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

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive (OIY): 102 FDA-registered makers in 15 countries

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

102 establishments in 15 countries are registered with the FDA to make Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive (product code OIY, Class 2, 21 CFR 888.3560). 8 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 12 510(k) clearances under this code, the latest on May 22, 2026, and lists 6 recall events (0 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.

Get every maker of this device Makers in the United States Watch this device

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

Makers by country

Country	Makers
United States	68
Ireland	6
China	5
Malaysia	5
Switzerland	3
United Kingdom	3
France	2
Canada	2
Taiwan	2
Belgium	1
Colombia	1
Ukraine	1
Indonesia	1
Australia	1
Germany	1

Makers of Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive

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	Source
Depuy Orthopaedics, Inc.	Warsaw, IN, United States	Manufacturer, Specification developer	4	November 1, 2024	1	api.fda.gov
Depuy (ireland)	CO. CORK Munster, Ireland	Manufacturer, Specification developer	3	August 30, 2011	0	api.fda.gov
Depuy Orthopaedics, Inc.	Raynham, MA, United States	Manufacturer	3	May 22, 2026	0	api.fda.gov
Depuy Synthes (suzhou) Medical Devices Co., Ltd.	SUZHOU Jiangsu, China	Manufacturer	3	May 22, 2026	0	api.fda.gov
Encore Medical, L.P.	Austin, TX, United States	Complaint file establishment, Manufacturer, Specification developer	3	August 15, 2012	3	api.fda.gov
Depuy Ireland UC	Co. Cork Munster, Ireland	Manufacturer, Specification developer	2	May 22, 2026	0	api.fda.gov
Biomet, Inc.	Warsaw, IN, United States	Manufacturer	1	March 9, 2010	0	api.fda.gov
Kyocera Medical Technologies, Inc.	Redlands, CA, United States	Complaint file establishment, Specification developer	1	February 14, 2013	0	api.fda.gov
Aps Materials, Inc.	Dayton, OH, United States	Contract manufacturer	0		0	api.fda.gov
Arthrex, Inc.	Naples, FL, United States	Specification developer	0		0	api.fda.gov
Arthrex Manufacturing Inc.	Pendleton, SC, United States	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Arthrex, Inc.	Ave Maria, FL, United States	Contract manufacturer, Contract sterilizer	0		0	api.fda.gov
Autocam Medical	Murfreesboro, TN, United States	Contract manufacturer	0		0	api.fda.gov
B-One Ortho, Corp.	Cedar Knolls, NJ, United States	Manufacturer	0		0	api.fda.gov
Baechler Feintech AG	Hoelstein Basel-Landschaft, Switzerland	Contract manufacturer	0		0	api.fda.gov
Branch Medical Group	Eagleville, PA, United States	Contract manufacturer	0		0	api.fda.gov
Branch Medical Group	Limerick, PA, United States	Contract manufacturer	0		0	api.fda.gov
Centex Machining, Inc.	Round Rock, TX, United States	Contract manufacturer	0		0	api.fda.gov
Changzhou Biomet Medical Devices Co., Ltd.	Changzhou City Jiangsu, China	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Complexus Medical	Mishawaka, IN, United States	Contract manufacturer	0		0	api.fda.gov
ConforMIS, Inc.	Wilmington, MA, United States	Complaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler, Reprocessor	0		0	api.fda.gov
Corin Limited	CIRENCESTER Gloucestershire, United Kingdom	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Donson Machine Company	Alsip, IL, United States	Contract manufacturer	0		0	api.fda.gov
Eptam Plastics, Ltd	Northfield, NH, United States	Contract manufacturer	0		0	api.fda.gov
Exactech, Inc.	Gainesville, FL, United States	Manufacturer	0		0	api.fda.gov
Globus Medical, Inc.	Audubon, PA, United States	Manufacturer	0		0	api.fda.gov
Globus Medical, Inc.	Memphis, TN, United States	Manufacturer	0		0	api.fda.gov
Howmedica Osteonics Corp	Mahwah, NJ, United States	Contract sterilizer, Manufacturer	0		0	api.fda.gov
Incipio Devices	Huntington, IN, United States	Contract manufacturer	0		0	api.fda.gov
LH Medical Corporation	Fort Wayne, IN, United States	Contract manufacturer	0		0	api.fda.gov
Lincotek Medical, LLC	Molalla, OR, United States	Contract manufacturer	0		0	api.fda.gov
Mach Medical	Columbia City, IN, United States	Contract manufacturer	0		0	api.fda.gov
Maitland Engineering	South Bend, IN, United States	Contract manufacturer	0		0	api.fda.gov
Mako Surgical Corp.	Weston, FL, United States	Specification developer	0		0	api.fda.gov
Marle Finishing SAS	La Talaudiere Loire, France	Contract manufacturer	0		0	api.fda.gov
Materialise N.V.	LEUVEN Vlaams Brabant, Belgium	Manufacturer	0		0	api.fda.gov
Medical Conteneur SAS	SAINT-SOUPPLETS Seine-et-Marne, France	Contract manufacturer	0		0	api.fda.gov
Millstone Medical Outsourcing LLC.	Fall River, MA, United States	Contract manufacturer	0		0	api.fda.gov
Materialise Colombia S.A.S	Medellin Antioquia, Colombia	Manufacturer	0		0	api.fda.gov
Materialise Sdn Bhd	Petaling Jaya Selangor, Malaysia	Manufacturer	0		0	api.fda.gov
Materialise USA, LLC.	Plymouth, MI, United States	Manufacturer	0		0	api.fda.gov
Materialise Ukraine, Rep. office	Kyiv Kyyiv, Misto, Ukraine	Manufacturer	0		0	api.fda.gov
Micron Solutions, Inc.	Fitchburg, MA, United States	Contract manufacturer	0		0	api.fda.gov
Millstone Medical Outsourcing LLC	Olive Branch, MS, United States	Contract manufacturer	0		0	api.fda.gov
NGInstruments, Inc dba Avalign Cutting Instruments	Warsaw, IN, United States	Contract manufacturer	0		0	api.fda.gov
Norwood Medical LLC	Dayton, OH, United States	Contract manufacturer	0		0	api.fda.gov
Optimotion Implants, LLC	Orlando, FL, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Orchid Orthopedic Solutions Oregon, Inc.	Oregon City, OR, United States	Contract manufacturer	0		0	api.fda.gov
Orchid Unique	Bridgeport, MI, United States	Contract manufacturer	0		0	api.fda.gov
Ortho Development Corp.	Draper, UT, United States	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Orthoplastics Ltd	Bacup Lancashire, United Kingdom	Contract manufacturer	0		0	api.fda.gov
Orchid Orthopedic Solutions Alabama LLC	Arab, AL, United States	Contract manufacturer	0		0	api.fda.gov
Paragon Medical, Inc.	Pierceton, IN, United States	Contract manufacturer	0		0	api.fda.gov
Perryman Company	Houston, PA, United States	Contract manufacturer	0		0	api.fda.gov
PPD Meditech, Div. Of Industries PPD Inc.	Waterville Quebec, Canada	Contract manufacturer	0		0	api.fda.gov
Precision Adm	Winnipeg Manitoba, Canada	Contract manufacturer	0		0	api.fda.gov
Pro-Tech Design & MFG., Inc.	Santa Fe Springs, CA, United States	Contract manufacturer	0		0	api.fda.gov
PRO-TECH Design & Mfg, Inc.	Arlington, TX, United States	Contract manufacturer	0		0	api.fda.gov
PT. Team Metal Indonesia	BATAM Riau, Indonesia	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Paragon Medical - Dayton	Dayton, OH, United States	Contract manufacturer	0		0	api.fda.gov
Paragon Medical Device (Changzhou) Co., Ltd.	Changzhou Jiangsu, China	Contract manufacturer	0		0	api.fda.gov
Quality Tech Services, LLC	Bloomington, MN, United States	Contract manufacturer	0		0	api.fda.gov
Restoration Medical Polymers	Columbia City, IN, United States	Contract manufacturer	0		0	api.fda.gov
RMS Co.	Minneapolis, MN, United States	Contract manufacturer	0		0	api.fda.gov
Shalby Advanced Technologies, Inc.	El Dorado Hills, CA, United States	Contract manufacturer, Contract sterilizer, Manufacturer	0		0	api.fda.gov
Signature Orthopaedics Pty Limited	Sydney New South Wales, Australia	Manufacturer	0		0	api.fda.gov
Single Source Medical LLC	Churubusco, IN, United States	Contract manufacturer	0		0	api.fda.gov
Smith & Nephew Orthopaedics AG	AARAU Aargau, Switzerland	Manufacturer	0		0	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	0		0	api.fda.gov
Steripack Usa (limited) LLC	Lakeland, FL, United States	Contract manufacturer	0		0	api.fda.gov
Straits Orthopaedics (MFG) Sdn Bhd	Simpang Ampat Pulau Pinang, Malaysia	Contract manufacturer	0		0	api.fda.gov
Straits Orthopaedics (MFG) Sdn Bhd	Perai Pulau Pinang, Malaysia	Contract manufacturer	0		0	api.fda.gov
Straits Orthopaedics (MFG) Sdn Bhd	Bandar Cassia Pulau Pinang, Malaysia	Contract manufacturer	0		0	api.fda.gov
Symmetry Medical Ireland Limited	Midleton, Cork Munster, Ireland	Contract manufacturer	0		0	api.fda.gov
Symmetry Medical Manufacturing Inc	Claypool, IN, United States	Contract manufacturer	0		0	api.fda.gov
Symmetry Medical Manufacturing Inc.	Warsaw, IN, United States	Contract manufacturer	0		0	api.fda.gov
Symmetry Medical Thornton Precision Components Ltd	SHEFFIELD, SOUTH YORKSHIRE Barnsley, United Kingdom	Contract manufacturer	0		0	api.fda.gov
Symmetry Medical, Inc. - Manchester	Manchester, NH, United States	Contract manufacturer	0		0	api.fda.gov
Signature Orthopaedics Europe Ltd	Athlone Westmeath, Ireland	Manufacturer	0		0	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	0		0	api.fda.gov
Smith and Nephew Operations Sdn. Bhd	Penang Pulau Pinang, Malaysia	Manufacturer	0		0	api.fda.gov
T & L Sharpening, Inc.	Indiana Beach, IN, United States	Contract manufacturer	0		0	api.fda.gov
Total Joint Orthopedics, Inc.	Salt Lake City, UT, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Trigon Incorporated	Mc Murray, PA, United States	Contract manufacturer	0		0	api.fda.gov
Turnco Tool & Instrument, Inc.	Georgetown, TX, United States	Contract manufacturer	0		0	api.fda.gov
United Orthopedic Corp.	Kaohsiung, Taiwan	Exporter to the US, Manufacturer	0		0	api.fda.gov
United Orthopedic Corporation	Hsinchu Hsinchu(County), Taiwan	Exporter to the US, Manufacturer	0		0	api.fda.gov
UOC USA Inc.	Irvine, CA, United States	Manufacturer, Manufacturer for export	0		0	api.fda.gov
VIPER TECHNOLOGIES, LLC. (d.b.a Avalign Thortex)	Parkrose, OR, United States	Contract manufacturer	0		0	api.fda.gov
Viant AS&O Holdings, LLC	Indianapolis, IN, United States	Contract manufacturer	0		0	api.fda.gov
Waldemar Link GmbH & Co. KG	Norderstedt Schleswig-Holstein, Germany	Manufacturer	0		0	api.fda.gov
Zimmer GMBH	WINTERTHUR Zurich, Switzerland	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Zimmer Manufacturing B.V.	Mercedita, PR, United States	Manufacturer	0		0	api.fda.gov
Zimmer, Inc.	Warsaw, IN, United States	Contract manufacturer, Manufacturer	0		1	api.fda.gov
Zhejiang Biomet Medical Products Co., Ltd.	Jinhua Zhejiang, China	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Zimmer Orthopedic Mfg Ltd	Shannon Clare, Ireland	Manufacturer	0		0	api.fda.gov
Zimmer Orthopedics Manufacturing Limited-Galway	Oranmore Galway(County), Ireland	Manufacturer	0		0	api.fda.gov
Zimmer Trabecular Metal Technology, Inc.	Parsippany, NJ, United States	Manufacturer	0		0	api.fda.gov
b-ONE Medical (Beijing) Co., Ltd.	Beijing, China	Contract manufacturer	0		0	api.fda.gov
b-ONE Ortho Corp.	Fairfield, NJ, United States	Specification developer	0		0	api.fda.gov
restor3d, inc.	Durham, NC, United States	Complaint file establishment, Manufacturer	0		0	api.fda.gov
rms Surgical	Anoka, MN, United States	Contract manufacturer	0		0	api.fda.gov

Updated May 22, 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.