510(k) Report

510(k) · Cleared

Cleared

Arthrex Prostop Plus Arthroereisis Subtalar Implant

K071456510(k) TraditionalCleared Jan 17, 2008237-day reviewClass II21 CFR 888.3030

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Arthrex, Inc. · MAI Fastener, Fixation, Biodegradable, Soft Tissue

Cleared on Jan 17, 2008 as substantially equivalent to K051611 (Kinetikos Medical, Inc., 2005) after a 237-day review. Its family tree reaches back 3 generations to 1980. 9 later devices descend from it.

Decided
Jan 17, 2008
Review
237 days
Class
Class II
Product code
MAI
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K792670 (1980). 4 ancestors in all. 9 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1998: 1 other ancestor2012: 1 descendant cleared2011: 2 descendants cleared2010: 1 descendant cleared2014: 1 descendant cleared2013: 1 descendant cleared2017: 1 descendant cleared2016: 1 descendant cleared2022: 1 descendant clearedK792670 · Smith Subtalar Peg · Dow Corning Wright · 1980K960692 · Subtalar Mba System · Kinetikos Medical, Inc. · 1996K051611 · Mbaresorb Implant · Kinetikos Medical, Inc. · 2005 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 4 descendants3 generations forward: 2 descendants K051611 · Mbaresorb Implant · Kinetikos Medical, Inc. · 2005 · recalledK960692 · 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 backK051611 Mbaresorb ImplantKinetikos Medical, Inc. · 2005 · Recalled
  4. This deviceK071456 Arthrex Prostop Plus Arthroereisis Subtalar ImplantArthrex, 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 · cites it directly · 3 of its ownK111834 Disco Subtalar ImplantTrilliant Surgical, Ltd. · 2011 · Recalled
  8. Descendant · 2 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 9 descendants. See all descendants

Descendants cleared per year

2010: 12011: 22012: 12013: 12014: 12016: 12017: 12022: 1
2010high 2 (2011) · low 0 (2015)2026

Most influential descendants

Showing 5 of 9 · 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 · cites it directly3descendants
  • K133035Normed Pellegrin Calcaneus Stop ScrewNormed Medizin-Technik GmbH · 2013 · 2 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—
−1K051611Mbaresorb ImplantKinetikos Medical, Inc.20053
0 (this device)K071456Arthrex Prostop Plus Arthroereisis Subtalar ImplantArthrex, Inc.2008—
+1K093820Subfix Arthroereisis Implant, Models SUT0065, SUT0080, SUT0090, SUT0100, SUT0115Memometal Technologies2010—
+2K103183Trilliant Surgical Subtalar ImplantTrilliant Surgical, Ltd.20111
+1K111834Disco Subtalar ImplantTrilliant Surgical, Ltd.20111
+2K133035Normed 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
199810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201120
201210
201310
201410
201610
201710
202210
FIG. 1 — Lineage of K071456, 1980–2022Source: 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 MAI? 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 MAI device

  1. #1 K203495 Arthrex SwiveLock Anchorscore 35.2 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #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.

TypeNumberDeviceApplicantDecidedRecalls
*K051611Mbaresorb Implant
Summary page 1
…~~~~~~~~~~~~~~~~~~~~~~....................... Product Code - HWC -Screw, Fixation, Bone Classification Name Predicate Device MBA Resorb Implant: K051611 Device Description The Arthrex ProStopTm Plus Arthroereisis Subtalar Implant isa fully and Intended Use threaded, cannul…
Kinetikos Medical, Inc.20053

Also cleared against K051611: 1 other device →

What descends from it? (9)

3 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
K111834Disco Subtalar ImplantTrilliant Surgical, Ltd.20113
K122738Gaitway Implant System, Surgical Instrument SetSolana Surgical, LLC20122

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 3 companies; a new generation was cleared every 9.1 years on median.
  • 1 of the 4 ancestors has a recall of any class.
  • Of its descendants, K093820 (Memometal Technologies, 2010) has gone furthest, with 8 descendants of its own.
  • 1 other device also cites its predicate K051611.

How does its category compare?

All MAI devices

MAI Fastener, Fixation, Biodegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · MAI

8in 2025

2007: 42008: 32009: 92010: 42011: 92012: 62013: 62014: 42015: 52016: 32017: 92018: 132019: 92020: 92021: 82022: 62023: 82024: 72025: 82026 (partial year): 5
2007high 13 (2018) · low 3 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MAI

54in 2025

2007: 100 days median2008: 83 days median2009: 74 days median2010: 122 days median2011: 90 days median2012: 56 days median2013: 135 days median2014: 86 days median2015: 95 days median2016: 191 days median2017: 113 days median2018: 108 days median2019: 41 days median2020: 78 days median2021: 115 days median2022: 136 days median2023: 34 days median2024: 53 days median2025: 54 days median2026 (partial year): 69 days median
2007high 191 (2016) · low 34 (2023)2026

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

Recalls per year · MAI

40in 2020

2011: 52012: 102019: 22020: 402026 (partial year): 1
2007high 40 (2020) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MAI

2,148in 2025

2007: 2722008: 1722009: 882010: 892011: 1292012: 1712013: 1662014: 1492015: 1822016: 3012017: 4782018: 1,5902019: 1,2482020: 9572021: 1,2672022: 1,4252023: 1,7182024: 2,3002025: 2,148
2007high 2,300 (2024) · low 88 (2009)2025

MAUDE reports naming product code MAI, 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
200741000272
20083830172
2009974088
20104122089
20119905129
201265610171
201361350166
20144860149
20155950182
201631910301
201791130478
20181310801,590
201994121,248
202097840957
2021811501,267
2022613601,425
202383401,718
202475302,300
202585402,148
20265691—

What is it indicated for?

The Arthrex ProStopTM Plus Arthroereisis Subtalar Implants are indicated as an internal support to primary surgical interventions in the treatment of flat foot, providing structural support at minimum during the first three months of healing.

Indications for use as stated in the FDA summary.

Also cleared against K051611

1 other device cites the same predicate.

  • K093820Subfix Arthroereisis Implant, Models SUT0065, SUT0080, SUT0090, SUT0100, SUT0115Memometal Technologies · 2010

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 MAI

The MAI category page

  • K262357Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc. · 2026
  • K253931Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc. · 2026
  • K260294SF Push-in AnchorSurgical Fusion Technologies GmbH · 2026
  • K254055OSSIOfiber® Suture AnchorOSSIO, Ltd. · 2026
  • K251680Biosteon® ScrewBiocomposites, Ltd. · 2026

https://510kreport.com/device/K071456 · printed Nov 6, 2026

Cite this page

510(k) Report. “K071456: Arthrex Prostop Plus Arthroereisis Subtalar Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071456

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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