510(k) Report

510(k) · Cleared

Cleared

Osteonics Unix Unicompartmental

K923011510(k) TraditionalCleared Nov 30, 1993526-day reviewClass II21 CFR 888.3530

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

Osteonics Corp. · HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer

Cleared on Nov 30, 1993 after a 526-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 122 later devices descend from it.

Decided
Nov 30, 1993
Review
526 days
Class
Class II
Product code
HRY
Recalls
None
Predicates
0

122 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2007: 5 descendants cleared2004: 1 descendant cleared2005: 2 descendants cleared2008: 5 descendants cleared2006: 4 descendants cleared2024: 6 descendants cleared2018: 3 descendants cleared2017: 4 descendants cleared2009: 3 descendants cleared2011: 3 descendants cleared2012: 7 descendants cleared2023: 10 descendants cleared2016: 7 descendants cleared2020: 9 descendants cleared2019: 8 descendants cleared2025: 5 descendants cleared2026: 7 descendants cleared2022: 5 descendants cleared2010: 1 descendant cleared2013: 7 descendants cleared2014: 7 descendants cleared2021: 10 descendants cleared2015: 3 descendants cleared1990200020102020
  1. This deviceK923011 Osteonics Unix UnicompartmentalOsteonics Corp. · 1993
  2. Descendant · cites it directly · 121 of its ownK033769 Eius Unicompartmental Knee SystemHowmedica Osteonics Corp. · 2004
  3. Descendant · 2 generations on · 62 of its ownK043570 Unicondylar Knee Repair System / Conformis UcdConformis, Inc. · 2005 · Recalled
  4. Descendant · 2 generations on · 56 of its ownK080368 Mako Surgical Corp. Unicondylar Knee Implant System IIMako Surgical Corp. · 2008
  5. Descendant · 3 generations on · 51 of its ownK082172 Mako Modular Knee Compartmental Implant SystemMako Surgical Corporation · 2008 · Recalled
  6. Descendant · 4 generations on · 50 of its ownK090763 Restoris Multicompartmental Knee (MCK) SystemMako Surgical Corporation · 2009 · Recalled

Showing 5 of 122 descendants. See all descendants

Descendants cleared per year

2004: 12005: 22006: 42007: 52008: 52009: 32010: 12011: 32012: 72013: 72014: 72015: 32016: 72017: 42018: 32019: 82020: 92021: 102022: 52023: 102024: 62025: 52026: 7
2004high 10 (2021) · low 1 (2004)2026

Most influential descendants

Showing 5 of 122 · See all
  • K033769Eius Unicompartmental Knee SystemHowmedica Osteonics Corp. · 2004 · cites it directly121descendants
  • K043570Unicondylar Knee Repair System / Conformis UcdConformis, Inc. · 2005 · 2 generations on62descendants
  • K080368Mako Surgical Corp. Unicondylar Knee Implant System IIMako Surgical Corp. · 2008 · 2 generations on56descendants
  • K082172Mako Modular Knee Compartmental Implant SystemMako Surgical Corporation · 2008 · 3 generations on51descendants
  • K090763Restoris Multicompartmental Knee (MCK) SystemMako Surgical Corporation · 2009 · 4 generations on50descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K923011Osteonics Unix UnicompartmentalOsteonics Corp.1993—
+1K033769Eius Unicompartmental Knee SystemHowmedica Osteonics Corp.2004—
+2K043570Unicondylar Knee Repair System / Conformis UcdConformis, Inc.20053
+2K080368Mako Surgical Corp. Unicondylar Knee Implant System IIMako Surgical Corp.2008—
+3K082172Mako Modular Knee Compartmental Implant SystemMako Surgical Corporation20082
+4K090763Restoris Multicompartmental Knee (MCK) SystemMako Surgical Corporation20095

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200520
200640
200750
200850
200930
201010
201130
201270
201370
201470
201530
201670
201740
201830
201980
202090
2021100
202250
2023100
202460
202550
202670
FIG. 1 — Lineage of K923011, 1993–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in HRY? 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 HRY device

  1. #1 K193549 SIGMA High Performance (HP) Partial Knee Systemscore 0.4 · 5 generations · no Class I recall
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (122)

See all 122

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

NumberDeviceApplicantDecidedDescendants
K033769Eius Unicompartmental Knee SystemHowmedica Osteonics Corp.2004121
K071881Triathlon PKR SystemHowmedica Osteonics Corp.200725

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?

  • Of its descendants, K033769 (Howmedica Osteonics Corp., 2004) has gone furthest, with 121 descendants of its own.

How does its category compare?

All HRY devices

HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HRY

1in 2020

2007: 32008: 32010: 12011: 12012: 12013: 12014: 12015: 12016: 12019: 12020: 1
2007high 3 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRY

138in 2008

2007: 92 days median2008: 138 days median
2007high 138 (2008) · low 92 (2007)2026

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

Recalls per year · HRY

3in 2022

2007: 12008: 12011: 12013: 12016: 12020: 12021: 12022: 3
2007high 3 (2022) · low 0 (2009)2026

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

Adverse event reports per year · HRY

290in 2025

2007: 2632008: 2852009: 2492010: 1802011: 1552012: 1372013: 3832014: 3052015: 3452016: 3432017: 4022018: 6132019: 3672020: 1,0542021: 1,2182022: 8402023: 3962024: 4302025: 290
2007high 1,218 (2021) · low 137 (2012)2025

MAUDE reports naming product code HRY, 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
20073921263
200831381285
20090—0249
20101—0180
20111—1155
20121—0137
20131—1383
20141—0305
20151—0345
20161—1343
20170—0402
20180—0613
20191—0367
20201—11,054
20210—11,218
20220—3840
20230—0396
20240—0430
20250—0290
20260—0—

More from Osteonics Corp.

178 FDA decisions under this applicant name. See the company

  • K983657Osteonics Series 7000 AD Tibial TrayOsteonics Corp. · 2000
  • K980070Osteonics HA-Coated DevicesOsteonics Corp. · 1999
  • K984375Osteonics Spinal System - Sacral Offset Connector AssemblyOsteonics Corp. · 1999
  • K982798Osteonics Anterior Cervical Compression Plating SystemOsteonics Corp. · 1999
  • K984585Osteonics +10 Unipolar Adaptor SleeveOsteonics Corp. · 1999

Recent decisions in HRY

The HRY category page

  • K193549SIGMA High Performance (HP) Partial Knee SystemDepuy Ireland UC · 2020
  • K190633NanoOrtho NanoKnee® SystemNanoortho, LLC · 2019
  • K152631MPO Total Knee Systems MR LabelingMicroport Orthopedics, Inc. · 2016
  • K150410Restoris Porous Partial Knee SystemMako Surgical Corporation · 2015
  • K133940Oxford Fixed Lateral Bearing Partial Knee Replacement (Bearings / Trays)Biomet UK, Ltd. · 20144 recalls

https://510kreport.com/device/K923011 · printed Nov 6, 2026

Cite this page

510(k) Report. “K923011: Osteonics Unix Unicompartmental.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K923011

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026