510(k) Report

510(k) · Cleared

Cleared

Mac Male Adapter

K102843510(k) SpecialCleared May 3, 2011216-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

Biomet Trauma (Aka Ebi, LLC) · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Cleared on May 3, 2011 as substantially equivalent to K021695 (Ebi, L.P., 2002) and 2 other predicates after a 216-day review. Its family tree reaches back 6 generations to 1999.

Decided
May 3, 2011
Review
216 days
Class
Class II
Product code
KTT
Recalls
None
Predicates
3

Its longest line of descent runs back 6 generations to K993886 (1999). 35 ancestors in all, the oldest K951357 (1995). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2003: 5 other ancestors2002: 8 other ancestors2005: 2 other ancestors2004: 1 other ancestor2001: 5 other ancestors2000: 3 other ancestors1999: 1 other ancestor1997: 1 other ancestor1996: 1 other ancestor1995: 2 other ancestorsK993886 · Ebi Xfix Vision Fixation System · Ebi, L.P. · 1999K011711 · Modification to Ebi Efix Vision Fixation System · Ebi, L.P. · 2001K014194 · Modification to Ebi Xfix Vision Fixation System · Ebi, L.P. · 2002K033635 · Modification to Ebi Xfix Vision Fixation System · Ebi, L.P. · 2003K040833 · Modification to Ebi Xfix Vision Fixation System · Ebi, L.P. · 2004K081244 · Lower Extremity External Fixation - Expanded Indications · Biomet Trauma · 2008 · recalled1995200020052010
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 27 other ancestors K081244 · Lower Extremity External Fixation - Expanded Indications · Biomet Trauma · 2008 · recalledK040833 · Modification to Ebi Xfix Vision Fixation System · Ebi, L.P. · 2004K033635 · Modification to Ebi Xfix Vision Fixation System · Ebi, L.P. · 2003K014194 · Modification to Ebi Xfix Vision Fixation System · Ebi, L.P. · 2002K011711 · Modification to Ebi Efix Vision Fixation System · Ebi, L.P. · 2001K993886 · Ebi Xfix Vision Fixation System · Ebi, L.P. · 1999−50
  1. Root · 6 generations backK993886 Ebi Xfix Vision Fixation SystemEbi, L.P. · 1999
  2. 5 generations backK011711 Modification to Ebi Efix Vision Fixation SystemEbi, L.P. · 2001
  3. 4 generations backK014194 Modification to Ebi Xfix Vision Fixation SystemEbi, L.P. · 2002
  4. 3 generations backK033635 Modification to Ebi Xfix Vision Fixation SystemEbi, L.P. · 2003
  5. 2 generations backK040833 Modification to Ebi Xfix Vision Fixation SystemEbi, L.P. · 2004
  6. 1 generation backK081244 Lower Extremity External Fixation - Expanded IndicationsBiomet Trauma · 2008 · Recalled
  7. This deviceK102843 Mac Male AdapterBiomet Trauma (Aka Ebi, LLC) · 2011
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K993886Ebi Xfix Vision Fixation SystemEbi, L.P.1999—
−5K011711Modification to Ebi Efix Vision Fixation SystemEbi, L.P.2001—
−4K014194Modification to Ebi Xfix Vision Fixation SystemEbi, L.P.2002—
−3K033635Modification to Ebi Xfix Vision Fixation SystemEbi, L.P.2003—
−2K040833Modification to Ebi Xfix Vision Fixation SystemEbi, L.P.2004—
−1K081244Lower Extremity External Fixation - Expanded IndicationsBiomet Trauma20081
0 (this device)K102843Mac Male AdapterBiomet Trauma (Aka Ebi, LLC)2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199520
199610
199710
199910
200030
200150
200280
200350
200410
200520
FIG. 1 — Lineage of K102843, 1999–2011Source: 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 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? (3)

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
*K021695Ebi Dynafix Diaphyseal Correction System
Summary page 2
…Page 4W MAC Female Diaphyseal Adapter (previously cleared in premarket notification K021 695). This device is intended to connect the MAC Module to other external fixation components. This component is made of similar mate…
Ebi, L.P.2002—
*K030372Modification to Ebi Dynafix Diaphyseal Correction System
Summary page 2
…do not present any new issues of safety or effectiveness. Examples of predicates include the MAC External Fixation System found substantially equivalent in K02 1695 and K030372. The MAC System was also found substantially equivalent for use in a pediatric population in K081244. Based upon the mechanical t…
Ebi, L.P.2003—
*K081244Lower Extremity External Fixation - Expanded Indications
Summary page 2
…ernal Fixation System found substantially equivalent in K02 1695 and K030372. The MAC System was also found substantially equivalent for use in a pediatric population in K081244. Based upon the mechanical testing, the new component of the MAC External Fixation System is substantially equivalent for its int…
Biomet Trauma20081

Also cleared against K021695: 3 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 12 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
  • 2 of the 35 ancestors have a recall of any class.
  • 3 other devices also cite its predicate K021695.

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. 2011, 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 MAC External Fixation System is a unilateral external fixation device intended for use in children and adults in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality.

Indications for use as stated in the FDA summary.

Also cleared against K021695

3 other devices cite the same predicate.

  • K111376Construx External Fixation DeviceEbi, LLC · 20111 recall
  • K081244Lower Extremity External Fixation - Expanded IndicationsBiomet Trauma · 20081 recall
  • K030372Modification to Ebi Dynafix Diaphyseal Correction SystemEbi, L.P. · 2003

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/K102843 · printed Nov 6, 2026

Cite this page

510(k) Report. “K102843: Mac Male Adapter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102843

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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