510(k) Report

510(k) · Cleared

Cleared

Natural-Knee II Patellofemoral Joint Prosthesis

K002356510(k) TraditionalCleared Oct 30, 200089-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

Sulzer Orthopedics, Inc. · KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer

Cleared on Oct 30, 2000 after an 89-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 143 later devices descend from it.

Decided
Oct 30, 2000
Review
89 days
Class
Class II
Product code
KRR
Recalls
None
Predicates
0

143 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2006: 1 descendant cleared2007: 4 descendants cleared2008: 2 descendants cleared2009: 2 descendants cleared2018: 6 descendants cleared2020: 12 descendants cleared2011: 4 descendants cleared2012: 7 descendants cleared2024: 11 descendants cleared2014: 9 descendants cleared2019: 9 descendants cleared2021: 18 descendants cleared2016: 7 descendants cleared2025: 10 descendants cleared2017: 3 descendants cleared2015: 5 descendants cleared2013: 7 descendants cleared2023: 8 descendants cleared2022: 7 descendants cleared2026: 11 descendants cleared200020052010201520202025
  1. This deviceK002356 Natural-Knee II Patellofemoral Joint ProsthesisSulzer Orthopedics, Inc. · 2000
  2. Descendant · cites it directly · 122 of its ownK070695 Zimmer Patellofemoral Joint ProsthesisZimmer, Inc. · 2007 · Recalled
  3. Descendant · 2 generations on · 117 of its ownK073286 Gender Solutions Natural-Knee Flex SystemZimmer, Inc. · 2008 · Recalled
  4. Descendant · 3 generations on · 96 of its ownK113369 Zimmer Persona Knee SystemZimmer, Inc. · 2012 · Recalled
  5. Descendant · 4 generations on · 59 of its ownK121771 Zimmer Persona the Personalized Knee SystemZimmer, Inc. · 2012 · Recalled
  6. Descendant · cites it directly · 35 of its ownK053488 Conformis Bicompartmental Knee Repair SystemConformis, Inc. · 2006

Showing 5 of 143 descendants. See all descendants

Descendants cleared per year

2006: 12007: 42008: 22009: 22011: 42012: 72013: 72014: 92015: 52016: 72017: 32018: 62019: 92020: 122021: 182022: 72023: 82024: 112025: 102026: 11
2006high 18 (2021) · low 0 (2010)2026

Most influential descendants

Showing 5 of 143 · See all
  • K070695Zimmer Patellofemoral Joint ProsthesisZimmer, Inc. · 2007 · cites it directly122descendants
  • K073286Gender Solutions Natural-Knee Flex SystemZimmer, Inc. · 2008 · 2 generations on117descendants
  • K113369Zimmer Persona Knee SystemZimmer, Inc. · 2012 · 3 generations on96descendants
  • K121771Zimmer Persona the Personalized Knee SystemZimmer, Inc. · 2012 · 4 generations on59descendants
  • K053488Conformis Bicompartmental Knee Repair SystemConformis, Inc. · 2006 · cites it directly35descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K002356Natural-Knee II Patellofemoral Joint ProsthesisSulzer Orthopedics, Inc.2000—
+1K070695Zimmer Patellofemoral Joint ProsthesisZimmer, Inc.20075
+2K073286Gender Solutions Natural-Knee Flex SystemZimmer, Inc.20085
+3K113369Zimmer Persona Knee SystemZimmer, Inc.201239
+4K121771Zimmer Persona the Personalized Knee SystemZimmer, Inc.20122
+1K053488Conformis Bicompartmental Knee Repair SystemConformis, Inc.2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200740
200820
200920
201140
201270
201370
201490
201550
201670
201730
201860
201990
2020120
2021180
202270
202380
2024110
2025100
2026110
FIG. 1 — Lineage of K002356, 2000–2026Source: 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 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (143)

See all 143

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

NumberDeviceApplicantDecidedDescendants
K070695Zimmer Patellofemoral Joint ProsthesisZimmer, Inc.2007122
K053488Conformis Bicompartmental Knee Repair SystemConformis, Inc.200635

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, K070695 (Zimmer, Inc., 2007) has gone furthest, with 122 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—

More from Sulzer Orthopedics, Inc.

45 FDA decisions under this applicant name. See the company

  • K022985Ascendent Acetabular SystemSulzer Orthopedics, Inc. · 20021 recall
  • K021578Natural-Knee II System Cocr Tibial BaseplateSulzer Orthopedics, Inc. · 2002
  • K020713MS-30 Lateral Femoral StemSulzer Orthopedics, Inc. · 20021 recall
  • K013935Allofit Acetabular System 32MM Alpha Durasul InsertsSulzer Orthopedics, Inc. · 2001
  • K013031Most Options SystemSulzer Orthopedics, Inc. · 20013 recalls

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/K002356 · printed Nov 6, 2026

Cite this page

510(k) Report. “K002356: Natural-Knee II Patellofemoral 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/K002356

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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