510(k) · Cleared
ClearedKlassic Knee Tibial Stem Extension
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Total Joint Orthopedics, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on May 16, 2014 as substantially equivalent to K112906 (Total Joint Orthopedics, Inc., 2012) and 2 other predicates after a 32-day review. Its family tree reaches back 4 generations to 1987. 27 later devices descend from it.
- Decided
- May 16, 2014
- Review
- 32 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K870730 (1987). 39 ancestors in all, the oldest P830055 (1985). 27 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK870730 Noiles Total Knee ProsthesisJoint Medical Products Corp. · 1987
- 3 generations backK003182 Orthogenesis LPS SystemDepuy, Inc. · 2001
- 2 generations backK040281 LPS Metaphyseal Sleeve (Limb Preservation System)DePuy Orthopaedics, Inc. · 2004
- 1 generation backK063633 Depuy Knee Prosthesis System Universal Stem Extensions and Femoral…DePuy Orthopaedics, Inc. · 2007 · Recalled
- This deviceK140942 Klassic Knee Tibial Stem ExtensionTotal Joint Orthopedics, Inc. · 2014
- Descendant · cites it directly · 23 of its ownK162422 Klassic Knee SystemTotal Joint Orthopedics, Inc. · 2016
- Descendant · cites it directly · 22 of its ownK180159 Klassic® Knee SystemTotal Joint Orthopedics, Inc. · 2018
- Descendant · 2 generations on · 15 of its ownK190562 iTotal Identity Cruciate Retaining Knee Replacement SystemConformis, Inc. · 2019
- Descendant · 3 generations on · 14 of its ownK201023 iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc. · 2020
- Descendant · 3 generations on · 12 of its ownK203447 iTotal Identity Cruciate Retaining (CR) Total Knee Replacement…Conformis, Inc. · 2020
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K162422Klassic Knee SystemTotal Joint Orthopedics, Inc. · 2016 · cites it directly23descendants
- K180159Klassic® Knee SystemTotal Joint Orthopedics, Inc. · 2018 · cites it directly22descendants
- K190562iTotal Identity Cruciate Retaining Knee Replacement SystemConformis, Inc. · 2019 · 2 generations on15descendants
- K201023iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc. · 2020 · 3 generations on14descendants
- K203447iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity…Conformis, Inc. · 2020 · 3 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K870730 | Noiles Total Knee Prosthesis | Joint Medical Products Corp. | 1987 | — |
| −3 | K003182 | Orthogenesis LPS System | Depuy, Inc. | 2001 | — |
| −2 | K040281 | LPS Metaphyseal Sleeve (Limb Preservation System) | DePuy Orthopaedics, Inc. | 2004 | — |
| −1 | K063633 | Depuy Knee Prosthesis System Universal Stem Extensions and Femoral Metaphyseal… | DePuy Orthopaedics, Inc. | 2007 | 1 |
| 0 (this device) | K140942 | Klassic Knee Tibial Stem Extension | Total Joint Orthopedics, Inc. | 2014 | — |
| +1 | K162422 | Klassic Knee System | Total Joint Orthopedics, Inc. | 2016 | — |
| +1 | K180159 | Klassic® Knee System | Total Joint Orthopedics, Inc. | 2018 | — |
| +2 | K190562 | iTotal Identity Cruciate Retaining Knee Replacement System | Conformis, Inc. | 2019 | — |
| +3 | K201023 | iTotal® Identity Posterior Stabilized Knee Replacement System | Conformis, Inc. | 2020 | — |
| +3 | K203447 | iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal… | Conformis, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1987 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 2 | 0 |
| 1995 | 5 | 0 |
| 1996 | 1 | 0 |
| 1997 | 5 | 0 |
| 1998 | 1 | 0 |
| 2000 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 5 | 0 |
| 2022 | 3 | 0 |
| 2023 | 8 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K112906 | Klassic Knee SystemSummary page 2…substantially equivalent in intended use, design, function, performance testing to the following predicate devices: *Kiassic Knee System - Total Joint Orthopedics K 112906 *Universal Stern Extensions - DePuy K06363 3 *Triathlon TS Knee System - Stryker Orthopedics K070095 INTENDED USE… | 2012 |
| * | K063633 | Depuy Knee Prosthesis System Universal Stem Extensions and Femoral Metaphyseal SleevesSummary page 2…function, performance testing to the following predicate devices: *Kiassic Knee System - Total Joint Orthopedics K 112906 *Universal Stern Extensions - DePuy K06363 3 *Triathlon TS Knee System - Stryker Orthopedics K070095 INTENDED USE The Klassic Knee Tibia[ Stein Extension is intended… | 2007 |
| * | K070095 | Triathlon TS Knee SystemSummary page 2…s: *Kiassic Knee System - Total Joint Orthopedics K 112906 *Universal Stern Extensions - DePuy K06363 3 *Triathlon TS Knee System - Stryker Orthopedics K070095 INTENDED USE The Klassic Knee Tibia[ Stein Extension is intended for use with the Klassic Knee System. The Kiassic Knee System… | 2007 |
What descends from it? (27)
See all 274 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 27 years and passes through 4 companies; a new generation was cleared every 7.2 years on median.
- 23 of the 39 ancestors have a recall of any class.
- Of its descendants, K162422 (Total Joint Orthopedics, Inc., 2016) has gone furthest, with 23 descendants of its own.
- 11 other devices also cite its predicate K112906.
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. 2014, 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 Klassic Knee Tibial Stem Extension is intended for use with the Klassic Knee System. The Klassic Knee System is intended for prosthetic replacement with the use of bone cement in treatment of the following:
Patient conditions of non-inflammatory degenerative joint disease (NIDJD): avascular necrosis and osteoarthritis
Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis
Patients with failed previous surgery where pain, deformity, or dysfunction persists
Correctable varus-valgus deformity and moderate flexion contracture
Revision of a previously failed knee arthroplasty
Patients who require a total knee replacement
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140942 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140942: Klassic Knee Tibial Stem Extension.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140942
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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