510(k) · Cleared

Cleared

Klassic Knee System-Sombrero Patella

K150105510(k) SpecialCleared Feb 17, 201528-day reviewClass II21 CFR 888.3560

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Total Joint Orthopedics, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Feb 17, 2015 as substantially equivalent to K112906 (Total Joint Orthopedics, Inc., 2012) and 1 other predicate after a 28-day review. Its family tree reaches back 4 generations to 1993. 24 later devices descend from it.

Decided: Feb 17, 2015
Review: 28 days
Class: Class II
Product code: JWH
Recalls: None
Predicates: 2

Its longest line of descent runs back 4 generations to K923277 (1993). 23 ancestors in all, the oldest P830055 (1985). 24 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 4 generations backK923277 Foundation Knee SystemEncore Orthopedics, Inc. · 1993 · Recalled
3 generations backK000666 TC-Plus Solution KneePlus Orthopedics · 2000 · Recalled
2 generations backK090705 Balanced Knee System Ultracongruent Tibial InsertOrtho Development Corp. · 2009 · Recalled
1 generation backK112906 Klassic Knee SystemTotal Joint Orthopedics, Inc. · 2012
This deviceK150105 Klassic Knee System-Sombrero PatellaTotal Joint Orthopedics, Inc. · 2015
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 24 descendants. See all descendants

Descendants cleared per year

2016high 7 (2023) · low 0 (2017)2026

Most influential descendants

Showing 5 of 24 · 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	K923277	Foundation Knee System	Encore Orthopedics, Inc.	1993	4
−3	K000666	TC-Plus Solution Knee	Plus Orthopedics	2000	9
−2	K090705	Balanced Knee System Ultracongruent Tibial Insert	Ortho Development Corp.	2009	1
−1	K112906	Klassic Knee System	Total Joint Orthopedics, Inc.	2012	—
0 (this device)	K150105	Klassic Knee System-Sombrero Patella	Total Joint Orthopedics, Inc.	2015	—
+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
1991	2	0
1993	1	0
1994	1	0
1995	4	0
1996	2	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
2016	1	0
2018	1	0
2019	3	0
2020	3	0
2021	5	0
2022	3	0
2023	7	0
2025	1	0

FIG. 1 — Lineage of K150105, 1993–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K112906	Klassic Knee System Summary page 5 …thylene in four diameters and two thicknesses. Predicate Devices: The Sombrero Patella is substantially equivalent to the primary predicate Klassic Knee Domed Patella (K112906) with respect to its intended use, material, geometry, and method of fixation. The Sombrero Patella is also substantially equival…	Total Joint Orthopedics, Inc.	2012	—
*	K934695	Natural-Knee Tibial Baseplate/All Poly Patella Summary page 5 …its intended use, material, geometry, and method of fixation. The Sombrero Patella is also substantially equivalent to the Zimmer Natural Knee All Polyethylene Patella (K934695) with respect to intended use, geometry and method of fixation. The information summarized in the Design Control Activities Summa…	Intermedics Orthopedics	1996	—

Also cleared against K112906: 11 other devices →

What descends from it? (24)

See all 24

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K162422	Klassic Knee System	Total Joint Orthopedics, Inc.	2016	23
K180159	Klassic® Knee System	Total Joint Orthopedics, Inc.	2018	22
K183596	Klassic Knee System - Klassic Knee PS-Post Femur; Klassic Knee Tibial Insert, PS-Post…	Total Joint Orthopedics, Inc.	2019	2
K190280	Klassic Knee System - Sombrero Patella with Standard Poly, Klassic Knee System -…	Total Joint Orthopedics, Inc.	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 22 years and passes through 4 companies; a new generation was cleared every 7.7 years on median.
16 of the 23 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 devices

JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · JWH

20in 2025

2007high 33 (2012) · low 11 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JWH

55in 2025

2007high 168 (2009) · low 55 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JWH

2in 2025

2007high 109 (2009) · low 2 (2020)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JWH

9,306in 2025

2007high 14,987 (2019) · low 1,305 (2007)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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K150105 · printed Nov 6, 2026

Cite this page

510(k) Report. “K150105: Klassic Knee System-Sombrero Patella.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150105

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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