Skip to the page

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

Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented (OQG): 79 FDA-registered makers in 13 countries

79 establishments in 13 countries are registered with the FDA to make Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented (product code OQG, Class 2, 21 CFR 888.3358). 10 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 20 510(k) clearances under this code, the latest on August 20, 2021, and lists 2 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.

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

Makers by country

CountryMakers
United States51
Germany7
China5
United Kingdom3
Malaysia3
Italy2
Ireland2
South Korea1
San Marino1
France1
Canada1
Australia1
Switzerland1

Makers of Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, 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
Kyocera Medical Technologies, Inc.Redlands, CA, United StatesComplaint file establishment, Specification developer4March 11, 2020000api.fda.gov
Encore Medical, L.P.Austin, TX, United StatesManufacturer3December 13, 2017000api.fda.gov
Globus Medical, Inc.Audubon, PA, United StatesManufacturer2October 9, 2012010api.fda.gov
Globus Medical, Inc.Memphis, TN, United StatesManufacturer2October 9, 2012000api.fda.gov
Total Joint Orthopedics, Inc.Salt Lake City, UT, United StatesComplaint file establishment, Specification developer2October 27, 2017000api.fda.gov
Aesculap AGTUTTLINGEN, DONAU Baden-Wurttemberg, GermanyManufacturer1October 30, 2013000api.fda.gov
Microport Orthopedics Inc.Arlington, TN, United StatesManufacturer1August 20, 2021000api.fda.gov
Novosource, LLCMorgantown, WV, United StatesComplaint file establishment, Manufacturer, Specification developer1June 27, 2014000api.fda.gov
Shalby Advanced Technologies, Inc.El Dorado Hills, CA, United StatesManufacturer1December 17, 2013000api.fda.gov
Zimmer, Inc.Warsaw, IN, United StatesContract manufacturer, Manufacturer, Specification developer1June 4, 2012000api.fda.gov
Aps Materials, Inc.Dayton, OH, United StatesContract manufacturer0000api.fda.gov
APS Materials SuzhouSuzhou Jiangsu, ChinaContract manufacturer0000api.fda.gov
ARCH Medical Solutions - SeabrookSeabrook, NH, United StatesContract manufacturer0000api.fda.gov
Autocam MedicalMurfreesboro, TN, United StatesContract manufacturer0000api.fda.gov
Avalign Additive / Slice Manufacturing StudiosAkron, OH, United StatesContract manufacturer0000api.fda.gov
B & G MFG. Co.Hatfield, PA, United StatesContract manufacturer0000api.fda.gov
Biomet Uk Ltd.Bridgend, United KingdomSpecification developer0000api.fda.gov
Biomet, Inc.Warsaw, IN, United StatesManufacturer, Specification developer0000api.fda.gov
Biopro, Inc.Port Huron, MI, United StatesContract manufacturer0000api.fda.gov
Centex Machining, Inc.Round Rock, TX, United StatesContract manufacturer0000api.fda.gov
CERAMTEC GmbH Medical Products DivisionMARKTREDWITZ Bavaria, GermanyContract manufacturer0000api.fda.gov
CERAMTEC GmbH Medical Products DivisionPLOCHINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Corentec Co., Ltd.Cheonan Si, Chungnam, South KoreaExporter to the US, Manufacturer0000api.fda.gov
Culver Tool & EngineeringPlymouth, IN, United StatesContract manufacturer0000api.fda.gov
Changzhou Biomet Medical Devices Co., Ltd.Changzhou City Jiangsu, ChinaManufacturer0000api.fda.gov
ConforMIS, Inc.Wilmington, MA, United StatesManufacturer, Specification developer0000api.fda.gov
Corin LimitedCIRENCESTER Gloucestershire, United KingdomComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Donson Machine CompanyAlsip, IL, United StatesContract manufacturer0000api.fda.gov
Ferry Machine CorporationOakland, NJ, United StatesContract manufacturer0000api.fda.gov
Flex-Cell Precision, Inc.Lancaster, PA, United StatesContract manufacturer0000api.fda.gov
Friedrich Daniels GMBHSOLINGEN North Rhine-Westphalia, GermanyContract manufacturer0000api.fda.gov
Ferry Machine CorporationLittle Ferry, NJ, United StatesContract manufacturer0000api.fda.gov
Hammill MFG. Co.Maumee, OH, United StatesContract manufacturer0000api.fda.gov
Harwood Design, Inc.Bristol, PA, United StatesContract manufacturer0000api.fda.gov
Ken-Mar Machine MFG CorpPaterson, NJ, 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
Lincotek (wuxi) Co., Ltd.Wuxi Jiangsu, ChinaContract manufacturer0000api.fda.gov
Lincotek Bologna S.R.L.Cadriano di Granarolo, Bologna, ItalyContract manufacturer0000api.fda.gov
LSM-MED S.r.l.Serravalle San Marino Citta, San MarinoContract manufacturer0000api.fda.gov
Limacorporate S.p.A.Villanova di San Daniele Udine, ItalyManufacturer0000api.fda.gov
Maitland EngineeringSouth Bend, IN, United StatesContract manufacturer0000api.fda.gov
Maxx Orthopedics Inc.Norristown, PA, United StatesManufacturer, Specification developer0000api.fda.gov
Medical Conteneur SASSAINT-SOUPPLETS Seine-et-Marne, FranceContract manufacturer0000api.fda.gov
Micropulse IncColumbia City, IN, United StatesContract manufacturer0000api.fda.gov
Mid South PrecisionMurfreesboro, TN, United StatesContract manufacturer0000api.fda.gov
Millstone Medical Outsourcing LLC.Fall River, MA, United StatesContract manufacturer0000api.fda.gov
MicroPort Orthopedics Global Supply Center LimitedShanghai, ChinaContract manufacturer0000api.fda.gov
Millstone Medical Outsourcing LLCOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
NGInstruments, Inc dba Avalign Cutting InstrumentsWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
Norwood Medical LLCDayton, OH, United StatesContract manufacturer0000api.fda.gov
Orthoplastics LtdBacup Lancashire, United KingdomContract manufacturer0000api.fda.gov
Perryman CompanyHouston, PA, United StatesContract manufacturer0000api.fda.gov
PPD Meditech, Div. Of Industries PPD Inc.Waterville Quebec, CanadaContract manufacturer0000api.fda.gov
Precision Forms, Inc.Butler, NJ, United StatesContract manufacturer0000api.fda.gov
Pro-Tech Design & MFG., Inc.Santa Fe Springs, CA, United StatesContract manufacturer0000api.fda.gov
PRO-TECH Design & Mfg, Inc.Arlington, TX, United StatesContract manufacturer0000api.fda.gov
Puracon GMBHRosenheim Bavaria, GermanyContract manufacturer0000api.fda.gov
Quality Tech Services, LLCBloomington, MN, United StatesContract manufacturer0000api.fda.gov
Signature Orthopaedics Pty LimitedSydney New South Wales, AustraliaManufacturer0000api.fda.gov
Single Source Medical LLCChurubusco, IN, United StatesContract manufacturer0000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
Straits Orthopaedics (MFG) Sdn BhdSimpang Ampat Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Straits Orthopaedics (MFG) Sdn BhdPerai Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Straits Orthopaedics (MFG) Sdn BhdBandar Cassia Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Symmetry Medical Manufacturing IncClaypool, IN, United StatesContract manufacturer0000api.fda.gov
Symmetry Medical Manufacturing Inc.Warsaw, IN, United StatesContract manufacturer0000api.fda.gov
Signature Orthopaedics Europe LtdAthlone Westmeath, IrelandManufacturer0000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
T & L Sharpening, Inc.Indiana Beach, IN, United StatesContract manufacturer0000api.fda.gov
Theken Companies, LLCAkron, OH, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Trilliant Surgical LLCHouston, TX, United StatesContract manufacturer0000api.fda.gov
VIPER TECHNOLOGIES, LLC. (d.b.a Avalign Thortex)Parkrose, OR, United StatesContract manufacturer0000api.fda.gov
Waldemar Link GmbH & Co. KGNorderstedt Schleswig-Holstein, GermanyManufacturer0000api.fda.gov
Zimmer GMBHWINTERTHUR Zurich, SwitzerlandContract manufacturer0000api.fda.gov
Zimmer Manufacturing B.V.Mercedita, PR, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Zhejiang Biomet Medical Products Co., Ltd.Jinhua Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Zimmer Orthopedics Manufacturing Limited-GalwayOranmore Galway(County), IrelandContract manufacturer0000api.fda.gov
restor3d, inc.Durham, NC, United StatesComplaint file establishment, Manufacturer0000api.fda.gov

Updated August 20, 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.