510(k) · Cleared
ClearedThe Optimotion Blue Total Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Optimotion Implants, LLC · MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Cleared on Apr 7, 2020 as substantially equivalent to K160515 (Consensus Orthopedics, Inc., 2016) and 2 other predicates after a 349-day review. Its family tree reaches back 8 generations to 1995. 1 later device descends from it.
- Decided
- Apr 7, 2020
- Review
- 349 days
- Class
- Class II
- Product code
- MBH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K933785 (1995). 37 ancestors in all, the oldest K884796 (1989). 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK933785 Next Generation Knee SystemZimmer, Inc. · 1995 · Recalled
- 7 generations backK023211 Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral…Zimmer, Inc. · 2002 · Recalled
- 6 generations backK060370 Nexgen Knee Gender Solutions Female (GSF) Femoral ComponentsZimmer, Inc. · 2006 · Recalled
- 5 generations backK070214 Gender Solutions Natural-Knee Flex SystemZimmer, Inc. · 2007 · Recalled
- 4 generations backK073286 Gender Solutions Natural-Knee Flex SystemZimmer, Inc. · 2008 · Recalled
- 3 generations backK110950 Consensus Knee SystemConsensus Orthopedics, Inc. · 2011
- 2 generations backK133919 Consensus Vitalite Tibial InsertConsensus Orthopedics, Inc. · 2014
- 1 generation backK160515 PS2 Knee SystemConsensus Orthopedics, Inc. · 2016
- This deviceK191084 The Optimotion Blue Total Knee SystemOptimotion Implants, LLC · 2020
- Descendant · cites it directly · 0 of its ownK240938 The Optimotion™ Blue Plus Knee SystemOptimotion Implants, LLC · 2024
Most influential descendants
Showing 1 of 1 · See all- K240938The Optimotion™ Blue Plus Knee SystemOptimotion Implants, LLC · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K933785 | Next Generation Knee System | Zimmer, Inc. | 1995 | 83 |
| −7 | K023211 | Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Components | Zimmer, Inc. | 2002 | 6 |
| −6 | K060370 | Nexgen Knee Gender Solutions Female (GSF) Femoral Components | Zimmer, Inc. | 2006 | 17 |
| −5 | K070214 | Gender Solutions Natural-Knee Flex System | Zimmer, Inc. | 2007 | 63 |
| −4 | K073286 | Gender Solutions Natural-Knee Flex System | Zimmer, Inc. | 2008 | 5 |
| −3 | K110950 | Consensus Knee System | Consensus Orthopedics, Inc. | 2011 | — |
| −2 | K133919 | Consensus Vitalite Tibial Insert | Consensus Orthopedics, Inc. | 2014 | — |
| −1 | K160515 | PS2 Knee System | Consensus Orthopedics, Inc. | 2016 | — |
| 0 (this device) | K191084 | The Optimotion Blue Total Knee System | Optimotion Implants, LLC | 2020 | — |
| +1 | K240938 | The Optimotion™ Blue Plus Knee System | Optimotion Implants, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2003 | 5 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2007 | 2 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 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 MBH? 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 19.9 · 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? (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 |
|---|---|---|---|
| * | K160515 | PS2 Knee SystemSummary page 4…ntact Name: Title: Device Trade Name: Device Common Name: Classification Name: Classification Code: Classification Panel: Regulation Number: C1. PREDICATE DEVICES K160515 K123486 K051380 November 6, 2019 Optimotion Implants, LLC 3505 Lake Lynda Drive, Bldg 300, Suite #206 Orlando, Florida 32817… | 2016 |
| * | K123486 | Triathlon Tritanium Tibial BaseplateSummary page 4…me: Title: Device Trade Name: Device Common Name: Classification Name: Classification Code: Classification Panel: Regulation Number: C1. PREDICATE DEVICES K160515 K123486 K051380 November 6, 2019 Optimotion Implants, LLC 3505 Lake Lynda Drive, Bldg 300, Suite #206 Orlando, Florida 32817 Not regi… | 2013 |
| * | K051380 | Triathlon Press-Fit Total Knee SystemSummary page 4…e: Device Trade Name: Device Common Name: Classification Name: Classification Code: Classification Panel: Regulation Number: C1. PREDICATE DEVICES K160515 K123486 K051380 November 6, 2019 Optimotion Implants, LLC 3505 Lake Lynda Drive, Bldg 300, Suite #206 Orlando, Florida 32817 Not registered a… | 2005 |
| † | K113369 | Zimmer Persona Knee System | 2012 |
| † | K102927 | Consensus Knee System | 2011 |
| † | K131864 | U2 Tibial Baseplate- Cma Type, Tibial Insert and Augment | 2014 |
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 |
|---|---|---|---|
| K240938 | The Optimotion™ Blue Plus 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 25 years and passes through 3 companies; a new generation was cleared every 3.3 years on median.
- 23 of the 37 ancestors have a recall of any class.
- Of its descendants, K240938 (Optimotion Implants, LLC, 2024) has gone furthest, with 0 descendants of its own.
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. 2020, 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?
Painful, disabling joint disease of the knee resulting from; noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis. Post-traumatic loss of knee joint configurations and function. Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. Revision of previous unsuccessful…
Read the full statement (121 words)
Painful, disabling joint disease of the knee resulting from; noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis.
Post-traumatic loss of knee joint configurations and function.
Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
Revision of previous unsuccessful knee replacement or other procedure.
Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture-management techniques.
Optimotion™ Blue Porous Tibial Baseplate components are indicated for Cemented or Cementless use. The Optimotion™ Blue Porous CR Femoral components are indicated for Cemented or Cementless use. The Optimotion™ Blue CEMENTED CR Femoral and CEMENTED Tibial Baseplate components are indicated 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/K191084 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191084: The Optimotion Blue 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/K191084
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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