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 Feb 1, 2012 as substantially equivalent to K994370 (Ortho Development Corp., 2000) and 6 other predicates after a 121-day review. Its family tree reaches back 3 generations to 1993. 33 later devices descend from it.
- Decided
- Feb 1, 2012
- Review
- 121 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 3 generations to K923277 (1993). 21 ancestors in all, the oldest P830055 (1985). 33 later devices descend from it, 12 citing it directly.
- Root · 3 generations backK923277 Foundation Knee SystemEncore Orthopedics, Inc. · 1993 · Recalled
- 2 generations backK000666 TC-Plus Solution KneePlus Orthopedics · 2000 · Recalled
- 1 generation backK090705 Balanced Knee System Ultracongruent Tibial InsertOrtho Development Corp. · 2009 · Recalled
- This deviceK112906 Klassic Knee SystemTotal Joint Orthopedics, Inc. · 2012
- Descendant · cites it directly · 27 of its ownK140942 Klassic Knee Tibial Stem ExtensionTotal Joint Orthopedics, Inc. · 2014
- Descendant · cites it directly · 24 of its ownK153310 Klassic Knee SystemTotal Joint Orthopedics, Inc. · 2015
- Descendant · cites it directly · 24 of its ownK153075 Klassic Knee SystemTotal Joint Orthopedics, Inc. · 2015
- Descendant · cites it directly · 24 of its ownK150105 Klassic Knee System-Sombrero PatellaTotal Joint Orthopedics, Inc. · 2015
- Descendant · cites it directly · 23 of its ownK162422 Klassic Knee SystemTotal Joint Orthopedics, Inc. · 2016
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 33 · See all- K140942Klassic Knee Tibial Stem ExtensionTotal Joint Orthopedics, Inc. · 2014 · cites it directly27descendants
- K153310Klassic Knee SystemTotal Joint Orthopedics, Inc. · 2015 · cites it directly24descendants
- K153075Klassic Knee SystemTotal Joint Orthopedics, Inc. · 2015 · cites it directly24descendants
- K150105Klassic Knee System-Sombrero PatellaTotal Joint Orthopedics, Inc. · 2015 · cites it directly24descendants
- K162422Klassic Knee SystemTotal Joint Orthopedics, Inc. · 2016 · cites it directly23descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K923277 | Foundation Knee System | Encore Orthopedics, Inc. | 1993 | 4 |
| −2 | K000666 | TC-Plus Solution Knee | Plus Orthopedics | 2000 | 9 |
| −1 | K090705 | Balanced Knee System Ultracongruent Tibial Insert | Ortho Development Corp. | 2009 | 1 |
| 0 (this device) | K112906 | Klassic Knee System | Total Joint Orthopedics, Inc. | 2012 | — |
| +1 | K140942 | Klassic Knee Tibial Stem Extension | Total Joint Orthopedics, Inc. | 2014 | — |
| +1 | K153310 | Klassic Knee System | Total Joint Orthopedics, Inc. | 2015 | — |
| +1 | K153075 | Klassic Knee System | Total Joint Orthopedics, Inc. | 2015 | — |
| +1 | K150105 | Klassic Knee System-Sombrero Patella | Total Joint Orthopedics, Inc. | 2015 | — |
| +1 | K162422 | Klassic Knee System | Total Joint Orthopedics, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1987 | 1 | 0 |
| 1991 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 6 | 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? (7)
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 |
|---|---|---|---|
| * | K994370 | Ortho Development Balanced Knee System | 2000 |
| * | K090705 | Balanced Knee System Ultracongruent Tibial InsertSummary page 2…* Ortho Development Corporation, Balanced Knee" System (K(9943 70) * Ortho Development Corporation, Balanced Knee" System Ultracongruent Tibial Insert (K090705) " Intermedics Orthopedics, Natural-Knee® 11 System (K936159) * OMNI Life Science, Inc., Apex Knee' System (K(960192)… | 2009 |
| * | K936159 | Natural-Knee II SystemSummary page 2…3 70) * Ortho Development Corporation, Balanced Knee" System Ultracongruent Tibial Insert (K090705) " Intermedics Orthopedics, Natural-Knee® 11 System (K936159) * OMNI Life Science, Inc., Apex Knee' System (K(960192) " Intermedics Orthopedics, Natural-Knee®/Apollo , Knee (K925242,… | 1995 |
| * | K060192 | Apex Knee System Our reading of the summary gave K960192, FDA’s number for Positron Coincidence Detection (Philips Medical Systems (Cleveland), Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “OMNI Life Science, Inc., Apex Knee System”. | 2006 |
| * | K925242 | Apollo (TM) Knee SystemSummary page 2…cs Orthopedics, Natural-Knee® 11 System (K936159) * OMNI Life Science, Inc., Apex Knee' System (K(960192) " Intermedics Orthopedics, Natural-Knee®/Apollo , Knee (K925242, K(935523) " Howmedica Corp., Kinemax Plus Total Knee System (K910500) INDICATIONS FOR USE The Kiassic" Knee System is inte… | 1993 |
| * | K935523 | Natural-Knee (R)/Apollo (TM) KneeSummary page 2…ics, Natural-Knee® 11 System (K936159) * OMNI Life Science, Inc., Apex Knee' System (K(960192) " Intermedics Orthopedics, Natural-Knee®/Apollo , Knee (K925242, K(935523) " Howmedica Corp., Kinemax Plus Total Knee System (K910500) INDICATIONS FOR USE The Kiassic" Knee System is intended for p… | 1995 |
| * | K910500 | Howmedica Kinemax Plus Total Knee SystemSummary page 2…Inc., Apex Knee' System (K(960192) " Intermedics Orthopedics, Natural-Knee®/Apollo , Knee (K925242, K(935523) " Howmedica Corp., Kinemax Plus Total Knee System (K910500) INDICATIONS FOR USE The Kiassic" Knee System is intended for prosthetic replacement with the use of bone cement in treatment o… | 1991 |
What descends from it? (33)
See all 3312 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140942 | Klassic Knee Tibial Stem Extension | 2014 | 27 |
| K153310 | Klassic Knee System | 2015 | 24 |
| K153075 | Klassic Knee System | 2015 | 24 |
| K150105 | Klassic Knee System-Sombrero Patella | 2015 | 24 |
| K162422 | Klassic Knee System | 2016 | 23 |
| K180159 | Klassic® Knee System | 2018 | 22 |
| K230537 | Klassic Knee Revision System | 2023 | 2 |
| K183596 | Klassic Knee System - Klassic Knee PS-Post Femur; Klassic Knee Tibial Insert, PS-Post… | 2019 | 2 |
| K243991 | Klassic Knee System - Revision Tibial Baseplate | 2025 | 1 |
| K232414 | Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post | 2023 | 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 19 years and passes through 4 companies; a new generation was cleared every 7.7 years on median.
- 16 of the 21 ancestors have a recall of any class.
- Of its descendants, K140942 (Total Joint Orthopedics, Inc., 2014) has gone furthest, with 27 descendants of its own.
- 5 other devices also cite its predicate K994370.
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. 2012, 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 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/K112906 · printed Nov 4, 2026
Cite this page
510(k) Report. “K112906: Klassic Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K112906
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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