510(k) Report

510(k) · Cleared

Cleared

TalarLift STS

K170624510(k) TraditionalCleared Aug 11, 2017162-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

Fusion Orthopedics, LLC · HWC Screw, Fixation, Bone

Cleared on Aug 11, 2017 as substantially equivalent to K093055 (Orthopro, LLC, 2010) and 4 other predicates after a 162-day review. Its family tree reaches back 4 generations to 1980.

Decided
Aug 11, 2017
Review
162 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
5

Its longest line of descent runs back 4 generations to K792670 (1980). 11 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2014: 1 other ancestor2010: 1 other ancestor2004: 2 other ancestors2003: 2 other ancestors2000: 1 other ancestorReference device: K140053 · Kangli Pedicle Screw Spinal System · Suzhou Kangli Orthopaedics Instrument Co., Ltd. · 2014Reference device: K142290 · KangLi pedical screw spinal system · Suzhou Kangli Orthopaedics Instrument Co., Ltd. · 2014Reference device: K161449 · HammerTech Fixation System · Fusion Orthopedics, LLC · 2016K792670 · Smith Subtalar Peg · Dow Corning Wright · 1980K960692 · Subtalar Mba System · Kinetikos Medical, Inc. · 1996K031155 · Osteomed Subtalar Implant System · Osteomed LP · 2003K080280 · Sub-Talar Lok, Model 7-11 MM · Instratek, Inc. · 20081980199020002010
Other ancestors, by generation 1 generation back: 4 other ancestors2 generations back: 2 other ancestors3 generations back: 1 other ancestor K080280 · Sub-Talar Lok, Model 7-11 MM · Instratek, Inc. · 2008K031155 · Osteomed Subtalar Implant System · Osteomed LP · 2003K960692 · Subtalar Mba System · Kinetikos Medical, Inc. · 1996K792670 · Smith Subtalar Peg · Dow Corning Wright · 19800
  1. Root · 4 generations backK792670 Smith Subtalar PegDow Corning Wright · 1980
  2. 3 generations backK960692 Subtalar Mba SystemKinetikos Medical, Inc. · 1996
  3. 2 generations backK031155 Osteomed Subtalar Implant SystemOsteomed LP · 2003
  4. 1 generation backK080280 Sub-Talar Lok, Model 7-11 MMInstratek, Inc. · 2008
  5. This deviceK170624 TalarLift STSFusion Orthopedics, LLC · 2017
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K792670Smith Subtalar PegDow Corning Wright1980—
−3K960692Subtalar Mba SystemKinetikos Medical, Inc.1996—
−2K031155Osteomed Subtalar Implant SystemOsteomed LP2003—
−1K080280Sub-Talar Lok, Model 7-11 MMInstratek, Inc.2008—
0 (this device)K170624TalarLift STSFusion Orthopedics, LLC2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010
200320
200420
201010
201410
FIG. 1 — Lineage of K170624, 1980–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K203011 Monster Screw Systemscore 22.2 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (5)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K093055CSTS Screw
Summary page 4
…HWC CFR Section 21 CFR section 888.3040 Device Panel Orthopedic Primary Predicate CSTS Screw, OrthoPro (K093055) Device STS Screw, OrthoPro (K032682) Secondary Predicate HyProCure II, GraMedica (K142534) Device…
Orthopro, LLC2010—
*K032682STS Screw
Summary page 4
…040 Device Panel Orthopedic Primary Predicate CSTS Screw, OrthoPro (K093055) Device STS Screw, OrthoPro (K032682) Secondary Predicate HyProCure II, GraMedica (K142534) Devices TALEX™ Subtalar Stabilization System, Vilex,…
Ortho-Pro, LLC2003—
*K142534HyProCure II
Summary page 4
…CSTS Screw, OrthoPro (K093055) Device STS Screw, OrthoPro (K032682) Secondary Predicate HyProCure II, GraMedica (K142534) Devices TALEX™ Subtalar Stabilization System, Vilex, Inc. (K041289) Sub-Talar Lok Impl…
Graham Medical Technologies, LLC Dba Gramedica2014—
*K041289Talus of Vilex (Tov)
Summary page 4
…STS Screw, OrthoPro (K032682) Secondary Predicate HyProCure II, GraMedica (K142534) Devices TALEX™ Subtalar Stabilization System, Vilex, Inc. (K041289) Sub-Talar Lok Implant, Instratek, Inc (K080280) Reference Predicate Kangli Pedicle Screw System (…
Vilex, Inc.2004—
*K080280Sub-Talar Lok, Model 7-11 MM
Summary page 4
…GraMedica (K142534) Devices TALEX™ Subtalar Stabilization System, Vilex, Inc. (K041289) Sub-Talar Lok Implant, Instratek, Inc (K080280) Reference Predicate Kangli Pedicle Screw System (K140053 and K142290) Devices HammerTech® Fixation System…
Instratek, Inc.2008—
†K140053Kangli Pedicle Screw Spinal SystemSuzhou Kangli Orthopaedics Instrument Co., Ltd.2014—
†K142290KangLi pedical screw spinal systemSuzhou Kangli Orthopaedics Instrument Co., Ltd.2014—
†K161449HammerTech Fixation SystemFusion Orthopedics, LLC2016—

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 37 years and passes through 5 companies; a new generation was cleared every 9.4 years on median.
  • None of the 11 ancestors has a recall.

How does its category compare?

All HWC devices

HWC Screw, 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 · HWC

15in 2025

2007: 352008: 332009: 272010: 232011: 352012: 202013: 252014: 312015: 412016: 262017: 402018: 202019: 302020: 282021: 262022: 262023: 242024: 172025: 152026 (partial year): 21
2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007: 77 days median2008: 76 days median2009: 113 days median2010: 110 days median2011: 88 days median2012: 99 days median2013: 90 days median2014: 88 days median2015: 85 days median2016: 131 days median2017: 127 days median2018: 106 days median2019: 108 days median2020: 75 days median2021: 84 days median2022: 167 days median2023: 104 days median2024: 90 days median2025: 111 days median2026 (partial year): 125 days median
2007high 167 (2022) · low 75 (2020)2026

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

Recalls per year · HWC

1in 2025

2007: 252008: 332009: 292010: 72011: 122012: 302013: 142014: 22015: 52016: 42017: 42018: 12019: 52020: 42021: 22022: 132025: 12026 (partial year): 2
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

2007: 6692008: 6602009: 6512010: 7652011: 1,1042012: 3,3392013: 3,8502014: 2,5492015: 2,7112016: 2,2852017: 2,5612018: 3,6622019: 5,4632020: 4,8202021: 4,4462022: 3,9342023: 3,7182024: 3,5752025: 2,893
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007357725669
2008337633660
20092711329651
2010231107765
20113588121,104
20122099303,339
20132590143,850
2014318822,549
2015418552,711
20162613142,285
20174012742,561
20182010613,662
20193010855,463
2020287544,820
2021268424,446
202226167133,934
20232410403,718
2024179003,575
20251511112,893
2026211252—

What is it indicated for?

The TalarLift STS arthroereisis implant is designed for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block the posterior and inferior displacement of the talus, allowing normal subtalar joint motion while blocking excessive pronation and the resulting sequelae. The TalarLift STS 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.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Fusion Orthopedics, LLC

11 FDA decisions under this applicant name. See the company

  • K210159IntraLock SystemFusion Orthopedics, LLC · 2021
  • K193377TopLock Anchor SystemFusion Orthopedics, LLC · 2020
  • K202959PolyLock Plating SystemFusion Orthopedics, LLC · 2020
  • K192323PolyLock Small Bone Plating SystemFusion Orthopedics, LLC · 2019
  • K190136Fusion Silastic SystemFusion Orthopedics, LLC · 2019

Recent decisions in HWC

The HWC category page

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  • K263116OsteoCentric Technologies Cannulated and Soild Fasteners with NutsOsteoCentric Technologies · 2026
  • K262975Arthrex Beaming SystemArthrex, Inc. · 2026
  • K260995DynaNail Helix® Fixation SystemMedShape, Inc. · 2026
  • K254280F.A.S.T ScrewSteps Ortho · 2026

https://510kreport.com/device/K170624 · printed Nov 6, 2026

Cite this page

510(k) Report. “K170624: TalarLift STS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170624

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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