510(k) · Cleared
ClearedThe Optimotion™ Blue Plus 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 Jun 27, 2024 as substantially equivalent to K141056 (Stryker Orthopaedics, 2014) and 1 other predicate after an 83-day review. Its family tree reaches back 9 generations to 1995.
- Decided
- Jun 27, 2024
- Review
- 83 days
- Class
- Class II
- Product code
- MBH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K933785 (1995). 55 ancestors in all, the oldest K884796 (1989). No later device cites it as a predicate yet.
- Root · 9 generations backK933785 Next Generation Knee SystemZimmer, Inc. · 1995 · Recalled
- 5 generations between
- 3 generations backK133919 Consensus Vitalite Tibial InsertConsensus Orthopedics, Inc. · 2014
- 2 generations backK160515 PS2 Knee SystemConsensus Orthopedics, Inc. · 2016
- 1 generation backK191084 The Optimotion Blue Total Knee SystemOptimotion Implants, LLC · 2020
- This deviceK240938 The Optimotion™ Blue Plus Knee SystemOptimotion Implants, LLC · 2024
Show all 9 generations
- Root · 9 generations backK933785 Next Generation Knee SystemZimmer, Inc. · 1995 · Recalled
- 8 generations backK023211 Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral…Zimmer, Inc. · 2002 · Recalled
- 7 generations backK060370 Nexgen Knee Gender Solutions Female (GSF) Femoral ComponentsZimmer, Inc. · 2006 · Recalled
- 6 generations backK070214 Gender Solutions Natural-Knee Flex SystemZimmer, Inc. · 2007 · Recalled
- 5 generations backK073286 Gender Solutions Natural-Knee Flex SystemZimmer, Inc. · 2008 · Recalled
- 4 generations backK110950 Consensus Knee SystemConsensus Orthopedics, Inc. · 2011
- 3 generations backK133919 Consensus Vitalite Tibial InsertConsensus Orthopedics, Inc. · 2014
- 2 generations backK160515 PS2 Knee SystemConsensus Orthopedics, Inc. · 2016
- 1 generation backK191084 The Optimotion Blue Total Knee SystemOptimotion Implants, LLC · 2020
- This deviceK240938 The Optimotion™ Blue Plus Knee SystemOptimotion Implants, LLC · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K933785 | Next Generation Knee System | Zimmer, Inc. | 1995 | 83 |
| −8 | K023211 | Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Components | Zimmer, Inc. | 2002 | 6 |
| −7 | K060370 | Nexgen Knee Gender Solutions Female (GSF) Femoral Components | Zimmer, Inc. | 2006 | 17 |
| −6 | K070214 | Gender Solutions Natural-Knee Flex System | Zimmer, Inc. | 2007 | 63 |
| −5 | K073286 | Gender Solutions Natural-Knee Flex System | Zimmer, Inc. | 2008 | 5 |
| −4 | K110950 | Consensus Knee System | Consensus Orthopedics, Inc. | 2011 | — |
| −3 | K133919 | Consensus Vitalite Tibial Insert | Consensus Orthopedics, Inc. | 2014 | — |
| −2 | K160515 | PS2 Knee System | Consensus Orthopedics, Inc. | 2016 | — |
| −1 | K191084 | The Optimotion Blue Total Knee System | Optimotion Implants, LLC | 2020 | — |
| 0 (this device) | 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 | 5 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 6 | 0 |
| 2004 | 2 | 0 |
| 2005 | 5 | 0 |
| 2006 | 3 | 0 |
| 2007 | 5 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 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? (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 |
|---|---|---|---|
| * | K141056 | Triathlon Knee System Posterior Stabilized ComponentsSummary page 4…Porous-Coated Uncemented Prosthesis Regulation Number: 21 CFR section 888.3565 Product Codes: MBH, JWH, OIY PREDICATE DEVICE K141056 Stryker Triathlon Knee System; Product Code MBH, JWH DEVICE DESCRIPTION SUMMARY The Optimotion™ Blu… | 2014 |
| * | K191084 | The Optimotion Blue Total Knee SystemSummary page 4…on Knee System; Product Code MBH, JWH DEVICE DESCRIPTION SUMMARY The Optimotion™ Blue Plus Knee System is a line addition to the Optimotion™ Blue Total Knee System (K191084) consisting of a posterior stabilizing (PS) femoral and PS tibial insert components. The femoral component is composed of CoCrMo… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
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 29 years and passes through 3 companies; a new generation was cleared every 3.3 years on median.
- 30 of the 55 ancestors have a recall of any class.
- 12 other devices also cite its predicate K141056.
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. 2024, 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…
Read the full statement (152 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.
• Ligamentous instability requiring implant bearing surface geometries with increased constraint.
• Absent or non-functioning posterior cruciate ligament.
• Severe anteroposterior instability of the knee joint
• Optimotion™ Blue Plus Knee System and Optimotion™ Blue Total Knee System non-porous implant components are indicated for cemented use only.
• Optimotion™ Blue Plus Knee System and Optimotion™ Blue Total Knee System porous coated implant components are indicated for cemented or uncemented use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240938 · printed Nov 5, 2026
Cite this page
510(k) Report. “K240938: The Optimotion™ Blue Plus 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/K240938
Report an extraction error
Are you the manufacturer?
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