510(k) · Cleared
ClearedTC-Plus Porous Femoral Components
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Plus Orthopedics · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on May 24, 2001 as substantially equivalent to K000666 (Plus Orthopedics, 2000) after a 30-day review. Its family tree reaches back 2 generations to 1993. 54 later devices descend from it.
- Decided
- May 24, 2001
- Review
- 30 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K923277 (1993). 54 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK923277 Foundation Knee SystemEncore Orthopedics, Inc. · 1993 · Recalled
- 1 generation backK000666 TC-Plus Solution KneePlus Orthopedics · 2000 · Recalled
- This deviceK011258 TC-Plus Porous Femoral ComponentsPlus Orthopedics · 2001
- Descendant · cites it directly · 53 of its ownK072858 TC-Plus Primary Knee SystemSmith & Nephew, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 52 of its ownK090988 GMK Total Knee SystemMedacta International S.A. · 2009 · Recalled
- Descendant · 3 generations on · 34 of its ownK102437 GMK Revision Knee SystemMedacta International S.A. · 2010
- Descendant · 3 generations on · 28 of its ownK103170 GMK Revision Knee SC LinersMedacta International S.A. · 2011
- Descendant · 3 generations on · 23 of its ownK113571 GMK Resufacing Patella Size 4Medacta International · 2012
Showing 5 of 54 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 54 · See all- K072858TC-Plus Primary Knee SystemSmith & Nephew, Inc. · 2007 · cites it directly53descendants
- K090988GMK Total Knee SystemMedacta International S.A. · 2009 · 2 generations on52descendants
- K102437GMK Revision Knee SystemMedacta International S.A. · 2010 · 3 generations on34descendants
- K103170GMK Revision Knee SC LinersMedacta International S.A. · 2011 · 3 generations on28descendants
- K113571GMK Resufacing Patella Size 4Medacta International · 2012 · 3 generations on23descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K923277 | Foundation Knee System | Encore Orthopedics, Inc. | 1993 | 4 |
| −1 | K000666 | TC-Plus Solution Knee | Plus Orthopedics | 2000 | 9 |
| 0 (this device) | K011258 | TC-Plus Porous Femoral Components | Plus Orthopedics | 2001 | — |
| +1 | K072858 | TC-Plus Primary Knee System | Smith & Nephew, Inc. | 2007 | 15 |
| +2 | K090988 | GMK Total Knee System | Medacta International S.A. | 2009 | 1 |
| +3 | K102437 | GMK Revision Knee System | Medacta International S.A. | 2010 | — |
| +3 | K103170 | GMK Revision Knee SC Liners | Medacta International S.A. | 2011 | — |
| +3 | K113571 | GMK Resufacing Patella Size 4 | Medacta International | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 4 | 0 |
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2020 | 5 | 0 |
| 2021 | 7 | 0 |
| 2022 | 3 | 0 |
| 2023 | 4 | 0 |
| 2024 | 2 | 0 |
| 2025 | 5 | 0 |
| 2026 | 6 | 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 |
|---|---|---|---|
| * | K000666 | TC-Plus Solution Knee | 2000 |
What descends from it? (54)
See all 541 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072858 | TC-Plus Primary Knee System | 2007 | 53 |
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 8 years and passes through 2 companies; a new generation was cleared every 7.7 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K072858 (Smith & Nephew, Inc., 2007) has gone furthest, with 53 descendants of its own.
- 4 other devices also cite its predicate K000666.
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 TC-PLUS TM Porous Femoral Component is intended as a cemented surface replacement in treating patients who are candidates for primary total knee arthroplasty or revision knee arthroplasty. It is indicated for degenerative, post-traumatic or rheumatoid arthritis, avascular necrosis of the femoral condyle, post-traumatic loss of joint configuration, in particular in the event of patello-femoral erosion, functional disability or an earlier patellectomy; moderate varus, valgus or flexure deformity and to correct earlier unsuccessful attempts at surgery.
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/K011258 · printed Nov 5, 2026
Cite this page
510(k) Report. “K011258: TC-Plus Porous Femoral Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011258
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026