510(k) · Cleared
ClearedApex Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Omnilife Science · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Apr 2, 2021 as substantially equivalent to K191765 (Omni Life Science, Inc., 2019) and 4 other predicates after a 291-day review. Its family tree reaches back 10 generations to 1998.
- Decided
- Apr 2, 2021
- Review
- 291 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 10 generations to K982302 (1998). 148 ancestors in all, the oldest K810520 (1981). No later device cites it as a predicate yet.
- Root · 10 generations backK982302 Implex Continuum Knee - Hedrocel Tibial SpacersImplex Corp. · 1998
- 6 generations between
- 3 generations backK153437 Apex Revision Knee SystemOmnilife Science · 2015 · Recalled
- 2 generations backK163332 Apex Revision Knee SystemOmnilife Science · 2017
- 1 generation backK191765 OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc. · 2019
- This deviceK201611 Apex Knee SystemOmnilife Science · 2021
Show all 10 generations
- Root · 10 generations backK982302 Implex Continuum Knee - Hedrocel Tibial SpacersImplex Corp. · 1998
- 9 generations backK024161 Nexgen Complete Knee Solution - Trabecular Metal AugmentsImplex Corp. · 2003 · Recalled
- 8 generations backK040487 Trabecular Metal Knee System AugmentsImplex Corp. · 2004 · Recalled
- 7 generations backK053505 Regenerex Ultra Porous Construct-Femoral and Tibial Knee AugmentsBiomet Manufacturing, Inc. · 2006
- 6 generations backK080361 Regenerex Tibial ComponentsBiomet, Inc. · 2008 · Recalled
- 5 generations backK101994 Apex Knee Modular Tibia SystemOmnlife Science · 2010 · Recalled
- 4 generations backK131472 Apex Knee Modular Tibia SystemOmni Life Science, Inc. · 2013
- 3 generations backK153437 Apex Revision Knee SystemOmnilife Science · 2015 · Recalled
- 2 generations backK163332 Apex Revision Knee SystemOmnilife Science · 2017
- 1 generation backK191765 OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc. · 2019
- This deviceK201611 Apex Knee SystemOmnilife Science · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K982302 | Implex Continuum Knee - Hedrocel Tibial Spacers | Implex Corp. | 1998 | — |
| −9 | K024161 | Nexgen Complete Knee Solution - Trabecular Metal Augments | Implex Corp. | 2003 | 2 |
| −8 | K040487 | Trabecular Metal Knee System Augments | Implex Corp. | 2004 | 1 |
| −7 | K053505 | Regenerex Ultra Porous Construct-Femoral and Tibial Knee Augments | Biomet Manufacturing, Inc. | 2006 | — |
| −6 | K080361 | Regenerex Tibial Components | Biomet, Inc. | 2008 | 1 |
| −5 | K101994 | Apex Knee Modular Tibia System | Omnlife Science | 2010 | 1 |
| −4 | K131472 | Apex Knee Modular Tibia System | Omni Life Science, Inc. | 2013 | — |
| −3 | K153437 | Apex Revision Knee System | Omnilife Science | 2015 | 1 |
| −2 | K163332 | Apex Revision Knee System | Omnilife Science | 2017 | — |
| −1 | K191765 | OMNI TiN Coated Apex Knee™ System | Omni Life Science, Inc. | 2019 | — |
| 0 (this device) | 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 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2017 | 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? (5)
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 |
|---|---|---|---|
| * | K191765 | OMNI TiN Coated Apex Knee™ SystemSummary page 4…l metal/polymer porous-coated uncemented prosthesis. MBH Predicate Device OMNI TiN Coated Apex Knee™ System- K191765 14/715 K201611 page 2 of 4 Purpose of Sub… | 2019 |
| * | K060192 | Apex Knee SystemSummary page 6…go the same validated sterilization process, using ethylene oxide (EO), as the predicate devices (K060192, K102578, K111184, K112891) under the sterility assurance level (SAL) of… | 2006 |
| * | K102578 | Apex PS Knee SystemSummary page 6…me validated sterilization process, using ethylene oxide (EO), as the predicate devices (K060192, K102578, K111184, K112891) under the sterility assurance level (SAL) of… | 2011 |
| * | K111184 | Apex PS Knee System - PS-C InsertSummary page 6…ted sterilization process, using ethylene oxide (EO), as the predicate devices (K060192, K102578, K111184, K112891) under the sterility assurance level (SAL) of 10… | 2011 |
| * | K112891 | Apex Revision Knee SystemsSummary page 6…lization process, using ethylene oxide (EO), as the predicate devices (K060192, K102578, K111184, K112891) under the sterility assurance level (SAL) of 10-6. All ethylene oxide residuals are monitore… | 2012 |
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 23 years and passes through 6 companies; a new generation was cleared every 2.2 years on median.
- 67 of the 148 ancestors have a recall of any class.
- 1 other device also cites its predicate K191765.
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. 2021, 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 Apex Knee™ System is intended for use as a primary or revision total knee replacement. 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 porous coated femoral component may be used cemented or…
Read the full statement (117 words)
The Apex Knee™ System is intended for use as a primary or revision total knee replacement. 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 porous coated femoral component may be used cemented or uncemented (biological fixation).
The porous coated tibial baseplate is to be used uncemented (biological fixation).
All other femoral, tibial baseplate, and patellar components are indicated for cemented use only.
The Apex Knee™ Modular Tibia System Tibial Augments are intended to be bolted to the Tibia baseplate and cemented to the prepared tibia.
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/K201611 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201611: Apex Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201611
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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