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

Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented (MBF): 64 FDA-registered makers in 12 countries

64 establishments in 12 countries are registered with the FDA to make Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented (product code MBF, Class 2, 21 CFR 888.3670). 12 of them have a 510(k) clearance or PMA approval on file and 4 have a recall event. The FDA has issued 37 510(k) clearances under this code, the latest on April 13, 2026, and lists 11 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 deviceMakers in the United StatesWatch this device
Product code
MBF
Device class
2
Regulation
888.3670
Medical specialty
Orthopedic
Implant
Yes

Makers by country

CountryMakers
United States36
Italy7
Ireland4
China4
Switzerland4
France3
United Kingdom1
New Zealand1
Germany1
San Marino1
Taiwan1
Canada1

Makers of Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Biomet, Inc.Warsaw, IN, United StatesManufacturer11October 28, 2020060api.fda.gov
Depuy Orthopaedics, Inc.Warsaw, IN, United StatesManufacturer, Specification developer7November 13, 2023000api.fda.gov
Limacorporate S.p.A.Villanova di San Daniele Udine, ItalyManufacturer6January 11, 2024030api.fda.gov
DePuy Mitek, Inc.Raynham, MA, United StatesSpecification developer5June 8, 2022000api.fda.gov
Zimmer, Inc.Warsaw, IN, United StatesContract manufacturer, Manufacturer5April 13, 2026000api.fda.gov
Depuy Ireland UCCo. Cork Munster, IrelandManufacturer, Specification developer4November 13, 2023000api.fda.gov
Zhejiang Biomet Medical Products Co., Ltd.Jinhua Zhejiang, ChinaContract manufacturer, Manufacturer4October 28, 2020000api.fda.gov
Changzhou Biomet Medical Devices Co., Ltd.Changzhou City Jiangsu, ChinaContract manufacturer, Manufacturer2October 28, 2020000api.fda.gov
Encore Medical, L.P.Austin, TX, United StatesManufacturer1September 30, 2008010api.fda.gov
FH IndustrieQUIMPER Finistere, FranceManufacturer1April 10, 2017000api.fda.gov
SHOULDER INNOVATIONS, IncGrand Rapids, MI, United StatesSpecification developer1October 23, 2018000api.fda.gov
Synthes (USA) Products LLCWest Chester, PA, United StatesComplaint file establishment, Specification developer1February 5, 2009000api.fda.gov
Aps Materials Inc. IrelandWaterford Waterford(County), IrelandContract manufacturer0000api.fda.gov
Aps Materials, Inc.Dayton, OH, United StatesContract manufacturer0000api.fda.gov
Arthrex, Inc.Naples, FL, United StatesSpecification developer0000api.fda.gov
Arthrex Manufacturing Inc.Pendleton, SC, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Arthrex, Inc.Ave Maria, FL, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Avalign Delivery Systems DivisionGreenwood, IN, United StatesContract manufacturer0000api.fda.gov
Avalign Instruments & ImplantsFort Wayne, IN, United StatesContract manufacturer0000api.fda.gov
Complexus MedicalMishawaka, IN, United StatesContract manufacturer0000api.fda.gov
Depuy (ireland)CO. CORK Munster, IrelandManufacturer0000api.fda.gov
Depuy Intl., Ltd.Leeds, United KingdomManufacturer0000api.fda.gov
Depuy Synthes (suzhou) Medical Devices Co., Ltd.SUZHOU Jiangsu, ChinaManufacturer0000api.fda.gov
Donson Machine CompanyAlsip, IL, United StatesContract manufacturer0000api.fda.gov
Dot America, Inc.Columbia City, IN, United StatesContract manufacturer0000api.fda.gov
Eddi Bressan S.R.L.CORMONS Gorizia, ItalyContract manufacturer0000api.fda.gov
Enztec LimitedCHRISTCHURCH Canterbury, New ZealandContract manufacturer0000api.fda.gov
HPF S.R.L.Forgaria nel Friuli Friuli Venezia Giulia, ItalyContract manufacturer0000api.fda.gov
Incipio DevicesHuntington, IN, United StatesContract manufacturer0000api.fda.gov
Jabil Inc. (Monument)Monument, CO, United StatesContract manufacturer0000api.fda.gov
Kammerer Medical Systems GmbH & Co. KGStockach Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
LH Medical CorporationFort Wayne, IN, United StatesContract manufacturer0000api.fda.gov
LSM-MED S.r.l.Serravalle San Marino Citta, San MarinoContract manufacturer0000api.fda.gov
LX Precision Shanghai Co LtdShanghai, ChinaContract manufacturer0000api.fda.gov
LaVezzi Precision, IncBloomingdale, IL, United StatesContract manufacturer0000api.fda.gov
Limacorporate S.p.A.Calatafimi Segesta (TP) Sicilia, ItalyContract manufacturer0000api.fda.gov
Lincotek MedicalBartlett, TN, United StatesContract manufacturer0000api.fda.gov
Medacta International SACastel San Pietro Ticino, SwitzerlandComplaint file establishment, Manufacturer0000api.fda.gov
Medacta International SARancate Ticino, SwitzerlandComplaint file establishment, Manufacturer0000api.fda.gov
Micro Precision SwissSanta Ana, CA, United StatesContract manufacturer0000api.fda.gov
Micropulse IncColumbia City, IN, United StatesContract manufacturer0000api.fda.gov
Oeb S.R.L.Camposanto Modena, ItalyContract manufacturer0000api.fda.gov
Orchid UniqueBridgeport, MI, United StatesContract manufacturer0000api.fda.gov
Paragon Medical, Inc.Pierceton, IN, United StatesContract manufacturer0000api.fda.gov
Paragon Medical - DaytonDayton, OH, United StatesContract manufacturer0000api.fda.gov
Paragon Medical Inc.Castleton, IN, United StatesContract manufacturer0000api.fda.gov
Paragon Medical Inc.Smithfield, UT, United StatesContract manufacturer0000api.fda.gov
ProMade PoC Center for Complex Orthopedic Solutions at HSSManhattan, NY, United StatesContract manufacturer0000api.fda.gov
Restoration Medical PolymersColumbia City, IN, United StatesContract manufacturer0000api.fda.gov
Revelation Medical Devices, LLCAuburn, IN, United StatesContract manufacturer0000api.fda.gov
RMS Co.Minneapolis, MN, United StatesContract manufacturer0000api.fda.gov
Single Source Medical LLCChurubusco, IN, United StatesContract manufacturer0000api.fda.gov
SQ Products AGInwil Luzern, SwitzerlandContract manufacturer0000api.fda.gov
Sti Lualdi S.R.L.Casiacco Pordenone, ItalyContract manufacturer0000api.fda.gov
Symmetry Medical Polyvac SASWAMBRECHIES Nord, FranceContract manufacturer0000api.fda.gov
Syntec Scientific Corp.CHANG HUA Changhua, TaiwanContract manufacturer0000api.fda.gov
Synthes GMBHZuchwil Solothurn, SwitzerlandSpecification developer0000api.fda.gov
Structure Medical, LLC.Mooresville, NC, United StatesContract manufacturer0000api.fda.gov
Valtecne SPABerbenno di Valtellina Sondrio, ItalyContract manufacturer0000api.fda.gov
Viant Medical, LLCFort Wayne, IN, United StatesContract manufacturer0000api.fda.gov
Westlake Plastics EuropeTOURCOING Nord, FranceContract manufacturer0000api.fda.gov
Zimmer CasMontreal, Quebec, CanadaManufacturer, Specification developer0000api.fda.gov
Zimmer Orthopedics Manufacturing Limited-GalwayOranmore Galway(County), IrelandContract manufacturer0010api.fda.gov
rms SurgicalAnoka, MN, United StatesContract manufacturer0000api.fda.gov

Updated April 13, 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.