Skip to the page

Data / Medical devices / Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer / United States

FDA-registered makers of Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer in the United States: 77 establishments

77 establishments in the United States are registered with the FDA to make Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer (product code HSX). 24 have a 510(k) clearance or PMA approval on file and 8 have a recall event. FDA data exported November 3, 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.

Device
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Product code
HSX
Country
United States

Makers of Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer13October 30, 2024060api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer13October 30, 2024000api.fda.gov
Zimmer, Inc.Warsaw, IN, United StatesContract manufacturer, Manufacturer8March 17, 2020040api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer7January 5, 2012000api.fda.gov
ConforMIS, Inc.Wilmington, MA, United StatesComplaint file establishment, Manufacturer6December 5, 2013010api.fda.gov
Arthrex, Inc.Naples, FL, United StatesSpecification developer5July 1, 2025010api.fda.gov
Mako Surgical Corp.Weston, FL, United StatesSpecification developer5June 2, 2022000api.fda.gov
Materialise USA, LLC.Plymouth, MI, United StatesManufacturer4October 2, 2020000api.fda.gov
Arthrex Manufacturing Inc.Pendleton, SC, United StatesContract manufacturer, Contract sterilizer, Manufacturer3December 15, 2016000api.fda.gov
Howmedica Osteonics CorpMahwah, NJ, United StatesContract manufacturer, Contract sterilizer, Manufacturer, Specification developer3June 2, 2022010api.fda.gov
Smith & Nephew Inc.Oklahoma City, OK, United StatesManufacturer3February 11, 2019000api.fda.gov
Biomet, Inc.Warsaw, IN, United StatesManufacturer2August 15, 2025020api.fda.gov
Globus Medical, Inc.Audubon, PA, United StatesManufacturer2December 6, 2024010api.fda.gov
Globus Medical, Inc.Memphis, TN, United StatesManufacturer2December 6, 2024000api.fda.gov
Overture OrthopaedicsIrvine, CA, United StatesComplaint file establishment, Specification developer2October 7, 2024000api.fda.gov
Shalby Advanced Technologies, Inc.El Dorado Hills, CA, United StatesManufacturer2April 2, 2026000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer2October 30, 2024000api.fda.gov
Arthrosurface, Inc.W Bridgewater, MA, United StatesManufacturer1October 11, 2005000api.fda.gov
Blue Belt Technologies, Inc.Pittsburgh, PA, United StatesManufacturer1May 31, 2013000api.fda.gov
Encore Medical, L.P.Austin, TX, United StatesManufacturer1July 16, 2019010api.fda.gov
Kyocera Medical Technologies, Inc.Redlands, CA, United StatesComplaint file establishment, Specification developer1April 4, 2024000api.fda.gov
Maxx Orthopedics Inc.Norristown, PA, United StatesComplaint file establishment, Manufacturer, Specification developer1June 16, 2022000api.fda.gov
Microport Orthopedics Inc.Arlington, TN, United StatesManufacturer1July 14, 1986000api.fda.gov
Ortho Development Corp.Draper, UT, United StatesComplaint file establishment, Manufacturer1December 16, 2021000api.fda.gov
3D MEDICAL MANUFACTURING, INC. (dba Tecomet)Riviera Beach, FL, United StatesContract manufacturer0000api.fda.gov
Almark Tool & Manufacturing Company, Inc.Garwood, NJ, United StatesContract manufacturer0000api.fda.gov
ARCH Medical Solutions - MemphisBartlett, TN, United StatesContract manufacturer0000api.fda.gov
ARCH Medical Solutions - MemphisLexington, TN, United StatesContract manufacturer0000api.fda.gov
Autocam MedicalKentwood, MI, United StatesContract manufacturer0000api.fda.gov
Advanced Machine, Inc.Winchester, TN, United StatesContract manufacturer0000api.fda.gov
Arthrex, Inc.Ave Maria, FL, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Autocam MedicalMurfreesboro, TN, United StatesContract manufacturer0000api.fda.gov
Centex Machining, Inc.Round Rock, TX, United StatesContract manufacturer0000api.fda.gov
Complexus MedicalMishawaka, IN, United StatesContract manufacturer0000api.fda.gov
Depuy Orthopaedics, Inc.Warsaw, IN, United StatesManufacturer, Specification developer0000api.fda.gov
Depuy Orthopaedics, Inc.Raynham, MA, United StatesManufacturer0000api.fda.gov
Eptam Plastics, LtdNorthfield, NH, United StatesContract manufacturer0000api.fda.gov
Engineered Medical Systems, LLCBartlett, TN, United StatesContract manufacturer0000api.fda.gov
Huron Tool & Cutter GrindingFarmingdale, NY, United StatesContract manufacturer0000api.fda.gov
Incipio DevicesHuntington, IN, United StatesContract manufacturer0000api.fda.gov
Instru-Med TechnologiesWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
Jarvis Surgical Inc.Westfield, MA, United StatesContract manufacturer0000api.fda.gov
Jatex, Inc.Nappanee, IN, United StatesContract manufacturer0000api.fda.gov
Ken-Mar Machine MFG CorpPaterson, NJ, United StatesContract manufacturer0000api.fda.gov
Life Science Outsourcing, Inc.Brea, CA, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Lincotek Medical LLCVandalia, OH, United StatesContract manufacturer0000api.fda.gov
Mach MedicalColumbia City, IN, United StatesContract manufacturer0000api.fda.gov
Marson Medical, Inc.Paramus, NJ, United StatesContract manufacturer0000api.fda.gov
Millstone Medical Outsourcing LLC.Fall River, MA, United StatesContract manufacturer0000api.fda.gov
Metal Craft Machine & Engineering, Inc.Elk River, MN, United StatesContract manufacturer0000api.fda.gov
Millstone Medical Outsourcing LLCOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
Oberg Medical Products CompanySarver, PA, United StatesContract manufacturer0000api.fda.gov
Onyx Medical LLCMemphis, TN, United StatesContract manufacturer0000api.fda.gov
Orchid Orthopedic Solutions Oregon, Inc.Oregon City, OR, United StatesContract manufacturer0000api.fda.gov
Orchid Orthopedics-ChelseaChelsea, MI, United StatesContract manufacturer0000api.fda.gov
Orchid UniqueBridgeport, MI, United StatesContract manufacturer0000api.fda.gov
Orchid Orthopedic Solutions Alabama LLCArab, AL, United StatesContract manufacturer0000api.fda.gov
Paragon Medical, Inc.Pierceton, IN, United StatesContract manufacturer0000api.fda.gov
Perryman CompanyHouston, PA, United StatesContract manufacturer0000api.fda.gov
Pulse Technologies, Inc.Quakertown, PA, United StatesContract manufacturer0000api.fda.gov
Paragon Medical - DaytonDayton, OH, United StatesContract manufacturer0000api.fda.gov
Paragon Medical Inc.Smithfield, UT, United StatesContract manufacturer0000api.fda.gov
Primo Medical Group, INCStoughton, MA, United StatesContract manufacturer0000api.fda.gov
Quality Tech Services, LLCBloomington, MN, United StatesContract manufacturer0000api.fda.gov
Riverside Machine & Engineering, Inc.Eau Claire, WI, United StatesContract manufacturer0000api.fda.gov
SCT, Inc.Franklin Lakes, NJ, United StatesContract manufacturer0000api.fda.gov
Smith & Nephew Inc.Mansfield, MA, United StatesManufacturer0000api.fda.gov
Structure Medical, LLC.Naples, FL, United StatesContract manufacturer0000api.fda.gov
Symmetry Medical Manufacturing IncClaypool, IN, United StatesContract manufacturer0000api.fda.gov
Symmetry Medical Manufacturing Inc.Warsaw, IN, United StatesContract manufacturer0000api.fda.gov
Structure Medical, LLC.Mooresville, NC, United StatesContract manufacturer0000api.fda.gov
T & L Sharpening, Inc.Indiana Beach, IN, United StatesContract manufacturer0000api.fda.gov
Turnco Tool & Instrument, Inc.Georgetown, TX, United StatesContract manufacturer0000api.fda.gov
Turner Medical Inc.Athens, AL, United StatesContract manufacturer0000api.fda.gov
Viant Medical, LLCFort Wayne, IN, United StatesContract manufacturer0000api.fda.gov
Watershed Idea Foundry, Inc.Carlsbad, CA, United StatesContract manufacturer0000api.fda.gov
rms SurgicalAnoka, MN, United StatesContract manufacturer0000api.fda.gov

Updated November 3, 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.