510(k) · Cleared
ClearedModification to: Apex Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Omnlife Science · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Feb 14, 2008 as substantially equivalent to K060192 (Omni Life Science, Inc., 2006) and 1 other predicate after a 55-day review. Its family tree reaches back 2 generations to 1994. 72 later devices descend from it.
- Decided
- Feb 14, 2008
- Review
- 55 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K943462 (1994). 7 ancestors in all, the oldest K933787 (1994). 72 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK943462 Darwin Knee SystemJohnson & Johnson Professionals, Inc. · 1994 · Recalled
- 1 generation backK060192 Apex Knee SystemOmni Life Science, Inc. · 2006 · Recalled
- This deviceK073602 Modification to: Apex Knee SystemOmnlife Science · 2008
- Descendant · cites it directly · 61 of its ownK080842 Apex Knee System, Model KC-230XY, KC-240XY [ NO Holes, 2 Holes]Omni Life Science, Inc. · 2008
- Descendant · 2 generations on · 60 of its ownK131353 Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp · 2013
- Descendant · 3 generations on · 21 of its ownK140478 Aequalis Reversed Shoulder ProsthesisTornier S.A.S. · 2014
- Descendant · 3 generations on · 20 of its ownK193373 Comprehensive® Reverse ShoulderBiomet, Inc. · 2020 · Recalled
- Descendant · 3 generations on · 20 of its ownK172502 Comprehensive Augmented Glenoid Components, Comprehensive Standard…Biomet Manufacturing Corp · 2018 · Recalled
Showing 5 of 72 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 72 · See all- K080842Apex Knee System, Model KC-230XY, KC-240XY [ NO Holes, 2 Holes]Omni Life Science, Inc. · 2008 · cites it directly61descendants
- K131353Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp · 2013 · 2 generations on60descendants
- K140478Aequalis Reversed Shoulder ProsthesisTornier S.A.S. · 2014 · 3 generations on21descendants
- K193373Comprehensive® Reverse ShoulderBiomet, Inc. · 2020 · 3 generations on20descendants
- K172502Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate…Biomet Manufacturing Corp · 2018 · 3 generations on20descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K943462 | Darwin Knee System | Johnson & Johnson Professionals, Inc. | 1994 | 8 |
| −1 | K060192 | Apex Knee System | Omni Life Science, Inc. | 2006 | 1 |
| 0 (this device) | K073602 | Modification to: Apex Knee System | Omnlife Science | 2008 | — |
| +1 | K080842 | Apex Knee System, Model KC-230XY, KC-240XY [ NO Holes, 2 Holes] | Omni Life Science, Inc. | 2008 | — |
| +2 | K131353 | Comprehensive Reverse Shoulder - Titanium Glenosphere | Biomet Manufacturing Corp | 2013 | — |
| +3 | K140478 | Aequalis Reversed Shoulder Prosthesis | Tornier S.A.S. | 2014 | — |
| +3 | K193373 | Comprehensive® Reverse Shoulder | Biomet, Inc. | 2020 | 2 |
| +3 | K172502 | Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate… | Biomet Manufacturing Corp | 2018 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2020 | 3 | 0 |
| 2021 | 6 | 0 |
| 2022 | 7 | 0 |
| 2023 | 8 | 0 |
| 2024 | 9 | 0 |
| 2025 | 10 | 0 |
| 2026 | 14 | 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? (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 |
|---|---|---|---|
| * | K060192 | Apex Knee SystemSummary page 2…taining the proper soft tissue balance across the knee joint. 5. Predicate Device Comparison Substantial equivalence is claimed to the Apex Knee System (K060192), distributed by OMNI life science, Inc., and the Sigma Cruciate-Retaining Porocoate Femoral Components distributed by DePuy Orth… | 2006 |
| * | K062654 | Depuy Sigma Cruciate Retaining Porocoat Femoral ComponentsSummary page 2…o the Apex Knee System (K060192), distributed by OMNI life science, Inc., and the Sigma Cruciate-Retaining Porocoate Femoral Components distributed by DePuy Orthopedics (K062654). The following table summarizes the similarities and differences between the subject uncemented femoral components of the Apex K… | 2006 |
| † | K031110 | Apex Modular Acetabular Cup | 2003 |
What descends from it? (72)
See all 723 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 14 years and passes through 3 companies; a new generation was cleared every 11.5 years on median.
- 4 of the 7 ancestors have a recall of any class.
- Of its descendants, K080842 (Omni Life Science, Inc., 2008) has gone furthest, with 61 descendants of its own.
- 8 other devices also cite its predicate K060192.
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. 2008, 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 knee replacement system is intended for cemented fixation, with the option of using a porous coated femoral comronent for uncemented or cemented fixation. 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;
• Congenital dislocation;
* Revision procedures where other treatments or devices have failed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073602 · printed Nov 3, 2026
Cite this page
510(k) Report. “K073602: Modification to: 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/K073602
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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