510(k) Report

510(k) · Cleared

Cleared

Avon Extra-Small Patello-Femoral Replacement

K041160510(k) SpecialCleared May 27, 200424-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. · KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer

Cleared on May 27, 2004 after a 24-day review. The FDA summary names its predicate without a number. 64 later devices descend from it.

Decided
May 27, 2004
Review
24 days
Class
Class II
Product code
KRR
Recalls
None
Predicates
0

64 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared2012: 2 descendants cleared2006: 1 descendant cleared2008: 3 descendants cleared2023: 4 descendants cleared2016: 2 descendants cleared2013: 2 descendants cleared2009: 1 descendant cleared2014: 1 descendant cleared2015: 3 descendants cleared2019: 9 descendants cleared2024: 6 descendants cleared2026: 6 descendants cleared2017: 3 descendants cleared2022: 3 descendants cleared2020: 6 descendants cleared2021: 5 descendants cleared2025: 4 descendants cleared2018: 2 descendants cleared200020052010201520202025
  1. This deviceK041160 Avon Extra-Small Patello-Femoral ReplacementHowmedica Osteonics Corp. · 2004
  2. Descendant · cites it directly · 55 of its ownK080029 Mako Surgical Corp. Patellofemoral Knee Implant SystemMako Surgical Corp. · 2008
  3. Descendant · 2 generations on · 51 of its ownK082172 Mako Modular Knee Compartmental Implant SystemMako Surgical Corporation · 2008 · Recalled
  4. Descendant · 3 generations on · 50 of its ownK090763 Restoris Multicompartmental Knee (MCK) SystemMako Surgical Corporation · 2009 · Recalled
  5. Descendant · 4 generations on · 26 of its ownK133039 Restoris Multicompartmental Knee SystemMako Surgical Corporation · 2013
  6. Descendant · 5 generations on · 25 of its ownK150307 RESTORIS Multicompartmental Knee SystemMako Surgical Corp. · 2015

Showing 5 of 64 descendants. See all descendants

Descendants cleared per year

2005: 12006: 12008: 32009: 12012: 22013: 22014: 12015: 32016: 22017: 32018: 22019: 92020: 62021: 52022: 32023: 42024: 62025: 42026: 6
2005high 9 (2019) · low 0 (2007)2026

Most influential descendants

Showing 5 of 64 · See all
  • K080029Mako Surgical Corp. Patellofemoral Knee Implant SystemMako Surgical Corp. · 2008 · cites it directly55descendants
  • K082172Mako Modular Knee Compartmental Implant SystemMako Surgical Corporation · 2008 · 2 generations on51descendants
  • K090763Restoris Multicompartmental Knee (MCK) SystemMako Surgical Corporation · 2009 · 3 generations on50descendants
  • K133039Restoris Multicompartmental Knee SystemMako Surgical Corporation · 2013 · 4 generations on26descendants
  • K150307RESTORIS Multicompartmental Knee SystemMako Surgical Corp. · 2015 · 5 generations on25descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K041160Avon Extra-Small Patello-Femoral ReplacementHowmedica Osteonics Corp.2004—
+1K080029Mako Surgical Corp. Patellofemoral Knee Implant SystemMako Surgical Corp.2008—
+2K082172Mako Modular Knee Compartmental Implant SystemMako Surgical Corporation20082
+3K090763Restoris Multicompartmental Knee (MCK) SystemMako Surgical Corporation20095
+4K133039Restoris Multicompartmental Knee SystemMako Surgical Corporation2013—
+5K150307RESTORIS Multicompartmental Knee SystemMako Surgical Corp.2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200610
200830
200910
201220
201320
201410
201530
201620
201730
201820
201990
202060
202150
202230
202340
202460
202540
202660
FIG. 1 — Lineage of K041160, 2004–2026Source: 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
*—Avon™ Small Patello-femoral Replacement
Named without a submission number
—

What descends from it? (64)

See all 64

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

NumberDeviceApplicantDecidedDescendants
K080029Mako Surgical Corp. Patellofemoral Knee Implant SystemMako Surgical Corp.200855
K051086Smith & Nephew Patello-Femoral ImplantSmith & Nephew, Inc.200511
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)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K080029 (Mako Surgical Corp., 2008) has gone furthest, with 55 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 AvonTM Patello-femoral Joint Replacement 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 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/K041160 · printed Nov 6, 2026

Cite this page

510(k) Report. “K041160: Avon Extra-Small Patello-Femoral Replacement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041160

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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