Biopro, Inc.
Port Huron, MI, US
BIOPRO, INC. appears in FDA device records in Port Huron, MI. FDA records list 41 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 39 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 41 510(k) clearances for Biopro, Inc. between 1987 and 2017. The busiest year on record is 1991, with 5. The most recent is 2017, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1987 | 3 |
| 1988 | 2 |
| 1989 | 3 |
| 1991 | 5 |
| 1992 | 1 |
| 1993 | 1 |
| 1994 | 2 |
| 1996 | 1 |
| 1999 | 1 |
| 2000 | 1 |
| 2001 | 3 |
| 2004 | 2 |
| 2005 | 2 |
| 2006 | 2 |
| 2007 | 1 |
| 2008 | 2 |
| 2009 | 2 |
| 2010 | 2 |
| 2012 | 1 |
| 2013 | 2 |
| 2017 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K163627 | Shotel Ankle Arthrodesis Nail System | HSB | Substantially Equivalent | |
| K162674 | BioPro Foot Plating Systems | HRS | Substantially Equivalent | |
| K132510 | BIOPRO - INFINITY PLATE ANCHOR SYSTEM | HTN | Substantially Equivalent | |
| K130298 | BIOPRO KWICK-WIRE UNIVERSAL SCREW SYSTEM | JDW | Substantially Equivalent | |
| K121973 | BIOPRO HEMI-EDGE TOE SYSTEM | KWD | Substantially Equivalent | |
| K100761 | BIOPRO POLAR HEAD | KWY | Substantially Equivalent | |
| K101030 | MODIFICATION TO HBS HEADLESS BONE SCREW | HWC | Substantially Equivalent | |
| K090208 | BIOPRO FEMORAL HEADS | JDI | Substantially Equivalent | |
| K083490 | BIOPRO K-WIRE, MODELS 16863, 17231, 17232, 18577, 18682-18685 | HTY | Substantially Equivalent | |
| K082705 | BIOPRO BIPOLAR HEAD, MODELS 18130-18152 | KWY | Substantially Equivalent | |
| K081149 | BIOPRO GO-EZ SCREW | HWC | Substantially Equivalent | |
| K072298 | BIOPRO MEMORY STAPLE, MODELS 18062-18073 | JDR | Substantially Equivalent | |
| K061798 | BIOPRO MEMORY STAPLE | JDR | Substantially Equivalent | |
| K061089 | MODULAR THUMB IMPLANT, MODELS 17600, 17601, 17602, 17603, 17596, 17597, 17598, 17599 | KYI | Substantially Equivalent | |
| K052596 | MODULAR THUMB IMPLANT, MODELS 17065,17066,17243,17067,17199,17238,17005,17239,17006,17240,17007,17241,17500,17501,17507 | KYI | Substantially Equivalent | |
| K043542 | BIOPRO TARA FEMORAL RESURFACING COMPONENT | KXA | Substantially Equivalent | |
| K041595 | TOE MP JOINT, MODELS 10412-10414, 14958, 14960, 1060-10062,16818,-16822,16867-16870 | KWD | Substantially Equivalent | |
| K041936 | BIOPRO SUBTALAR IMPLANT | HWC | Substantially Equivalent | |
| K011460 | WUJIN #3 TIBIAL BONE PLATE | HRS | Substantially Equivalent | |
| K011459 | WUJIN #3 FEMORAL BONE PLATE | HRS | Substantially Equivalent | |
| K010149 | WUJIN #3 FEMORAL NAIL | HSB | Substantially Equivalent | |
| K001046 | BIOPRO GLENOID COMPONENT W/ KEEL & W/ POSTS | KWS | Substantially Equivalent | |
| K990821 | PROVIDENCE CUP SYSTEM | JDI | Substantially Equivalent | |
| K960467 | POWDER FREE LATEX EXAMINATION GLOVE | LYY | Substantially Equivalent | |
| K925682 | BIOPRO ZIRALLOY MODULAR FEMORAL HEADS, MODIFIED | LZO | Substantially Equivalent for Some Indications | |
| K922500 | PSL TOTAL HIP REPLACEMENT SYSTEM | LPH | Substantially Equivalent | |
| K922841 | BIOPRO MODULAR TIBIAL TRAY | JWH | Substantially Equivalent | |
| K920145 | BIOPRO DRG CUSTOM HIP REPLACEMENT SYSTEM | LZO | Substantially Equivalent | |
| K912641 | BIOPRO ZIRALLOY MODULAR FEMORAL HEADS | LZO | Substantially Equivalent | |
| K911378 | TOWNLEY GREAT TOE JOINT | KWD | Substantially Equivalent | |
| K904448 | TOWNLEY TOTAL KNEE (TTK) | JWH | Substantially Equivalent | |
| K910352 | BIOPRO METAL BACKED CEMENTED ACETABULAR CUP | JDI | Substantially Equivalent | |
| K904207 | BIOPRO TRINITY ACETABULAR CUP | JDI | Substantially Equivalent for Some Indications | |
| K895886 | BIOPRO HEMI-ENDO MODULAR HEAD FOR PSL SYSTEM | KWL | Substantially Equivalent | |
| K894604 | BIOPRO PROXIMAL FEMORAL ARTICULAR REPLACEMENT | KXA | Substantially Equivalent for Some Indications | |
| K890044 | BIOPRO ANATOMIC UNICOMPARTMENTAL KNEE | HRY | Substantially Equivalent for Some Indications | |
| K882869 | TOWNLEY COX COMB ACETABULAR COMPONENT | JDI | Substantially Equivalent for Some Indications | |
| K882146 | BIOPRO PC FEMORAL HIP COMPONENT | JDI | Substantially Equivalent for Some Indications | |
| K874099 | REGENT DISPO STERILE BIOGEL STARCH FREE SURG GLOVE | KGO | Substantially Equivalent | |
| K872535 | BIOPRO FEMORAL HIP COMPONENT | KWL | Substantially Equivalent | |
| K872856 | BIOPRO 32MM BALL | JDI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1833506 | 1832656 | BIOPRO, INC. | 2929 Lapeer Rd, PORT HURON, MI 48060 US | 2026 | and 35 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- FZHApparatus, Air Handling, Room
- KWQAppliance, Fixation, Spinal Intervertebral Body
- HTWBit, Drill
- PLFBone Wedge
- HWBExtractor
- HTJGauge, Depth
- FZXGuide, Surgical, Instrument
- OQGHip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
- OQIHip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
- HXPInstrument, Bending Or Contouring
- HWNInstrument, Compression
- ODPIntervertebral Fusion Device With Bone Graft, Cervical
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- EMFKnife, Surgical
- LYYLatex Patient Examination Glove
- LXHOrthopedic Manual Surgical Instrument
- OLOOrthopedic Stereotaxic Instrument
- GFIOsteotome, Manual
- HTYPin, Fixation, Smooth
- JDWPin, Fixation, Threaded
- HRSPlate, Fixation, Bone
- KXAProsthesis, Hip, Femoral, Resurfacing
- KWLProsthesis, Hip, Hemi-, Femoral, Metal
- LZYProsthesis, Hip, Hemi-, Femoral, Metal Ball
- KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
- HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
- KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
- KWDProsthesis, Toe, Hemi-, Phalangeal
- KYIProsthesis, Wrist, Carpal Trapezium
- HTOReamer
- GADRetractor
- HSBRod, Fixation, Intramedullary And Accessories
- HWCScrew, Fixation, Bone
- HXXScrewdriver
- PHXShoulder Prosthesis, Reverse Configuration
- JDRStaple, Fixation, Bone
- KGOSurgeon'S Gloves
- HWTTemplate
- NKBThoracolumbosacral Pedicle Screw System
- FSMTray, Surgical, Instrument
- HTNWasher, Bolt Nut
Recall records
Showing 25 of 39| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0153-2026 | BioPro Femoral Head Product ID/Description 14089 HEAD FEMORAL 28 SH LT 14090 HEAD FEMORAL 28 MD LT 14091 HEAD FEMORAL 28 LG LT 14094 HEAD FEMORAL 32 SH LT 14095 HEAD FEMORAL 32 MD LT 14096 HEAD FEMORAL 32 LG LT | Potential 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. | Class II | Open, Classified | |
| Z-0152-2026 | BioPro Endo Head (Ceramic) Product ID/Description 13006 ENDO MODULAR CERAMIC SH 38 13012 ENDO MODULAR CERAMIC SH 51 13013 ENDO MODULAR CERAMIC MD 38 13019 ENDO MODULAR CERAMIC MD 51 13007 ENDO MODULAR CERAMIC SH 41 13008 ENDO MODULAR CERAMIC SH 43 13009 ENDO MODULAR CERAMIC SH 45 13010 ENDO MODULAR CERAMIC SH 47 13011 ENDO MODULAR CERAMIC SH 49 13014 ENDO MODULAR CERAMIC MD 41 13015 ENDO MODULAR CERAMIC MD 43 13016 ENDO MODULAR CERAMIC MD 45 13017 ENDO MODULAR CERAMIC MD 47 13018 ENDO MODULAR CERAMIC MD 49 14823 ENDO MODULAR CERAMIC SH 53 14824 ENDO MODULAR CERAMIC MD 53 14825 ENDO MODULAR CERAMIC SH 55 14826 ENDO MODULAR CERAMIC MD 55 17295 ENDO MODULAR CERAMIC SH 36 17296 ENDO MODULAR CERAMIC MD 36 | Potential 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. | Class II | Open, Classified | |
| Z-0151-2026 | BioPro Femoral Head (Ceramic heads 28-30) Product ID/Description 19023 HEAD FEMORAL CERAMIC 28MM -3 19024 HEAD FEMORAL CERAMIC 28MM +0 19025 HEAD FEMORAL CERAMIC 32MM -3 19026 HEAD FEMORAL CERAMIC 32MM +0 19027 HEAD FEMORAL CERAMIC 32MM +3 | Potential 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. | Class II | Open, Classified | |
| Z-0150-2026 | BioPro Bipolar Head Product ID/Description 18130 BIPOLAR HEAD 38MM 18131 BIPOLAR HEAD 39MM 18132 BIPOLAR HEAD 40MM 18133 BIPOLAR HEAD 41MM 18134 BIPOLAR HEAD 42MM 18135 BIPOLAR HEAD 43MM 18136 BIPOLAR HEAD 44MM 18137 BIPOLAR HEAD 45MM 18138 BIPOLAR HEAD 46MM 18139 BIPOLAR HEAD 47MM 18140 BIPOLAR HEAD 48MM 18141 BIPOLAR HEAD 49MM 18142 BIPOLAR HEAD 50MM 18143 BIPOLAR HEAD 51MM 18144 BIPOLAR HEAD 52MM 18145 BIPOLAR HEAD 53MM 18146 BIPOLAR HEAD 54MM 18147 BIPOLAR HEAD 55MM 18148 BIPOLAR HEAD 56MM 18149 BIPOLAR HEAD 57MM 18150 BIPOLAR HEAD 58MM 18151 BIPOLAR HEAD 59MM 18152 BIPOLAR HEAD 60MM | Potential 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. | Class II | Open, Classified | |
| Z-0149-2026 | BioPro Endo Head (Metal uni-polar, 38-55) Product Number/Description 10179 ENDO MD 38 10180 ENDO MD 41 10181 ENDO MD 43 10182 ENDO MD 45 10183 ENDO MD 47 10184 ENDO MD 49 10185 ENDO MD 51 10186 ENDO MD 53 10187 ENDO MD 55 10188 ENDO SH 38 10189 ENDO SH 41 10190 ENDO SH 43 10191 ENDO SH 45 10192 ENDO SH 47 10193 ENDO SH 49 10194 ENDO SH 51 10195 ENDO SH 53 10196 ENDO SH 55 | Potential 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. | Class II | Open, Classified | |
| Z-0148-2026 | BioPro 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 FEMORAL 28MM+0 19006 HEAD FEMORAL 28MM+3 19007 HEAD FEMORAL 28MM+6 19008 HEAD FEMORAL 28MM+9 19053 HEAD FEMORAL 36MM -3 19054 HEAD FEMORAL 36MM +0 19055 HEAD FEMORAL 36MM +3 19056 HEAD FEMORAL 36MM +6 19057 HEAD FEMORAL 36MM +9 19130 HEAD FEMORAL 32MM-6 19131 HEAD FEMORAL 32MM-3 19132 HEAD FEMORAL 32MM+0 19133 HEAD FEMORAL 32MM +3 19134 HEAD FEMORAL 32MM+6 19135 HEAD FEMORAL 32MM +9 | Potential 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. | Class II | Open, Classified | |
| Z-0691-2022 | Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MS, Part ID 17198 | There 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 MPJ. | Class II | Terminated | |
| Z-0690-2022 | Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MS, Part ID 17197 | There 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 MPJ. | Class II | Terminated | |
| Z-0689-2022 | Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC LG, Part ID 17038 | There 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 MPJ. | Class II | Terminated | |
| Z-0688-2022 | Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC M/L, Part ID 17037 | There 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 MPJ. | Class II | Terminated | |
| Z-0687-2022 | Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MD, Part ID 17036 | There 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 MPJ. | Class II | Terminated | |
| Z-0686-2022 | Titanium MPJ (Toe Implant)TOE JOINT TITANIUM PC SM, Part ID 17035 | There 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 MPJ. | Class II | Terminated | |
| Z-0685-2022 | Titanium MPJ (Toe Implant)TOE JOINT TITANIUM NPC LG, Part ID 16816 | There 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 MPJ. | Class II | Terminated | |
| Z-0684-2022 | Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC ML, Part ID 16815 | There 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 MPJ. | Class II | Terminated | |
| Z-0683-2022 | Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MD, Part ID 16814 | There 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 MPJ. | Class II | Terminated | |
| Z-0682-2022 | Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC SM, Part ID 16813 | There 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 MPJ. | Class II | Terminated | |
| Z-2259-2019 | K-Wire HBS Sterile Lot, 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 spine | Manufacturing flaw in the sterile barrier system | Class II | Terminated | |
| Z-2258-2019 | Go-EZ Screw 6.5x38, Item Number 19655 - 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 spine | Manufacturing flaw in the sterile barrier system | Class II | Terminated | |
| Z-2257-2019 | Go-EZ Screw 6.5x120, Item Number 19672 - 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 spine | Manufacturing flaw in the sterile barrier system | Class II | Terminated | |
| Z-2256-2019 | Go-EZ Screw 6.5x110, Item Number 19670 - 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 spine | Manufacturing flaw in the sterile barrier system | Class II | Terminated | |
| Z-2255-2019 | Go-EZ Screw 6.5x105, Item Number 19669 - 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 spine | Manufacturing flaw in the sterile barrier system | Class II | Terminated | |
| Z-2254-2019 | Go-EZ Screw 6.5x32, Item Number 19652 - 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 spine | Manufacturing flaw in the sterile barrier system | Class II | Terminated | |
| Z-2253-2019 | Go-EZ Screw 6.5x115, Item Number 19671 - 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 spine | Manufacturing flaw in the sterile barrier system | Class II | Terminated | |
| Z-2252-2019 | Go-EZ Screw 6.5x90, Item Number 19666 - 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 spine | Manufacturing flaw in the sterile barrier system | Class II | Terminated | |
| Z-2251-2019 | Go-EZ Screw 6.5x85, Item Number 19665 - 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 spine | Manufacturing flaw in the sterile barrier system | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain