510(k) · Cleared

Cleared

Biopro Subtalar Implant

K041936510(k) TraditionalCleared Sep 8, 200451-day reviewClass II21 CFR 888.3040

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

Biopro, Inc. · HWC Screw, Fixation, Bone

Cleared on Sep 8, 2004 as substantially equivalent to K960692 (Kinetikos Medical, Inc., 1996) and 1 other predicate after a 51-day review. Its family tree reaches back 2 generations to 1980.

Decided: Sep 8, 2004
Review: 51 days
Class: Class II
Product code: HWC
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K792670 (1980). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK792670 Smith Subtalar PegDow Corning Wright · 1980
1 generation backK960692 Subtalar Mba SystemKinetikos Medical, Inc. · 1996
This deviceK041936 Biopro Subtalar ImplantBiopro, Inc. · 2004

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K792670	Smith Subtalar Peg	Dow Corning Wright	1980	—
−1	K960692	Subtalar Mba System	Kinetikos Medical, Inc.	1996	—
0 (this device)	K041936	Biopro Subtalar Implant	Biopro, Inc.	2004	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0

FIG. 1 — Lineage of K041936, 1980–2004Source: 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 HWC? 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 HWC device

#1 K203011 Monster Screw Systemscore 22.2 · 14 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? (2)

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
*	K960692	Subtalar Mba System Summary page 1 …substantially equivalent in design, composition and function to other orthopedice screws manufactured and approved for maket such as: KMI Subtalar MVBA SystemnTm K960692 and the Kalix® implant K001231 Device Description: The Biopro Sub-talar Implant is a combination of three components. T…	Kinetikos Medical, Inc.	1996	—
*	K001231	The Kalix Implant Summary page 1 …ign, composition and function to other orthopedice screws manufactured and approved for maket such as: KMI Subtalar MVBA SystemnTm K960692 and the Kalix® implant K001231 Device Description: The Biopro Sub-talar Implant is a combination of three components. Two components made of titan…	New Deal, S.A.	2000	—

Also cleared against K960692: 8 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 24 years and passes through 3 companies; a new generation was cleared every 16.4 years on median.
None of the 3 ancestors has a recall.
8 other devices also cite its predicate K960692.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HWC

15in 2025

2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007high 167 (2022) · low 75 (2020)2026

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

Recalls per year · HWC

1in 2025

2007high 33 (2008) · low 0 (2023)2026

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

Adverse event reports per year · HWC

2,893in 2025

2007high 5,463 (2019) · low 651 (2009)2025

MAUDE reports naming product code HWC, 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	77	25	669
2008	33	76	33	660
2009	27	113	29	651
2010	23	110	7	765
2011	35	88	12	1,104
2012	20	99	30	3,339
2013	25	90	14	3,850
2014	31	88	2	2,549
2015	41	85	5	2,711
2016	26	131	4	2,285
2017	40	127	4	2,561
2018	20	106	1	3,662
2019	30	108	5	5,463
2020	28	75	4	4,820
2021	26	84	2	4,446
2022	26	167	13	3,934
2023	24	104	0	3,718
2024	17	90	0	3,575
2025	15	111	1	2,893
2026	21	125	2	—

What is it indicated for?

The Biopro subtalar implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela. Conditions include:

Flat foot treatment in children and adolescents

Congenital flat foot

Unsuccessful long term orthopedic treatment (orthodics)

Tarsal coalitions

Painfully flat foot

Supple deformity in posterior tibial tendon dysfunction

Paralytic flat foot

Subtalar instability

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K041936 · printed Nov 6, 2026

Cite this page

510(k) Report. “K041936: Biopro Subtalar Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041936

Report an extraction error

Are you the manufacturer?

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