510(k) · Cleared
ClearedA3 Total Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beijing AK Medical Co., Ltd. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Jun 22, 2018 as substantially equivalent to K113550 (Biomet Manufacturing Corp, 2012) and 1 other predicate after a 116-day review. Its family tree reaches back 7 generations to 1981. 1 later device descends from it.
- Decided
- Jun 22, 2018
- Review
- 116 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K810258 (1981). 42 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 6 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 5 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 4 generations backK050327 E-Poly (Vitamin E) Acetabular LinersBiomet, Inc. · 2005
- 3 generations backK070364 100KGY E-Poly Maxrom Acetabular LinersBiomet, Inc. · 2007
- 2 generations backK080528 E-Poly Tibial BearingsBiomet Orthopedics, Inc. · 2008
- 1 generation backK113550 Vanguard Complete Knee SystemBiomet Manufacturing Corp · 2012 · Recalled
- This deviceK180493 A3 Total Knee SystemBeijing AK Medical Co., Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK230120 KeYi Total Knee SystemBeijing Keyi Medical Device Technology Co., Ltd. · 2024
Most influential descendants
Showing 1 of 1 · See all- K230120KeYi Total Knee SystemBeijing Keyi Medical Device Technology Co., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −6 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −5 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −4 | K050327 | E-Poly (Vitamin E) Acetabular Liners | Biomet, Inc. | 2005 | — |
| −3 | K070364 | 100KGY E-Poly Maxrom Acetabular Liners | Biomet, Inc. | 2007 | — |
| −2 | K080528 | E-Poly Tibial Bearings | Biomet Orthopedics, Inc. | 2008 | — |
| −1 | K113550 | Vanguard Complete Knee System | Biomet Manufacturing Corp | 2012 | 7 |
| 0 (this device) | K180493 | A3 Total Knee System | Beijing AK Medical Co., Ltd. | 2018 | — |
| +1 | K230120 | KeYi Total Knee System | Beijing Keyi Medical Device Technology Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 6 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 5 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 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 |
|---|---|---|---|
| * | K113550 | Vanguard Complete Knee SystemSummary page 4…joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Product Code JWH Regulatory Class II Predicate Devices Primary - K113550, Biomet Vanguard Complete Knee System Additional – K031729, Stryker Triatholon Posteriorly Stabilized (PS) Total Knee System ==… | 2012 |
| * | K031729 | Triathlon Posteriorly Stabilized (PS) Total Knee SystemSummary page 4…ined cemented prosthesis Product Code JWH Regulatory Class II Predicate Devices Primary - K113550, Biomet Vanguard Complete Knee System Additional – K031729, Stryker Triatholon Posteriorly Stabilized (PS) Total Knee System… | 2003 |
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 |
|---|---|---|---|
| K230120 | KeYi 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 37 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- 15 of the 42 ancestors have a recall of any class.
- Of its descendants, K230120 (Beijing Keyi Medical Device Technology Co., Ltd., 2024) has gone furthest, with 0 descendants of its own.
- 17 other devices also cite its predicate K113550.
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. 2018, 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?
Painful, disabling joint disease of the knee resulting from: non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis) or rheumatoid arthritis.
Correction of functional deformities.
Post-traumatic loss of knee joint configuration and function.
Moderate valgus, varus, or flexion deformity.
Knee fractures untreatable by other methods.
The A3 Total Knee System is indicated for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180493 · printed Nov 5, 2026
Cite this page
510(k) Report. “K180493: A3 Total 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/K180493
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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