510(k) · Cleared
ClearedEVOLUTION Revision CCK System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microport Orthopedics, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Aug 8, 2017 as substantially equivalent to K093552 (Wrightmedicaltechnologyinc, 2010) and 2 other predicates after an 89-day review. Its family tree reaches back 4 generations to 2005. 3 later devices descend from it.
- Decided
- Aug 8, 2017
- Review
- 89 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K043083 (2005). 7 ancestors in all, the oldest K932677 (1994). 3 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK043083 Advance HA Coated Spiked Tibial Base and Advance HA Coated Modular…Wrightmedicaltechnologyinc · 2005
- 3 generations backK143366 ADVANCE Porous Coated Spiked Tibial BaseMicroport Orthopedics, Inc. · 2015
- 2 generations backK152298 EVOLUTION BIOFOAM Tibial Base, EVOLUTION Modular Keels, ADVANCE…Microport Orthopedics, Inc. · 2015
- 1 generation backK162026 EVOLUTION Revision Tibial Base, EVOLUTION Revision Tibial Block…Microport Orthopedics, Inc. · 2017
- This deviceK171389 EVOLUTION Revision CCK SystemMicroport Orthopedics, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK240043 EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW…Microport Orthopedics, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK213817 MPO Knee Instruments; MPO PROPHECY Knee InstrumentsMicroport Orthopedics, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK180317 EVOLUTION® Knee Systems – MR Labeling, EVOLUTION® BIOFOAM® Tibial…Microport Orthopedics, Inc. · 2018
Most influential descendants
Showing 3 of 3 · See all- K240043EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Femoral…Microport Orthopedics, Inc. · 2024 · cites it directly0descendants
- K213817MPO Knee Instruments; MPO PROPHECY Knee InstrumentsMicroport Orthopedics, Inc. · 2022 · cites it directly0descendants
- K180317EVOLUTION® Knee Systems – MR Labeling, EVOLUTION® BIOFOAM® Tibial System, EVOLUTION®…Microport Orthopedics, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K043083 | Advance HA Coated Spiked Tibial Base and Advance HA Coated Modular Keel | Wrightmedicaltechnologyinc | 2005 | — |
| −3 | K143366 | ADVANCE Porous Coated Spiked Tibial Base | Microport Orthopedics, Inc. | 2015 | — |
| −2 | K152298 | EVOLUTION BIOFOAM Tibial Base, EVOLUTION Modular Keels, ADVANCE Modular Keels… | Microport Orthopedics, Inc. | 2015 | — |
| −1 | K162026 | EVOLUTION Revision Tibial Base, EVOLUTION Revision Tibial Block Augment… | Microport Orthopedics, Inc. | 2017 | — |
| 0 (this device) | K171389 | EVOLUTION Revision CCK System | Microport Orthopedics, Inc. | 2017 | — |
| +1 | K240043 | EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal… | Microport Orthopedics, Inc. | 2024 | — |
| +1 | K213817 | MPO Knee Instruments; MPO PROPHECY Knee Instruments | Microport Orthopedics, Inc. | 2022 | — |
| +1 | K180317 | EVOLUTION® Knee Systems – MR Labeling, EVOLUTION® BIOFOAM® Tibial System… | Microport Orthopedics, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2022 | 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? (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 |
|---|---|---|---|
| * | K093552 | Evolution MP Total Knee SystemSummary page 4…d cemented prosthesis. Class II Subject Product Code Orthopedics/87/JWH and Panel Code: Predicate Device: K093552 EVOLUTION® MP Total Knee System K142550 EVOLUTION® MP Revision Femur… | 2010 |
| * | K142550 | EVOLUTION MP Revision Femur, EVOLUTION Femoral AugmentsSummary page 4…Product Code Orthopedics/87/JWH and Panel Code: Predicate Device: K093552 EVOLUTION® MP Total Knee System K142550 EVOLUTION® MP Revision Femur K162026 EVOLUTION® Revision Tibial System… | 2014 |
| * | K162026 | EVOLUTION Revision Tibial Base, EVOLUTION Revision Tibial Block Augment, EVOLUTION…Summary page 4…Device: K093552 EVOLUTION® MP Total Knee System K142550 EVOLUTION® MP Revision Femur K162026 EVOLUTION® Revision Tibial System K093552 EVOLUTION® MP Total Knee System MicroPort Orthope… | 2017 |
| † | K990030 | Advanced Revision Product Line Extension | 1999 |
| † | K063731 | Advance Stature Femoral Component | 2007 |
| † | K901992 | Whiteside Ortholoc Modular Post. Stab. Knee System | 1990 |
| † | K932677 | Axiom Total Knee System | 1994 |
| † | K863668 | Omnifit (TM) Total Knee Prosthesis System | 1986 |
| † | K871769 | Omnifit (R) Total Knee System (Modification) | 1987 |
| † | K892800 | MG II Porous Total Knee System | 1989 |
| † | K895639 | MG II Porous Total Knee System/Metal-Back Patellar | 1990 |
| † | K911572 | MG II Porous Cobal T-Chrome Femoral Component | 1991 |
| † | K930831 | MG II Porous Knee System Femoral Components | 1993 |
| † | K862837 | Omnifit Total Knee Prosthesis System | 1986 |
| † | K882322 | Continuum Knee System (CKS) | 1989 |
| † | K896542 | Addition to the Continuum Knee System (CKS (TM)) | 1990 |
| † | K901457 | Continuum Knee System (CKS) | 1990 |
| † | K914072 | Continuum Knee System (CKS) | 1992 |
| † | K953439 | Ultrack Total Knee System | 1996 |
| † | K972626 | Advance Knee System | 1997 |
| † | K973524 | Advance Modular Tibial Component | 1997 |
| † | K972770 | Advance Ultra-Congruent Tibial Insert | 1997 |
| † | K102380 | Evolution MP Total Knee System | 2011 |
| † | K152298 | EVOLUTION BIOFOAM Tibial Base, EVOLUTION Modular Keels, ADVANCE Modular Keels, ADVANCE… | 2015 |
| † | K063128 | Advance Spiked Porous Tibial Base | 2007 |
What descends from it? (3)
3 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)
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 12 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K240043 (Microport Orthopedics, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 14 other devices also cite its predicate K093552.
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. 2017, 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 EVOLUTION® Revision CCK System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:
1. Non-inflammatory degenerative joint disease: including osteoarthritis, traumatic arthritis, or avascular necrosis
2. Inflammatory degenerative joint disease, including rheumatoid arthritis;
3. Correction of functional deformity
4. Revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques,
The EVOLUTION® Medial-Pivot Total Knee System Nonporous implants are for cemented 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/K171389 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171389: EVOLUTION Revision CCK System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171389
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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