510(k) · Cleared
Recalled · Class II · 2012Tibial Baseplate Augment Model KC-22118, KC-22128, KC-22138, KC-22148, KC-22158
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 Mar 5, 2010 as substantially equivalent to K060192 (Omni Life Science, Inc., 2006) and 1 other predicate after a 66-day review. Its family tree reaches back 2 generations to 1994. 7 later devices descend from it. It has been recalled 6 times.
- Decided
- Mar 5, 2010
- Review
- 66 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 6
- Predicates
- 2
Its longest line of descent runs back 2 generations to K943462 (1994). 6 ancestors in all. 7 later devices descend from it, 1 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 deviceK094017 Tibial Baseplate Augment Model KC-22118, KC-22128, KC-22138…Omni Life Science, Inc. · 2010
- Descendant · cites it directly · 6 of its ownK101994 Apex Knee Modular Tibia SystemOmnlife Science · 2010 · Recalled
- Descendant · 2 generations on · 5 of its ownK131472 Apex Knee Modular Tibia SystemOmni Life Science, Inc. · 2013
- Descendant · 3 generations on · 4 of its ownK153437 Apex Revision Knee SystemOmnilife Science · 2015 · Recalled
- Descendant · 4 generations on · 3 of its ownK163332 Apex Revision Knee SystemOmnilife Science · 2017
- Descendant · 5 generations on · 2 of its ownK191765 OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc. · 2019
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K101994Apex Knee Modular Tibia SystemOmnlife Science · 2010 · cites it directly6descendants
- K131472Apex Knee Modular Tibia SystemOmni Life Science, Inc. · 2013 · 2 generations on5descendants
- K153437Apex Revision Knee SystemOmnilife Science · 2015 · 3 generations on4descendants
- K163332Apex Revision Knee SystemOmnilife Science · 2017 · 4 generations on3descendants
- K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc. · 2019 · 5 generations on2descendants
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) | K094017 | Tibial Baseplate Augment Model KC-22118, KC-22128, KC-22138, KC-22148, KC-22158 | Omni Life Science, Inc. | 2010 | — |
| +1 | K101994 | Apex Knee Modular Tibia System | Omnlife Science | 2010 | 1 |
| +2 | K131472 | Apex Knee Modular Tibia System | Omni Life Science, Inc. | 2013 | — |
| +3 | K153437 | Apex Revision Knee System | Omnilife Science | 2015 | 1 |
| +4 | K163332 | Apex Revision Knee System | Omnilife Science | 2017 | — |
| +5 | K191765 | OMNI TiN Coated Apex Knee™ System | Omni Life Science, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 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? (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 1…sification Panel Orthopedic (OR) Regulatory Class Class 11per 21 CFR 888.3560 Product Code JWH Legally Marketed Apex Knee System K060192 Predicate Device(s) Tibial Spacer for the Natural Knee K031183 Device Description The Augments are used as option… | 2006 |
| * | K031183 | Tibial Spacer for the Natural-Knee II Cemented Modular Tibial BaseplateSummary page 1…s 11per 21 CFR 888.3560 Product Code JWH Legally Marketed Apex Knee System K060192 Predicate Device(s) Tibial Spacer for the Natural Knee K031183 Device Description The Augments are used as optional spacers and are cemented below the Tibia… | 2003 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101994 | Apex Knee Modular Tibia System | 2010 | 6 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 9, 2012 | Class II | Z-2372-2012 | Packaging | The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility |
| Aug 9, 2012 | Class II | Z-2370-2012 | Packaging | The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility |
| Aug 9, 2012 | Class II | Z-2374-2012 | Packaging | The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility |
| Aug 9, 2012 | Class II | Z-2371-2012 | Packaging | The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility |
| Aug 9, 2012 | Class II | Z-2373-2012 | Packaging | The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility |
| Aug 9, 2012 | Class II | Z-2375-2012 | Packaging | The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 2 companies; a new generation was cleared every 11.5 years on median.
- 4 of the 6 ancestors have a recall of any class.
- Of its descendants, K101994 (Omnlife Science, 2010) has gone furthest, with 6 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. 2010, 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 Tibial Baseplate Augment is intended for use with the Apex Knee System as a primary or revision total knee replacement. This knee replacement system is intended for cemented fixation and 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K094017 · printed Nov 6, 2026
Cite this page
510(k) Report. “K094017: Tibial Baseplate Augment Model KC-22118, KC-22128, KC-22138, KC-22148, KC-22158.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K094017
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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