Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1833506

FEI Number

1832656

Entity Name

BIOPRO, INC.

City/State/Country

PORT HURON, MI, US

Establishment Address

2929 Lapeer Rd, PORT HURON, MI 48060, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BIOPRO, INC. (Owner Number: 9001497)

Owner / Operator Contact Address

2929 Lapeer Rd., --, Port Huron, MI 48060, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K052596

PMA Number

N/A

All Registered Proprietary Names

0 Degree Bipolar Liners BIOPRO MODULAR THUMB IMPLANT iNSitu Bipolar Hip System BREAK OUT TruTrack Sterile Drills BioPro Sterile Drills Orthonovus Sterile Drills HBS Non-Sterile Screw System Sterile K-wire Osteotomes Sevin Reverse Shoulder Tyber Medical Trauma Screw Sterile Spine ACP System iNSitu Head Extractor Hemi Endo Femoral Head BioPro Tendon Anchor System Depth Gauge Wedge System Wedge System, Fixation Plate Wedge System, Fixation Screw Wedge System, Bone wedge INnate Cannulated Screw System (*306 BioPro Anatomic Unicompartmental Knee System B-P Hip Acetabluar Bearing IngenTotal Shoulder System KORONA Staple System Clover Staple BioPro Ceramic Femoral Head B-P Hip Acetabluar Components Go-EZ Screw GO-EZ SimpliFix Hip Fixation System Digital Compression Screw Tyber Medical PT Interbody Spacer Modular Thumb PS SERPENS CMC Implant System B-P Shoulder Humeral Resurfacing Head Ingenix Ingenix Polyaxial Deformity Screw Kit KneeAlign 2 UniAlign KA2 iNSitu Total Hip System Tyber Medical Trauma Screw INFrame Bending Iron BioPro Femoral Head BIOPRO SURGICAL INSTRUMENTS iNSitu Bipolar Head Trials Carina Memory Staple TRUTRACK MEMORY STAPLE MaxxHealth Memory Staple OrthoNovis Memory Staple MEMORY STAPLE Screwdriver Nano Screws Hintermann Compressor Hintermann Distractor WishBone Bone Plates and Screws BioPro Hemi-Edge Toe System Effi+Pro Single Use Compression/Distraction Kit Tyber Medical Interbody System Tyber Medical TLIF Tyber Medical OLIF Tyber Medical PLIF Tyber Medical DLIF Tyber Medical ALIF Tyber Medical ACIF Harvey Surgical Assistant System BioPro PSL Total Hip System ArcPhix ArrowPhix King Cobra Anterior Cervical Plate OrthAlign HipAlign Cox Comb Cup B-P Hip Femoral Components B-P HIP ACETABULAR FIXATION CUP W/BIOCOAT & W/ULTRACOAT VOLANS Lesser MPJ Hemi Implant System NAOS First MPJ Hemi Implant System First MPJ Implant Monogram mBos TKA System BioPro Endo Modular Ceramic OrthAlign Sterile Pin Pack Bipolar Femoral Component Surgical Instrument Tray BioPro Endo Modular Ceramic PSL Hip System BioPro Femoral Heads Horizon Subtalar CORVUS Subtalar Implant System HBS Headless Bone Screw HBS Reamer BIOPRO MODULAR THUMB IMPLANTS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2019-04-30
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2019-04-30
KYI	Prosthesis, Wrist, Carpal Trapezium	Orthopedic	Class 2	888.3770	2006-03-16
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2020-01-07
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2017-07-11
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-10-08
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2010-10-28
GFI	Osteotome, Manual	General, Plastic Surgery	Class 1	878.4800	2019-03-06
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2025-04-09
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2017-05-18
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2021-01-18
HWB	Extractor	Orthopedic	Class 1	888.4540	2017-12-21
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2015-08-26
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2014-06-05
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2014-06-05
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2017-07-11
PLF	Bone Wedge	Orthopedic	Class 2	888.3030	2018-11-27
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2018-11-27
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2018-11-27
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-07-08
HRY	Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3530	2011-11-30
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2024-06-13
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2025-04-09
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2010-10-28
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2019-03-05
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2020-05-28
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2020-05-28
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2010-10-28
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-04-01
JDW	Pin, Fixation, Threaded	Orthopedic	Class 2	888.3040	2010-10-28
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2020-01-07
KYI	Prosthesis, Wrist, Carpal Trapezium	Orthopedic	Class 2	888.3770	2007-12-03
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2021-01-18
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2024-06-06
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2018-11-27
OQG	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	Orthopedic	Class 2	888.3358	2024-06-13
OQI	Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented	Orthopedic	Class 2	888.3353	2024-06-13
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2024-06-13
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2024-06-13
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2017-05-18
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-07-08
HXP	Instrument, Bending Or Contouring	Orthopedic	Class 1	888.4540	2017-07-11
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2011-11-30
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2011-11-30
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2004-12-08
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2006-11-17
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2017-07-11
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-03-08
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2026-05-06
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2018-11-28
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2018-11-28
KWD	Prosthesis, Toe, Hemi-, Phalangeal	Orthopedic	Class 2	888.3730	2012-11-09
HWN	Instrument, Compression	Orthopedic	Class 1	888.4540	2014-12-10
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2017-05-18
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2017-05-18
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2020-07-08
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2006-03-16
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2006-03-16
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-07-08
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2017-05-18
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2018-11-27
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2019-03-05
KXA	Prosthesis, Hip, Femoral, Resurfacing	Orthopedic	Class 2	888.3400	2020-05-28
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2024-06-13
KWD	Prosthesis, Toe, Hemi-, Phalangeal	Orthopedic	Class 2	888.3730	2006-03-16
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2026-04-28
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2019-03-05
LZY	Prosthesis, Hip, Hemi-, Femoral, Metal Ball	Orthopedic	Class 2	888.3360	2019-03-05
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2020-07-08
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2011-01-25
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2012-11-19
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2019-03-05
LZY	Prosthesis, Hip, Hemi-, Femoral, Metal Ball	Orthopedic	Class 2	888.3360	2019-03-05
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2025-09-15
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2007-12-03
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2010-10-28
HTO	Reamer	Orthopedic	Class 1	888.4540	2017-07-11
KYI	Prosthesis, Wrist, Carpal Trapezium	Orthopedic	Class 2	888.3770	2006-03-16

Official Correspondent

Kimberly Light

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BIOPRO, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K042344	Aesculap, Inc.	EXCIA TOTAL HIP SYSTEM	2005-03-16
K860442	Howmedica Corp.	PRECISION HIP SYSTEM PROXIMAL FEMORAL SPACER #6259	1986-05-06
K973124	Sulzer Orthopedics, Inc.	APR POROUS HA HIP SYSTEM	1997-11-03
K823482	Intermedics Orthopedics	101 UNIVERSAL ENDOPROSTHESIS	1983-02-07
K062348	Medtronic Neurosurgery	TIMESH SELF DRILLING SCREW	2006-09-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0014-2014	Synthes USA HQ, Inc.	2	Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016	Ortho Solutions Inc 330 Franklin Tnpk	2	Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0043-2018	MicroPort Orthopedics Inc.	2	MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1833506. Last updated year: 2026. Please use registration number 1833506 when referencing this establishment in official correspondence.