON-TEES Stockton-on-Tees, United Kingdom	Manufacturer	1	November 6, 1998	0	0	api.fda.gov
Kyocera Medical Technologies, Inc.	Redlands, CA, United States	Complaint file establishment, Specification developer	1	June 20, 2019	0	0	api.fda.gov
L&K Biomed Co.,ltd.	Yongin-SI Gyeonggi, South Korea	Manufacturer	1	August 3, 2018	0	0	api.fda.gov
Matortho Limited	Leatherhead Surrey, United Kingdom	Manufacturer	1	November 17, 2014	0	0	api.fda.gov
MatOrtho Limited	Plymouth Devon, United Kingdom	Manufacturer	1	November 17, 2014	0	0	api.fda.gov
Skyve Co., Ltd.	Seoul, South Korea	Manufacturer	1	November 21, 2023	0	0	api.fda.gov
Surgtech, Inc.	Westlake, OH, United States	Manufacturer, Specification developer	1	August 1, 2019	0	0	api.fda.gov
Suzhou Microport Orthorecon Co., Ltd.	Suzhou Jiangsu, China	Manufacturer	1	February 28, 2025	0	0	api.fda.gov
Suzhou Elite Precision Machinery Co., Ltd.	Kunshan Jiangsu, China	Contract manufacturer, Manufacturer	1	October 27, 2015	0	0	api.fda.gov
Tecres SPA	VERONA Veneto, Italy	Contract manufacturer, Manufacturer	1	April 27, 2019	0	0	api.fda.gov
Unik Orthopedics, Inc	San Jose, CA, United States	Manufacturer	1	June 27, 2024	0	0	api.fda.gov
Zimmer GMBH	WINTERTHUR Zurich, Switzerland	Contract manufacturer, Manufacturer	1	September 28, 2021	0	0	api.fda.gov
implantcast GmbH	Buxtehude Lower Saxony, Germany	Complaint file establishment, Manufacturer	1	September 6, 2024	0	0	api.fda.gov
Advanced Concept Innovations LLC	Lakeland, FL, United States	Contract manufacturer	0		0	0	api.fda.gov
Aesculap SAS	CHAUMONT Grand Est, France	Contract manufacturer	0		0	0	api.fda.gov
Akshar Gamma Steriles LLP	THANE Maharashtra, India	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 Medical Solutions - Warsaw	Warsaw, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
ARCH-MedTorque	Kenosha, WI, United States	Contract manufacturer	0		0	0	api.fda.gov
Armbruster GMBH	Steinach Baden-Wurttemberg, Germany	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
Avalign Instruments & Implants	Fort Wayne, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
B-One Medical (suzhou) Co., Ltd.	Suzhou Jiangsu, China	Contract manufacturer	0		0	0	api.fda.gov
Baechler Feintech AG	Hoelstein Basel-Landschaft, Switzerland	Contract manufacturer	0		0	0	api.fda.gov
Biocomposites Ltd.	Keele Staffordshire, United Kingdom	Specification developer	0		0	0	api.fda.gov
Branch Medical Group	Eagleville, PA, United States	Contract manufacturer	0		0	0	api.fda.gov
Branch Medical Group	Limerick, PA, United States	Contract manufacturer	0		0	0	api.fda.gov
Blue Belt Technologies, Inc.	Pittsburgh, PA, United States	Manufacturer	0		0	0	api.fda.gov
C&A Tool Engineering, Inc. Auburn Plant	Auburn, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
C+a Tool Engineering, Inc.	Churubusco, IN, United States	Contract 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
Cefimeca	La Talaudiere Loire, France	Contract manufacturer	0		0	0	api.fda.gov
Centex Machining, Inc.	Round Rock, TX, United States	Contract manufacturer	0		0	0	api.fda.gov
Changzhou Wastonortho Medical Appliance Co., Ltd.	Changzhou Jiangsu, China	Contract manufacturer	0		0	0	api.fda.gov
Culver Tool & Engineering	Plymouth, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Complexus Medical	Mishawaka, IN, United States	Contract 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
Enztec Limited	CHRISTCHURCH Canterbury, New Zealand	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
Five Star Manufacturing, Inc.	New Bedford, MA, United States	Contract manufacturer	0		0	0	api.fda.gov
Friedrich Daniels GMBH	SOLINGEN North Rhine-Westphalia, Germany	Contract manufacturer	0		0	0	api.fda.gov
Frueh Verpackungstechnik AG	Fehraltorf Zurich, Switzerland	Contract manufacturer	0		0	0	api.fda.gov
Freudenberg Medical, LLC	Carpinteria, CA, United States	Contract manufacturer	0		0	0	api.fda.gov
G21 S.R.I.	San Possidonio Modena, Italy	Complaint file establishment, Manufacturer	0		0	0	api.fda.gov
Gauthier Biomedical, Inc.	Grafton, WI, United States	Contract manufacturer	0		0	0	api.fda.gov
Gsell Medical Plastics AG	Muri Aargau, Switzerland	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
HPF S.R.L.	Forgaria nel Friuli Friuli Venezia Giulia, Italy	Contract manufacturer	0		0	0	api.fda.gov
Heraeus Medical GmbH	WEHRHEIM Hesse, Germany	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
Innotool&greminger AG	Erlen Thurgau, Switzerland	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
Isomedix Operations Inc.	Spartanburg, SC, United States	Contract sterilizer, Manufacturer for export	0		0	0	api.fda.gov
Jarvis Surgical Inc.	Westfield, MA, United States	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
Kammerer Medical Systems GmbH & Co. KG	Stockach Baden-Wurttemberg, Germany	Contract manufacturer	0		0	0	api.fda.gov
Laboratorios SL SA	Malvinas Argentinas Buenos Aires, Argentina	Contract manufacturer	0		0	0	api.fda.gov
LH Medical Corporation	Fort Wayne, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Lincotek Medical, LLC	Molalla, OR, United States	Contract manufacturer	0		0	0	api.fda.gov
Lincotek Trento S.P.A	Cire di Pergine Trento, Italy	Contract manufacturer	0		0	0	api.fda.gov
Lowell,inc.	Brooklyn Park, MN, 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
LX Precision Shanghai Co Ltd	Shanghai, China	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	Bartlett, TN, United States	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
Marle Finishing SAS	La Talaudiere Loire, France	Contract manufacturer	0		0	0	api.fda.gov
Marson Medical, Inc.	Paramus, NJ, United States	Contract manufacturer	0		0	0	api.fda.gov
Medical Conteneur SAS	SAINT-SOUPPLETS Seine-et-Marne, France	Contract manufacturer	0		0	0	api.fda.gov
Medical Modeling - A 3D Systems Company	Littleton, CO, United States	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
Mendell	Lakeville, MN, United States	Contract 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
Microport Orthopedics, S.A.	Sabana Norte San Jose, Costa Rica	Specification developer	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
Onkos Surgical, Inc.	Parsippany, NJ, United States	Complaint file establishment, Specification developer	0		0	0	api.fda.gov
Onyx Medical LLC	Memphis, TN, United States	Contract manufacturer	0		0	0	api.fda.gov
Optimotion Implants, LLC	Orlando, FL, United States	Complaint file establishment, Specification developer	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
Osartis GMBH	Muenster Hesse, Germany	Specification developer	0		0	0	api.fda.gov
Oberg Medical - Finishing Solutions	Wallingford, CT, United States	Contract manufacturer	0		0	0	api.fda.gov
Oberg Medical - XL Division	Chicago, IL, 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
Pro-Tech Design & MFG., Inc.	Santa Fe Springs, CA, United States	Contract manufacturer	0		0	0	api.fda.gov
PRO-TECH Design & Mfg, Inc.	Arlington, TX, United States	Contract manufacturer	0		0	0	api.fda.gov
Puracon GMBH	Rosenheim Bavaria, Germany	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
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
SAS Etablissements Maurice Marle	NOGENT Haute-Marne, France	Contract manufacturer	0		0	0	api.fda.gov
SCT, Inc.	Franklin Lakes, NJ, United States	Contract manufacturer	0		0	0	api.fda.gov
Sferic	MENARS Centre-Val de Loire, France	Contract manufacturer	0		0	0	api.fda.gov
Sheffield Precision Medical Ltd	Sheffield, United Kingdom	Contract manufacturer	0		0	0	api.fda.gov
Simagec	ROUSSET CEDEX Bouches-du-Rhone, France	Contract manufacturer	0		0	0	api.fda.gov
Simon SAS	Bayeux Calvados, France	Contract manufacturer	0		0	0	api.fda.gov
Single Source Medical LLC	Churubusco, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Smith & Nephew Inc.	Mansfield, MA, United States	Manufacturer	0		0	0	api.fda.gov
Spang & Brands GMBH	Friedrichsdorf Hesse, Germany	Contract 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
Symmetry Medical Thornton Precision Components Ltd	SHEFFIELD, SOUTH YORKSHIRE Barnsley, United Kingdom	Contract manufacturer	0		0	0	api.fda.gov
Symmetry Medical, Inc. - Manchester	Manchester, NH, 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
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
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
Trigon Incorporated	Mc Murray, PA, United States	Contract manufacturer	0		0	0	api.fda.gov
Turnco Tool & Instrument, Inc.	Georgetown, TX, United States	Contract manufacturer	0		0	0	api.fda.gov
Tecomet Inc.	Wilmington, MA, United States	Contract manufacturer	0		0	0	api.fda.gov
Trilliant Surgical LLC	Houston, TX, United States	Contract manufacturer	0		0	0	api.fda.gov
Valtecne SPA	Berbenno di Valtellina Sondrio, Italy	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
VIPER TECHNOLOGIES, LLC. (d.b.a Avalign Thortex)	Parkrose, OR, United States	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 AS&O Holdings, LLC	Brimfield, MA, 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
Westlake Plastics Europe	TOURCOING Nord, France	Contract manufacturer	0		0	0	api.fda.gov
Yu Xin Technology(huizhou) Co.,ltd	HuiZhou Guangdong, China	Contract manufacturer	0		0	0	api.fda.gov
b-ONE Medical (Beijing) Co., Ltd.	Beijing, China	Contract manufacturer	0		0	0	api.fda.gov
restor3d, inc.	Durham, NC, United States	Complaint file establishment, Manufacturer	0		0	0	api.fda.gov
rms Surgical	Anoka, MN, United States	Contract manufacturer	0		0	0	api.fda.gov

Updated September 15, 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.