510(k) · Cleared

Cleared

Natural-Knee Ultra Congruent Tibial Insert

K912663510(k) TraditionalCleared Sep 16, 199190-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

Intermedics Orthopedics · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Sep 16, 1991 after a 90-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 53 later devices descend from it.

Decided: Sep 16, 1991
Review: 90 days
Class: Class II
Product code: JWH
Recalls: None
Predicates: 0

53 later devices descend from it, 2 citing it directly.

This deviceK912663 Natural-Knee Ultra Congruent Tibial InsertIntermedics Orthopedics · 1991
Descendant · cites it directly · 42 of its ownK090705 Balanced Knee System Ultracongruent Tibial InsertOrtho Development Corp. · 2009 · Recalled
Descendant · 2 generations on · 33 of its ownK112906 Klassic Knee SystemTotal Joint Orthopedics, Inc. · 2012
Descendant · 3 generations on · 27 of its ownK140942 Klassic Knee Tibial Stem ExtensionTotal Joint Orthopedics, Inc. · 2014
Descendant · 3 generations on · 24 of its ownK153310 Klassic Knee SystemTotal Joint Orthopedics, Inc. · 2015
Descendant · 3 generations on · 24 of its ownK153075 Klassic Knee SystemTotal Joint Orthopedics, Inc. · 2015

Showing 5 of 53 descendants. See all descendants

Descendants cleared per year

1996high 8 (2021) · low 0 (1997)2026

Most influential descendants

Showing 5 of 53 · See all

K090705Balanced Knee System Ultracongruent Tibial InsertOrtho Development Corp. · 2009 · cites it directly42descendants
K112906Klassic Knee SystemTotal Joint Orthopedics, Inc. · 2012 · 2 generations on33descendants
K140942Klassic Knee Tibial Stem ExtensionTotal Joint Orthopedics, Inc. · 2014 · 3 generations on27descendants
K153310Klassic Knee SystemTotal Joint Orthopedics, Inc. · 2015 · 3 generations on24descendants
K153075Klassic Knee SystemTotal Joint Orthopedics, Inc. · 2015 · 3 generations on24descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K912663	Natural-Knee Ultra Congruent Tibial Insert	Intermedics Orthopedics	1991	—
+1	K090705	Balanced Knee System Ultracongruent Tibial Insert	Ortho Development Corp.	2009	1
+2	K112906	Klassic Knee System	Total Joint Orthopedics, Inc.	2012	—
+3	K140942	Klassic Knee Tibial Stem Extension	Total Joint Orthopedics, Inc.	2014	—
+3	K153310	Klassic Knee System	Total Joint Orthopedics, Inc.	2015	—
+3	K153075	Klassic Knee System	Total Joint Orthopedics, Inc.	2015	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
2009	1	0
2012	1	0
2013	1	0
2014	3	0
2015	5	0
2016	4	0
2017	2	0
2018	1	0
2019	4	0
2020	4	0
2021	8	0
2022	4	0
2023	8	0
2024	1	0
2025	4	0
2026	1	0

FIG. 1 — Lineage of K912663, 1991–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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

Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (53)

See all 53

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

Number	Device	Applicant	Decided	Descendants
K090705	Balanced Knee System Ultracongruent Tibial Insert	Ortho Development Corp.	2009	42
K953443	Consensus PCL Subsituting Tibial Insert	U.S. Medical Products, Inc.	1996	9

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?

Of its descendants, K090705 (Ortho Development Corp., 2009) has gone furthest, with 42 descendants of its own.

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.

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	—

https://510kreport.com/device/K912663 · printed Nov 6, 2026

Cite this page

510(k) Report. “K912663: Natural-Knee Ultra Congruent Tibial Insert.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K912663

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026