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

Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented (PAO): 49 FDA-registered makers in 13 countries

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

49 establishments in 13 countries are registered with the FDA to make Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented (product code PAO, Class 2, 21 CFR 888.3660). 2 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on September 11, 2020, and lists 3 recall events (1 Class I). FDA data exported November 2, 2026.

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Product code: PAO
Device class: 2
Regulation: 888.3660
Medical specialty: Orthopedic
Implant: Yes

Makers by country

Country	Makers
United States	25
Italy	6
Malaysia	4
Ireland	3
Switzerland	3
Poland	1
China	1
New Zealand	1
San Marino	1
United Kingdom	1
Taiwan	1
France	1
Germany	1

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

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
TORNIER Inc.	Columbia City, IN, United States	Specification developer	1	September 11, 2020	0	0	api.fda.gov
Tornier, Inc.	Bloomington, MN, United States	Complaint file establishment, Manufacturer	1	September 11, 2020	1	0	api.fda.gov
AMETEK Poland sp. z o.o.	Siechnice Dolnoslaskie, Poland	Contract manufacturer	0		0	0	api.fda.gov
Aps Materials Inc. Ireland	Waterford Waterford(County), Ireland	Contract manufacturer	0		0	0	api.fda.gov
Aps Materials, Inc.	Dayton, OH, 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
Biomet, Inc.	Warsaw, IN, United States	Manufacturer	0		2	1	api.fda.gov
C+a Tool Engineering, Inc.	Churubusco, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Changzhou Biomet Medical Devices Co., Ltd.	Changzhou City Jiangsu, China	Manufacturer	0		0	0	api.fda.gov
Depuy Orthopaedics, Inc.	Warsaw, IN, United States	Specification developer	0		0	0	api.fda.gov
Donson Machine Company	Alsip, IL, United States	Contract manufacturer	0		0	0	api.fda.gov
DePuy Mitek, Inc.	Raynham, MA, United States	Specification developer	0		0	0	api.fda.gov
Depuy Ireland UC	Co. Cork Munster, Ireland	Manufacturer, Specification developer	0		0	0	api.fda.gov
Eddi Bressan S.R.L.	CORMONS Gorizia, Italy	Contract manufacturer	0		0	0	api.fda.gov
Encore Medical, L.P.	Austin, TX, United States	Manufacturer	0		0	0	api.fda.gov
Enztec Limited	CHRISTCHURCH Canterbury, New Zealand	Contract manufacturer	0		0	0	api.fda.gov
Exactech, Inc.	Gainesville, FL, United States	Manufacturer	0		0	0	api.fda.gov
Incipio Devices	Huntington, 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
LaVezzi Precision, Inc	Bloomingdale, IL, United States	Contract manufacturer	0		0	0	api.fda.gov
Limacorporate S.p.A.	Villanova di San Daniele Udine, Italy	Manufacturer	0		0	0	api.fda.gov
Limacorporate S.p.A.	Calatafimi Segesta (TP) Sicilia, Italy	Contract manufacturer	0		0	0	api.fda.gov
Micropulse Inc	Columbia City, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Moser-Baer AG	Sumiswald Bern, Switzerland	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
Oeb S.R.L.	Camposanto Modena, Italy	Contract manufacturer	0		0	0	api.fda.gov
Orthoplastics Ltd	Bacup Lancashire, United Kingdom	Contract manufacturer	0		0	0	api.fda.gov
Ortho Solutions Sdn Bhd	Prai, Penang Pulau Pinang, Malaysia	Contract manufacturer	0		0	0	api.fda.gov
Paragon Medical, Inc.	Pierceton, IN, United States	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 Inc.	Castleton, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Paragon Medical Inc.	Smithfield, UT, United States	Contract manufacturer	0		0	0	api.fda.gov
ProMade PoC Center for Complex Orthopedic Solutions at HSS	Manhattan, NY, 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
Single Source Medical LLC	Churubusco, IN, 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
Syntec Scientific Corp.	CHANG HUA Changhua, Taiwan	Contract manufacturer	0		0	0	api.fda.gov
Stryker Macroom	Co Cork Munster, Ireland	Contract manufacturer	0		0	0	api.fda.gov
Turnco Tool & Instrument, Inc.	Georgetown, TX, United States	Contract manufacturer	0		0	0	api.fda.gov
Tornier S.A.S.	Montbonnot Saint-Martin Isere, France	Contract manufacturer	0		0	0	api.fda.gov
Valtecne SPA	Berbenno di Valtellina Sondrio, Italy	Contract manufacturer	0		0	0	api.fda.gov
Waldemar Link GmbH & Co. KG	Norderstedt Schleswig-Holstein, Germany	Manufacturer	0		0	0	api.fda.gov
Zimmer GMBH	WINTERTHUR Zurich, Switzerland	Manufacturer	0		0	0	api.fda.gov
Zimmer, Inc.	Warsaw, IN, United States	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 11, 2020. 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.