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Data / Medical devices / United States / Biopro, Inc.

Biopro, Inc.: FDA-registered device maker in Port Huron, MI, United States, 32 510(k) clearances

Biopro, Inc. is registered with the FDA (registration 1833506) in Port Huron, MI, United States. It lists 48 device types. The FDA files 32 510(k) clearances under its listings, the newest dated March 14, 2025. 4 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this oneWatch Biopro, Inc.
FDA registration number
1833506
FEI number
1832656
Address
2929 Lapeer Rd, Port Huron, MI, United States, 48060
Owner or operator
BIOPRO, INC. (9001497)
Roles
Contract manufacturer, Manufacturer, Repackager or relabeler
First device listed
December 8, 2004
Registered through
2027
Brand names listed
0 Degree Bipolar Liners, 10 Degree Bipolar Liners, ACCU-CUT, APEX Hip, ArcPhix, ArrowPhix, B-P HIP ACETABULAR FIXATION CUP W/BIOCOAT & W/ULTRACOAT, B-P Hip Acetabluar Bearing and more

Devices it lists

DeviceProduct codeClassRoleSource
Apparatus, Air Handling, RoomFZH2Contract manufactureraccessdata.fda.gov
Appliance, Fixation, Spinal Intervertebral BodyKWQ2Contract manufactureraccessdata.fda.gov
Bit, DrillHTW1Manufactureraccessdata.fda.gov
Bone WedgePLF2Contract manufactureraccessdata.fda.gov
ExtractorHWB1Contract manufactureraccessdata.fda.gov
Gauge, DepthHTJ1Manufactureraccessdata.fda.gov
Guide, Surgical, InstrumentFZX1Manufactureraccessdata.fda.gov
Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, UncementedOQG2Contract manufactureraccessdata.fda.gov
Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous UncementedOQI2Contract manufactureraccessdata.fda.gov
Instrument, Bending Or ContouringHXP1Manufactureraccessdata.fda.gov
Instrument, CompressionHWN1Contract manufacturer, Manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, CervicalODP2Contract manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, LumbarMAX2Contract manufactureraccessdata.fda.gov
Knife, SurgicalEMF1Manufactureraccessdata.fda.gov
Neurological Stereotaxic InstrumentHAW2Repackager or relabeleraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Contract manufacturer, Manufactureraccessdata.fda.gov
Orthopedic Stereotaxic InstrumentOLO2Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Osteotome, ManualGFI1Manufactureraccessdata.fda.gov
Pin, Fixation, SmoothHTY2Manufactureraccessdata.fda.gov
Pin, Fixation, ThreadedJDW2Manufactureraccessdata.fda.gov
Plate, Fixation, BoneHRS2Contract manufacturer, Manufactureraccessdata.fda.gov
Prosthesis, Hip, Femoral, ResurfacingKXA2Contract manufacturer, Manufactureraccessdata.fda.gov
Prosthesis, Hip, Hemi-, Femoral, MetalKWL2Contract manufacturer, Manufactureraccessdata.fda.gov
Prosthesis, Hip, Hemi-, Femoral, Metal BallLZY2Manufactureraccessdata.fda.gov
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedKWY2Contract manufacturer, Manufactureraccessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedLZO2Contract manufacturer, Manufactureraccessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, CementedJDI2Contract manufacturer, Manufactureraccessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedLPH2Contract manufacturer, Manufactureraccessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, UncementedLWJ2Contract manufactureraccessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateMEH2Contract manufactureraccessdata.fda.gov
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/PolymerHRY2Manufactureraccessdata.fda.gov
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerJWH2Manufactureraccessdata.fda.gov
Prosthesis, Shoulder, Hemi-, Humeral, Metallic UncementedHSD2Contract manufactureraccessdata.fda.gov
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedKWS2Contract manufactureraccessdata.fda.gov
Prosthesis, Toe, Hemi-, PhalangealKWD2Manufactureraccessdata.fda.gov
Prosthesis, Wrist, Carpal TrapeziumKYI2Manufactureraccessdata.fda.gov
ReamerHTO1Manufactureraccessdata.fda.gov
RetractorGAD1Repackager or relabeleraccessdata.fda.gov
Rod, Fixation, Intramedullary And AccessoriesHSB2Manufactureraccessdata.fda.gov
Screw, Fixation, BoneHWC2Contract manufacturer, Manufactureraccessdata.fda.gov
ScrewdriverHXX1Manufactureraccessdata.fda.gov
Shoulder Prosthesis, Reverse ConfigurationPHX2Contract manufactureraccessdata.fda.gov
Staple, Fixation, BoneJDR2Manufactureraccessdata.fda.gov
System, Skin ClosureMKY1Contract manufactureraccessdata.fda.gov
TemplateHWT1Contract manufactureraccessdata.fda.gov
Thoracolumbosacral Pedicle Screw SystemNKB2Contract manufactureraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Manufactureraccessdata.fda.gov
Washer, Bolt NutHTN2Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
March 14, 2025K242121mBôs (Monogram mBôs TKA System)OLOSubstantially EquivalentMonogram Orthopaedics, Inc.accessdata.fda.gov
September 14, 2017K163627Shotel Ankle Arthrodesis Nail SystemHSBSubstantially EquivalentBiopro, Inc.accessdata.fda.gov
June 16, 2017K162674BioPro Foot Plating SystemsHRSSubstantially EquivalentBiopro, Inc.accessdata.fda.gov
October 24, 2013K132510BIOPRO - INFINITY PLATE ANCHOR SYSTEMHTNSubstantially EquivalentBiopro, Inc.accessdata.fda.gov
October 30, 2012K121973BIOPRO HEMI-EDGE TOE SYSTEMKWDSubstantially EquivalentBiopro, Inc.accessdata.fda.gov
December 3, 2010K100761BIOPRO POLAR HEADKWYSubstantially EquivalentBiopro, Inc.accessdata.fda.gov
June 3, 2010K101030MODIFICATION TO HBS HEADLESS BONE SCREWHWCSubstantially EquivalentBiopro, Inc.accessdata.fda.gov
May 22, 2009K090208BIOPRO FEMORAL HEADSJDISubstantially EquivalentBiopro, Inc.accessdata.fda.gov
March 18, 2009K083490BIOPRO K-WIRE, MODELS 16863, 17231, 17232, 18577, 18682-18685HTYSubstantially EquivalentBiopro, Inc.accessdata.fda.gov
August 5, 2008K081149BIOPRO GO-EZ SCREWHWCSubstantially EquivalentBiopro, Inc.accessdata.fda.gov
October 29, 2007K072298BIOPRO MEMORY STAPLE, MODELS 18062-18073JDRSubstantially EquivalentBiopro, Inc.accessdata.fda.gov
August 21, 2006K061798BIOPRO MEMORY STAPLEJDRSubstantially EquivalentBiopro, Inc.accessdata.fda.gov
June 20, 2006K061089MODULAR THUMB IMPLANT, MODELS 17600, 17601, 17602, 17603, 17596, 17597, 17598, 17599KYISubstantially EquivalentBiopro, Inc.accessdata.fda.gov
November 15, 2005K052596MODULAR THUMB IMPLANT, MODELS 17065,17066,17243,17067,17199,17238,17005,17239,17006,17240,17007,17241,17500,17501,17507KYISubstantially EquivalentBiopro, Inc.accessdata.fda.gov
May 18, 2005K043542BIOPRO TARA FEMORAL RESURFACING COMPONENTKXASubstantially EquivalentBiopro, Inc.accessdata.fda.gov
November 12, 2004K041595TOE MP JOINT, MODELS 10412-10414, 14958, 14960, 1060-10062,16818,-16822,16867-16870KWDSubstantially EquivalentBiopro, Inc.accessdata.fda.gov
September 8, 2004K041936BIOPRO SUBTALAR IMPLANTHWCSubstantially EquivalentBiopro, Inc.accessdata.fda.gov
January 27, 2004K033621NDI PASSIVE SPHERESHAWSubstantially EquivalentNorthern Digital, Inc.accessdata.fda.gov
June 6, 2002K020791HBS HEADLESS BONE SCREWHWCSubstantially EquivalentMillennium Medical Technologies, Inc.accessdata.fda.gov
April 29, 1999K990821PROVIDENCE CUP SYSTEMJDISubstantially EquivalentBiopro, Inc.accessdata.fda.gov
February 3, 1997K964472RIOPRO COBALT TRAPEZIOMETARCARPAL RESURFACING COMPONENTKYISubstantially EquivalentBiologically Oriented Prosthesesaccessdata.fda.gov
November 6, 1996K963433THREADED FIXATION PINJDWSubstantially EquivalentOrthopaedic Biosystems, Ltd.accessdata.fda.gov
January 18, 1996K954768BIOPRO HEMI-ENDO MODULAR CERAMIC HEADLZOSubstantially EquivalentBiologically Oriented Prosthesesaccessdata.fda.gov
September 27, 1995K953045BIOPRO HEMI-ENDO MODULAR CERAMIC HEADLZOSubstantially Equivalent for Some IndicationsBiologically Oriented Prosthesesaccessdata.fda.gov
January 7, 1994K922500PSL TOTAL HIP REPLACEMENT SYSTEMLPHSubstantially EquivalentBiopro, Inc.accessdata.fda.gov
September 21, 1993K922841BIOPRO MODULAR TIBIAL TRAYJWHSubstantially EquivalentBiopro, Inc.accessdata.fda.gov
November 27, 1991K912641BIOPRO ZIRALLOY MODULAR FEMORAL HEADSLZOSubstantially EquivalentBiopro, Inc.accessdata.fda.gov
July 17, 1991K904448TOWNLEY TOTAL KNEE (TTK)JWHSubstantially EquivalentBiopro, Inc.accessdata.fda.gov
December 1, 1989K895886BIOPRO HEMI-ENDO MODULAR HEAD FOR PSL SYSTEMKWLSubstantially EquivalentBiopro, Inc.accessdata.fda.gov
November 6, 1989K890044BIOPRO ANATOMIC UNICOMPARTMENTAL KNEEHRYSubstantially Equivalent for Some IndicationsBiopro, Inc.accessdata.fda.gov
October 14, 1988K882869TOWNLEY COX COMB ACETABULAR COMPONENTJDISubstantially Equivalent for Some IndicationsBiopro, Inc.accessdata.fda.gov
August 17, 1987K872856BIOPRO 32MM BALLJDISubstantially EquivalentBiopro, Inc.accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
September 9, 202597605Class IIOngoingBioPro Femoral Head (Metal 22, 28, 32, 36, 40) cobalt chromium and ceramic heads Part ID/Description: 18593 HEAD FEMORAL 22MM -3 18594 HEAD FEMORAL 22MM +0 19003 HEAD FEMORAL 28MM-6 19004 HEAD FEMORAL 28MM-3 19005 HEAD FPotential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.accessdata.fda.gov
February 1, 202289605Class IITerminatedTitanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC SM, Part ID 16813There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the accessdata.fda.gov
June 25, 201983288Class IITerminatedK-Wire HBS Sterile, Item Number 19688 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the Manufacturing flaw in the sterile barrier systemaccessdata.fda.gov
September 21, 201160143Not yet classifiedTerminatedBioPro Femoral Head 28 mm -6 mm, Item 19003. Orthopedic femoral head for implantation.BioPro Femoral Head Outer Packaging was found lacking proper seal,compromising sterility.accessdata.fda.gov

Compare with other makers

Updated October 14, 2025. 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.