510(k) · Cleared
ClearedOMNI TiN Coated Apex Knee™ System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Omni Life Science, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Sep 25, 2019 as substantially equivalent to K163332 (Omnilife Science, 2017) and 8 other predicates after an 86-day review. Its family tree reaches back 9 generations to 1998. 2 later devices descend from it.
- Decided
- Sep 25, 2019
- Review
- 86 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 9 generations to K982302 (1998). 146 ancestors in all, the oldest K810520 (1981). 2 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK982302 Implex Continuum Knee - Hedrocel Tibial SpacersImplex Corp. · 1998
- 5 generations between
- 3 generations backK131472 Apex Knee Modular Tibia SystemOmni Life Science, Inc. · 2013
- 2 generations backK153437 Apex Revision Knee SystemOmnilife Science · 2015 · Recalled
- 1 generation backK163332 Apex Revision Knee SystemOmnilife Science · 2017
- This deviceK191765 OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK252044 Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025
- Descendant · cites it directly · 0 of its ownK201611 Apex Knee SystemOmnilife Science · 2021
Show all 9 generations
- Root · 9 generations backK982302 Implex Continuum Knee - Hedrocel Tibial SpacersImplex Corp. · 1998
- 8 generations backK024161 Nexgen Complete Knee Solution - Trabecular Metal AugmentsImplex Corp. · 2003 · Recalled
- 7 generations backK040487 Trabecular Metal Knee System AugmentsImplex Corp. · 2004 · Recalled
- 6 generations backK053505 Regenerex Ultra Porous Construct-Femoral and Tibial Knee AugmentsBiomet Manufacturing, Inc. · 2006
- 5 generations backK080361 Regenerex Tibial ComponentsBiomet, Inc. · 2008 · Recalled
- 4 generations backK101994 Apex Knee Modular Tibia SystemOmnlife Science · 2010 · Recalled
- 3 generations backK131472 Apex Knee Modular Tibia SystemOmni Life Science, Inc. · 2013
- 2 generations backK153437 Apex Revision Knee SystemOmnilife Science · 2015 · Recalled
- 1 generation backK163332 Apex Revision Knee SystemOmnilife Science · 2017
- This deviceK191765 OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc. · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K982302 | Implex Continuum Knee - Hedrocel Tibial Spacers | Implex Corp. | 1998 | — |
| −8 | K024161 | Nexgen Complete Knee Solution - Trabecular Metal Augments | Implex Corp. | 2003 | 2 |
| −7 | K040487 | Trabecular Metal Knee System Augments | Implex Corp. | 2004 | 1 |
| −6 | K053505 | Regenerex Ultra Porous Construct-Femoral and Tibial Knee Augments | Biomet Manufacturing, Inc. | 2006 | — |
| −5 | K080361 | Regenerex Tibial Components | Biomet, Inc. | 2008 | 1 |
| −4 | K101994 | Apex Knee Modular Tibia System | Omnlife Science | 2010 | 1 |
| −3 | K131472 | Apex Knee Modular Tibia System | Omni Life Science, Inc. | 2013 | — |
| −2 | K153437 | Apex Revision Knee System | Omnilife Science | 2015 | 1 |
| −1 | K163332 | Apex Revision Knee System | Omnilife Science | 2017 | — |
| 0 (this device) | K191765 | OMNI TiN Coated Apex Knee™ System | Omni Life Science, Inc. | 2019 | — |
| +1 | K252044 | Triathlon® Total Knee System - Triathlon® Gold Femoral Components | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2025 | — |
| +1 | K201611 | Apex Knee System | Omnilife Science | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 2 | 0 |
| 1991 | 4 | 0 |
| 1992 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 9 | 0 |
| 1995 | 10 | 0 |
| 1996 | 13 | 0 |
| 1997 | 6 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 8 | 0 |
| 2001 | 6 | 0 |
| 2002 | 11 | 0 |
| 2003 | 13 | 0 |
| 2004 | 4 | 0 |
| 2005 | 5 | 0 |
| 2006 | 5 | 0 |
| 2007 | 7 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 5 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2025 | 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? (10)
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 |
|---|---|---|---|
| * | K163332 | Apex Revision Knee SystemSummary page 5…K191765 - Page 2 of 2 4. Predicate Devices: Primary Predicate: OMNI life science™ - Apex Revision Knee System, K163332 Additional Predicate: Consensus Orthopedics – CKS Plus Knee System, K163167, K110950 Additional Predicate: DJO Sur… | 2017 |
| * | K163167 | CKS Plus Knee SystemSummary page 5…ices: Primary Predicate: OMNI life science™ - Apex Revision Knee System, K163332 Additional Predicate: Consensus Orthopedics – CKS Plus Knee System, K163167, K110950 Additional Predicate: DJO Surgical - Foundation Knee -Armor Coat- System, K122239, K020114 Additional Pre… | 2017 |
| * | K110950 | Consensus Knee SystemSummary page 5…Primary Predicate: OMNI life science™ - Apex Revision Knee System, K163332 Additional Predicate: Consensus Orthopedics – CKS Plus Knee System, K163167, K110950 Additional Predicate: DJO Surgical - Foundation Knee -Armor Coat- System, K122239, K020114 Additional Predicate: A… | 2011 |
| * | K122239 | Foundation Knee System with Tinbn Coating Foundation PS Knee System with Tinbn Coating…Summary page 5…tional Predicate: Consensus Orthopedics – CKS Plus Knee System, K163167, K110950 Additional Predicate: DJO Surgical - Foundation Knee -Armor Coat- System, K122239, K020114 Additional Predicate: Aesculap Implant Systems - VEGA, Columbus, Additional Predicate: EnduRo Knee -Advanced S… | 2013 |
| * | K020114 | 3D KNEESummary page 5…edicate: Consensus Orthopedics – CKS Plus Knee System, K163167, K110950 Additional Predicate: DJO Surgical - Foundation Knee -Armor Coat- System, K122239, K020114 Additional Predicate: Aesculap Implant Systems - VEGA, Columbus, Additional Predicate: EnduRo Knee -Advanced Surface Te… | 2002 |
| * | K143443 | VEGA Knee System, Columbus Total Knee SystemSummary page 5…22239, K020114 Additional Predicate: Aesculap Implant Systems - VEGA, Columbus, Additional Predicate: EnduRo Knee -Advanced Surface Technology- System(s), K143443, K143106, K120955, K101815 5. Comparable Features to the Predicate Device(s): Features comparable to the Predicate Devices incl… | 2015 |
| * | K143106 | VEGA Knee SystemSummary page 5…20114 Additional Predicate: Aesculap Implant Systems - VEGA, Columbus, Additional Predicate: EnduRo Knee -Advanced Surface Technology- System(s), K143443, K143106, K120955, K101815 5. Comparable Features to the Predicate Device(s): Features comparable to the Predicate Devices include: indi… | 2014 |
| * | K120955 | Columbus Total Knee System as Columbus Revision Knee System Enduro Knee SystemSummary page 5…Additional Predicate: Aesculap Implant Systems - VEGA, Columbus, Additional Predicate: EnduRo Knee -Advanced Surface Technology- System(s), K143443, K143106, K120955, K101815 5. Comparable Features to the Predicate Device(s): Features comparable to the Predicate Devices include: indications f… | 2012 |
| * | K101815 | Enduro Knee SystemSummary page 5…nal Predicate: Aesculap Implant Systems - VEGA, Columbus, Additional Predicate: EnduRo Knee -Advanced Surface Technology- System(s), K143443, K143106, K120955, K101815 5. Comparable Features to the Predicate Device(s): Features comparable to the Predicate Devices include: indications for cement… | 2010 |
| * | — | Aesculap Implant Systems - VEGA, Columbus Named without a submission number |
What descends from it? (2)
2 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 21 years and passes through 6 companies; a new generation was cleared every 2.2 years on median.
- 67 of the 146 ancestors have a recall of any class.
- Of its descendants, K252044 (Howmedica Osteonics Corp., Dba Stryker Orthopaedics, 2025) has gone furthest, with 0 descendants of its own.
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. 2019, 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 OMNI TiN Coated Apex Knee™ System is intended for use as a primary or revision total knee replacement. This knee replacement system is intended for cemented single use implantation. This prosthesis may be used for the following conditions, as appropriate: • Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; • Rheumatoid arthritis; • Correction of functional deformity; • Revision procedures where other…
Read the full statement (121 words)
The OMNI TiN Coated Apex Knee™ System is intended for use as a primary or revision total knee replacement. This knee replacement system is intended for cemented single use implantation. This prosthesis may be used for the following conditions, as appropriate:
• Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
• Rheumatoid arthritis;
• Correction of functional deformity;
• Revision procedures where other treatments or devices have failed;
The Apex Knee™ Modular Tibia System Tibial Augments with TiN coating are intended to be bolted to the TiN coated Tibia Baseplate and cemented to the prepared tibia. The Apex Knee Revision Femur System Augments are intended to be bolted to the TiN coated femoral component and cemented to the prepared femur.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191765 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191765: OMNI TiN Coated Apex 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/K191765
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