510(k) · Cleared
ClearedProfix Conforming Plus Tibial Insert
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew Richards, Inc. · KWH Prosthesis, Toe, Constrained, Polymer
Cleared on Jul 6, 1995 after a 196-day review. The FDA summary names its predicate without a number. 13 later devices descend from it.
- Decided
- Jul 6, 1995
- Review
- 196 days
- Class
- Class II
- Product code
- KWH
- Recalls
- None
- Predicates
- 0
13 later devices descend from it, 2 citing it directly.
- This deviceK946236 Profix Conforming Plus Tibial InsertSmith & Nephew Richards, Inc. · 1995
- 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 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · 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 |
|---|---|---|---|---|---|
| 0 (this device) | K946236 | Profix Conforming Plus Tibial Insert | Smith & Nephew Richards, Inc. | 1995 | — |
| +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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 KWH? 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 KWH device
- #1 K191966 NewPrim Systemscore -0.6 · 3 generations · no Class I recall
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | — | Ortholoc Modular Total Condylar System Named without a submission number | |
| * | — | Miller/Gallante Revision System Named without a submission number | |
| * | — | MG II Total Knee System Named without a submission number | |
| * | — | New Jersey LCS Total Knee System Named without a submission number | |
| * | — | Duracon Total Knee System Named without a submission number |
What descends from it? (13)
See all 132 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?
- Of its descendants, K113482 (Smith & Nephew, Inc., 2012) has gone furthest, with 6 descendants of its own.
How does its category compare?
All KWH devicesKWH Prosthesis, Toe, Constrained, Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWH
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · KWH
Too few KWH 510(k)s in any year since 2007 to give a median.
Recalls per year · KWH
2in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWH
8in 2025
MAUDE reports naming product code KWH, 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 | 0 | — | 0 | 2 |
| 2008 | 0 | — | 0 | 4 |
| 2009 | 0 | — | 2 | 5 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 1 | — | 0 | 2 |
| 2012 | 0 | — | 0 | 6 |
| 2013 | 0 | — | 0 | 5 |
| 2014 | 0 | — | 0 | 6 |
| 2015 | 0 | — | 0 | 6 |
| 2016 | 1 | — | 0 | 6 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 1 | — | 0 | 7 |
| 2019 | 1 | — | 0 | 15 |
| 2020 | 1 | — | 0 | 8 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 5 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 8 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
This device is intended for use in patients with 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; and failed osteotomies or unicompartmental replacement.
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/K946236 · printed Nov 6, 2026
Cite this page
510(k) Report. “K946236: Profix Conforming Plus Tibial Insert.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K946236
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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