510(k) Report

510(k) · Cleared

Cleared

Sub-Talar Lok, Model 7-11 MM

K080280510(k) TraditionalCleared Mar 14, 200839-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

Instratek, Inc. · HWC Screw, Fixation, Bone

Cleared on Mar 14, 2008 as substantially equivalent to K032902 (Nexa Orthopedics, Inc., 2003) and 1 other predicate after a 39-day review. Its family tree reaches back 3 generations to 1980. 12 later devices descend from it.

Decided
Mar 14, 2008
Review
39 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K792670 (1980). 5 ancestors in all. 12 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 1 other ancestor2000: 1 other ancestor2017: 2 descendants cleared2012: 1 descendant cleared2011: 4 descendants cleared2010: 1 descendant cleared2014: 1 descendant cleared2022: 1 descendant cleared2013: 1 descendant cleared2016: 1 descendant clearedK792670 · Smith Subtalar Peg · Dow Corning Wright · 1980K960692 · Subtalar Mba System · Kinetikos Medical, Inc. · 1996K031155 · Osteomed Subtalar Implant System · Osteomed LP · 200319801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor 1 generation forward: 5 descendants2 generations forward: 3 descendants3 generations forward: 2 descendants4 generations forward: 1 descendant5 generations forward: 1 descendant K031155 · Osteomed Subtalar Implant System · Osteomed LP · 2003K960692 · Subtalar Mba System · Kinetikos Medical, Inc. · 1996K792670 · Smith Subtalar Peg · Dow Corning Wright · 19800+5
  1. Root · 3 generations backK792670 Smith Subtalar PegDow Corning Wright · 1980
  2. 2 generations backK960692 Subtalar Mba SystemKinetikos Medical, Inc. · 1996
  3. 1 generation backK031155 Osteomed Subtalar Implant SystemOsteomed LP · 2003
  4. This deviceK080280 Sub-Talar Lok, Model 7-11 MMInstratek, Inc. · 2008
  5. Descendant · cites it directly · 8 of its ownK093820 Subfix Arthroereisis Implant, Models SUT0065, SUT0080, SUT0090…Memometal Technologies · 2010
  6. Descendant · 2 generations on · 4 of its ownK103183 Trilliant Surgical Subtalar ImplantTrilliant Surgical, Ltd. · 2011 · Recalled
  7. Descendant · 3 generations on · 3 of its ownK111834 Disco Subtalar ImplantTrilliant Surgical, Ltd. · 2011 · Recalled
  8. Descendant · 4 generations on · 2 of its ownK133035 Normed Pellegrin Calcaneus Stop ScrewNormed Medizin-Technik GmbH · 2013
  9. Descendant · cites it directly · 2 of its ownK122738 Gaitway Implant System, Surgical Instrument SetSolana Surgical, LLC · 2012

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2010: 12011: 42012: 12013: 12014: 12016: 12017: 22022: 1
2010high 4 (2011) · low 0 (2015)2026

Most influential descendants

Showing 5 of 12 · See all
  • K093820Subfix Arthroereisis Implant, Models SUT0065, SUT0080, SUT0090, SUT0100, SUT0115Memometal Technologies · 2010 · cites it directly8descendants
  • K103183Trilliant Surgical Subtalar ImplantTrilliant Surgical, Ltd. · 2011 · 2 generations on4descendants
  • K111834Disco Subtalar ImplantTrilliant Surgical, Ltd. · 2011 · 3 generations on3descendants
  • K133035Normed Pellegrin Calcaneus Stop ScrewNormed Medizin-Technik GmbH · 2013 · 4 generations on2descendants
  • K122738Gaitway Implant System, Surgical Instrument SetSolana Surgical, LLC · 2012 · cites it directly2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K792670Smith Subtalar PegDow Corning Wright1980—
−2K960692Subtalar Mba SystemKinetikos Medical, Inc.1996—
−1K031155Osteomed Subtalar Implant SystemOsteomed LP2003—
0 (this device)K080280Sub-Talar Lok, Model 7-11 MMInstratek, Inc.2008—
+1K093820Subfix Arthroereisis Implant, Models SUT0065, SUT0080, SUT0090, SUT0100, SUT0115Memometal Technologies2010—
+2K103183Trilliant Surgical Subtalar ImplantTrilliant Surgical, Ltd.20111
+3K111834Disco Subtalar ImplantTrilliant Surgical, Ltd.20111
+4K133035Normed Pellegrin Calcaneus Stop ScrewNormed Medizin-Technik GmbH2013—
+1K122738Gaitway Implant System, Surgical Instrument SetSolana Surgical, LLC2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010
200310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201140
201210
201310
201410
201610
201720
202210
FIG. 1 — Lineage of K080280, 1980–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K032902Subtalar Arthrorisis Implant
Summary page 1
…Subtalar Implant Device classification name: Screw, Fixation, Bone. HWC at 21 CFR Part 880.3040 Legally marketed device to K032902, Futura Conical Subtalar Implant, Nexa Orthopedics which the device is K031155, Extremity Talar-Fit Implant, Osteomed…
Nexa Orthopedics, Inc.2003—
*K031155Osteomed Subtalar Implant System
Summary page 1
…HWC at 21 CFR Part 880.3040 Legally marketed device to K032902, Futura Conical Subtalar Implant, Nexa Orthopedics which the device is K031155, Extremity Talar-Fit Implant, Osteomed. substantially equivalent: Description of the device: The Instratek Sub-Talar Lok…
Osteomed LP2003—

Also cleared against K032902: 5 other devices →

What descends from it? (12)

See all 12

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

NumberDeviceApplicantDecidedDescendants
K093820Subfix Arthroereisis Implant, Models SUT0065, SUT0080, SUT0090, SUT0100, SUT0115Memometal Technologies20108
K122738Gaitway Implant System, Surgical Instrument SetSolana Surgical, LLC20122
K170624TalarLift STSFusion Orthopedics, LLC20170
K112658Osteospring Footjack Subtalar Implant SystemOsteospring Medical, Inc.20110
K111799Nugait (TM) Subtalar Implant SystemAscension Orthopedic20110

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 28 years and passes through 4 companies; a new generation was cleared every 7.1 years on median.
  • None of the 5 ancestors has a recall.
  • Of its descendants, K093820 (Memometal Technologies, 2010) has gone furthest, with 8 descendants of its own.
  • 5 other devices also cite its predicate K032902.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Instratek Sub-Talar Lok arthroereisis implant restricts excessive subtalar pronation in all three planes, providing for a more normal subtalar joint motion in patients. The Sub-Talar Lok 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 as stated in the FDA summary.

Also cleared against K032902

5 other devices cite the same predicate.

  • K113399Ifs Subtalar ImplantInternal Fixation Systems, Inc. · 2011
  • K093055CSTS ScrewOrthopro, LLC · 2010
  • K093820Subfix Arthroereisis Implant, Models SUT0065, SUT0080, SUT0090, SUT0100, SUT0115Memometal Technologies · 2010
  • K081755Fusion Medical StiJohn Riccio · 2009
  • K071498Subtalar ImplantBiomet Sports Medicine, Inc. · 20077 recalls

More from Instratek, Inc.

10 FDA decisions under this applicant name. See the company

  • K133523Stapix Superelastic Implant Bone StaplesInstratek, Inc. · 2014
  • K131620Jones-FX Fracture SystemInstratek, Inc. · 2013
  • K120493Mini Cannulated Headed and Headless Screw SetInstratek, Inc. · 20121 recall
  • K111032CMC Cable FixInstratek, Inc. · 2011
  • K091763Michelangelo Bunion System - Mabs, Model: MA6000Instratek, Inc. · 2009

Recent decisions in HWC

The HWC category page

  • K261961Ntegrate Threaded Nail SystemNvision Biomedical Technologies · 2026
  • 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/K080280 · printed Nov 6, 2026

Cite this page

510(k) Report. “K080280: Sub-Talar Lok, Model 7-11 MM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080280

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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