Company ยท US
Biopro, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1987 to 2017. Name variants (Inc, Corp, punctuation) are merged.
41510(k) clearances (0 in 12 months)
39recalls (0 in 12 months)
34recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| NBH | Accessories, Arthroscopic | 21 |
| KWD | Prosthesis, Toe, Hemi-, Phalangeal | 13 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 10 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 4 |
| HRS | Plate, Fixation, Bone | 3 |
| HWC | Screw, Fixation, Bone | 3 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 3 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 3 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 2 |
| JDR | Staple, Fixation, Bone | 2 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 2 |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | 2 |
| KXA | Prosthesis, Hip, Femoral, Resurfacing | 2 |
| KYI | Prosthesis, Wrist, Carpal Trapezium | 2 |
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | 1 |
| HTN | Washer, Bolt Nut | 1 |
| HTY | Pin, Fixation, Smooth | 1 |
| JDW | Pin, Fixation, Threaded | 1 |
| KGO | Surgeon'S Gloves | 1 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 14, 2017 | K163627 | Shotel Ankle Arthrodesis Nail System Biopro, Inc. | HSB |
| Jun 16, 2017 | K162674 | BioPro Foot Plating Systems Biopro, Inc. | HRS |
| Oct 24, 2013 | K132510 | BIOPRO - INFINITY PLATE ANCHOR SYSTEM Biopro, Inc. | HTN |
| Jun 18, 2013 | K130298 | BIOPRO KWICK-WIRE UNIVERSAL SCREW SYSTEM Biopro, Inc. | JDW |
| Oct 30, 2012 | K121973 | BIOPRO HEMI-EDGE TOE SYSTEM Biopro, Inc. | KWD |
| Dec 3, 2010 | K100761 | BIOPRO POLAR HEAD Biopro, Inc. | KWY |
| Jun 3, 2010 | K101030 | MODIFICATION TO HBS HEADLESS BONE SCREW Biopro, Inc. | HWC |
| May 22, 2009 | K090208 | BIOPRO FEMORAL HEADS Biopro, Inc. | JDI |
| Mar 18, 2009 | K083490 | BIOPRO K-WIRE, MODELS 16863, 17231, 17232, 18577, 18682-18685 Biopro, Inc. | HTY |
| Dec 15, 2008 | K082705 | BIOPRO BIPOLAR HEAD, MODELS 18130-18152 Biopro, Inc. | KWY |
| Aug 5, 2008 | K081149 | BIOPRO GO-EZ SCREW Biopro, Inc. | HWC |
| Oct 29, 2007 | K072298 | BIOPRO MEMORY STAPLE, MODELS 18062-18073 Biopro, Inc. | JDR |
| Aug 21, 2006 | K061798 | BIOPRO MEMORY STAPLE Biopro, Inc. | JDR |
| Jun 20, 2006 | K061089 | MODULAR THUMB IMPLANT, MODELS 17600, 17601, 17602, 17603, 17596, 17597, 17598, 17599 Biopro, Inc. | KYI |
| Nov 15, 2005 | K052596 | MODULAR THUMB IMPLANT, MODELS 17065,17066,17243,17067,17199,17238,17005,17239,17006,17240,17007,17241,17500,17501,17507 Biopro, Inc. | KYI |
| May 18, 2005 | K043542 | BIOPRO TARA FEMORAL RESURFACING COMPONENT Biopro, Inc. | KXA |
| Nov 12, 2004 | K041595 | TOE MP JOINT, MODELS 10412-10414, 14958, 14960, 1060-10062,16818,-16822,16867-16870 Biopro, Inc. | KWD |
| Sep 8, 2004 | K041936 | BIOPRO SUBTALAR IMPLANT Biopro, Inc. | HWC |
| Aug 7, 2001 | K011460 | WUJIN #3 TIBIAL BONE PLATE Biopro, Inc. | HRS |
| Aug 7, 2001 | K011459 | WUJIN #3 FEMORAL BONE PLATE Biopro, Inc. | HRS |
| Apr 17, 2001 | K010149 | WUJIN #3 FEMORAL NAIL Biopro, Inc. | HSB |
| Jun 8, 2000 | K001046 | BIOPRO GLENOID COMPONENT W/ KEEL & W/ POSTS Biopro, Inc. | KWS |
| Apr 29, 1999 | K990821 | PROVIDENCE CUP SYSTEM Biopro, Inc. | JDI |
| May 24, 1996 | K960467 | POWDER FREE LATEX EXAMINATION GLOVE Biopro, Inc. | LYY |
| Jan 7, 1994 | K925682 | BIOPRO ZIRALLOY MODULAR FEMORAL HEADS, MODIFIED Biopro, Inc. | LZO |
| Jan 7, 1994 | K922500 | PSL TOTAL HIP REPLACEMENT SYSTEM Biopro, Inc. | LPH |
| Sep 21, 1993 | K922841 | BIOPRO MODULAR TIBIAL TRAY Biopro, Inc. | JWH |
| Oct 15, 1992 | K920145 | BIOPRO DRG CUSTOM HIP REPLACEMENT SYSTEM Biopro, Inc. | LZO |
| Nov 27, 1991 | K912641 | BIOPRO ZIRALLOY MODULAR FEMORAL HEADS Biopro, Inc. | LZO |
| Nov 22, 1991 | K911378 | TOWNLEY GREAT TOE JOINT Biopro, Inc. | KWD |
| Jul 17, 1991 | K904448 | TOWNLEY TOTAL KNEE (TTK) Biopro, Inc. | JWH |
| Jun 13, 1991 | K910352 | BIOPRO METAL BACKED CEMENTED ACETABULAR CUP Biopro, Inc. | JDI |
| Jan 4, 1991 | K904207 | BIOPRO TRINITY ACETABULAR CUP Biopro, Inc. | JDI |
| Dec 1, 1989 | K895886 | BIOPRO HEMI-ENDO MODULAR HEAD FOR PSL SYSTEM Biopro, Inc. | KWL |
| Nov 17, 1989 | K894604 | BIOPRO PROXIMAL FEMORAL ARTICULAR REPLACEMENT Biopro, Inc. | KXA |
| Nov 6, 1989 | K890044 | BIOPRO ANATOMIC UNICOMPARTMENTAL KNEE Biopro, Inc. | HRY |
| Oct 14, 1988 | K882869 | TOWNLEY COX COMB ACETABULAR COMPONENT Biopro, Inc. | JDI |
| Aug 29, 1988 | K882146 | BIOPRO PC FEMORAL HIP COMPONENT Biopro, Inc. | JDI |
| Dec 14, 1987 | K874099 | REGENT DISPO STERILE BIOGEL STARCH FREE SURG GLOVE Biopro, Inc. | KGO |
| Aug 26, 1987 | K872535 | BIOPRO FEMORAL HIP COMPONENT Biopro, Inc. | KWL |
| Aug 17, 1987 | K872856 | BIOPRO 32MM BALL Biopro, Inc. | JDI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 14, 2025 | BioPro, Inc. 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 FEMO Open, Classified |
JDI | K872856 |
| Oct 14, 2025 | BioPro, Inc. 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 MODULA Open, Classified |
LZY | K954768 |
| Oct 14, 2025 | BioPro, Inc. 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 32 Open, Classified |
LZO | K912641 |
| Oct 14, 2025 | BioPro, Inc. 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 BIPOLA Open, Classified |
KWY | K100761 |
| Oct 14, 2025 | BioPro, Inc. 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 Open, Classified |
LPH | K895886 |
| Oct 14, 2025 | BioPro, Inc. 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 FEMORA Open, Classified |
LPH | K090208 |
| Feb 1, 2022 | BioPro, Inc. Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MS, Part ID 17198 Terminated |
KWD | K041595 |
| Feb 1, 2022 | BioPro, Inc. Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MS, Part ID 17197 Terminated |
KWD | K041595 |
| Feb 1, 2022 | BioPro, Inc. Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC LG, Part ID 17038 Terminated |
KWD | K041595 |
| Feb 1, 2022 | BioPro, Inc. Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC M/L, Part ID 17037 Terminated |
KWD | K041595 |
| Feb 1, 2022 | BioPro, Inc. Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MD, Part ID 17036 Terminated |
KWD | K041595 |
| Feb 1, 2022 | BioPro, Inc. Titanium MPJ (Toe Implant)TOE JOINT TITANIUM PC SM, Part ID 17035 Terminated |
KWD | K041595 |
| Feb 1, 2022 | BioPro, Inc. Titanium MPJ (Toe Implant)TOE JOINT TITANIUM NPC LG, Part ID 16816 Terminated |
KWD | K041595 |
| Feb 1, 2022 | BioPro, Inc. Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC ML, Part ID 16815 Terminated |
KWD | K041595 |
| Feb 1, 2022 | BioPro, Inc. Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MD, Part ID 16814 Terminated |
KWD | K041595 |
| Feb 1, 2022 | BioPro, Inc. Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC SM, Part ID 16813 Terminated |
KWD | K041595 |
| Jun 25, 2019 | BioPro, Inc. 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 Terminated |
NBH | K101030 |
| Jun 25, 2019 | BioPro, Inc. 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 inte Terminated |
NBH | None listed |
| Jun 25, 2019 | BioPro, Inc. 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 int Terminated |
NBH | K081149 |
| Jun 25, 2019 | BioPro, Inc. 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 inte Terminated |
NBH | K081149 |
| Jun 25, 2019 | BioPro, Inc. 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 int Terminated |
NBH | K081149 |
| Jun 25, 2019 | BioPro, Inc. 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 inte Terminated |
NBH | K081149 |
| Jun 25, 2019 | BioPro, Inc. 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 int Terminated |
NBH | K081149 |
| Jun 25, 2019 | BioPro, Inc. 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 inten Terminated |
NBH | K081149 |
| Jun 25, 2019 | BioPro, Inc. 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 inte Terminated |
NBH | K081149 |
| Jun 25, 2019 | BioPro, Inc. Go-EZ Screw 6.5x34, Item Number 19653 - 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 inte Terminated |
NBH | K081149 |
| Jun 25, 2019 | BioPro, Inc. Go-EZ Screw 6.5x95, Item Number 19667 - 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 inte Terminated |
NBH | K081149 |
| Jun 25, 2019 | BioPro, Inc. Go-EZ Screw 6.5x36, Item Number 19654 - 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 inte Terminated |
NBH | K081149 |
| Jun 25, 2019 | BioPro, Inc. Go-EZ Screw 6.5x100, Item Number 19668 - 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 int Terminated |
NBH | K081149 |
| Jun 25, 2019 | BioPro, Inc. Go-EZ Screw 6.5x30, Item Number 19651 - 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 inte Terminated |
NBH | K081149 |
| Jun 25, 2019 | BioPro, Inc. K-Wire Single Trocar 2.5x150mm, Item Number OL15025S - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures Terminated |
NBH | None listed |
| Jun 25, 2019 | BioPro, Inc. K-Wire Single Trocar 1.1x150mm, Item Number OL15011S - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures Terminated |
NBH | None listed |
| Jun 25, 2019 | BioPro, Inc. K-Wire Single Trocar 1.6x150mm, Item Number OL15016S - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures Terminated |
NBH | None listed |
| Jun 25, 2019 | BioPro, Inc. K-Wire Single Trocar 2.5x170mm, Item Number OL17025S - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures Terminated |
NBH | None listed |
| Jun 25, 2019 | BioPro, Inc. K-Wire Sterile Single Trochar .045, Item Number 19108 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures Terminated |
NBH | K081149 |
| Jun 25, 2019 | BioPro, Inc. K-Wire Sterile Single Trochar, Item Number 19106 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but Terminated |
NBH | K081149 |
| Jun 25, 2019 | BioPro, Inc. K-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 inte Terminated |
NBH | K101030 |
| Nov 4, 2011 | Biopro, Inc. BioPro Femoral Head 28 mm +18, Item 19010.
Orthopedic femoral head for implantation Terminated |
JDI | K090208 |
| Nov 4, 2011 | Biopro, Inc. BioPro Femoral Head 28 mm -6 mm, Item 19003.
Orthopedic femoral head for implantation. Terminated |
JDI | K090208 |