510(k) Report

510(k) · Cleared

Cleared

Mdpo Frame System

K093753510(k) TraditionalCleared Aug 26, 2010262-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

Mdpo, LLC · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Cleared on Aug 26, 2010 as substantially equivalent to K870961 (Richards Medical Co., Inc., 1987) and 5 other predicates after a 262-day review. Its family tree reaches back 3 generations to 1983.

Decided
Aug 26, 2010
Review
262 days
Class
Class II
Product code
KTT
Recalls
None
Predicates
6

Its longest line of descent runs back 3 generations to K831576 (1983). 17 ancestors in all, the oldest K801594 (1980). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2009: 2 other ancestors2000: 1 other ancestor1996: 2 other ancestors1987: 1 other ancestor2007: 1 other ancestor2005: 1 other ancestor2004: 1 other ancestor1995: 1 other ancestor1988: 1 other ancestor1986: 1 other ancestor1980: 1 other ancestor1989: 1 other ancestorK831576 · Orthofix · Electro-Biology, Inc. · 1983K955848 · Orthofix Modulsystem · Orthofix, Inc. · 1996 · recalledK071395 · Biomet Vision Footring System · Biomet Manufacturing Corp · 20071980198519901995200020052010
Other ancestors, by generation 1 generation back: 5 other ancestors2 generations back: 8 other ancestors3 generations back: 1 other ancestor K071395 · Biomet Vision Footring System · Biomet Manufacturing Corp · 2007K955848 · Orthofix Modulsystem · Orthofix, Inc. · 1996 · recalledK831576 · Orthofix · Electro-Biology, Inc. · 19830
  1. Root · 3 generations backK831576 OrthofixElectro-Biology, Inc. · 1983
  2. 2 generations backK955848 Orthofix ModulsystemOrthofix, Inc. · 1996 · Recalled
  3. 1 generation backK071395 Biomet Vision Footring SystemBiomet Manufacturing Corp · 2007
  4. This deviceK093753 Mdpo Frame SystemMdpo, LLC · 2010
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K831576OrthofixElectro-Biology, Inc.1983—
−2K955848Orthofix ModulsystemOrthofix, Inc.199623
−1K071395Biomet Vision Footring SystemBiomet Manufacturing Corp2007—
0 (this device)K093753Mdpo Frame SystemMdpo, LLC2010—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198010
198610
198710
198810
198910
199510
199620
200010
200410
200510
200710
200920
FIG. 1 — Lineage of K093753, 1983–2010Source: 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 KTT? 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 KTT device

  1. #1 K242861 TrueLok Elevatescore 21.3 · 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? (6)

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
*K870961Richards External Fixation System
Summary page 2
…K093753 Predicate Devices: The MDPO Frame System is similar to several predicates including the following: * Smith &NephewlIlizarov External Fixation System (K870961, K962808, K994143) * DePuy ACE-Fischer External Fixation System (K083789) * Biomet Vision FootRing System (K071395, K093057…
Richards Medical Co., Inc.1987—
*K962808Ilizarov External Fixation System
Summary page 2
…93753 Predicate Devices: The MDPO Frame System is similar to several predicates including the following: * Smith &NephewlIlizarov External Fixation System (K870961, K962808, K994143) * DePuy ACE-Fischer External Fixation System (K083789) * Biomet Vision FootRing System (K071395, K093057) Techno…
Smith & Nephew Richards, Inc.1996—
*K994143Smith & Nephew External Fixation System [Unilateral (Linear) & Multilateral (Circular)…
Summary page 2
…redicate Devices: The MDPO Frame System is similar to several predicates including the following: * Smith &NephewlIlizarov External Fixation System (K870961, K962808, K994143) * DePuy ACE-Fischer External Fixation System (K083789) * Biomet Vision FootRing System (K071395, K093057) Technological C…
Smith & Nephew, Inc.200019
*K083789Ace Fischer External Fixation System
Summary page 2
…ral predicates including the following: * Smith &NephewlIlizarov External Fixation System (K870961, K962808, K994143) * DePuy ACE-Fischer External Fixation System (K083789) * Biomet Vision FootRing System (K071395, K093057) Technological Characteristics The MDPO Frame System was characterized and…
DePuy Orthopaedics, Inc.2009—
*K071395Biomet Vision Footring System
Summary page 2
…Smith &NephewlIlizarov External Fixation System (K870961, K962808, K994143) * DePuy ACE-Fischer External Fixation System (K083789) * Biomet Vision FootRing System (K071395, K093057) Technological Characteristics The MDPO Frame System was characterized and evaluated according applicable requirements…
Biomet Manufacturing Corp2007—
*K093057Biomet Vision Footring System
Summary page 2
…phewlIlizarov External Fixation System (K870961, K962808, K994143) * DePuy ACE-Fischer External Fixation System (K083789) * Biomet Vision FootRing System (K071395, K093057) Technological Characteristics The MDPO Frame System was characterized and evaluated according applicable requirements outlined…
Ebi, L.P.2009—

Also cleared against K870961: 9 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 27 years and passes through 4 companies; a new generation was cleared every 11.3 years on median.
  • 4 of the 17 ancestors have a recall of any class.
  • 9 other devices also cite its predicate K870961.

How does its category compare?

All KTT devices

KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · KTT

10in 2025

2007: 92008: 112009: 112010: 122011: 102012: 92013: 72014: 142015: 122016: 102017: 112018: 62019: 82020: 92021: 102022: 32023: 72024: 52025: 102026 (partial year): 5
2007high 14 (2014) · low 3 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KTT

88in 2025

2007: 55 days median2008: 73 days median2009: 94 days median2010: 148 days median2011: 157 days median2012: 140 days median2013: 87 days median2014: 129 days median2015: 60 days median2016: 142 days median2017: 184 days median2018: 149 days median2019: 110 days median2020: 200 days median2021: 83 days median2022: 25 days median2023: 29 days median2024: 90 days median2025: 88 days median2026 (partial year): 68 days median
2007high 200 (2020) · low 25 (2022)2026

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

Recalls per year · KTT

2in 2021

2007: 22008: 12009: 22010: 12012: 42013: 72017: 12018: 142019: 32021: 22026 (partial year): 11
2007high 14 (2018) · low 0 (2011)2026

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

Adverse event reports per year · KTT

673in 2025

2007: 452008: 662009: 452010: 1212011: 1962012: 5272013: 8982014: 4452015: 4012016: 4002017: 4852018: 5972019: 8002020: 9422021: 9612022: 6272023: 5542024: 5232025: 673
2007high 961 (2021) · low 45 (2007)2025

MAUDE reports naming product code KTT, 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
2007955245
20081173166
20091194245
2010121481121
2011101570196
201291404527
20137877898
2014141290445
201512600401
2016101420400
2017111841485
2018614914597
201981103800
202092000942
202110832961
20223250627
20237290554
20245900523
202510880673
202656811—

What is it indicated for?

The MDPO Frame System is indicated for use in the lower extremity for: open and closed long bone fracture fixation, to include tensioned wire fixation of periarticular fractures, arthrodesis, osteotomy, reconstruction, non-unions, pseudoarthrosis, correction of bony or soft tissue defects and deformities, dislocations, arthrodiastasis, and Charcot foot reconstruction and Lisfranc dislocations.

Indications for use as stated in the FDA summary.

Also cleared against K870961

9 other devices cite the same predicate.

  • K190069SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)Arrowhead De, LLC · 2019
  • K151881X-Fix Line AdditionsVilex IN Tennessee, Inc. · 20162 recalls
  • K130479Ilizarov Drill Tip WiresSmith & Nephew, Inc. · 2013
  • K120871Smith & Nephew, Inc. External Fixation System InstrumentationSmith & Nephew, Inc. · 2012
  • K093047Smith & Nephew Circular Fixation SystemSmith & Nephew, Inc. · 20101 recall
  • K042436Iiizarov Pulley SystemSmith & Nephew, Inc. · 2004

Recent decisions in KTT

The KTT category page

  • K263083Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC · 2026
  • K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLC · 2026
  • K260900DYNEX® External Fixation SystemsVilex, LLC · 2026
  • K260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc. · 2026
  • K253291Excelsior SystemBlue Ocean Global · 2026

https://510kreport.com/device/K093753 · printed Nov 6, 2026

Cite this page

510(k) Report. “K093753: Mdpo Frame System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093753

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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