510(k) · Cleared
ClearedApex Knee System, Model KC-230XY, KC-240XY [ NO Holes, 2 Holes]
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Omni Life Science, Inc. · MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Cleared on May 23, 2008 as substantially equivalent to K060192 (Omni Life Science, Inc., 2006) and 2 other predicates after a 59-day review. Its family tree reaches back 3 generations to 1991. 61 later devices descend from it.
- Decided
- May 23, 2008
- Review
- 59 days
- Class
- Class II
- Product code
- MBH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K913231 (1991). 18 ancestors in all. 61 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK913231 S-Rom (TM) Total Lhip System W/Ceramic HeadJoint Medical Products Corp. · 1991
- 2 generations backK000788 Apex Modular Hip StemApex Surgical, LLC · 2000
- 1 generation backK043123 Apex Modular HA Hip StemApex Surgical, LLC · 2005
- This deviceK080842 Apex Knee System, Model KC-230XY, KC-240XY [ NO Holes, 2 Holes]Omni Life Science, Inc. · 2008
- Descendant · cites it directly · 60 of its ownK131353 Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp · 2013
- Descendant · 2 generations on · 21 of its ownK140478 Aequalis Reversed Shoulder ProsthesisTornier S.A.S. · 2014
- Descendant · 2 generations on · 20 of its ownK193373 Comprehensive® Reverse ShoulderBiomet, Inc. · 2020 · Recalled
- Descendant · 2 generations on · 20 of its ownK172502 Comprehensive Augmented Glenoid Components, Comprehensive Standard…Biomet Manufacturing Corp · 2018 · Recalled
- Descendant · 3 generations on · 20 of its ownK151293 Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder…Tornier S.A.S. · 2015
Showing 5 of 61 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 61 · See all- K131353Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp · 2013 · cites it directly60descendants
- K140478Aequalis Reversed Shoulder ProsthesisTornier S.A.S. · 2014 · 2 generations on21descendants
- K193373Comprehensive® Reverse ShoulderBiomet, Inc. · 2020 · 2 generations on20descendants
- K172502Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate…Biomet Manufacturing Corp · 2018 · 2 generations on20descendants
- K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S. · 2015 · 3 generations on20descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K913231 | S-Rom (TM) Total Lhip System W/Ceramic Head | Joint Medical Products Corp. | 1991 | — |
| −2 | K000788 | Apex Modular Hip Stem | Apex Surgical, LLC | 2000 | — |
| −1 | K043123 | Apex Modular HA Hip Stem | Apex Surgical, LLC | 2005 | — |
| 0 (this device) | K080842 | Apex Knee System, Model KC-230XY, KC-240XY [ NO Holes, 2 Holes] | Omni Life Science, Inc. | 2008 | — |
| +1 | K131353 | Comprehensive Reverse Shoulder - Titanium Glenosphere | Biomet Manufacturing Corp | 2013 | — |
| +2 | K140478 | Aequalis Reversed Shoulder Prosthesis | Tornier S.A.S. | 2014 | — |
| +2 | K193373 | Comprehensive® Reverse Shoulder | Biomet, Inc. | 2020 | 2 |
| +2 | K172502 | Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate… | Biomet Manufacturing Corp | 2018 | 1 |
| +3 | K151293 | Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis | Tornier S.A.S. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 5 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 2 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 5 | 0 |
| 2022 | 7 | 0 |
| 2023 | 8 | 0 |
| 2024 | 8 | 0 |
| 2025 | 9 | 0 |
| 2026 | 13 | 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 |
|---|---|---|---|
| * | K060192 | Apex Knee SystemSummary page 2…ble to aid in obtaining the proper soft tissue balance across the knee joint. 5. Predicate Device Comparison Substantial equivalence is claimed to the Apex Knee System (K060192 and K073602) and the Apex Modular T M HA Hip Stem (K043123), distributed by OMNI life science, Inc. The following table summarize… | 2006 |
| * | K073602 | Modification to: Apex Knee SystemSummary page 2…n obtaining the proper soft tissue balance across the knee joint. 5. Predicate Device Comparison Substantial equivalence is claimed to the Apex Knee System (K060192 and K073602) and the Apex Modular T M HA Hip Stem (K043123), distributed by OMNI life science, Inc. The following table summarizes the simila… | 2008 |
| * | K043123 | Apex Modular HA Hip StemSummary page 2…ss the knee joint. 5. Predicate Device Comparison Substantial equivalence is claimed to the Apex Knee System (K060192 and K073602) and the Apex Modular T M HA Hip Stem (K043123), distributed by OMNI life science, Inc. The following table summarizes the similarities and differences between the subject unce… | 2005 |
What descends from it? (61)
See all 611 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131353 | Comprehensive Reverse Shoulder - Titanium Glenosphere | 2013 | 60 |
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 17 years and passes through 3 companies; a new generation was cleared every 4.5 years on median.
- 5 of the 18 ancestors have a recall of any class.
- Of its descendants, K131353 (Biomet Manufacturing Corp, 2013) has gone furthest, with 60 descendants of its own.
- 8 other devices also cite its predicate K060192.
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. 2008, 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?
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 component may be used uncemented (biological fixation). All other femoral, tibial baseplate, and patellar components are indicated for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080842 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080842: Apex Knee System, Model KC-230XY, KC-240XY [ NO Holes, 2 Holes].” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080842
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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