510(k) · Cleared
Recalled · 2006UC-Plus Solution Unicondylar Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Plus Orthopedics · HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Cleared on Jul 30, 1999 as substantially equivalent to K954481 (Johnson & Johnson Professionals, Inc., 1996) after a 351-day review. Its family tree reaches back 1 generation to 1996. 25 later devices descend from it. It has been recalled once.
- Decided
- Jul 30, 1999
- Review
- 351 days
- Class
- Class II
- Product code
- HRY
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K954481 (1996). 25 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK954481 P.F.C. Uni-Compartmental Knee SystemJohnson & Johnson Professionals, Inc. · 1996
- This deviceK982859 UC-Plus Solution Unicondylar Knee SystemPlus Orthopedics · 1999
- Descendant · cites it directly · 20 of its ownK033810 Natural-Knee II Unicompartmental Knee SystemCenterpulse Orthopedics, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 19 of its ownK133811 Restoris Porous Partial Knee SystemMako Surgical Corp. · 2014
- Descendant · 3 generations on · 8 of its ownK163700 Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc. · 2017
- Descendant · 4 generations on · 7 of its ownK181302 Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc. · 2019
- Descendant · 3 generations on · 5 of its ownK190439 Engage™ Partial Knee SystemEngage Uni, LLC · 2019 · Recalled
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K033810Natural-Knee II Unicompartmental Knee SystemCenterpulse Orthopedics, Inc. · 2004 · cites it directly20descendants
- K133811Restoris Porous Partial Knee SystemMako Surgical Corp. · 2014 · 2 generations on19descendants
- K163700Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc. · 2017 · 3 generations on8descendants
- K181302Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc. · 2019 · 4 generations on7descendants
- K190439Engage™ Partial Knee SystemEngage Uni, LLC · 2019 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954481 | P.F.C. Uni-Compartmental Knee System | Johnson & Johnson Professionals, Inc. | 1996 | — |
| 0 (this device) | K982859 | UC-Plus Solution Unicondylar Knee System | Plus Orthopedics | 1999 | — |
| +1 | K033810 | Natural-Knee II Unicompartmental Knee System | Centerpulse Orthopedics, Inc. | 2004 | 1 |
| +2 | K133811 | Restoris Porous Partial Knee System | Mako Surgical Corp. | 2014 | — |
| +3 | K163700 | Bodycad Unicompartmental Knee System | Bodycad Laboratories, Inc. | 2017 | — |
| +4 | K181302 | Bodycad Unicompartmental Knee System | Bodycad Laboratories, Inc. | 2019 | — |
| +3 | K190439 | Engage™ Partial Knee System | Engage Uni, LLC | 2019 | 4 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 5 | 0 |
| 2021 | 4 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 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 HRY? 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 HRY device
- #1 K193549 SIGMA High Performance (HP) Partial Knee Systemscore 0.4 · 5 generations · no Class I recall
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 |
|---|---|---|---|
| * | K954481 | P.F.C. Uni-Compartmental Knee SystemSummary page 1…is Knee Joint Femorotibial Metal/Polymer Semi-Constrained Cemented Prosthesis {21 CFR 888.3530, 87HRY) P.F.C. Sigma Uni-Compartmental Knee System (Johnson & Johnson), K954481, SE date 10/10/96 The UC-PLUS Solution Unicondylar Knee System consists of a femoral component and a tibial component. The femor… | 1996 |
What descends from it? (25)
See all 253 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 18, 2006 | Not classified | Z-0191-2007 | Other | There exists the possibility that incomplete bony support or insufficient cementing of the implanted device can result in fatigue fracture of the UC-PLUS Solution Femoral Component. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All HRY devicesHRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HRY
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · HRY
138in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRY
3in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRY
290in 2025
MAUDE reports naming product code HRY, 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 | 3 | 92 | 1 | 263 |
| 2008 | 3 | 138 | 1 | 285 |
| 2009 | 0 | — | 0 | 249 |
| 2010 | 1 | — | 0 | 180 |
| 2011 | 1 | — | 1 | 155 |
| 2012 | 1 | — | 0 | 137 |
| 2013 | 1 | — | 1 | 383 |
| 2014 | 1 | — | 0 | 305 |
| 2015 | 1 | — | 0 | 345 |
| 2016 | 1 | — | 1 | 343 |
| 2017 | 0 | — | 0 | 402 |
| 2018 | 0 | — | 0 | 613 |
| 2019 | 1 | — | 0 | 367 |
| 2020 | 1 | — | 1 | 1,054 |
| 2021 | 0 | — | 1 | 1,218 |
| 2022 | 0 | — | 3 | 840 |
| 2023 | 0 | — | 0 | 396 |
| 2024 | 0 | — | 0 | 430 |
| 2025 | 0 | — | 0 | 290 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The UC-PLUS Solution Unicondylar Knee System is intended for use in
unicompartmental degenerative arthritis, local osteonecrosis of the femoral condyle,
light to medium unicompartmental destruction of the knee joint due to idiopathic and
post-traumatic degenerative arthritis, traumatic unicompartmental bone and/or
cartilage lesions. For use with bone cement only.
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/K982859 · printed Nov 5, 2026
Cite this page
510(k) Report. “K982859: UC-Plus Solution Unicondylar Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K982859
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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