510(k) · Cleared
ClearedKlassic® Knee System
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 Mar 9, 2018 as substantially equivalent to K112906 (Total Joint Orthopedics, Inc., 2012) and 5 other predicates after a 49-day review. Its family tree reaches back 6 generations to 1987. 22 later devices descend from it.
- Decided
- Mar 9, 2018
- Review
- 49 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 6 generations to K870730 (1987). 45 ancestors in all, the oldest P830055 (1985). 22 later devices descend from it, 4 citing it directly.
- Root · 6 generations backK870730 Noiles Total Knee ProsthesisJoint Medical Products Corp. · 1987
- 5 generations backK003182 Orthogenesis LPS SystemDepuy, Inc. · 2001
- 4 generations backK040281 LPS Metaphyseal Sleeve (Limb Preservation System)DePuy Orthopaedics, Inc. · 2004
- 3 generations backK063633 Depuy Knee Prosthesis System Universal Stem Extensions and Femoral…DePuy Orthopaedics, Inc. · 2007 · Recalled
- 2 generations backK140942 Klassic Knee Tibial Stem ExtensionTotal Joint Orthopedics, Inc. · 2014
- 1 generation backK162422 Klassic Knee SystemTotal Joint Orthopedics, Inc. · 2016
- This deviceK180159 Klassic® Knee SystemTotal Joint Orthopedics, Inc. · 2018
- Descendant · cites it directly · 15 of its ownK190562 iTotal Identity Cruciate Retaining Knee Replacement SystemConformis, Inc. · 2019
- Descendant · 2 generations on · 14 of its ownK201023 iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc. · 2020
- Descendant · 2 generations on · 12 of its ownK203447 iTotal Identity Cruciate Retaining (CR) Total Knee Replacement…Conformis, Inc. · 2020
- Descendant · 2 generations on · 10 of its ownK210191 Identity Imprint Knee Replacement SystemConformis, Inc. · 2021 · Recalled
- Descendant · 2 generations on · 9 of its ownK212411 Identity Imprint Knee Replacement System (including Identity Imprint…Conformis, Inc. · 2021
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K190562iTotal Identity Cruciate Retaining Knee Replacement SystemConformis, Inc. · 2019 · cites it directly15descendants
- K201023iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc. · 2020 · 2 generations on14descendants
- K203447iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity…Conformis, Inc. · 2020 · 2 generations on12descendants
- K210191Identity Imprint Knee Replacement SystemConformis, Inc. · 2021 · 2 generations on10descendants
- K212411Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc. · 2021 · 2 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K870730 | Noiles Total Knee Prosthesis | Joint Medical Products Corp. | 1987 | — |
| −5 | K003182 | Orthogenesis LPS System | Depuy, Inc. | 2001 | — |
| −4 | K040281 | LPS Metaphyseal Sleeve (Limb Preservation System) | DePuy Orthopaedics, Inc. | 2004 | — |
| −3 | K063633 | Depuy Knee Prosthesis System Universal Stem Extensions and Femoral Metaphyseal… | DePuy Orthopaedics, Inc. | 2007 | 1 |
| −2 | K140942 | Klassic Knee Tibial Stem Extension | Total Joint Orthopedics, Inc. | 2014 | — |
| −1 | K162422 | Klassic Knee System | Total Joint Orthopedics, Inc. | 2016 | — |
| 0 (this device) | K180159 | Klassic® Knee System | Total Joint Orthopedics, Inc. | 2018 | — |
| +1 | K190562 | iTotal Identity Cruciate Retaining Knee Replacement System | Conformis, Inc. | 2019 | — |
| +2 | K201023 | iTotal® Identity Posterior Stabilized Knee Replacement System | Conformis, Inc. | 2020 | — |
| +2 | K203447 | iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal… | Conformis, Inc. | 2020 | — |
| +2 | K210191 | Identity Imprint Knee Replacement System | Conformis, Inc. | 2021 | 1 |
| +2 | K212411 | Identity Imprint Knee Replacement System (including Identity Imprint Posterior… | Conformis, Inc. | 2021 | — |
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 | 2 | 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 |
| 2015 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 5 | 0 |
| 2022 | 3 | 0 |
| 2023 | 7 | 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? (6)
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 5…and thicknesses to match patient anatomy. Predicate Devices: The E-Link® Knee Components are substantially equivalent to the predicate Klassic® Knee System Components (K112906, K140942, K150105, K153075, K153310, and K162422) with respect to indications, design, and function. The E-Link material is the s… | 2012 |
| * | K140942 | Klassic Knee Tibial Stem ExtensionSummary page 5…knesses to match patient anatomy. Predicate Devices: The E-Link® Knee Components are substantially equivalent to the predicate Klassic® Knee System Components (K112906, K140942, K150105, K153075, K153310, and K162422) with respect to indications, design, and function. The E-Link material is the same as th… | 2014 |
| * | K150105 | Klassic Knee System-Sombrero PatellaSummary page 5…o match patient anatomy. Predicate Devices: The E-Link® Knee Components are substantially equivalent to the predicate Klassic® Knee System Components (K112906, K140942, K150105, K153075, K153310, and K162422) with respect to indications, design, and function. The E-Link material is the same as the E-link… | 2015 |
| * | K153075 | Klassic Knee SystemSummary page 5…atient anatomy. Predicate Devices: The E-Link® Knee Components are substantially equivalent to the predicate Klassic® Knee System Components (K112906, K140942, K150105, K153075, K153310, and K162422) with respect to indications, design, and function. The E-Link material is the same as the E-link material… | 2015 |
| * | K153310 | Klassic Knee SystemSummary page 5…atomy. Predicate Devices: The E-Link® Knee Components are substantially equivalent to the predicate Klassic® Knee System Components (K112906, K140942, K150105, K153075, K153310, and K162422) with respect to indications, design, and function. The E-Link material is the same as the E-link material used in t… | 2015 |
| * | K162422 | Klassic Knee SystemSummary page 5…cate Devices: The E-Link® Knee Components are substantially equivalent to the predicate Klassic® Knee System Components (K112906, K140942, K150105, K153075, K153310, and K162422) with respect to indications, design, and function. The E-Link material is the same as the E-link material used in the Klassic HD… | 2016 |
| † | K141972 | Klassic HD Acetabular Insert with E-Link Poly | 2014 |
| † | K112802 | Pipeline Total Hip System | 2012 |
What descends from it? (22)
See all 224 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190562 | iTotal Identity Cruciate Retaining Knee Replacement System | 2019 | 15 |
| K183596 | Klassic Knee System - Klassic Knee PS-Post Femur; Klassic Knee Tibial Insert, PS-Post… | 2019 | 2 |
| K211877 | Klassic Knee System | 2022 | 1 |
| K190280 | Klassic Knee System - Sombrero Patella with Standard Poly, Klassic Knee System -… | 2019 | 0 |
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 31 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- 23 of the 45 ancestors have a recall of any class.
- Of its descendants, K190562 (Conformis, Inc., 2019) has gone furthest, with 15 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. 2018, 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 System is intended for prosthetic replacement 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…
Read the full statement (101 words)
The Klassic® Knee System is intended for prosthetic replacement 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
The Klassic® Knee System is indicated for cemented use only, except for the Klassic Femur, Porous, and the Klassic Tibial Baseplate, Porous, which are indicated for cementless use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180159 · printed Nov 5, 2026
Cite this page
510(k) Report. “K180159: Klassic® Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K180159
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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