510(k) Report

510(k) · Cleared

Cleared

Ibalance Akrfx Medial Opening Wedge Tibial System, Ifx Medial Peek Implant and Anchor, Akrfx Instrumentation

K092381510(k) TraditionalCleared Oct 27, 200983-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

Ibalance Medical, Inc. · HRS Plate, Fixation, Bone

Cleared on Oct 27, 2009 as substantially equivalent to K032187 (Arthrex, Inc., 2003) and 4 other predicates after an 83-day review. Its family tree reaches back 2 generations to 1998.

Decided
Oct 27, 2009
Review
83 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
5

Its longest line of descent runs back 2 generations to K973812 (1998). 6 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2009: 1 other ancestor2008: 1 other ancestor2003: 1 other ancestor2002: 1 other ancestorK973812 · Arthrex Puddu Osteotomy System · Arthrex, Inc. · 1998K033303 · Wafer System · Spine Wave, Inc. · 20041995200020052010
Other ancestors, by generation 1 generation back: 4 other ancestors K033303 · Wafer System · Spine Wave, Inc. · 2004K973812 · Arthrex Puddu Osteotomy System · Arthrex, Inc. · 19980
  1. Root · 2 generations backK973812 Arthrex Puddu Osteotomy SystemArthrex, Inc. · 1998
  2. 1 generation backK033303 Wafer SystemSpine Wave, Inc. · 2004
  3. This deviceK092381 Ibalance Akrfx Medial Opening Wedge Tibial System, Ifx Medial Peek…Ibalance Medical, Inc. · 2009
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K973812Arthrex Puddu Osteotomy SystemArthrex, Inc.1998—
−1K033303Wafer SystemSpine Wave, Inc.2004—
0 (this device)K092381Ibalance Akrfx Medial Opening Wedge Tibial System, Ifx Medial Peek Implant and…Ibalance Medical, Inc.2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200210
200310
200810
200910
FIG. 1 — Lineage of K092381, 1998–2009Source: 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 HRS? 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 HRS device

  1. #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 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? (5)

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
*K032187Anthrex Titanium Opening Wedge Osteotomy System
Summary page 1
…Wedge Osteotomy device Classification Name: Bone fixation appliances and accessories Predicate Devices Arthrex, Inc.'s Titanium Opening Wedge Osteotomy System (K032187) Spine Wave, Inc.'s Wafer System (K033303) Synthes Spiked Washer (KO0 1583) Cayenne AperFix Interference Scr…
Arthrex, Inc.20031
*K033303Wafer System
Summary page 1
…fixation appliances and accessories Predicate Devices Arthrex, Inc.'s Titanium Opening Wedge Osteotomy System (K032187) Spine Wave, Inc.'s Wafer System (K033303) Synthes Spiked Washer (KO0 1583) Cayenne AperFix Interference Screw (K073426) Cayenne AperFix Implant (K083…
Spine Wave, Inc.2004—
*K011583Spiked Washer
Our reading of the summary gave K001583, FDA’s number for Island Biosurgical BNS Kit #3 (Island Biosurgical, LLC). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Synthes Spiked Washer”.
Synthes (Usa)20021
*K073426Aperfix Interference Screw 7-12 MM X 20 MM; 7-12 MM X 25 MM; 7-12 MM X 30 MM
Summary page 1
…ning Wedge Osteotomy System (K032187) Spine Wave, Inc.'s Wafer System (K033303) Synthes Spiked Washer (KO0 1583) Cayenne AperFix Interference Screw (K073426) Cayenne AperFix Implant (K083607) Intended Use / Indications for Use The iBalance AKRFx Medial Opening Wedge Tib…
Cayenne Medical, Inc.2008—
*K083607Aperfix Implant with Inserter, 8, 9, 10, 11, MM X30 MM
Summary page 1
…Spine Wave, Inc.'s Wafer System (K033303) Synthes Spiked Washer (KO0 1583) Cayenne AperFix Interference Screw (K073426) Cayenne AperFix Implant (K083607) Intended Use / Indications for Use The iBalance AKRFx Medial Opening Wedge Tibial System includes instrumentation,…
Cayenne Medical, Inc.2009—

Also cleared against K032187: 2 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 11 years and passes through 3 companies; a new generation was cleared every 6.0 years on median.
  • 2 of the 6 ancestors have a recall of any class.
  • 2 other devices also cite its predicate K032187.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · HRS

54in 2025

2007: 352008: 352009: 472010: 492011: 432012: 592013: 562014: 762015: 562016: 442017: 572018: 402019: 462020: 482021: 402022: 472023: 402024: 542025: 542026 (partial year): 51
2007high 76 (2014) · low 35 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRS

90in 2025

2007: 63 days median2008: 87 days median2009: 85 days median2010: 100 days median2011: 88 days median2012: 106 days median2013: 89 days median2014: 57 days median2015: 97 days median2016: 109 days median2017: 122 days median2018: 116 days median2019: 89 days median2020: 88 days median2021: 87 days median2022: 144 days median2023: 120 days median2024: 96 days median2025: 90 days median2026 (partial year): 82 days median
2007high 144 (2022) · low 57 (2014)2026

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

Recalls per year · HRS

1in 2025

2007: 22008: 112009: 32010: 162011: 52012: 42013: 112015: 72016: 52017: 32018: 22019: 252020: 12021: 92022: 32023: 12025: 12026 (partial year): 3
2007high 25 (2019) · low 0 (2014)2026

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

Adverse event reports per year · HRS

2,306in 2025

2007: 3392008: 3112009: 4352010: 4912011: 7732012: 1,6632013: 2,6432014: 2,4132015: 3,0952016: 2,2762017: 2,2202018: 2,6632019: 3,3592020: 2,7902021: 2,4422022: 1,7002023: 2,0492024: 1,8492025: 2,306
2007high 3,359 (2019) · low 311 (2008)2025

MAUDE reports naming product code HRS, 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
200735632339
2008358711311
200947853435
20104910016491
201143885773
20125910641,663
20135689112,643
2014765702,413
2015569773,095
20164410952,276
20175712232,220
20184011622,663
20194689253,359
2020488812,790
2021408792,442
20224714431,700
20234012012,049
2024549601,849
2025549012,306
202651823—

What is it indicated for?

The iBalance AKRFx Medial Opening Wedge Tibial System includes instrumentation, implant, and fixation and is used to provide fixation following Proximal Tibial opening Wedge osteotomies.

It is intended to be used with adequate post-operative immobilization.

Indications for use as stated in the FDA summary.

Also cleared against K032187

2 other devices cite the same predicate.

  • K141548High Tibial Osteotomy SystemNewclip Technics · 2015
  • K140397Paralock Plating System / Tuffnek ScrewParagon 28 · 2014

Recent decisions in HRS

The HRS category page

  • K262779ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2026
  • K263407Tempo Plating SystemPace Surgical · 2026
  • K263269Park's Pectus SystemTdm Co., Ltd. · 2026
  • K261611TDM Large Bone Plate and Screw SystemTdm Co., Ltd. · 2026
  • K262649Alians ForearmNewclip Technics · 2026

https://510kreport.com/device/K092381 · printed Nov 6, 2026

Cite this page

510(k) Report. “K092381: Ibalance Akrfx Medial Opening Wedge Tibial System, Ifx Medial Peek Implant and Anchor, Akrfx Instrumentation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092381

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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