510(k) · Cleared

Cleared

BioPro Foot Plating Systems

K162674510(k) TraditionalCleared Jun 16, 2017263-day reviewClass II21 CFR 888.3030

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Biopro, Inc. · HRS Plate, Fixation, Bone

Cleared on Jun 16, 2017 as substantially equivalent to K072740 (Mondeal Medical Systems GmbH, 2007) and 21 other predicates after a 263-day review. Its family tree reaches back 12 generations to 1996. 19 later devices descend from it.

Decided: Jun 16, 2017
Review: 263 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 22

Its longest line of descent runs back 12 generations to K962616 (1996). 206 ancestors in all, the oldest K792022 (1979). 19 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 12 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
8 generations between
3 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
2 generations backK140376 Variax 2 SystemStryker Trauma AG · 2014
1 generation backK141992 Variax 2 SystemStryker Trauma AG · 2014
This deviceK162674 BioPro Foot Plating SystemsBiopro, Inc. · 2017
Descendant · cites it directly · 11 of its ownK193222 Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2020
Descendant · 2 generations on · 10 of its ownK203817 Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2021
Descendant · 2 generations on · 9 of its ownK222465 Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2023
Descendant · cites it directly · 5 of its ownK183011 Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics · 2019
Descendant · 2 generations on · 4 of its ownK193614 FINE Osteotomy around the kneeBodycad Laboratories, Inc. · 2020

Show all 12 generations

Root · 12 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
11 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
10 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
9 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
8 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
7 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
6 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
5 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
4 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
3 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
2 generations backK140376 Variax 2 SystemStryker Trauma AG · 2014
1 generation backK141992 Variax 2 SystemStryker Trauma AG · 2014
This deviceK162674 BioPro Foot Plating SystemsBiopro, Inc. · 2017

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

2019high 6 (2023) · low 0 (2022)2026

Most influential descendants

Showing 5 of 19 · See all

K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2020 · cites it directly11descendants
K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2021 · 2 generations on10descendants
K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2023 · 2 generations on9descendants
K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics · 2019 · cites it directly5descendants
K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc. · 2020 · 2 generations on4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−12	K962616	Synthes Dorsal Distal Radius Plate (DDRP) System	Synthes (Usa)	1996	—
−11	K982732	Synthes (Usa) Distal Radius Plate System (DRPS)	Synthes	1998	—
−10	K023007	Distal Radius Fracture Repair System	Hand Innovations, Inc.	2002	—
−9	K030198	Hand Innovations, Inc. Distal Radius Fracture Repair System	Hand Innovations, Inc.	2003	—
−8	K032705	Distal Radius Fracture Repair System	Hand Innovations, Inc.	2003	—
−7	K050932	Distal Volar Radius Anatomical Plate System	Hand Innovations, Inc.	2005	1
−6	K051735	Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity	Smith & Nephew, Inc.	2005	—
−5	K071563	Peri-Loc Periarticular Locked Plating System	Smith & Nephew, Inc.	2007	—
−4	K090675	Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories	Smith & Nephew, Inc.	2009	—
−3	K100776	Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System	Synthes (Usa)	2010	—
−2	K140376	Variax 2 System	Stryker Trauma AG	2014	—
−1	K141992	Variax 2 System	Stryker Trauma AG	2014	—
0 (this device)	K162674	BioPro Foot Plating Systems	Biopro, Inc.	2017	—
+1	K193222	Tyber Medical Anatomical Plating System	Tyber Medical, LLC	2020	—
+2	K203817	Tyber Medical Anatomical Plating System	Tyber Medical, LLC	2021	—
+2	K222465	Tyber Medical Anatomical Plating System	Tyber Medical, LLC	2023	—
+1	K183011	Additive Orthopaedics Patient Specific 3D Locking Lattice Plates	Additive Orthopaedics	2019	—
+2	K193614	FINE Osteotomy around the knee	Bodycad Laboratories, Inc.	2020	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1979	1	0
1980	1	0
1981	1	0
1988	1	0
1989	3	0
1990	3	0
1991	2	0
1992	5	0
1993	3	0
1994	6	0
1995	5	0
1996	13	0
1997	2	0
1998	7	0
1999	10	0
2000	13	0
2001	13	0
2002	13	0
2003	6	0
2004	9	0
2005	13	0
2006	12	0
2007	9	0
2008	12	0
2009	10	0
2010	11	0
2011	3	0
2012	5	0
2014	1	0
2015	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2019	1	0
2020	2	0
2021	2	0
2023	6	0
2024	3	0
2025	3	0
2026	2	0

FIG. 1 — Lineage of K162674, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in HRS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new HRS device

#1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (22)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K072740	Mondeal Extremity Bone Fixation System Summary page 4 …HWC SUBSTANTIALLY EQUIVALENT DEVICES: Forefoot System Mid & Hindfoot System Ankle Fracture System Primary Predicates K072740 Mondeal- K111678 OrthoSolutions – K001945 Synthes – Medial Extremity Bone Extremity…	Mondeal Medical Systems GmbH	2007	—
*	K111678	Ortho Solutions Extremity Fixation Implants for Osteosysnthesis Summary page 4 …EQUIVALENT DEVICES: Forefoot System Mid & Hindfoot System Ankle Fracture System Primary Predicates K072740 Mondeal- K111678 OrthoSolutions – K001945 Synthes – Medial Extremity Bone Extremity Fixation Implants for…	Ortho Solutions Limited	2012	1
*	K001945	Synthes (Usa) Medial Distal Tibia Plates Summary page 4 …Forefoot System Mid & Hindfoot System Ankle Fracture System Primary Predicates K072740 Mondeal- K111678 OrthoSolutions – K001945 Synthes – Medial Extremity Bone Extremity Fixation Implants for Distal Tibia Plate System…	Synthes (Usa)	2000	—
*	K091479	Aptus Foot System Summary page 4 …one Extremity Fixation Implants for Distal Tibia Plate System Fixation - M2 System Osteosynthesis - FPS System Additional Predicates K091479 & K142581 K091479 & K142581 K073460 & K083213 Medartis – APTUS Medartis – APTU…	Medartis AG	2009	2
*	K142581	APTUS Foot System Summary page 4 …Extremity Fixation Implants for Distal Tibia Plate System Fixation - M2 System Osteosynthesis - FPS System Additional Predicates K091479 & K142581 K091479 & K142581 K073460 & K083213 Medartis – APTUS Medartis – APTUS Foot…	Medartis AG	2015	—
*	K140376	Variax 2 System Summary page 4 …– APTUS Foot Synthes – LCP Distal Fibula Foot System System Plate System K140376 & K141992 K140376 & K141992 Stryker K063672 I.T.S. – Fibula Stryker – VariAx 2 -VariAx 2…	Stryker Trauma AG	2014	—
*	K141992	Variax 2 System Summary page 4 …oot Synthes – LCP Distal Fibula Foot System System Plate System K140376 & K141992 K140376 & K141992 Stryker K063672 I.T.S. – Fibula Stryker – VariAx 2 -VariAx 2 Foot Locki…	Stryker Trauma AG	2014	—
*	K090692	Ortholoc 2.0/2.4 Plate System Summary page 4 …rolock with Angular Foot Locking Plate System Stability System System K090692 Wright – K100776 Synthes – LCP K092812 & K013248 ORTHOLOC 2.0/2.4 Variable Angle M…	Wrightmedicaltechnologyinc	2009	1
*	K100776	Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System Summary page 4 …Foot Locking Plate System Stability System System K090692 Wright – K100776 Synthes – LCP K092812 & K013248 ORTHOLOC 2.0/2.4 Variable Angle Midfoot System Synth…	Synthes (Usa)	2010	—
*	K141784	Ortho Solutions Ultos Plating System Summary page 5 …K162674 Page 2/2 Additional Predicates Forefoot System Mid & Hindfoot System Ankle Fracture System Continued: K141784 K121651, K120359, K090692 K013248, K082807 OrthoSolutions - Wright – ORTHOLO…	Ortho Solutions Limited	2014	2
*	K090675	Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories Summary page 5 …Medial Distal Tibia K123000 Integra – Total Foot Plates System – MOWO & Rearfoot K090675 Smith & K110908 Medartis Ag - Aptus Nephew - VLP Foot Foot 3.5 System…	Smith & Nephew, Inc.	2009	—
*	K121651	Ortholoc 3DI Midfoot/Flatfoot System Summary page 5 …ge 2/2 Additional Predicates Forefoot System Mid & Hindfoot System Ankle Fracture System Continued: K141784 K121651, K120359, K090692 K013248, K082807 OrthoSolutions - Wright – ORTHOLOC 3Di Synthes…	Wrightmedicaltechnologyinc	2012	—
*	K061808	Darco Locking Bone Plate System Summary page 4 …LCP Anterolateral Plate System Distal Tibia Plate System K100776 Synthes – K061808 Dacrco International, LCP Variable Angle Inc. - Darco Locking Bone Plate Forefo…	Darco International, Inc.	2006	3
*	K120359	Ortholoc 3DI Hallux System Summary page 5 …Additional Predicates Forefoot System Mid & Hindfoot System Ankle Fracture System Continued: K141784 K121651, K120359, K090692 K013248, K082807 OrthoSolutions - Wright – ORTHOLOC 3Di Synthes – LCP Dis…	Wrightmedicaltechnologyinc	2012	2
*	K123000	Integra Total Foot Systems Summary page 5 …Systems Arthrodesis Plates K001945 Synthes. – Medial Distal Tibia K123000 Integra – Total Foot Plates System – MOWO & Rearfoot K090675 S…	Integra LifeSciences Corporation	2012	—
*	K110908	Aptus Foot 3.5 System Summary page 5 …l Distal Tibia K123000 Integra – Total Foot Plates System – MOWO & Rearfoot K090675 Smith & K110908 Medartis Ag - Aptus Nephew - VLP Foot Foot 3.5 System Plating/Screw System…	Medartis AG	2011	—
*	K073460	Synthes 2.7 MM/3.5 MM LCP Distal Fibula Plates Summary page 4 …Plate System Fixation - M2 System Osteosynthesis - FPS System Additional Predicates K091479 & K142581 K091479 & K142581 K073460 & K083213 Medartis – APTUS Medartis – APTUS Foot Synthes – LCP Distal Fibula…	Synthes (Usa)	2008	—
*	K083213	Synthes 2.7 MM/3.5 MM LCP Distal Fibula Plates Summary page 4 …tem Fixation - M2 System Osteosynthesis - FPS System Additional Predicates K091479 & K142581 K091479 & K142581 K073460 & K083213 Medartis – APTUS Medartis – APTUS Foot Synthes – LCP Distal Fibula…	Synthes (Usa)	2008	—
*	K063672	Fibula Plate Prolock with Angular Stability Summary page 4 …Foot System System Plate System K140376 & K141992 K140376 & K141992 Stryker K063672 I.T.S. – Fibula Stryker – VariAx 2 -VariAx 2 Foot Locking Plate Plate Prolock with Angular…	I.T.S. Implantat-Technologie-Systeme GmbH	2007	1
*	K092812	Synthes (Usa) 2.7MM/ 3.5MM LCP Anterolateral Distal Tibia Plates Summary page 4 …late System Stability System System K090692 Wright – K100776 Synthes – LCP K092812 & K013248 ORTHOLOC 2.0/2.4 Variable Angle Midfoot System Synthes – LCP Anterolateral…	Synthes (Usa)	2010	—
*	K013248	Synthes LCP Distal Tibia Plates Summary page 4 …ystem Stability System System K090692 Wright – K100776 Synthes – LCP K092812 & K013248 ORTHOLOC 2.0/2.4 Variable Angle Midfoot System Synthes – LCP Anterolateral…	Synthes (Usa)	2001	—
*	K082807	Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded Indications Summary page 5 …t System Mid & Hindfoot System Ankle Fracture System Continued: K141784 K121651, K120359, K090692 K013248, K082807 OrthoSolutions - Wright – ORTHOLOC 3Di Synthes – LCP Distal Tibia…	Synthes (Usa)	2008	—
†	K922500	PSL Total Hip Replacement System	Biopro, Inc.	1994	—
†	K132510	Biopro - Infinity Plate Anchor System	Biopro, Inc.	2013	—

Also cleared against K072740: 4 other devices →

What descends from it? (19)

See all 19

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K193222	Tyber Medical Anatomical Plating System	Tyber Medical, LLC	2020	11
K183011	Additive Orthopaedics Patient Specific 3D Locking Lattice Plates	Additive Orthopaedics	2019	5
K251892	MAXXOS P.A.C.E. Foot & Ankle Plating System	Maxxos Medical GmbH	2025	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 21 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
44 of the 206 ancestors have a recall of any class.
Of its descendants, K193222 (Tyber Medical, LLC, 2020) has gone furthest, with 11 descendants of its own.
4 other devices also cite its predicate K072740.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

FDA decisions per year · HRS

54in 2025

2007high 76 (2014) · low 35 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRS

90in 2025

2007high 144 (2022) · low 57 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HRS

1in 2025

2007high 25 (2019) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HRS

2,306in 2025

2007high 3,359 (2019) · low 311 (2008)2025

MAUDE reports naming product code HRS, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	35	63	2	339
2008	35	87	11	311
2009	47	85	3	435
2010	49	100	16	491
2011	43	88	5	773
2012	59	106	4	1,663
2013	56	89	11	2,643
2014	76	57	0	2,413
2015	56	97	7	3,095
2016	44	109	5	2,276
2017	57	122	3	2,220
2018	40	116	2	2,663
2019	46	89	25	3,359
2020	48	88	1	2,790
2021	40	87	9	2,442
2022	47	144	3	1,700
2023	40	120	1	2,049
2024	54	96	0	1,849
2025	54	90	1	2,306
2026	51	82	3	—

What is it indicated for?

The intended use of the BioPro Foot Plating Systems is to draw two or more aligned bone fragments together to facilitate healing in an adult patient and is composed of the following bone plate categories: I. Forefoot System: The BioPro Forefoot Plating System is Indicated for Use in fixation of small bones and small bone fragments in the foot (Phalanges and Metatarsals) for stabilization of fractures, joint fusions, osteotomies, nonunions, malunions…

Read the full statement (258 words)

I. Forefoot System:

The BioPro Forefoot Plating System is Indicated for Use in fixation of small bones and small bone fragments in the foot (Phalanges and Metatarsals) for stabilization of fractures, joint fusions, osteotomies, nonunions, malunions, reconstruction of small bones, revision surgeries and replantations in an adult patient.

The Forefoot System is not for Spinal Use.

II. Mid & Hindfoot System:

The BioPro Mid & Hindfoot Plating System is Indicated for Use in fixation of medium/large bones and medium/large bone multi-fragments in the foot (Cuneiform, Cuboid, Navicular, Talus and Calcaneus) for stabilization of fractures, joint fusions, osteotomies, nonunions, malunions, reconstruction of medium/large bones, revision surgeries and replantations in an adult patient.

The Mid & Hindfoot System is not for Spinal Use.

III. Ankle Fracture System:

The BioPro Ankle Fracture System is Indicated for Use in:

1). Fixation of fractures of the distal tibia included, but not limited to, ankle fractures, perarticular fractures, corrective osteotomies, non-unions, intra- and extra- articular and distal tibia fractures with a shaft extension, and malleolar fractures;

2). In intra- and extra articular fractures, osteotomies, medial malleolar fractures and non-unions of the metaphyseal and diaphyseal region of the distal fibula;

3). In distal tibia/fibula long bones which include the metaphyseal and diaphyseal regions of the tibia and fibula in the ankle.

The Ankle Fracture System is not for Spinal Use.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K162674 · printed Nov 6, 2026

Cite this page

510(k) Report. “K162674: BioPro Foot Plating Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162674

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026