510(k) Report

510(k) · Cleared

Cleared

Subfix Arthroereisis Implant, Models SUT0065, SUT0080, SUT0090, SUT0100, SUT0115

K093820510(k) TraditionalCleared May 19, 2010156-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

Memometal Technologies · HWC Screw, Fixation, Bone

Cleared on May 19, 2010 as substantially equivalent to K960692 (Kinetikos Medical, Inc., 1996) and 8 other predicates after a 156-day review. Its family tree reaches back 4 generations to 1980. 8 later devices descend from it.

Decided
May 19, 2010
Review
156 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
9

Its longest line of descent runs back 4 generations to K792670 (1980). 11 ancestors in all. 8 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2008: 1 other ancestor2004: 1 other ancestor2003: 3 other ancestors2000: 1 other ancestor1998: 1 other ancestor2014: 1 descendant cleared2012: 1 descendant cleared2011: 2 descendants cleared2017: 1 descendant cleared2013: 1 descendant cleared2022: 1 descendant cleared2016: 1 descendant clearedK792670 · Smith Subtalar Peg · Dow Corning Wright · 1980K960692 · Subtalar Mba System · Kinetikos Medical, Inc. · 1996K051611 · Mbaresorb Implant · Kinetikos Medical, Inc. · 2005 · recalledK071456 · Arthrex Prostop Plus Arthroereisis Subtalar Implant · Arthrex, Inc. · 200819801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 2 other ancestors 1 generation forward: 3 descendants2 generations forward: 2 descendants3 generations forward: 2 descendants4 generations forward: 1 descendant K071456 · Arthrex Prostop Plus Arthroereisis Subtalar Implant · Arthrex, Inc. · 2008K051611 · Mbaresorb Implant · Kinetikos Medical, Inc. · 2005 · recalledK960692 · 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 backK051611 Mbaresorb ImplantKinetikos Medical, Inc. · 2005 · Recalled
  4. 1 generation backK071456 Arthrex Prostop Plus Arthroereisis Subtalar ImplantArthrex, Inc. · 2008
  5. This deviceK093820 Subfix Arthroereisis Implant, Models SUT0065, SUT0080, SUT0090…Memometal Technologies · 2010
  6. Descendant · cites it directly · 4 of its ownK103183 Trilliant Surgical Subtalar ImplantTrilliant Surgical, Ltd. · 2011 · Recalled
  7. Descendant · 2 generations on · 3 of its ownK111834 Disco Subtalar ImplantTrilliant Surgical, Ltd. · 2011 · Recalled
  8. Descendant · 3 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
  10. Descendant · 2 generations on · 1 of its ownK170688 PIT’Stop® implantIn2bones Sas · 2017

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2011: 22012: 12013: 12014: 12016: 12017: 12022: 1
2011high 2 (2011) · low 0 (2015)2026

Most influential descendants

Showing 5 of 8 · See all
  • K103183Trilliant Surgical Subtalar ImplantTrilliant Surgical, Ltd. · 2011 · cites it directly4descendants
  • K111834Disco Subtalar ImplantTrilliant Surgical, Ltd. · 2011 · 2 generations on3descendants
  • K133035Normed Pellegrin Calcaneus Stop ScrewNormed Medizin-Technik GmbH · 2013 · 3 generations on2descendants
  • K122738Gaitway Implant System, Surgical Instrument SetSolana Surgical, LLC · 2012 · cites it directly2descendants
  • K170688PIT’Stop® implantIn2bones Sas · 2017 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K792670Smith Subtalar PegDow Corning Wright1980—
−3K960692Subtalar Mba SystemKinetikos Medical, Inc.1996—
−2K051611Mbaresorb ImplantKinetikos Medical, Inc.20053
−1K071456Arthrex Prostop Plus Arthroereisis Subtalar ImplantArthrex, Inc.2008—
0 (this device)K093820Subfix Arthroereisis Implant, Models SUT0065, SUT0080, SUT0090, SUT0100, SUT0115Memometal Technologies2010—
+1K103183Trilliant Surgical Subtalar ImplantTrilliant Surgical, Ltd.20111
+2K111834Disco Subtalar ImplantTrilliant Surgical, Ltd.20111
+3K133035Normed Pellegrin Calcaneus Stop ScrewNormed Medizin-Technik GmbH2013—
+1K122738Gaitway Implant System, Surgical Instrument SetSolana Surgical, LLC2012—
+2K170688PIT’Stop® implantIn2bones Sas2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
200010
200330
200410
200810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201120
201210
201310
201410
201610
201710
202210
FIG. 1 — Lineage of K093820, 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? (9)

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
*K960692Subtalar Mba System
Summary page 1
…ation Number: 888.3040 Product Code: HWC Predicate Devices: K960692 KMI Subtalar MBA8 Arthroereisis Implant (now owned by…
Kinetikos Medical, Inc.1996—
*K031155Osteomed Subtalar Implant System
Summary page 1
…Arthroereisis Implant (now owned by Intregra) K03 1155 Osteomed Talar-EitTM Subtalar Arthroereisis Implant…
Osteomed LP2003—
*K032902Subtalar Arthrorisis Implant
Summary page 1
…K03 1155 Osteomed Talar-EitTM Subtalar Arthroereisis Implant K032902 Nexa Orthopedics, INC Subtalar K041289 Arthroereisis Implant Talus of…
Nexa Orthopedics, Inc.2003—
*K041289Talus of Vilex (Tov)
Summary page 1
…Arthroereisis Implant K032902 Nexa Orthopedics, INC Subtalar K041289 Arthroereisis Implant Talus of Vilex (TOV)…
Vilex, Inc.2004—
*K080280Sub-Talar Lok, Model 7-11 MM
Summary page 1
…K041289 Arthroereisis Implant Talus of Vilex (TOV) K080280 Instratek, INC.Sub-Talar Lok, Model 7-11 mm…
Instratek, Inc.2008—
*K792670Smith Subtalar Peg
Summary page 1
…K080280 Instratek, INC.Sub-Talar Lok, Model 7-11 mm K792670 Wright Medical Smith Sta-Peg K033046 Nexa Orthopedics Subtalar Peg…
Dow Corning Wright1980—
*K033046Subtalar Peg Implant
Summary page 1
…Model 7-11 mm K792670 Wright Medical Smith Sta-Peg K033046 Nexa Orthopedics Subtalar Peg ASI…
Nexa Orthopedics, Inc.2003—
*K051611Mbaresorb Implant
Summary page 1
…K033046 Nexa Orthopedics Subtalar Peg ASI KO051611 KMI MBATm Resorb K07 1456 Arthrex Pro Stop Plus Registration Number:…
Kinetikos Medical, Inc.20053
*K071456Arthrex Prostop Plus Arthroereisis Subtalar Implant
Summary page 1
…ASI KO051611 KMI MBATm Resorb K07 1456 Arthrex Pro Stop Plus Registration Number: 3004082045 Owner Operator Number:…
Arthrex, Inc.2008—

Also cleared against K960692: 8 other devices →

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K103183Trilliant Surgical Subtalar ImplantTrilliant Surgical, Ltd.20114
K122738Gaitway Implant System, Surgical Instrument SetSolana Surgical, LLC20122
K140962Normed Vario Subtalar ScrewNormed Nedizin Technik GmbH20140

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 30 years and passes through 4 companies; a new generation was cleared every 9.1 years on median.
  • 1 of the 11 ancestors has a recall of any class.
  • Of its descendants, K103183 (Trilliant Surgical, Ltd., 2011) has gone furthest, with 4 descendants of its own.
  • 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. 2010, 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 Memometal - Technologies' SubFix Arthroereisis Implant is intended to treat the hyperpronated foot and stabilize the subtalar joint. It is intended to block forward, downward and medial displacement of the talus, thus allowing subtalar joint motion but blocking excessive pronation and the resulting sequela.

The SubFix Arthroereisis Implants are intended for single use only.

Indications for use as stated in the FDA summary.

Also cleared against K960692

8 other devices cite the same predicate.

  • K210016Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot System,Integra CAPTURE Screw…Integra LifeSciences Corporation · 2021
  • K103183Trilliant Surgical Subtalar ImplantTrilliant Surgical, Ltd. · 20111 recall
  • K071498Subtalar ImplantBiomet Sports Medicine, Inc. · 20077 recalls
  • K053543Arthrex Arthoeresis ImplantArthrex, Inc. · 2006
  • K051611Mbaresorb ImplantKinetikos Medical, Inc. · 20053 recalls
  • K041936Biopro Subtalar ImplantBiopro, Inc. · 2004

More from Memometal Technologies

10 FDA decisions under this applicant name. See the company

  • K112197Memometal Intra-Medullary Bone FastenerMemometal Technologies · 20111 recall
  • K101930Memometal Navis Bone Plating SystemMemometal Technologies · 2011
  • K102072Memometal Implants (K-Snap & TI-Fuse)Memometal Technologies · 2010
  • K083447Memometal Anchorage Bone Plate System, Models PLSS/PLSL, PLP10/PLP20/PLP30/PLP40/PLP50Memometal Technologies · 2009
  • K071941Memometal Bone AnchorsMemometal Technologies · 2007

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/K093820 · printed Nov 5, 2026

Cite this page

510(k) Report. “K093820: Subfix Arthroereisis Implant, Models SUT0065, SUT0080, SUT0090, SUT0100, SUT0115.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K093820

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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