510(k) Report

510(k) · Cleared

Cleared

Smith & Nephew Patello-Femoral Implant

K051086510(k) AbbreviatedCleared May 31, 200533-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

Smith & Nephew, Inc. · KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer

Cleared on May 31, 2005 as substantially equivalent to K010100 (Howmedica Osteonics Corp., 2001) and 1 other predicate after a 33-day review. Its family tree reaches back 1 generation to 2001. 11 later devices descend from it.

Decided
May 31, 2005
Review
33 days
Class
Class II
Product code
KRR
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K010100 (2001). 2 ancestors in all. 11 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 1 other ancestor2012: 2 descendants cleared2023: 1 descendant cleared2016: 1 descendant cleared2019: 2 descendants cleared2024: 3 descendants cleared2026: 1 descendant cleared2022: 1 descendant clearedReference device: K951987 · Genesis II Total Knee System · Smith & Nephew Richards, Inc. · 1995 · recalledK010100 · Avon Patello-Femoral Joint Prosthesis · Howmedica Osteonics Corp. · 2001200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 5 descendants3 generations forward: 2 descendants K010100 · Avon Patello-Femoral Joint Prosthesis · Howmedica Osteonics Corp. · 20010
  1. Root · 1 generation backK010100 Avon Patello-Femoral Joint ProsthesisHowmedica Osteonics Corp. · 2001
  2. This deviceK051086 Smith & Nephew Patello-Femoral ImplantSmith & Nephew, Inc. · 2005
  3. Descendant · cites it directly · 8 of its ownK160738 ZUK Select Knee SystemSmith & Nephew, Inc. · 2016
  4. Descendant · 2 generations on · 7 of its ownK190085 Journey II Unicompartmental Knee SystemSmith & Nephew, Inc. · 2019 · Recalled
  5. Descendant · cites it directly · 3 of its ownK230653 Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee…Smith & Nephew, Inc. · 2023 · Recalled
  6. Descendant · 2 generations on · 1 of its ownK191211 JOURNEY II Unicompartmental Knee SystemSmith & Nephew, Inc. · 2019
  7. Descendant · 2 generations on · 0 of its ownK261462 LANDMARK Total Knee SystemSmith & Nephew, Inc. · 2026

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2012: 22016: 12019: 22022: 12023: 12024: 32026: 1
2012high 3 (2024) · low 0 (2013)2026

Most influential descendants

Showing 5 of 11 · See all
  • K160738ZUK Select Knee SystemSmith & Nephew, Inc. · 2016 · cites it directly8descendants
  • K190085Journey II Unicompartmental Knee SystemSmith & Nephew, Inc. · 2019 · 2 generations on7descendants
  • K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc. · 2023 · cites it directly3descendants
  • K191211JOURNEY II Unicompartmental Knee SystemSmith & Nephew, Inc. · 2019 · 2 generations on1descendant
  • K261462LANDMARK Total Knee SystemSmith & Nephew, Inc. · 2026 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K010100Avon Patello-Femoral Joint ProsthesisHowmedica Osteonics Corp.2001—
0 (this device)K051086Smith & Nephew Patello-Femoral ImplantSmith & Nephew, Inc.2005—
+1K160738ZUK Select Knee SystemSmith & Nephew, Inc.2016—
+2K190085Journey II Unicompartmental Knee SystemSmith & Nephew, Inc.20193
+1K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System…Smith & Nephew, Inc.20231
+2K191211JOURNEY II Unicompartmental Knee SystemSmith & Nephew, Inc.2019—
+2K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201220
201610
201920
202210
202310
202430
202610
FIG. 1 — Lineage of K051086, 2001–2026Source: 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? (3)

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
*K010100Avon Patello-Femoral Joint Prosthesis
Summary page 1
…d for implantation with bone cement. These indications are the same as found with the Howmedica Osteonics Avon~'Patetto-Femora[ Joint Prosthesis cleared via K010100 and K041160. B. DEVICE DESCRIPTION: The Smith & Nephew Patello-Femoral Components are intended to replace the patellofe…
Howmedica Osteonics Corp.2001—
*K041160Avon Extra-Small Patello-Femoral Replacement
Summary page 1
…tation with bone cement. These indications are the same as found with the Howmedica Osteonics Avon~'Patetto-Femora[ Joint Prosthesis cleared via K010100 and K041160. B. DEVICE DESCRIPTION: The Smith & Nephew Patello-Femoral Components are intended to replace the patellofemoral…
Howmedica Osteonics Corp.2004—
*—Smith & Nephew (formerly Richards Medical) Patella Type 1
Named without a submission number
—
†K951987Genesis II Total Knee SystemSmith & Nephew Richards, Inc.19956

Also cleared against K010100: 2 other devices →

What descends from it? (11)

See all 11

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

NumberDeviceApplicantDecidedDescendants
K160738ZUK Select Knee SystemSmith & Nephew, Inc.20168
K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.20233
K111970Kneetec PFJ&HLS Kneetec Patellar ComponentTornier20120
K113038Smith & Nephew Inc. Unicompartmental and Biocompartmental Knee System InstrumentsSmith & Nephew, Inc.20120

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?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K160738 (Smith & Nephew, Inc., 2016) has gone furthest, with 8 descendants of its own.
  • 2 other devices also cite its predicate K010100.

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 Smith & Nephew Pate~io-Femoral Implant is indicated for replacement of the femoral side of the patelto-femorat joint. Itis intended to be used in patellofemoral arthroplasty in patients with:

1. Degenerative arthritis in the distat femur and patella.

2. A history of pateltar dislocation or pateflar fracture.

3. Failed previous surgery (arthroptasty, tibial tubercle elevation, lateral release) where pain, deformity or dysfunction persists.

The Smith & Nephew Patello-Femorat Implants are for single use only and are intended for implantation with bone cement.

Indications for use as stated in the FDA summary.

Also cleared against K010100

2 other devices cite the same predicate.

  • K111970Kneetec PFJ&HLS Kneetec Patellar ComponentTornier · 2012
  • K082088Mako Surgical Corp. Patellofemoral Knee Implant System IIMako Surgical Corp. · 2008

More from Smith & Nephew, Inc.

692 FDA decisions under this applicant name. See the company

  • K263348Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor…Smith & Nephew, Inc. · 2026
  • K261462LANDMARK Total Knee SystemSmith & Nephew, Inc. · 2026
  • K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981)…Smith & Nephew, Inc. · 2026
  • DEN250037TESSA Spatial Surgery System; INTELLIO Tablet (72205455)Smith & Nephew, Inc. · 2026
  • K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc. · 2026

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/K051086 · printed Nov 4, 2026

Cite this page

510(k) Report. “K051086: Smith & Nephew Patello-Femoral Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K051086

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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