510(k) · Cleared

Cleared

Nugait (TM) Subtalar Implant System

K111799510(k) TraditionalCleared Aug 19, 201153-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

Ascension Orthopedic · HWC Screw, Fixation, Bone

Cleared on Aug 19, 2011 as substantially equivalent to K080280 (Instratek, Inc., 2008) after a 53-day review. Its family tree reaches back 4 generations to 1980.

Decided: Aug 19, 2011
Review: 53 days
Class: Class II
Product code: HWC
Recalls: None
Predicates: 1

Its longest line of descent runs back 4 generations to K792670 (1980). 6 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 4 generations backK792670 Smith Subtalar PegDow Corning Wright · 1980
3 generations backK960692 Subtalar Mba SystemKinetikos Medical, Inc. · 1996
2 generations backK031155 Osteomed Subtalar Implant SystemOsteomed LP · 2003
1 generation backK080280 Sub-Talar Lok, Model 7-11 MMInstratek, Inc. · 2008
This deviceK111799 Nugait (TM) Subtalar Implant SystemAscension Orthopedic · 2011

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K792670	Smith Subtalar Peg	Dow Corning Wright	1980	—
−3	K960692	Subtalar Mba System	Kinetikos Medical, Inc.	1996	—
−2	K031155	Osteomed Subtalar Implant System	Osteomed LP	2003	—
−1	K080280	Sub-Talar Lok, Model 7-11 MM	Instratek, Inc.	2008	—
0 (this device)	K111799	Nugait (TM) Subtalar Implant System	Ascension Orthopedic	2011	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0
2003	1	0

FIG. 1 — Lineage of K111799, 1980–2011Source: 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

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What was it cleared against? (1)

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
*	K080280	Sub-Talar Lok, Model 7-11 MM Summary page 1 …fixation fastener. Panel: Orthopedic Predicate Device: Sub-Talar Lok" Arthroereisis Implant System; K(080280, cleared 14 March 2008; manufactured by Instratek, Inc. Device Description:…	Instratek, Inc.	2008	—

Also cleared against K080280: 4 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 31 years and passes through 5 companies; a new generation was cleared every 7.1 years on median.
None of the 6 ancestors has a recall.
4 other devices also cite its predicate K080280.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

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 NuGait Subtalar Implant System restricts excessive subtalar pronation in the downward, forward, and medial planes, providing for a more normal subtalar joint motion in patients. The NuGait Subtalar Implant System is intended for the following pathological conditions resulting from disease, injury, or other trauma:

* Hypermobile pes valgus;

* Posterior tibial tendon dysfunction;

* Severe pronation;

* Subtalar instability;

* Hypermobile flexible congenital flat foot.

The NuGait Subtalar Implant System implants are intended for single use only.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K111799 · printed Nov 6, 2026

Cite this page

510(k) Report. “K111799: Nugait (TM) Subtalar Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111799

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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