510(k) · Cleared
Recalled · Class II · 2016TC-Plus Primary Knee System
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 Nov 20, 2007 as substantially equivalent to K000666 (Plus Orthopedics, 2000) and 2 other predicates after a 46-day review. Its family tree reaches back 3 generations to 1993. 53 later devices descend from it. It has been recalled 15 times.
- Decided
- Nov 20, 2007
- Review
- 46 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 15
- Predicates
- 3
Its longest line of descent runs back 3 generations to K923277 (1993). 4 ancestors in all. 53 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK923277 Foundation Knee SystemEncore Orthopedics, Inc. · 1993 · Recalled
- 2 generations backK000666 TC-Plus Solution KneePlus Orthopedics · 2000 · Recalled
- 1 generation backK011258 TC-Plus Porous Femoral ComponentsPlus Orthopedics · 2001
- This deviceK072858 TC-Plus Primary Knee SystemSmith & Nephew, Inc. · 2007
- Descendant · cites it directly · 52 of its ownK090988 GMK Total Knee SystemMedacta International S.A. · 2009 · Recalled
- Descendant · 2 generations on · 34 of its ownK102437 GMK Revision Knee SystemMedacta International S.A. · 2010
- Descendant · 2 generations on · 28 of its ownK103170 GMK Revision Knee SC LinersMedacta International S.A. · 2011
- Descendant · 2 generations on · 23 of its ownK113571 GMK Resufacing Patella Size 4Medacta International · 2012
- Descendant · 2 generations on · 20 of its ownK121416 GMK SphereMedacta International · 2012
Showing 5 of 53 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 53 · See all- K090988GMK Total Knee SystemMedacta International S.A. · 2009 · cites it directly52descendants
- K102437GMK Revision Knee SystemMedacta International S.A. · 2010 · 2 generations on34descendants
- K103170GMK Revision Knee SC LinersMedacta International S.A. · 2011 · 2 generations on28descendants
- K113571GMK Resufacing Patella Size 4Medacta International · 2012 · 2 generations on23descendants
- K121416GMK SphereMedacta International · 2012 · 2 generations on20descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K923277 | Foundation Knee System | Encore Orthopedics, Inc. | 1993 | 4 |
| −2 | K000666 | TC-Plus Solution Knee | Plus Orthopedics | 2000 | 9 |
| −1 | K011258 | TC-Plus Porous Femoral Components | Plus Orthopedics | 2001 | — |
| 0 (this device) | K072858 | TC-Plus Primary Knee System | Smith & Nephew, Inc. | 2007 | — |
| +1 | K090988 | GMK Total Knee System | Medacta International S.A. | 2009 | 1 |
| +2 | K102437 | GMK Revision Knee System | Medacta International S.A. | 2010 | — |
| +2 | K103170 | GMK Revision Knee SC Liners | Medacta International S.A. | 2011 | — |
| +2 | K113571 | GMK Resufacing Patella Size 4 | Medacta International | 2012 | — |
| +2 | K121416 | GMK Sphere | Medacta International | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K000666 | TC-Plus Solution KneeSummary page 1…System and the TC-PLUS Solution Knee System. The femoral components are the previously- cleared TC-PEUS Solution femoral components available with (K0112581 or without (K000666) atitanium plasma-spray coating. The articular insert and tibia[ baseplate components in the TC-PLUS Primary Knee System are iden… | 2000 |
| * | K011258 | TC-Plus Porous Femoral ComponentsSummary page 1…usly-cleared VKS Knee System and the TC-PLUS Solution Knee System. The femoral components are the previously- cleared TC-PEUS Solution femoral components available with (K0112581 or without (K000666) atitanium plasma-spray coating. The articular insert and tibia[ baseplate components in the TC-PLUS Primary… | 2001 |
| * | K022204 | VKS Knee SystemSummary page 1…6) atitanium plasma-spray coating. The articular insert and tibia[ baseplate components in the TC-PLUS Primary Knee System are identical to those of the VKS Knee System (K022204). The titanium ptasma-sprayed tibial baseplates in the system feature holes to accept cancellous bone screws' for supplemental fi… | 2002 |
What descends from it? (53)
See all 531 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090988 | GMK Total Knee System | 2009 | 52 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 11, 2016 | Class II | Z-1544-2016 | Process control | The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery. |
| Mar 11, 2016 | Class II | Z-1539-2016 | Process control | The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery. |
| Mar 11, 2016 | Class II | Z-1538-2016 | Process control | The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery. |
| Mar 11, 2016 | Class II | Z-1547-2016 | Process control | The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery. |
| Mar 11, 2016 | Class II | Z-1551-2016 | Process control | The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery. |
| Mar 11, 2016 | Class II | Z-1546-2016 | Process control | The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery. |
| Mar 11, 2016 | Class II | Z-1537-2016 | Process control | The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery. |
| Mar 11, 2016 | Class II | Z-1540-2016 | Process control | The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery. |
| Mar 11, 2016 | Class II | Z-1545-2016 | Process control | The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery. |
| Mar 11, 2016 | Class II | Z-1542-2016 | Process control | The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery. |
| Mar 11, 2016 | Class II | Z-1549-2016 | Process control | The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery. |
| Mar 11, 2016 | Class II | Z-1550-2016 | Process control | The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery. |
| Mar 11, 2016 | Class II | Z-1543-2016 | Process control | The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery. |
| Mar 11, 2016 | Class II | Z-1548-2016 | Process control | The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery. |
| Mar 11, 2016 | Class II | Z-1541-2016 | Process control | The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery. |
The 5 latest of 15 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 6.5 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K090988 (Medacta International S.A., 2009) has gone furthest, with 52 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. 2007, this device’s year, is highlighted.
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 Primary Knee is intended as a cemented surface replacement in treating patients who are candidates for primary total knee adhroplasty or revision knee arthroplasy. 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 patel[ectomy; moderate varus, va[gus or flexure deformity and to correct earlier unsuccessful attempts at surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072858 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072858: TC-Plus Primary Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072858
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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