510(k) · Cleared
Recalled · Class II · 2025Apex Knee Modular Tibia 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 Sep 28, 2010 as substantially equivalent to K060192 (Omni Life Science, Inc., 2006) and 2 other predicates after a 75-day review. Its family tree reaches back 5 generations to 1998. 6 later devices descend from it. It has been recalled once.
- Decided
- Sep 28, 2010
- Review
- 75 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 5 generations to K982302 (1998). 32 ancestors in all, the oldest K833921 (1984). 6 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK982302 Implex Continuum Knee - Hedrocel Tibial SpacersImplex Corp. · 1998
- 4 generations backK024161 Nexgen Complete Knee Solution - Trabecular Metal AugmentsImplex Corp. · 2003 · Recalled
- 3 generations backK040487 Trabecular Metal Knee System AugmentsImplex Corp. · 2004 · Recalled
- 2 generations backK053505 Regenerex Ultra Porous Construct-Femoral and Tibial Knee AugmentsBiomet Manufacturing, Inc. · 2006
- 1 generation backK080361 Regenerex Tibial ComponentsBiomet, Inc. · 2008 · Recalled
- This deviceK101994 Apex Knee Modular Tibia SystemOmnlife Science · 2010
- Descendant · cites it directly · 5 of its ownK131472 Apex Knee Modular Tibia SystemOmni Life Science, Inc. · 2013
- Descendant · 2 generations on · 4 of its ownK153437 Apex Revision Knee SystemOmnilife Science · 2015 · Recalled
- Descendant · 3 generations on · 3 of its ownK163332 Apex Revision Knee SystemOmnilife Science · 2017
- Descendant · 4 generations on · 2 of its ownK191765 OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc. · 2019
- Descendant · 5 generations on · 0 of its ownK252044 Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K131472Apex Knee Modular Tibia SystemOmni Life Science, Inc. · 2013 · cites it directly5descendants
- K153437Apex Revision Knee SystemOmnilife Science · 2015 · 2 generations on4descendants
- K163332Apex Revision Knee SystemOmnilife Science · 2017 · 3 generations on3descendants
- K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc. · 2019 · 4 generations on2descendants
- K252044Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K982302 | Implex Continuum Knee - Hedrocel Tibial Spacers | Implex Corp. | 1998 | — |
| −4 | K024161 | Nexgen Complete Knee Solution - Trabecular Metal Augments | Implex Corp. | 2003 | 2 |
| −3 | K040487 | Trabecular Metal Knee System Augments | Implex Corp. | 2004 | 1 |
| −2 | K053505 | Regenerex Ultra Porous Construct-Femoral and Tibial Knee Augments | Biomet Manufacturing, Inc. | 2006 | — |
| −1 | K080361 | Regenerex Tibial Components | Biomet, Inc. | 2008 | 1 |
| 0 (this device) | K101994 | Apex Knee Modular Tibia System | Omnlife Science | 2010 | — |
| +1 | K131472 | Apex Knee Modular Tibia System | Omni Life Science, Inc. | 2013 | — |
| +2 | K153437 | Apex Revision Knee System | Omnilife Science | 2015 | 1 |
| +3 | K163332 | Apex Revision Knee System | Omnilife Science | 2017 | — |
| +4 | K191765 | OMNI TiN Coated Apex Knee™ System | Omni Life Science, Inc. | 2019 | — |
| +5 | K252044 | Triathlon® Total Knee System - Triathlon® Gold Femoral Components | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 5 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 1…nstrained cemented Name prosthesis Regulatory Class Class 11per 21 CFR §888.3560 Product Code JWH, MBH Legally Marketed * K060192- Apex Knee System, cleared 15.1u2006 Predicate Device(s) * K094017- Apex Knee System Tibial Baseplate Augment, cleared O5… | 2006 |
| * | K094017 | Tibial Baseplate Augment Model KC-22118, KC-22128, KC-22138, KC-22148, KC-22158Summary page 1…Class 11per 21 CFR §888.3560 Product Code JWH, MBH Legally Marketed * K060192- Apex Knee System, cleared 15.1u2006 Predicate Device(s) * K094017- Apex Knee System Tibial Baseplate Augment, cleared O5Mar2OlO K080361- Biomet, Regenerex'T Tibial C… | 2010 |
| * | K080361 | Regenerex Tibial ComponentsSummary page 1…92- Apex Knee System, cleared 15.1u2006 Predicate Device(s) * K094017- Apex Knee System Tibial Baseplate Augment, cleared O5Mar2OlO K080361- Biomet, Regenerex'T Tibial Component, cleared 2lApril2008 Device Description The Modular Tibia[ Baseplate isoffered in siz… | 2008 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131472 | Apex Knee Modular Tibia System | 2013 | 5 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 23, 2025 | Class II | Z-2069-2025 | Nonconforming Material/Component | Investigation has identified that the age of the nylon packaging material has caused a loss of integrity of some pouches. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 15 of the 32 ancestors have a recall of any class.
- Of its descendants, K131472 (Omni Life Science, Inc., 2013) has gone furthest, with 5 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 TM 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 (119 words)
The Apex Knee TM 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 uncemnented (biological fixation). The porous coated tibial baseplate component may be used uncemented (biological fixation). All other femoral, tibia] baseplate and patellar components are indicated for cemented use only. The Apex Knee T" Modular Tibia System Tibial Augments are intended to be bolted to the Tibia baseplate and cemented to the prepared tibia.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101994 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101994: Apex Knee Modular Tibia System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101994
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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