510(k) Report

510(k) · Cleared

Cleared

Depuy Sigma Cruciate Retaining Porocoat Femoral Components

K062654510(k) TraditionalCleared Sep 29, 200622-day reviewClass II21 CFR 888.3565

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

DePuy Orthopaedics, Inc. · MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

Cleared on Sep 29, 2006 as substantially equivalent to K943462 (Johnson & Johnson Professionals, Inc., 1994) and 2 other predicates after a 22-day review. Its family tree reaches back 1 generation to 1994. 120 later devices descend from it.

Decided
Sep 29, 2006
Review
22 days
Class
Class II
Product code
MBH
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K933787 (1994). 3 ancestors in all. 120 later devices descend from it, 6 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1996: 1 other ancestor1994: 1 other ancestor2015: 9 descendants cleared2008: 2 descendants cleared2010: 1 descendant cleared2024: 15 descendants cleared2014: 4 descendants cleared2019: 8 descendants cleared2011: 3 descendants cleared2026: 16 descendants cleared2012: 3 descendants cleared2018: 3 descendants cleared2020: 8 descendants cleared2021: 11 descendants cleared2013: 4 descendants cleared2017: 3 descendants cleared2023: 9 descendants cleared2025: 12 descendants cleared2022: 9 descendants clearedReference device: P830055 · LCS (R) Total Knee System · Depuy, Inc. · 1985 · recalledK933787 · Porocoat Porous Coating/Aml Proximally-Coated Stem · Depuy, Inc. · 19941990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 6 descendants2 generations forward: 11 descendants3 generations forward: 16 descendants4 generations forward: 20 descendants5 generations forward: 23 descendants6 generations forward: 25 descendants7 generations forward: 12 descendants8 generations forward: 6 descendants9 generations forward: 1 descendant K933787 · Porocoat Porous Coating/Aml Proximally-Coated Stem · Depuy, Inc. · 19940+5
  1. Root · 1 generation backK933787 Porocoat Porous Coating/Aml Proximally-Coated StemDepuy, Inc. · 1994
  2. This deviceK062654 Depuy Sigma Cruciate Retaining Porocoat Femoral ComponentsDePuy Orthopaedics, Inc. · 2006
  3. Descendant · cites it directly · 72 of its ownK073602 Modification to: Apex Knee SystemOmnlife Science · 2008
  4. Descendant · 2 generations on · 61 of its ownK080842 Apex Knee System, Model KC-230XY, KC-240XY [ NO Holes, 2 Holes]Omni Life Science, Inc. · 2008
  5. Descendant · 3 generations on · 60 of its ownK131353 Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp · 2013
  6. Descendant · cites it directly · 45 of its ownK101499 Journey CR Knee SystemSmith & Nephew, Inc. · 2010
  7. Descendant · 2 generations on · 37 of its ownK121443 Journey II CR Knee SystemSmith & Nephew, Inc. · 2012

Showing 5 of 120 descendants. See all descendants

Descendants cleared per year

2008: 22010: 12011: 32012: 32013: 42014: 42015: 92017: 32018: 32019: 82020: 82021: 112022: 92023: 92024: 152025: 122026: 16
2008high 16 (2026) · low 0 (2009)2026

Most influential descendants

Showing 5 of 120 · See all
  • K073602Modification to: Apex Knee SystemOmnlife Science · 2008 · cites it directly72descendants
  • K080842Apex Knee System, Model KC-230XY, KC-240XY [ NO Holes, 2 Holes]Omni Life Science, Inc. · 2008 · 2 generations on61descendants
  • K131353Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp · 2013 · 3 generations on60descendants
  • K101499Journey CR Knee SystemSmith & Nephew, Inc. · 2010 · cites it directly45descendants
  • K121443Journey II CR Knee SystemSmith & Nephew, Inc. · 2012 · 2 generations on37descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K933787Porocoat Porous Coating/Aml Proximally-Coated StemDepuy, Inc.1994—
0 (this device)K062654Depuy Sigma Cruciate Retaining Porocoat Femoral ComponentsDePuy Orthopaedics, Inc.2006—
+1K073602Modification to: Apex Knee SystemOmnlife Science2008—
+2K080842Apex Knee System, Model KC-230XY, KC-240XY [ NO Holes, 2 Holes]Omni Life Science, Inc.2008—
+3K131353Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp2013—
+1K101499Journey CR Knee SystemSmith & Nephew, Inc.2010—
+2K121443Journey II CR Knee SystemSmith & Nephew, Inc.2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200820
201010
201130
201230
201340
201440
201590
201730
201830
201980
202080
2021110
202290
202390
2024150
2025120
2026160
FIG. 1 — Lineage of K062654, 1994–2026Source: 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 MBH? 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 MBH device

  1. #1 K241597 Freedom® Total Knee System - Porous Tibial…score 19.9 · 8 generations · 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
*K943462Darwin Knee System
Summary page 1
…JWH, MB3H SUBSTANTIALLY EQUIVALENT PFC Sigma® Knee System (cleared as Darwin DEVICES: Knee System), K943462 PFC Cruciate Retaining Knee System, Size 1.5,…
Johnson & Johnson Professionals, Inc.19948
*K961685P.F.C. Cruciate Retaining Knee System (Size 1.5)
Summary page 1
…nee System), K943462 PFC Cruciate Retaining Knee System, Size 1.5, K961685 AML® Proximally Coated Hip, K933787 DEVICE 'DESCRIPTION: The Sigma C/R Por…
Johnson & Johnson Professionals, Inc.19967
*K933787Porocoat Porous Coating/Aml Proximally-Coated Stem
Summary page 1
…taining Knee System, Size 1.5, K961685 AML® Proximally Coated Hip, K933787 DEVICE 'DESCRIPTION: The Sigma C/R Porocoat Femoral Components are part of the Sigma Total Knee Replacement System. They are p…
Depuy, Inc.1994—
†P830055LCS (R) Total Knee SystemDepuy, Inc.198510

Also cleared against K943462: 11 other devices →

What descends from it? (120)

See all 120

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

NumberDeviceApplicantDecidedDescendants
K073602Modification to: Apex Knee SystemOmnlife Science200872
K101499Journey CR Knee SystemSmith & Nephew, Inc.201045
K140881Depuy Attune Knee System - Cementless CR and PS Femoral ComponenetsDepuy (Ireland)20153
K182301PFC SIGMA Knee SystemDePuy Orthopaedics, Inc.20191
K140302Optetrak Logic Porous Femoral ComponentsExactech, Inc.20141
K241000ATTUNE™ Revision Knee System; DePuy Knee Prosthesis System Universal Stem Extensions and…Depuy Ireland UC20240

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?

  • 2 of the 3 ancestors have a recall of any class.
  • Of its descendants, K073602 (Omnlife Science, 2008) has gone furthest, with 72 descendants of its own.
  • 11 other devices also cite its predicate K943462.

How does its category compare?

All MBH devices

MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MBH

8in 2025

2007: 102008: 32009: 32010: 42011: 52012: 52013: 62014: 92015: 82016: 42017: 42018: 62019: 12020: 72021: 62022: 72023: 62024: 102025: 82026 (partial year): 7
2007high 10 (2007) · low 1 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MBH

98in 2025

2007: 59 days median2008: 70 days median2009: 209 days median2010: 84 days median2011: 84 days median2012: 90 days median2013: 138 days median2014: 114 days median2015: 100 days median2016: 74 days median2017: 115 days median2018: 89 days median2020: 112 days median2021: 48 days median2022: 57 days median2023: 94 days median2024: 84 days median2025: 98 days median2026 (partial year): 153 days median
2007high 209 (2009) · low 48 (2021)2026

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

Recalls per year · MBH

1in 2024

2009: 22011: 152012: 1, 1 Class I2013: 4, 4 Class I2016: 12017: 92018: 12019: 12020: 22023: 22024: 12026 (partial year): 4
2007high 15 (2011) · low 0 (2007)2026

Class I (5 since 2007) Class II/III not classified

Adverse event reports per year · MBH

1,561in 2025

2007: 272008: 212009: 892010: 1212011: 2472012: 3702013: 3082014: 3852015: 9552016: 1,0342017: 1,0072018: 1,1912019: 1,3942020: 1,0892021: 1,5392022: 1,2612023: 1,2632024: 1,4972025: 1,561
2007high 1,561 (2025) · low 21 (2008)2025

MAUDE reports naming product code MBH, 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
20071059027
2008370021
20093209289
20104840121
201158415247
20125901 (1)370
201361384 (4)308
201491140385
201581000955
201647411,034
2017411591,007
201868911,191
20191—11,394
2020711221,089
202164801,539
202275701,261
202369421,263
2024108411,497
202589801,561
202671534—

What is it indicated for?

The Sigma Cruciate Retaining Porocoat Femoral Components are intended for cemented or cementless use as the femoral components of a Total Knee Replacement system. Total Knee Replacement is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Candidates for total knee replacement include elderly…

Read the full statement (159 words)

The Sigma Cruciate Retaining Porocoat Femoral Components are intended for cemented or cementless use as the femoral components of a Total Knee Replacement system.

Total Knee Replacement is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

Candidates for total knee replacement include elderly patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant. Total knee replacement may be considered for younger patients if, in the opinion of the surgeon, an unequivocal indication for total knee replacement outweighs the risks associated with the age of the patient, and if limited demands regarding activity and kneejoint loading can be assured. This includes severely crippled patients with multiple joint involvement for whom a gain in knee mobility may lead to significant improvement in their quality of life.

Indications for use as stated in the FDA summary.

Also cleared against K943462

11 other devices cite the same predicate.

  • K241000ATTUNE™ Revision Knee System; DePuy Knee Prosthesis System Universal Stem Extensions and Universal Femoral…Depuy Ireland UC · 2024
  • K193057ATTUNE All-Polyethylene TibiaDepuy Ireland UC · 2020
  • K182301PFC SIGMA Knee SystemDePuy Orthopaedics, Inc. · 2019
  • K150496Total Knee Arthroplasty SystemResponsive Orthopedics, LLC · 201512 recalls
  • K101433Depuy Attune Knee SystemDePuy Orthopaedics, Inc. · 2010
  • K082500Depuy Sigma CR-F Femoral ComponentDePuy Orthopaedics, Inc. · 2008

More from DePuy Orthopaedics, Inc.

361 FDA decisions under this applicant name. See the company

  • P070026/S129Ceramax Ceramic Hip SystemDePuy Orthopaedics, Inc. · 2026
  • P070026/S130CERAMAX Ceramic Hip SystemDePuy Orthopaedics, Inc. · 2026
  • P070026/S128CERAMAX® Ceramic Total Hip SystemDePuy Orthopaedics, Inc. · 2026
  • P070026/S127Ceramax Ceramic Hip SystemDePuy Orthopaedics, Inc. · 2026
  • K252887DePuy ATTUNE™ Knee SystemDePuy Orthopaedics, Inc. · 2026

Recent decisions in MBH

The MBH category page

  • K261275Unity Total Knee System, Unity Knee Cementless CR FemurCorin, Ltd. · 2026
  • K261462LANDMARK Total Knee SystemSmith & Nephew, Inc. · 2026
  • K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc. · 2026
  • K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc. · 2026
  • K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc. · 2026

https://510kreport.com/device/K062654 · printed Nov 6, 2026

Cite this page

510(k) Report. “K062654: Depuy Sigma Cruciate Retaining Porocoat Femoral Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062654

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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