510(k) Report

510(k) · Cleared

Cleared

Avon Patello-femoral Joint Prosthesis

K211303510(k) TraditionalCleared Jun 4, 202136-day reviewClass II21 CFR 888.3540

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

Howmedica Osteonics Corp., Dba Stryker Orthopaedics · KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer

Cleared on Jun 4, 2021 as substantially equivalent to K051948 (Howmedica Osteonics Corp., 2005) after a 36-day review. Its family tree reaches back 1 generation to 2005. 4 later devices descend from it.

Decided
Jun 4, 2021
Review
36 days
Class
Class II
Product code
KRR
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K051948 (2005). 4 later devices descend from it, 1 citing it directly.

Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 3 descendants K051948 · Avon Patello-Femoral Joint Prosthesis · Howmedica Osteonics Corp. · 2005 · recalled0
  1. Root · 1 generation backK051948 Avon Patello-Femoral Joint ProsthesisHowmedica Osteonics Corp. · 2005 · Recalled
  2. This deviceK211303 Avon Patello-femoral Joint ProsthesisHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2021
  3. Descendant · cites it directly · 3 of its ownK242831 Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2024
  4. Descendant · 2 generations on · 0 of its ownK261898 Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total…Howmedica Osteonics Corp. dba Stryker Orthopaedics · 2026
  5. Descendant · 2 generations on · 0 of its ownK253637 Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2026
  6. Descendant · 2 generations on · 0 of its ownK252898 Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium®…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025 · Recalled

Most influential descendants

Showing 4 of 4 · See all
  • K242831Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2024 · cites it directly3descendants
  • K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics · 2026 · 2 generations on0descendants
  • K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2026 · 2 generations on0descendants
  • K252898Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K051948Avon Patello-Femoral Joint ProsthesisHowmedica Osteonics Corp.20057
0 (this device)K211303Avon Patello-femoral Joint ProsthesisHowmedica Osteonics Corp., Dba Stryker Orthopaedics2021—
+1K242831Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components…Howmedica Osteonics Corp., Dba Stryker Orthopaedics2024—
+2K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics2026—
+2K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing…Howmedica Osteonics Corp., Dba Stryker Orthopaedics2026—
+2K252898Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric…Howmedica Osteonics Corp., Dba Stryker Orthopaedics20251

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202410
202510
202620
FIG. 1 — Lineage of K211303, 2005–2026Source: 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), 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 KRR? 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 KRR device

  1. #1 K231253 Overture Orthopaedics Patellofemoral Systemscore 5.6 · 1 generation · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (1)

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
*K051948Avon Patello-Femoral Joint Prosthesis
Summary page 4
…oduct Codes: KRR Legally Marketed Devices to which Substantial Equivalence is Claimed: Primary Predicate Device: x Avon Patello-femoral Joint Prosthesis (K051948) Reference Devices: x Avon Extra-small Patello-femoral Replacement (K041160) x Avon Patellar Component (K020841) x…
Howmedica Osteonics Corp.20057
†K041160Avon Extra-Small Patello-Femoral ReplacementHowmedica Osteonics Corp.2004—
†K020841Avon Patellar ComponentHowmedica Osteonics Corp.2002—
†K010100Avon Patello-Femoral Joint ProsthesisHowmedica Osteonics Corp.2001—

Also cleared against K051948: 3 other devices →

What descends from it? (4)

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

NumberDeviceApplicantDecidedDescendants
K242831Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon…Howmedica Osteonics Corp., Dba Stryker Orthopaedics20243

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?

  • Its one ancestor has a recall.
  • Of its descendants, K242831 (Howmedica Osteonics Corp., Dba Stryker Orthopaedics, 2024) has gone furthest, with 3 descendants of its own.
  • 3 other devices also cite its predicate K051948.

How does its category compare?

All KRR devices

KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.

FDA decisions per year · KRR

1in 2023

2007: 22008: 32012: 12013: 12015: 12016: 12018: 12020: 12021: 12022: 12023: 1
2007high 3 (2008) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KRR

116in 2008

2008: 116 days median
2007high 116 (2008)2026

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

Recalls per year · KRR

3in 2022

2013: 12016: 12017: 22022: 3
2007high 3 (2022) · low 0 (2007)2026

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

Adverse event reports per year · KRR

36in 2025

2009: 122010: 62011: 32012: 92013: 92014: 262015: 182016: 142017: 152018: 142019: 162020: 62021: 82022: 92023: 122024: 252025: 36
2007high 36 (2025) · low 0 (2007)2025

MAUDE reports naming product code KRR, 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
20072—00
2008311600
20090—012
20100—06
20110—03
20121—09
20131—19
20140—026
20151—018
20161—114
20170—215
20181—014
20190—016
20201—06
20211—08
20221—39
20231—012
20240—025
20250—036
20260—0—

What is it indicated for?

The Avon Patello-femoral Joint Prosthesis is intended to be used in cemented patellofemoral arthroplasty in patients with degenerative arthritis in the distal femur and patella, patients with a history of patellar dislocation or patella fracture, or patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release) where pain, deformity or dysfunction persists.

These components are single use only and are intended for implantation with bone cement.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Cite this page

510(k) Report. “K211303: Avon Patello-femoral Joint Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211303

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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