510(k) Report

510(k) · Cleared

Cleared

Arthrex Arthoeresis Implant

K053543510(k) TraditionalCleared Apr 3, 2006104-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

Arthrex, Inc. · HWC Screw, Fixation, Bone

Cleared on Apr 3, 2006 as substantially equivalent to K960692 (Kinetikos Medical, Inc., 1996) and 3 other predicates after a 104-day review. Its family tree reaches back 3 generations to 1980.

Decided
Apr 3, 2006
Review
104 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
4

Its longest line of descent runs back 3 generations to K792670 (1980). 5 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2004: 1 other ancestor2000: 1 other ancestorK792670 · Smith Subtalar Peg · Dow Corning Wright · 1980K960692 · Subtalar Mba System · Kinetikos Medical, Inc. · 1996K031155 · Osteomed Subtalar Implant System · Osteomed LP · 2003198019851990199520002005
Other ancestors, by generation 1 generation back: 2 other ancestors K031155 · Osteomed Subtalar Implant System · Osteomed LP · 2003K960692 · Subtalar Mba System · Kinetikos Medical, Inc. · 1996K792670 · Smith Subtalar Peg · Dow Corning Wright · 19800
  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 deviceK053543 Arthrex Arthoeresis ImplantArthrex, Inc. · 2006
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)K053543Arthrex Arthoeresis ImplantArthrex, Inc.2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010
200410
FIG. 1 — Lineage of K053543, 1980–2006Source: 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? (4)

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
…508 Contact: Ann Waterhouse Device Name: Arthrex Arthroeresis Family Classification: Strew, Fixation, Bone Product Code: HWC Predicate Devices: K960692, MVBA Subtalar by KMI, K001231, Kalix Implant by New Deal, K042030, HyProCure Subtalar Implant system by Graham Medical Technolog…
Kinetikos Medical, Inc.1996—
*K001231The Kalix Implant
Summary page 1
…erhouse Device Name: Arthrex Arthroeresis Family Classification: Strew, Fixation, Bone Product Code: HWC Predicate Devices: K960692, MVBA Subtalar by KMI, K001231, Kalix Implant by New Deal, K042030, HyProCure Subtalar Implant system by Graham Medical Technologies, LLC, and the OsteoMed Subt…
New Deal, S.A.2000—
*K042030Hyprocure Subtalar Implant System
Summary page 1
…Arthroeresis Family Classification: Strew, Fixation, Bone Product Code: HWC Predicate Devices: K960692, MVBA Subtalar by KMI, K001231, Kalix Implant by New Deal, K042030, HyProCure Subtalar Implant system by Graham Medical Technologies, LLC, and the OsteoMed Subtalar Implant by Osteomed, K031 155.…
Graham Medical Technologies, LLC2004—
*K031155Osteomed Subtalar Implant System
Summary page 1
…y KMI, K001231, Kalix Implant by New Deal, K042030, HyProCure Subtalar Implant system by Graham Medical Technologies, LLC, and the OsteoMed Subtalar Implant by Osteomed, K031 155. Description: The Arthrex Arthroeresis Family is currently comprised of titanium alloy implants according to ASTM F-1 36. They…
Osteomed LP2003—

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 26 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.
  • 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

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 Arthrex Subtalar (Arthoeresis) Implant is intended to assist in treating the hyperpronated foot by stabilizing the subtalar joint. It is intended to block forward, downward, and medial displacement of the talus thereby limiting excessive eversion of the hindfoot

Examples include:

* Symptomatic acquired flat foot treatment in children and adolescents

* Symptomatic congenital flexible flat foot

* Tarsal coalitions when associated with a flatfoot deformity

* Posterior tibial tendon dysfunction with supple feet

* Paralytic flat foot

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
  • K093820Subfix Arthroereisis Implant, Models SUT0065, SUT0080, SUT0090, SUT0100, SUT0115Memometal Technologies · 2010
  • K071498Subtalar ImplantBiomet Sports Medicine, Inc. · 20077 recalls
  • K051611Mbaresorb ImplantKinetikos Medical, Inc. · 20053 recalls
  • K041936Biopro Subtalar ImplantBiopro, Inc. · 2004

More from Arthrex, Inc.

355 FDA decisions under this applicant name. See the company

  • K262975Arthrex Beaming SystemArthrex, Inc. · 2026
  • K262618Arthrex Spine Compression FT ScrewArthrex, Inc. · 2026
  • K262451Arthrex DynaNite StaplesArthrex, Inc. · 2026
  • K262357Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc. · 2026
  • K260624Arthrex Radial Head Replacement SystemArthrex, Inc. · 2026

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/K053543 · printed Nov 6, 2026

Cite this page

510(k) Report. “K053543: Arthrex Arthoeresis Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053543

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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