Data / Medical devices / Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous

Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous (MBL): 88 FDA-registered makers in 12 countries

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

88 establishments in 12 countries are registered with the FDA to make Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous (product code MBL, Class 2, 21 CFR 888.3358). 7 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 13 510(k) clearances under this code, the latest on August 24, 2021, and lists 5 recall events (1 Class I). FDA data exported November 2, 2026.

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Product code: MBL
Device class: 2
Regulation: 888.3358
Medical specialty: Orthopedic
Implant: Yes

Makers by country

Country	Makers
United States	49
Italy	10
Ireland	8
Malaysia	5
China	4
Germany	4
France	3
Switzerland	1
United Kingdom	1
San Marino	1
Australia	1
Poland	1

Makers of Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous

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
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	9	October 6, 2020	3	0	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	9	October 6, 2020	0	0	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	6	April 27, 2012	0	0	api.fda.gov
Smith and Nephew Operations Sdn. Bhd	Penang Pulau Pinang, Malaysia	Manufacturer	4	April 27, 2012	0	0	api.fda.gov
Microport Orthopedics Inc.	Arlington, TN, United States	Manufacturer	2	August 24, 2021	1	1	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	2	December 14, 2016	0	0	api.fda.gov
Smith & Nephew Orthopaedics AG	AARAU Aargau, Switzerland	Manufacturer	1	March 27, 1996	0	0	api.fda.gov
Adler Ortho S.P.A.	Cormano Milano, Italy	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. 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
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
Adler Ortho SpA	Mezzolombardo Trento, Italy	Contract manufacturer	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
B & G MFG. Co.	Hatfield, PA, United States	Contract manufacturer	0		0	0	api.fda.gov
Biomet, Inc.	Warsaw, IN, 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
Cep Bio-Coat, LLC	Farmington Hills, MI, United States	Contract manufacturer	0		0	0	api.fda.gov
CERAMTEC GmbH Medical Products Division	MARKTREDWITZ Bavaria, Germany	Contract manufacturer	0		0	0	api.fda.gov
CERAMTEC GmbH Medical Products Division	PLOCHINGEN Baden-Wurttemberg, Germany	Contract manufacturer, Contract sterilizer	0		0	0	api.fda.gov
Corin Limited	CIRENCESTER Gloucestershire, United Kingdom	Complaint file establishment, 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
Exactech, Inc.	Gainesville, FL, United States	Manufacturer	0		0	0	api.fda.gov
Engineered Medical Systems, LLC	Bartlett, TN, United States	Contract manufacturer	0		0	0	api.fda.gov
Ferry Machine Corporation	Oakland, NJ, United States	Contract manufacturer	0		0	0	api.fda.gov
Flex-Cell Precision, Inc.	Lancaster, PA, 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
Ferry Machine Corporation	Little Ferry, NJ, 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
Harwood Design, Inc.	Bristol, PA, United States	Contract manufacturer	0		0	0	api.fda.gov
Howmedica International S. De R.L.	LIMERICK Munster, Ireland	Manufacturer	0		0	0	api.fda.gov
Howmedica Osteonics Corp	Mahwah, NJ, United States	Manufacturer, Specification developer	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
Hipp Medical AG	Renquishausen Baden-Wurttemberg, Germany	Contract manufacturer	0		0	0	api.fda.gov
Instru-Med Technologies	Warsaw, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Lincotek Bologna S.R.L.	Cadriano di Granarolo, Bologna, 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
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
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
Mendell	Lakeville, 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
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
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 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
Ortho Development Corp.	Draper, UT, United States	Complaint file establishment, Manufacturer, Specification developer	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
Precera Medical Herouville SAS	HEROUVILLE ST CLAIR CEDEX Normandie, France	Contract manufacturer	0		0	0	api.fda.gov
Phillips Precision Inc	Elmwood Park, NJ, 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
Quality Tech Services, LLC	Bloomington, 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
Serf	DECINES CHARPIEU Rhone, France	Manufacturer	0		0	0	api.fda.gov
Signature Orthopaedics Pty Limited	Sydney New South Wales, Australia	Manufacturer	0		0	0	api.fda.gov
Smith & Nephew Inc.	Oklahoma City, OK, United States	Manufacturer	0		0	0	api.fda.gov
Smithstown Light Engineering	Shannon Clare, Ireland	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
Stryker Ireland Osteonics	County Cork, Ireland	Manufacturer, Specification developer	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, Inc. - Manchester	Manchester, NH, United States	Contract manufacturer	0		0	0	api.fda.gov
Signature Orthopaedics Europe Ltd	Athlone Westmeath, Ireland	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 Poland Manufacturing Sp. z o.o.	Skawina Malopolskie, Poland	Contract manufacturer	0		0	0	api.fda.gov
Suzhou Elite Precision Machinery Co., Ltd.	Kunshan Jiangsu, China	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
Total Joint Orthopedics, Inc.	Salt Lake City, UT, United States	Complaint file establishment, Specification developer	0		0	0	api.fda.gov
Valtecne SPA	Berbenno di Valtellina Sondrio, Italy	Contract manufacturer	0		0	0	api.fda.gov
Westlake Plastics Europe	TOURCOING Nord, France	Contract manufacturer	0		0	0	api.fda.gov

Updated August 24, 2021. 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.