510(k) Report

510(k) · Cleared

Cleared

Thigh and Foot Positioner, Suprone Plus, Model RT-6010

K050701510(k) TraditionalCleared Apr 1, 200514-day reviewClass II21 CFR 892.5050

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

Bionix Development Corp. · IYE Accelerator, Linear, Medical

Cleared on Apr 1, 2005 as substantially equivalent to K933227 (Medtec, Inc., 1994) and 1 other predicate after a 14-day review. Its family tree reaches back 1 generation to 1994. 6 later devices descend from it.

Decided
Apr 1, 2005
Review
14 days
Class
Class II
Product code
IYE
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K933227 (1994). 2 ancestors in all. 6 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor2013: 1 descendant cleared2018: 1 descendant cleared2016: 1 descendant cleared2017: 1 descendant cleared2021: 1 descendant cleared2023: 1 descendant clearedK933227 · Uni-Frame Head Immobilization System · Medtec, Inc. · 1994 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 2 descendants4 generations forward: 1 descendant K933227 · Uni-Frame Head Immobilization System · Medtec, Inc. · 1994 · recalled0
  1. Root · 1 generation backK933227 Uni-Frame Head Immobilization SystemMedtec, Inc. · 1994 · Recalled
  2. This deviceK050701 Thigh and Foot Positioner, Suprone Plus, Model RT-6010Bionix Development Corp. · 2005
  3. Descendant · cites it directly · 5 of its ownK122888 CDR Systems Precision Patient Positioning SystemCdr Systems, Inc. · 2013
  4. Descendant · 2 generations on · 3 of its ownK153026 Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body…Medtec, Inc. D/B/A Civco Medical Solutions · 2016
  5. Descendant · 3 generations on · 1 of its ownK210894 Siddharth-II; ImpactPanacea Medical Technologies Pvt., Ltd. · 2021
  6. Descendant · 4 generations on · 0 of its ownK222762 Siddharth-II;ImpactPanacea Medical Technologies Pvt., Ltd. · 2023
  7. Descendant · 2 generations on · 0 of its ownK182079 Solstice SRS Immobilization System; Solstat Immobilization System…Medtec Inc. Dba Civco Medical Solutions · 2018 · Recalled

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2013: 12016: 12017: 12018: 12021: 12023: 1
2013high 1 (2013) · low 0 (2014)2026

Most influential descendants

Showing 5 of 6 · See all
  • K122888CDR Systems Precision Patient Positioning SystemCdr Systems, Inc. · 2013 · cites it directly5descendants
  • K153026Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt…Medtec, Inc. D/B/A Civco Medical Solutions · 2016 · 2 generations on3descendants
  • K210894Siddharth-II; ImpactPanacea Medical Technologies Pvt., Ltd. · 2021 · 3 generations on1descendant
  • K222762Siddharth-II;ImpactPanacea Medical Technologies Pvt., Ltd. · 2023 · 4 generations on0descendants
  • K182079Solstice SRS Immobilization System; Solstat Immobilization System; Solstice…Medtec Inc. Dba Civco Medical Solutions · 2018 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K933227Uni-Frame Head Immobilization SystemMedtec, Inc.19942
0 (this device)K050701Thigh and Foot Positioner, Suprone Plus, Model RT-6010Bionix Development Corp.2005—
+1K122888CDR Systems Precision Patient Positioning SystemCdr Systems, Inc.2013—
+2K153026Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body…Medtec, Inc. D/B/A Civco Medical Solutions2016—
+3K210894Siddharth-II; ImpactPanacea Medical Technologies Pvt., Ltd.2021—
+4K222762Siddharth-II;ImpactPanacea Medical Technologies Pvt., Ltd.2023—
+2K182079Solstice SRS Immobilization System; Solstat Immobilization System; Solstice…Medtec Inc. Dba Civco Medical Solutions20181

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201610
201710
201810
202110
202310
FIG. 1 — Lineage of K050701, 1994–2023Source: 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 IYE? 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 IYE device

  1. #1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 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
*K933227Uni-Frame Head Immobilization System
Summary page 4
…Orange City, Iowa. The Uni-frame Head and Neck Immobilization System is listed under regulation number 892.5050, and has been assigned the document control number K933227. The Uni-frame Head and Neck Immobilization System from Med-Tec are designed to position and immobilize the head during ra…
Medtec, Inc.19942
*K021124Accufix Tilting Radiotranslucent Headholder
Summary page 6
…ast Corp., of Wyckoff, NJ. The Accufix Tilting Radiotranslucent Head holder is listed under regulation number 892.5050, and has been assigned the document control number K021124. The Accufix Tilting Radiotranslucent Head holder from WFR/Aquaplast is designed to position and immobilize the head during radi…
Wfr/Aquaplast Corp.2002—
*—Dual Leg Positioner
Named without a submission number
—
*—Knee-and-Foot Lok
Named without a submission number
—
*—Kneefix Cushion
Named without a submission number
—
*—Feetfix Cushion
Named without a submission number
—

Also cleared against K933227: 3 other devices →

What descends from it? (6)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K122888CDR Systems Precision Patient Positioning SystemCdr Systems, Inc.20135

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?

  • 1 of the 2 ancestors has a recall of any class.
  • Of its descendants, K122888 (Cdr Systems, Inc., 2013) has gone furthest, with 5 descendants of its own.
  • 3 other devices also cite its predicate K933227.

How does its category compare?

All IYE devices

IYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IYE

12in 2025

2007: 232008: 142009: 202010: 232011: 112012: 282013: 182014: 202015: 202016: 212017: 232018: 212019: 192020: 202021: 192022: 122023: 182024: 92025: 122026 (partial year): 14
2007high 28 (2012) · low 9 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYE

170in 2025

2007: 44 days median2008: 69 days median2009: 63 days median2010: 74 days median2011: 94 days median2012: 106 days median2013: 88 days median2014: 100 days median2015: 108 days median2016: 97 days median2017: 94 days median2018: 58 days median2019: 83 days median2020: 67 days median2021: 86 days median2022: 172 days median2023: 129 days median2024: 239 days median2025: 170 days median2026 (partial year): 120 days median
2007high 239 (2024) · low 44 (2007)2026

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

Recalls per year · IYE

1in 2025

2007: 782008: 492009: 222010: 272011: 732012: 202013: 112014: 142015: 82016: 72017: 72018: 72019: 22020: 42021: 52022: 32023: 72024: 12025: 12026 (partial year): 4
2007high 78 (2007) · low 1 (2024)2026

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

Adverse event reports per year · IYE

101in 2025

2007: 1552008: 1142009: 1742010: 2462011: 2802012: 1282013: 962014: 1242015: 1002016: 972017: 1252018: 852019: 912020: 742021: 682022: 662023: 1282024: 812025: 101
2007high 280 (2011) · low 66 (2022)2025

MAUDE reports naming product code IYE, 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
2007234478155
2008146949114
2009206322174
2010237427246
2011119473280
20122810620128
201318881196
20142010014124
2015201088100
20162197797
201723947125
20182158785
20191983291
20202067474
20211986568
202212172366
2023181297128
20249239181
2025121701101
2026141204—

What is it indicated for?

The Bionix Thigh and Foot Positioner patient positioning system developed and manufactured by Bionix Development Corp., Toledo, Ohio, is intended to be used for the positioning and re-positioning of patients undergoing or receiving a course of external beam radiation therapy for the treatment of cancer and other diseases.

It is intended to be used by or under the direction of a licensed physician.

Indications for use as stated in the FDA summary.

Also cleared against K933227

3 other devices cite the same predicate.

  • K080072Mri Patient Positioning DevicesCIVCO Medical Instruments Co., Inc. · 2008
  • K030051Versaboard, Model 7040Bionix Development Corp. · 2003
  • K981115Radio-PlastSmith & Nephew, Inc. · 1998

More from Bionix Development Corp.

12 FDA decisions under this applicant name. See the company

  • K153270TruGuard Custom Tongue and Jaw PositionerBionix Development Corp. · 2016
  • K123411Little Angels Swaddling BlanketBionix Development Corp. · 2013
  • K120335Embrace ThermoplasticBionix Development Corp. · 2012
  • K100691Omni V SBRT Positioning System, Model RT-4500Bionix Development Corp. · 2010
  • K100264T-Form Extremity Immobilizer, Model RT-6060Bionix Development Corp. · 2010

Recent decisions in IYE

The IYE category page

  • K261865AerFrame™ Alignment Laser Box (LBV2)Stabilix, LLC · 2026
  • K261718EZFluence (RADEZ V2)Radformation, Inc. · 2026
  • K260733MRIA Radiation Therapy Information System (MRIA)Manteia Technologies Co., Ltd. · 2026
  • K261856Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc. · 2026
  • K252937ThinkQA 3Dosisoft SA · 2026

https://510kreport.com/device/K050701 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050701: Thigh and Foot Positioner, Suprone Plus, Model RT-6010.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050701

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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