510(k) · Cleared
ClearedProfix Flex Cruciate Retaining Articular Insert
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Jul 20, 2005 as substantially equivalent to K933958 (Smith & Nephew Richards, Inc., 1995) and 2 other predicates after a 68-day review. Its family tree reaches back 4 generations to 1995. 14 later devices descend from it.
- Decided
- Jul 20, 2005
- Review
- 68 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K951987 (1995). 12 ancestors in all, the oldest K853730 (1986). 14 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK951987 Genesis II Total Knee SystemSmith & Nephew Richards, Inc. · 1995 · Recalled
- 3 generations backK030612 Genesis II Total Knee SystemSmith & Nephew, Inc. · 2003
- 2 generations backK032295 Genesis II Posterior Stabilized High Flexion Articular InsertSmith & Nephew, Inc. · 2003 · Recalled
- 1 generation backK041825 Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular…Smith & Nephew, Inc. · 2005
- This deviceK051229 Profix Flex Cruciate Retaining Articular InsertSmith & Nephew, Inc. · 2005
- Descendant · cites it directly · 6 of its ownK113482 Journey II Deep Dished Articular InsertsSmith & Nephew, Inc. · 2012
- Descendant · cites it directly · 5 of its ownK121393 Smith & Nephew, Inc. Total Knee System InstrumentationSmith & Nephew, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 3 of its ownK230653 Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee…Smith & Nephew, Inc. · 2023 · Recalled
- Descendant · 2 generations on · 2 of its ownK123159 Smith & Newphew, Inc. Disposable Knee InstrumentsSmith & Nephew, Inc. · 2013
- Descendant · 2 generations on · 1 of its ownK211671 Journey II Mid-Level Tibial InsertsSmith & Nephew, Inc. · 2021
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K113482Journey II Deep Dished Articular InsertsSmith & Nephew, Inc. · 2012 · cites it directly6descendants
- K121393Smith & Nephew, Inc. Total Knee System InstrumentationSmith & Nephew, Inc. · 2012 · cites it directly5descendants
- K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc. · 2023 · 2 generations on3descendants
- K123159Smith & Newphew, Inc. Disposable Knee InstrumentsSmith & Nephew, Inc. · 2013 · 2 generations on2descendants
- K211671Journey II Mid-Level Tibial InsertsSmith & Nephew, Inc. · 2021 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K951987 | Genesis II Total Knee System | Smith & Nephew Richards, Inc. | 1995 | 6 |
| −3 | K030612 | Genesis II Total Knee System | Smith & Nephew, Inc. | 2003 | — |
| −2 | K032295 | Genesis II Posterior Stabilized High Flexion Articular Insert | Smith & Nephew, Inc. | 2003 | 6 |
| −1 | K041825 | Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular Insert | Smith & Nephew, Inc. | 2005 | — |
| 0 (this device) | K051229 | Profix Flex Cruciate Retaining Articular Insert | Smith & Nephew, Inc. | 2005 | — |
| +1 | K113482 | Journey II Deep Dished Articular Inserts | Smith & Nephew, Inc. | 2012 | — |
| +1 | K121393 | Smith & Nephew, Inc. Total Knee System Instrumentation | Smith & Nephew, Inc. | 2012 | 4 |
| +2 | K230653 | Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System… | Smith & Nephew, Inc. | 2023 | 1 |
| +2 | K123159 | Smith & Newphew, Inc. Disposable Knee Instruments | Smith & Nephew, Inc. | 2013 | — |
| +2 | K211671 | Journey II Mid-Level Tibial Inserts | Smith & Nephew, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K933958 | Richards Total Knee SystemSummary page 1…omical capability to allow a greater flexion range. The insert is used with existing femoral, tibial, and patetlar components of the Profix Total Knee System cleared via K933958 (cemented use) and K(030623 (uncemented use).… | 1995 |
| * | K030623 | Smith & Nephew Profix Total Knee SystemSummary page 1…______ Yr~o~ix Flex CR insert for MlI- Kejonpaeofrroiil21CF -K030623 use with Prefix Total Orthopaedlics metal/polymer porous-coated… | 2003 |
| * | K041825 | Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular InsertSummary page 2…composition to the following predicate devices - Smith & Nephew's Profix Total Knee System 1K933958 and K(030623) and the Genesis II Deep Flexion C/R Articular Insert K10418251. DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service… | 2005 |
What descends from it? (14)
See all 143 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 1.6 years on median.
- 3 of the 12 ancestors have a recall of any class.
- Of its descendants, K113482 (Smith & Nephew, Inc., 2012) has gone furthest, with 6 descendants of its own.
- 2 other devices also cite its predicate K933958.
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?
Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result; failed osteotomies, unicompartmental replacement, or total knee replacement. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate…
Read the full statement (106 words)
Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result; failed osteotomies, unicompartmental replacement, or total knee replacement. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are absent or incompetent and the collateral ligaments remain intact.
The Profix Flex Cruciate Retaining (CR) articular insert is a single-use component intended to be used in conjunction with existing components of the Profix Total Knee System cleared for cemented use (K933958) or uncemented use (K030623).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051229 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051229: Profix Flex Cruciate Retaining Articular Insert.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051229
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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