510(k) Report

510(k) · Cleared

Cleared

Osteonics Ion Implant Mod-ML Uniknee Femoral Comp

K911373510(k) TraditionalCleared Jun 26, 199190-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 Jun 26, 1991 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 26 later devices descend from it.

Decided
Jun 26, 1991
Review
90 days
Class
Class II
Product code
HRY
Recalls
None
Predicates
0

26 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2007: 1 descendant cleared2024: 3 descendants cleared2018: 2 descendants cleared2017: 1 descendant cleared2020: 5 descendants cleared2019: 2 descendants cleared2025: 2 descendants cleared2023: 3 descendants cleared2026: 4 descendants cleared2022: 2 descendants cleared2021: 1 descendant cleared1990200020102020
  1. This deviceK911373 Osteonics Ion Implant Mod-ML Uniknee Femoral CompOsteonics Corp. · 1991
  2. Descendant · cites it directly · 25 of its ownK071881 Triathlon PKR SystemHowmedica Osteonics Corp. · 2007 · Recalled
  3. Descendant · 2 generations on · 24 of its ownK172326 Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee…Stryker Orthopaedics · 2017 · Recalled
  4. Descendant · 3 generations on · 14 of its ownK173849 Triathlon Total Knee SystemStryker Orthopaedics · 2018 · Recalled
  5. Descendant · 3 generations on · 11 of its ownK190402 Triathlon Total Knee System-Additional ComponentsStryker Orthopaedics (Aka Howmedica Osteonics Corp.) · 2019
  6. Descendant · 3 generations on · 4 of its ownK230952 Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023

Showing 5 of 26 descendants. See all descendants

Descendants cleared per year

2007: 12017: 12018: 22019: 22020: 52021: 12022: 22023: 32024: 32025: 22026: 4
2007high 5 (2020) · low 0 (2008)2026

Most influential descendants

Showing 5 of 26 · See all
  • K071881Triathlon PKR SystemHowmedica Osteonics Corp. · 2007 · cites it directly25descendants
  • K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics · 2017 · 2 generations on24descendants
  • K173849Triathlon Total Knee SystemStryker Orthopaedics · 2018 · 3 generations on14descendants
  • K190402Triathlon Total Knee System-Additional ComponentsStryker Orthopaedics (Aka Howmedica Osteonics Corp.) · 2019 · 3 generations on11descendants
  • K230952Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral ComponentHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023 · 3 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K911373Osteonics Ion Implant Mod-ML Uniknee Femoral CompOsteonics Corp.1991—
+1K071881Triathlon PKR SystemHowmedica Osteonics Corp.20071
+2K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics20171
+3K173849Triathlon Total Knee SystemStryker Orthopaedics20183
+3K190402Triathlon Total Knee System-Additional ComponentsStryker Orthopaedics (Aka Howmedica Osteonics Corp.)2019—
+3K230952Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS)…Howmedica Osteonics Corp., Dba Stryker Orthopaedics2023—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
201710
201820
201920
202050
202110
202220
202330
202430
202520
202640
FIG. 1 — Lineage of K911373, 1991–2026Source: 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? (26)

See all 26

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

NumberDeviceApplicantDecidedDescendants
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, K071881 (Howmedica Osteonics Corp., 2007) has gone furthest, with 25 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/K911373 · printed Nov 4, 2026

Cite this page

510(k) Report. “K911373: Osteonics Ion Implant Mod-ML Uniknee Femoral Comp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K911373

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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