510(k) · Cleared
ClearedUnity Total Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corin U.S.A. Limited · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Jun 4, 2019 as substantially equivalent to K113060 (Corin USA, 2012) and 1 other predicate after a 167-day review. Its family tree reaches back 3 generations to 2004. 1 later device descends from it.
- Decided
- Jun 4, 2019
- Review
- 167 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K040267 (2004). 19 ancestors in all, the oldest K915192 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK040267 Triathlon Cruciate Retaining (CR) Total KneeHowmedica Osteonics Corp. · 2004 · Recalled
- 2 generations backK042883 Size 1 Triathlon Cruciate Retaining (CR) Tibial InsertHowmedica Osteonics Corp. · 2004
- 1 generation backK063423 Triathlon CS (Condylar Stabilizing) Lipped InsertHowmedica Osteonics · 2007
- This deviceK183533 Unity Total Knee SystemCorin U.S.A. Limited · 2019
- Descendant · cites it directly · 0 of its ownK241570 Unity Total Knee SystemCorin U.S.A. Limited · 2024
Most influential descendants
Showing 1 of 1 · See all- K241570Unity Total Knee SystemCorin U.S.A. Limited · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K040267 | Triathlon Cruciate Retaining (CR) Total Knee | Howmedica Osteonics Corp. | 2004 | 1 |
| −2 | K042883 | Size 1 Triathlon Cruciate Retaining (CR) Tibial Insert | Howmedica Osteonics Corp. | 2004 | — |
| −1 | K063423 | Triathlon CS (Condylar Stabilizing) Lipped Insert | Howmedica Osteonics | 2007 | — |
| 0 (this device) | K183533 | Unity Total Knee System | Corin U.S.A. Limited | 2019 | — |
| +1 | K241570 | Unity Total Knee System | Corin U.S.A. Limited | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2005 | 3 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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? (2)
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 |
|---|---|---|---|
| * | K113060 | Unity Toatal Knee SystemSummary page 4…cemented prostheses (21CFR 888.3560) 8. Legally Marketed Devices to which Substantial Equivalence is claimed: x Corin Unity Total Knee System (K113060) x Stryker Triathlon® CS (Condylar Stabilizing) Lipped Insert (K063423) 9. Device Description: The Unity Knee™ is a fixed b… | 2012 |
| * | K063423 | Triathlon CS (Condylar Stabilizing) Lipped InsertSummary page 4…ed Devices to which Substantial Equivalence is claimed: x Corin Unity Total Knee System (K113060) x Stryker Triathlon® CS (Condylar Stabilizing) Lipped Insert (K063423) 9. Device Description: The Unity Knee™ is a fixed bearing total knee replacement system that consists of a Cobalt Chromium Allo… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241570 | Unity Total Knee System | 2024 | 0 |
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 15 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- 11 of the 19 ancestors have a recall of any class.
- Of its descendants, K241570 (Corin U.S.A. Limited, 2024) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K113060.
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. 2019, 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?
General total knee arthroplasty indications include: Painful, disabling joint disease of the knee resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis Post-traumatic loss of knee joint configuration and function Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function Revision of previous unsuccessful knee replacement or other procedure, where soft tissue…
Read the full statement (116 words)
General total knee arthroplasty indications include:
Painful, disabling joint disease of the knee resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis
Post-traumatic loss of knee joint configuration and function
Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function
Revision of previous unsuccessful knee replacement or other procedure, where soft tissue stability is adequate
Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture management techniques
The posterior stabilized variant is also indicated for PCL instability requiring implant bearing surface geometries with increased anterior-posterior constraint and absent or non-functioning posterior cruciate ligament
The Unity Knee™ is intended for cemented use, single use 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/K183533 · printed Nov 4, 2026
Cite this page
510(k) Report. “K183533: Unity Total 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/K183533
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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