510(k) · Cleared
Recalled · Class II · 2014Symmetric Total Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Signal Medical Corporation · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Jul 3, 2008 as substantially equivalent to K051510 (Signal Medical Corp., 2006) and 1 other predicate after a 160-day review. Its family tree reaches back 1 generation to 1995. 2 later devices descend from it. It has been recalled once.
- Decided
- Jul 3, 2008
- Review
- 160 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K933958 (1995). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK933958 Richards Total Knee SystemSmith & Nephew Richards, Inc. · 1995
- This deviceK080199 Symmetric Total Knee SystemSignal Medical Corporation · 2008
- Descendant · cites it directly · 0 of its ownK242412 Agility Symmetric™ Total Knee SystemMedisurge, LLC · 2024
- Descendant · cites it directly · 0 of its ownK203779 Symmetric Total Knee SystemSignal Medical Corporation · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K933958 | Richards Total Knee System | Smith & Nephew Richards, Inc. | 1995 | — |
| 0 (this device) | K080199 | Symmetric Total Knee System | Signal Medical Corporation | 2008 | — |
| +1 | K242412 | Agility Symmetric™ Total Knee System | Medisurge, LLC | 2024 | — |
| +1 | K203779 | Symmetric Total Knee System | Signal Medical Corporation | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K051510 | Signal Medical Corporation Beacon Knee SystemSummary page 1…lofemorotibial, semi-constrained, cemented, metal/polymer (888.3560 - JWH) Class II JWH Orthopedic 21 CFR 888.3560 Beacon Cemented and Uncemented Total Knee System (K051510), Profix Total Knee System (K933958) Similarities to these components are based on design, indications for use, and materials. 3… | 2006 |
| * | K933958 | Richards Total Knee SystemSummary page 1…mented, metal/polymer (888.3560 - JWH) Class II JWH Orthopedic 21 CFR 888.3560 Beacon Cemented and Uncemented Total Knee System (K051510), Profix Total Knee System (K933958) Similarities to these components are based on design, indications for use, and materials. 3/4/11 Sec 5: Page 1 of 4 === Page 2… | 1995 |
What descends from it? (2)
2 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 |
|---|---|---|---|---|
| Sep 30, 2014 | Class II | Z-0111-2015 | Packaging | Packaging of a device was compromised |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- Of its descendants, K242412 (Medisurge, LLC, 2024) has gone furthest, with 0 descendants of its own.
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. 2008, 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 Symmetric™ Total Knee System consist of single use components intended
for total knee arthroplasty with the following indications.
Osteoarthritis (for cemented use only)
Rheumatoid Arthritis (for cemented use only)
Traumatic Arthritis (for cemented use only)
Where the use of a more conservative procedure has failed or is unacceptable.
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/K080199 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080199: Symmetric Total Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080199
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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