510(k) · Cleared
ClearedMPO Knee Instruments; MPO PROPHECY Knee Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microport Orthopedics, Inc. · MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Cleared on Jan 5, 2022 as substantially equivalent to K140735 (Microport Orthopedics, Inc., 2014) and 8 other predicates after a 29-day review. Its family tree reaches back 5 generations to 2004. 1 of the 23 devices in its family, counting itself, has a Class I recall.
- Decided
- Jan 5, 2022
- Review
- 29 days
- Class
- Class II
- Product code
- MBH
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 5 generations to K033890 (2004). 22 ancestors in all, the oldest K894334 (1989). No later device cites it as a predicate yet. 1 of the 23 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK033890 Advance Double High InsertWrightmedicaltechnologyinc · 2004
- 4 generations backK102380 Evolution MP Total Knee SystemWrightmedicaltechnologyinc · 2011 · Recalled
- 3 generations backK113325 Evolution MP Adaptive CS InsertWrightmedicaltechnologyinc · 2011
- 2 generations backK131679 Evolution MP Adaptive PS Tibial InsertWrightmedicaltechnologyinc · 2013
- 1 generation backK140735 Evolution MP CS/CR Porous Femur/Evolution Adaptive CS and PS InsertsMicroport Orthopedics, Inc. · 2014 · Recalled
- This deviceK213817 MPO Knee Instruments; MPO PROPHECY Knee InstrumentsMicroport Orthopedics, Inc. · 2022
Class I recalls in this family
- K061223 Advance Total Knee System2 generations back · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K033890 | Advance Double High Insert | Wrightmedicaltechnologyinc | 2004 | — |
| −4 | K102380 | Evolution MP Total Knee System | Wrightmedicaltechnologyinc | 2011 | 4 |
| −3 | K113325 | Evolution MP Adaptive CS Insert | Wrightmedicaltechnologyinc | 2011 | — |
| −2 | K131679 | Evolution MP Adaptive PS Tibial Insert | Wrightmedicaltechnologyinc | 2013 | — |
| −1 | K140735 | Evolution MP CS/CR Porous Femur/Evolution Adaptive CS and PS Inserts | Microport Orthopedics, Inc. | 2014 | 1 |
| 0 (this device) | K213817 | MPO Knee Instruments; MPO PROPHECY Knee Instruments | Microport Orthopedics, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 1 |
| 2007 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 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.
1 device in this family has a Class I recall. 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 MBH device
- #1 K241597 Freedom® Total Knee System - Porous Tibial…score 20.0 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (9)
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 |
|---|---|---|---|
| * | K140735 | Evolution MP CS/CR Porous Femur/Evolution Adaptive CS and PS InsertsSummary page 5…Class II Subject Product Code and Orthopedics/87/ MBH, JWH, OOG Panel Code: Predicate Devices: EVOLUTION® MP CS/CR Porous Femur (K140735) EVOLUTION® Adaptive CS and PS Inserts (K140735) EVOLUTION® MP… | 2014 |
| * | K142550 | EVOLUTION MP Revision Femur, EVOLUTION Femoral AugmentsSummary page 5…Femur (K140735) EVOLUTION® Adaptive CS and PS Inserts (K140735) EVOLUTION® MP Revision Femoral System (K142550) ADVANCE® Porous Coated Spiked Tibial Base (K143366) EVOLUTION®… | 2014 |
| * | K143366 | ADVANCE Porous Coated Spiked Tibial BaseSummary page 5…ts (K140735) EVOLUTION® MP Revision Femoral System (K142550) ADVANCE® Porous Coated Spiked Tibial Base (K143366) EVOLUTION® BIOFOAM® Tibial System (K152298) ADVANCE® BIOFOAM®… | 2015 |
| * | K152298 | EVOLUTION BIOFOAM Tibial Base, EVOLUTION Modular Keels, ADVANCE Modular Keels, ADVANCE…Summary page 5…System (K142550) ADVANCE® Porous Coated Spiked Tibial Base (K143366) EVOLUTION® BIOFOAM® Tibial System (K152298) ADVANCE® BIOFOAM® Tibia (K152298) EVOLUTION® Revision Tibial S… | 2015 |
| * | K162026 | EVOLUTION Revision Tibial Base, EVOLUTION Revision Tibial Block Augment, EVOLUTION…Summary page 5…® BIOFOAM® Tibial System (K152298) ADVANCE® BIOFOAM® Tibia (K152298) EVOLUTION® Revision Tibial System (K162026) EVOLUTION® Revision CCK System (K171389) EVOLUTION® Stemmed CS… | 2017 |
| * | K171389 | EVOLUTION Revision CCK SystemSummary page 5…E® BIOFOAM® Tibia (K152298) EVOLUTION® Revision Tibial System (K162026) EVOLUTION® Revision CCK System (K171389) EVOLUTION® Stemmed CS Femur (K182125) PROPHECY® ADVANCE® Navig… | 2017 |
| * | K182125 | EVOLUTION Stemmed CS FemurSummary page 5…Revision Tibial System (K162026) EVOLUTION® Revision CCK System (K171389) EVOLUTION® Stemmed CS Femur (K182125) PROPHECY® ADVANCE® Navigation Guides (K093405) PROPHECY® EVOLU… | 2018 |
| * | K093405 | Prophecy Pre-Operative Navigation Alignment GuidesSummary page 5…vision CCK System (K171389) EVOLUTION® Stemmed CS Femur (K182125) PROPHECY® ADVANCE® Navigation Guides (K093405) PROPHECY® EVOLUTION® Navigation Guides (K103598)… | 2010 |
| * | K103598 | Prophecy Pre-Operative Navigation Alignment GuidesSummary page 5…Femur (K182125) PROPHECY® ADVANCE® Navigation Guides (K093405) PROPHECY® EVOLUTION® Navigation Guides (K103598) K213817 - Page 2 of 3 DEVICE… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K061223Advance Total Knee SystemWrightmedicaltechnologyinc · 2006 · 2 generations back · ◆ in the 2006 ancestors bar of FIG. 111 Class I recalls
What does this lineage say?
- The line of descent spans 18 years and passes through 2 companies; a new generation was cleared every 1.9 years on median.
- 5 of the 22 ancestors have a recall of any class; 1 has a Class I recall.
- 3 other devices also cite its predicate K140735.
How does its category compare?
All MBH devicesMBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · MBH
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBH
98in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBH
1in 2024
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · MBH
1,561in 2025
MAUDE reports naming product code MBH, 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 | 10 | 59 | 0 | 27 |
| 2008 | 3 | 70 | 0 | 21 |
| 2009 | 3 | 209 | 2 | 89 |
| 2010 | 4 | 84 | 0 | 121 |
| 2011 | 5 | 84 | 15 | 247 |
| 2012 | 5 | 90 | 1 (1) | 370 |
| 2013 | 6 | 138 | 4 (4) | 308 |
| 2014 | 9 | 114 | 0 | 385 |
| 2015 | 8 | 100 | 0 | 955 |
| 2016 | 4 | 74 | 1 | 1,034 |
| 2017 | 4 | 115 | 9 | 1,007 |
| 2018 | 6 | 89 | 1 | 1,191 |
| 2019 | 1 | — | 1 | 1,394 |
| 2020 | 7 | 112 | 2 | 1,089 |
| 2021 | 6 | 48 | 0 | 1,539 |
| 2022 | 7 | 57 | 0 | 1,261 |
| 2023 | 6 | 94 | 2 | 1,263 |
| 2024 | 10 | 84 | 1 | 1,497 |
| 2025 | 8 | 98 | 0 | 1,561 |
| 2026 | 7 | 153 | 4 | — |
What is it indicated for?
MicroPort knee instruments are accessory devices and are intended to be used to assist in the implantation of MicroPort Total Knee Systems in their cleared Indications for Use as provided below: MicroPort Total Knee Systems are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2)…
Read the full statement (219 words)
MicroPort knee instruments are accessory devices and are intended to be used to assist in the implantation of MicroPort Total Knee Systems in their cleared Indications for Use as provided below:
MicroPort Total Knee Systems are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:
1) noninflammatory 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.
Non-porous MicroPort total knee replacement implants are for cemented use only.
Porous coated MicroPort total knee replacement implants, including ADVANCE® BIOFOAM@ Tibial System and EVOLUTION® BIOFOAM@ Tibial System implants, are for use without bone cement.
MicroPort's PROPHECY® Pre-Operative Navigation Alignment Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking of bone before cutting. The PROPHECY® Pre-Operative Navigation Alignment Guides are intended for use with MicroPort's ADVANCE® and EVOLUTION® Total Knee Systems and their cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. The PROPHECY® Pre-Operative Navigation Alignment Guides are intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213817 · printed Nov 4, 2026
Cite this page
510(k) Report. “K213817: MPO Knee Instruments; MPO PROPHECY Knee Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K213817
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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