510(k) Report

510(k) · Cleared

Recalled · Class II · 2019

Mbaresorb Implant

K051611510(k) TraditionalCleared Sep 6, 200581-day reviewClass II21 CFR 888.3040Recalls 3

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

Kinetikos Medical, Inc. · HWC Screw, Fixation, Bone

Cleared on Sep 6, 2005 as substantially equivalent to K960692 (Kinetikos Medical, Inc., 1996) and 1 other predicate after an 81-day review. Its family tree reaches back 2 generations to 1980. 10 later devices descend from it. It has been recalled 3 times.

Decided
Sep 6, 2005
Review
81 days
Class
Class II
Product code
HWC
Recalls
3
Predicates
2

Its longest line of descent runs back 2 generations to K792670 (1980). 3 ancestors in all. 10 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1998: 1 other ancestor2008: 1 descendant cleared2010: 1 descendant cleared2012: 1 descendant cleared2011: 2 descendants 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. · 199619801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 4 descendants3 generations forward: 2 descendants4 generations forward: 2 descendants K960692 · Subtalar Mba System · Kinetikos Medical, Inc. · 1996K792670 · Smith Subtalar Peg · Dow Corning Wright · 19800
  1. Root · 2 generations backK792670 Smith Subtalar PegDow Corning Wright · 1980
  2. 1 generation backK960692 Subtalar Mba SystemKinetikos Medical, Inc. · 1996
  3. This deviceK051611 Mbaresorb ImplantKinetikos Medical, Inc. · 2005
  4. Descendant · cites it directly · 9 of its ownK071456 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 · 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

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2008: 12010: 12011: 22012: 12013: 12014: 12016: 12017: 12022: 1
2008high 2 (2011) · low 0 (2009)2026

Most influential descendants

Showing 5 of 10 · See all
  • K071456Arthrex Prostop Plus Arthroereisis Subtalar ImplantArthrex, Inc. · 2008 · cites it directly9descendants
  • 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 · 2 generations on3descendants
  • K133035Normed Pellegrin Calcaneus Stop ScrewNormed Medizin-Technik GmbH · 2013 · 3 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K792670Smith Subtalar PegDow Corning Wright1980—
−1K960692Subtalar Mba SystemKinetikos Medical, Inc.1996—
0 (this device)K051611Mbaresorb ImplantKinetikos Medical, Inc.2005—
+1K071456Arthrex Prostop Plus Arthroereisis Subtalar ImplantArthrex, Inc.2008—
+1K093820Subfix Arthroereisis Implant, Models SUT0065, SUT0080, SUT0090, SUT0100, SUT0115Memometal Technologies2010—
+2K103183Trilliant Surgical Subtalar ImplantTrilliant Surgical, Ltd.20111
+2K111834Disco Subtalar ImplantTrilliant Surgical, Ltd.20111
+3K133035Normed Pellegrin Calcaneus Stop ScrewNormed Medizin-Technik GmbH2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201010
201120
201210
201310
201410
201610
201710
202210
FIG. 1 — Lineage of K051611, 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 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
*K960692Subtalar Mba System
Summary page 1
…Name: Orthopedic Foot Implant 3. Predicate or legally marketed devices which are substantially equivalent -KMI Subtalar MBA Orthopedic Foot Implant (K960692 cleared Jul 23, 1996) -Linvatec BioScrew Absorbable Interference Screw (K973758 cleared Feb 27, 1998) 4. Descrip…
Kinetikos Medical, Inc.1996—
*K973758Bioscrew Absorbable Interference Srew
Summary page 1
…are substantially equivalent -KMI Subtalar MBA Orthopedic Foot Implant (K960692 cleared Jul 23, 1996) -Linvatec BioScrew Absorbable Interference Screw (K973758 cleared Feb 27, 1998) 4. Description of Device The MBAResorb Implant consists of a soft-threaded implant designed to be…
Linvatec Corp.1998—

Also cleared against K960692: 8 other devices →

What descends from it? (10)

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

NumberDeviceApplicantDecidedDescendants
K071456Arthrex Prostop Plus Arthroereisis Subtalar ImplantArthrex, Inc.20089
K093820Subfix Arthroereisis Implant, Models SUT0065, SUT0080, SUT0090, SUT0100, SUT0115Memometal Technologies20108

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Mar 1, 2019Class IIZ-1089-2019Process controlTemperature indicator may have changed color to dark gray or black prior to shipment. Change in color may indicate the product exposure to temperatures greater than 110¿F
Mar 1, 2019Class IIZ-1090-2019Process controlTemperature indicator may have changed color to dark gray or black prior to shipment. Change in color may indicate the product exposure to temperatures greater than 110¿F
Mar 1, 2019Class IIZ-1091-2019Process controlTemperature indicator may have changed color to dark gray or black prior to shipment. Change in color may indicate the product exposure to temperatures greater than 110¿F

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 25 years and passes through 2 companies; a new generation was cleared every 16.4 years on median.
  • None of the 3 ancestors has a recall.
  • Of its descendants, K071456 (Arthrex, Inc., 2008) has gone furthest, with 9 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.

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 MBAResorb Implant is indicated as an internal support to primary surgical interventions in the treatment of fiat 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 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
  • K053543Arthrex Arthoeresis ImplantArthrex, Inc. · 2006
  • K041936Biopro Subtalar ImplantBiopro, Inc. · 2004

More from Kinetikos Medical, Inc.

19 FDA decisions under this applicant name. See the company

  • K061749Eclipse Total Ankle ImplantKinetikos Medical, Inc. · 2006
  • K061465Kmi Cement Restrictor ImplantKinetikos Medical, Inc. · 2006
  • K041461Kmi Distal Volar Radius Plate SystemKinetikos Medical, Inc. · 2004
  • K032806Katalyst Radial Head ImplantKinetikos Medical, Inc. · 2004
  • K040356Kompressor Screw SystemKinetikos Medical, Inc. · 2004

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/K051611 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051611: Mbaresorb Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051611

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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