510(k) · Cleared
ClearedP.F.C. Sigma Knee System (Size 1.5)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Johnson & Johnson Professionals, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Jul 17, 1997 after a 107-day review. The FDA summary names its predicate without a number. 356 later devices descend from it.
- Decided
- Jul 17, 1997
- Review
- 107 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 0
356 later devices descend from it, 7 citing it directly.
- This deviceK971189 P.F.C. Sigma Knee System (Size 1.5)Johnson & Johnson Professionals, Inc. · 1997
- Descendant · cites it directly · 351 of its ownK033272 Depuy Sigma Tibial InsertsDePuy Orthopaedics, Inc. · 2004 · Recalled
- Descendant · cites it directly · 324 of its ownK040166 Depuy Sigma XLK Tibial InsertsDePuy Orthopaedics, Inc. · 2004
- Descendant · 2 generations on · 158 of its ownK052472 Depuy Global Shoulder Crosslink GlenoidDePuy Orthopaedics, Inc. · 2005
- Descendant · 2 generations on · 114 of its ownK101433 Depuy Attune Knee SystemDePuy Orthopaedics, Inc. · 2010
- Descendant · 3 generations on · 75 of its ownK092122 Global Shoulder Steptech Anchor Peg GlenoidDePuy Orthopaedics, Inc. · 2009
Showing 5 of 356 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 356 · See all- K033272Depuy Sigma Tibial InsertsDePuy Orthopaedics, Inc. · 2004 · cites it directly351descendants
- K040166Depuy Sigma XLK Tibial InsertsDePuy Orthopaedics, Inc. · 2004 · cites it directly324descendants
- K052472Depuy Global Shoulder Crosslink GlenoidDePuy Orthopaedics, Inc. · 2005 · 2 generations on158descendants
- K101433Depuy Attune Knee SystemDePuy Orthopaedics, Inc. · 2010 · 2 generations on114descendants
- K092122Global Shoulder Steptech Anchor Peg GlenoidDePuy Orthopaedics, Inc. · 2009 · 3 generations on75descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971189 | P.F.C. Sigma Knee System (Size 1.5) | Johnson & Johnson Professionals, Inc. | 1997 | — |
| +1 | K033272 | Depuy Sigma Tibial Inserts | DePuy Orthopaedics, Inc. | 2004 | 51 |
| +1 | K040166 | Depuy Sigma XLK Tibial Inserts | DePuy Orthopaedics, Inc. | 2004 | — |
| +2 | K052472 | Depuy Global Shoulder Crosslink Glenoid | DePuy Orthopaedics, Inc. | 2005 | — |
| +2 | K101433 | Depuy Attune Knee System | DePuy Orthopaedics, Inc. | 2010 | — |
| +3 | K092122 | Global Shoulder Steptech Anchor Peg Glenoid | DePuy Orthopaedics, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 5 | 0 |
| 2010 | 3 | 0 |
| 2011 | 6 | 0 |
| 2012 | 4 | 0 |
| 2013 | 7 | 0 |
| 2014 | 8 | 0 |
| 2015 | 18 | 0 |
| 2016 | 19 | 0 |
| 2017 | 13 | 0 |
| 2018 | 13 | 0 |
| 2019 | 30 | 0 |
| 2020 | 29 | 0 |
| 2021 | 32 | 0 |
| 2022 | 27 | 0 |
| 2023 | 32 | 0 |
| 2024 | 37 | 0 |
| 2025 | 31 | 0 |
| 2026 | 33 | 0 |
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 JWH? 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 JWH device
- #1 K221479 Persona Personalized Knee Systemscore 22.4 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | P.F.C. Sigma Knee System Named without a submission number |
What descends from it? (356)
See all 3567 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033272 | Depuy Sigma Tibial Inserts | 2004 | 351 |
| K040166 | Depuy Sigma XLK Tibial Inserts | 2004 | 324 |
| K073529 | Depuy Sigma PS Femoral Components | 2008 | 40 |
| K182301 | PFC SIGMA Knee System | 2019 | 1 |
| K241000 | ATTUNE™ Revision Knee System; DePuy Knee Prosthesis System Universal Stem Extensions and… | 2024 | 0 |
| K193057 | ATTUNE All-Polyethylene Tibia | 2020 | 0 |
| K122975 | GKS Prime Flex CR Total Knee System | 2012 | 0 |
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, K033272 (DePuy Orthopaedics, Inc., 2004) has gone furthest, with 351 descendants of its own.
How does its category compare?
All JWH devicesJWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JWH
20in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JWH
55in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JWH
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JWH
9,306in 2025
MAUDE reports naming product code JWH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 18 | 74 | 14 | 1,305 |
| 2008 | 17 | 81 | 10 | 1,483 |
| 2009 | 11 | 168 | 109 | 1,870 |
| 2010 | 19 | 85 | 32 | 3,286 |
| 2011 | 25 | 87 | 27 | 5,133 |
| 2012 | 33 | 85 | 85 | 5,203 |
| 2013 | 31 | 128 | 31 | 6,135 |
| 2014 | 33 | 98 | 13 | 6,722 |
| 2015 | 27 | 87 | 11 | 6,881 |
| 2016 | 18 | 88 | 17 | 7,586 |
| 2017 | 25 | 118 | 61 | 12,263 |
| 2018 | 25 | 90 | 14 | 14,071 |
| 2019 | 28 | 133 | 5 | 14,987 |
| 2020 | 22 | 59 | 2 | 12,592 |
| 2021 | 24 | 61 | 8 | 9,408 |
| 2022 | 17 | 56 | 12 | 8,364 |
| 2023 | 20 | 57 | 67 | 8,947 |
| 2024 | 19 | 89 | 7 | 10,828 |
| 2025 | 20 | 55 | 2 | 9,306 |
| 2026 | 12 | 63 | 4 | — |
What is it indicated for?
The P.F.C. Sigma Knee System (Size 1.5) is indicated for use only with bone cement (PMMA) for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders or pseudogout. This damage may also be the result of trauma or failed prior surgical intervention.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971189 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971189: P.F.C. Sigma Knee System (Size 1.5).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971189
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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