510(k) Report

510(k) · Cleared

Recalled · Class II · 2026

Avon Patello-Femoral Joint Prosthesis

K051948510(k) TraditionalCleared Oct 21, 200595-day reviewClass II21 CFR 888.3540Recalls 7

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

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

Cleared on Oct 21, 2005 after a 95-day review. The FDA summary names its predicate without a number. 10 later devices descend from it. It has been recalled 7 times.

Decided
Oct 21, 2005
Review
95 days
Class
Class II
Product code
KRR
Recalls
7
Predicates
0

10 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2012: 1 descendant cleared2006: 1 descendant cleared2021: 1 descendant cleared2008: 1 descendant cleared2013: 1 descendant cleared2024: 1 descendant cleared2015: 1 descendant cleared2025: 1 descendant cleared2026: 2 descendants cleared20052010201520202025
  1. This deviceK051948 Avon Patello-Femoral Joint ProsthesisHowmedica Osteonics Corp. · 2005
  2. Descendant · cites it directly · 4 of its ownK211303 Avon Patello-femoral Joint ProsthesisHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2021
  3. Descendant · 2 generations on · 3 of its ownK242831 Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2024
  4. Descendant · cites it directly · 2 of its ownK082088 Mako Surgical Corp. Patellofemoral Knee Implant System IIMako Surgical Corp. · 2008
  5. Descendant · 2 generations on · 1 of its ownK123907 Prelude PF Femoral Components (Mim Cocrmo), Prelude PF Femoral…Biomet Manufacturing Corp · 2013 · Recalled
  6. Descendant · 3 generations on · 0 of its ownK261898 Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total…Howmedica Osteonics Corp. dba Stryker Orthopaedics · 2026

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2006: 12008: 12012: 12013: 12015: 12021: 12024: 12025: 12026: 2
2006high 2 (2026) · low 0 (2007)2026

Most influential descendants

Showing 5 of 10 · See all
  • K211303Avon Patello-femoral Joint ProsthesisHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2021 · cites it directly4descendants
  • K242831Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2024 · 2 generations on3descendants
  • K082088Mako Surgical Corp. Patellofemoral Knee Implant System IIMako Surgical Corp. · 2008 · cites it directly2descendants
  • K123907Prelude PF Femoral Components (Mim Cocrmo), Prelude PF Femoral Components (Cast Cocrmo)…Biomet Manufacturing Corp · 2013 · 2 generations on1descendant
  • K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics · 2026 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K051948Avon Patello-Femoral Joint ProsthesisHowmedica Osteonics Corp.2005—
+1K211303Avon Patello-femoral Joint ProsthesisHowmedica Osteonics Corp., Dba Stryker Orthopaedics2021—
+2K242831Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components…Howmedica Osteonics Corp., Dba Stryker Orthopaedics2024—
+1K082088Mako Surgical Corp. Patellofemoral Knee Implant System IIMako Surgical Corp.2008—
+2K123907Prelude PF Femoral Components (Mim Cocrmo), Prelude PF Femoral Components…Biomet Manufacturing Corp20131
+3K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics2026—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200810
201210
201310
201510
202110
202410
202510
202620
FIG. 1 — Lineage of K051948, 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
Get a 510(k) Report

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
*—Avon PFJ Prosthesis
Named without a submission number
—

What descends from it? (10)

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

NumberDeviceApplicantDecidedDescendants
K211303Avon Patello-femoral Joint ProsthesisHowmedica Osteonics Corp., Dba Stryker Orthopaedics20214
K082088Mako Surgical Corp. Patellofemoral Knee Implant System IIMako Surgical Corp.20082
K111970Kneetec PFJ&HLS Kneetec Patellar ComponentTornier20120
K061433Vanguard Anatomic Patella Groove (Apg) / Vanguard V GrooveBiomet Manufacturing, Inc.20060

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jul 30, 2026Class IIZ-3206-2026Process change controlAffected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading…
Dec 1, 2023Class IIZ-0893-2024Nonconforming Material/ComponentProduct manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
Dec 1, 2023Class IIZ-0895-2024Nonconforming Material/ComponentProduct manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
Dec 1, 2023Class IIZ-0896-2024Nonconforming Material/ComponentProduct manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
Dec 1, 2023Class IIZ-0897-2024Nonconforming Material/ComponentProduct manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
Dec 1, 2023Class IIZ-0900-2024Nonconforming Material/ComponentProduct manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
Dec 1, 2023Class IIZ-0894-2024Nonconforming Material/ComponentProduct manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

The 5 latest of 7 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K211303 (Howmedica Osteonics Corp., Dba Stryker Orthopaedics, 2021) has gone furthest, with 4 descendants of its own.

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.

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 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 arc intended for implantation with bone cement.

Indications for use as stated in the FDA summary.

More from Howmedica Osteonics Corp.

319 FDA decisions under this applicant name. See the company

  • P000013/S027Trident Alumina Insert (625-0T-XXX); Osteonics® ABC/Trident® SystemHowmedica Osteonics Corp. · 2025
  • P000013/S026Trident Acetabular System: Trident Alumina InsertsHowmedica Osteonics Corp. · 2025
  • P000013/S025Trident® Acetabular SystemHowmedica Osteonics Corp. · 2024
  • P000013/S024Trident (R), ABC (R)Howmedica Osteonics Corp. · 2024
  • P000013/S021Trident Ceramic SystemHowmedica Osteonics Corp. · 2023

Recent decisions in KRR

The KRR category page

  • K231253Overture Orthopaedics Patellofemoral SystemOverture Resurfacing, Inc. · 2023
  • K221048Episealer Patellofemoral SystemEpisurf Medical, Inc. · 2022
  • K211303Avon Patello-femoral Joint ProsthesisHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2021
  • K200122MOTO PFJ SystemMedacta International S.A. · 2020
  • K181280Patello-Femoral Wave (Kahuna) Arthroplasty SystemArthrosurface, Inc. · 20183 recalls

https://510kreport.com/device/K051948 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051948: 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/K051948

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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