510(k) · Cleared

Recalled · Class II · 2014

Balanced Knee System Ultracongruent Tibial Insert

K090705510(k) TraditionalCleared Oct 9, 2009206-day reviewClass II21 CFR 888.3560Recalls 1

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

Ortho Development Corp. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Oct 9, 2009 as substantially equivalent to K994370 (Ortho Development Corp., 2000) and 9 other predicates after a 206-day review. Its family tree reaches back 2 generations to 1993. 42 later devices descend from it. It has been recalled once.

Decided: Oct 9, 2009
Review: 206 days
Class: Class II
Product code: JWH
Recalls: 1
Predicates: 10

Its longest line of descent runs back 2 generations to K923277 (1993). 14 ancestors in all, the oldest P830055 (1985). 42 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 2 generations backK923277 Foundation Knee SystemEncore Orthopedics, Inc. · 1993 · Recalled
1 generation backK000666 TC-Plus Solution KneePlus Orthopedics · 2000 · Recalled
This deviceK090705 Balanced Knee System Ultracongruent Tibial InsertOrtho Development Corp. · 2009
Descendant · cites it directly · 33 of its ownK112906 Klassic Knee SystemTotal Joint Orthopedics, Inc. · 2012
Descendant · 2 generations on · 27 of its ownK140942 Klassic Knee Tibial Stem ExtensionTotal Joint Orthopedics, Inc. · 2014
Descendant · 2 generations on · 24 of its ownK153310 Klassic Knee SystemTotal Joint Orthopedics, Inc. · 2015
Descendant · 2 generations on · 24 of its ownK153075 Klassic Knee SystemTotal Joint Orthopedics, Inc. · 2015
Descendant · 2 generations on · 24 of its ownK150105 Klassic Knee System-Sombrero PatellaTotal Joint Orthopedics, Inc. · 2015

Showing 5 of 42 descendants. See all descendants

Descendants cleared per year

2012high 8 (2023) · low 0 (2013)2026

Most influential descendants

Showing 5 of 42 · See all

K112906Klassic Knee SystemTotal Joint Orthopedics, Inc. · 2012 · cites it directly33descendants
K140942Klassic Knee Tibial Stem ExtensionTotal Joint Orthopedics, Inc. · 2014 · 2 generations on27descendants
K153310Klassic Knee SystemTotal Joint Orthopedics, Inc. · 2015 · 2 generations on24descendants
K153075Klassic Knee SystemTotal Joint Orthopedics, Inc. · 2015 · 2 generations on24descendants
K150105Klassic Knee System-Sombrero PatellaTotal Joint Orthopedics, Inc. · 2015 · 2 generations on24descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K923277	Foundation Knee System	Encore Orthopedics, Inc.	1993	4
−1	K000666	TC-Plus Solution Knee	Plus Orthopedics	2000	9
0 (this device)	K090705	Balanced Knee System Ultracongruent Tibial Insert	Ortho Development Corp.	2009	—
+1	K112906	Klassic Knee System	Total Joint Orthopedics, Inc.	2012	—
+2	K140942	Klassic Knee Tibial Stem Extension	Total Joint Orthopedics, Inc.	2014	—
+2	K153310	Klassic Knee System	Total Joint Orthopedics, Inc.	2015	—
+2	K153075	Klassic Knee System	Total Joint Orthopedics, Inc.	2015	—
+2	K150105	Klassic Knee System-Sombrero Patella	Total Joint Orthopedics, Inc.	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1985	1	0
1987	1	0
1991	1	0
1994	1	0
1995	3	0
1996	1	0
1997	1	0
2000	2	0
2004	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0
2014	2	0
2015	5	0
2016	3	0
2017	1	0
2018	1	0
2019	3	0
2020	3	0
2021	7	0
2022	4	0
2023	8	0
2025	3	0
2026	1	0

FIG. 1 — Lineage of K090705, 1993–2026Source: 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

Get a 510(k) Report

What was it cleared against? (10)

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
*	K994370	Ortho Development Balanced Knee System Our reading of the summary gave K994770, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Ortho Development Corporation Balanced Knee System CR or PS Insert”.	Ortho Development Corp.	2000	6
*	K033272	Depuy Sigma Tibial Inserts Summary page 1 …tially equivalent: * Ortho Development Corporation Balanced Knee System CR or PS Insert (K994770) * Depuy Sigma Deep Dish Insert (K033272) · Depuy LCS Deep Dish Bearing (P830055) · Encore Medical Foundation Ultracongruent Insert (K923277)…	DePuy Orthopaedics, Inc.	2004	51
*	P830055	LCS (R) Total Knee System Summary page 1 …orporation Balanced Knee System CR or PS Insert (K994770) * Depuy Sigma Deep Dish Insert (K033272) · Depuy LCS Deep Dish Bearing (P830055) · Encore Medical Foundation Ultracongruent Insert (K923277) * Hayes Medical Concensus Ultracongruent Ins…	Depuy, Inc.	1985	10
*	K923277	Foundation Knee System Summary page 1 …) * Depuy Sigma Deep Dish Insert (K033272) · Depuy LCS Deep Dish Bearing (P830055) · Encore Medical Foundation Ultracongruent Insert (K923277) * Hayes Medical Concensus Ultracongruent Insert (KO01456) · OMNI Life Science Apex Knee Ultracongruent I…	Encore Orthopedics, Inc.	1993	4
*	K001456	Consensus Knee System	Hayes Medical, Inc.	2000	—
*	K951987	Genesis II Total Knee System Summary page 1 …oncensus Ultracongruent Insert (KO01456) · OMNI Life Science Apex Knee Ultracongruent Insert (KO01456) * Smith & Nephew Genesis II Dished Insert (K951987) . Smith & Nephew (Plus Orthopedics) TC-PLUS Solution Ultracongruent Insert (K000666) · Z…	Smith & Nephew Richards, Inc.	1995	6
*	K000666	TC-Plus Solution Knee Summary page 1 …) * Smith & Nephew Genesis II Dished Insert (K951987) . Smith & Nephew (Plus Orthopedics) TC-PLUS Solution Ultracongruent Insert (K000666) · Zimmer Insall-Bernstein PSCK Tibial Insert (K872379) · Zimmer (Intermedics) Natural Knee IIUltracongru…	Plus Orthopedics	2000	9
*	K872379	Insall/Burstein* II Modular Total Knee Summary page 1 …. Smith & Nephew (Plus Orthopedics) TC-PLUS Solution Ultracongruent Insert (K000666) · Zimmer Insall-Bernstein PSCK Tibial Insert (K872379) · Zimmer (Intermedics) Natural Knee IIUltracongruent and PS Insert (K912663, K936159) === Page 2 ==…	Zimmer, Inc.	1987	11
*	K912663	Natural-Knee Ultra Congruent Tibial Insert Summary page 1 …00666) · Zimmer Insall-Bernstein PSCK Tibial Insert (K872379) · Zimmer (Intermedics) Natural Knee IIUltracongruent and PS Insert (K912663, K936159) .0 Description of the device: The Balanced Knee ® System Ultracongruent Tibial Insert…	Intermedics Orthopedics	1991	—
*	K936159	Natural-Knee II System Summary page 1 …· Zimmer Insall-Bernstein PSCK Tibial Insert (K872379) · Zimmer (Intermedics) Natural Knee IIUltracongruent and PS Insert (K912663, K936159) .0 Description of the device: The Balanced Knee ® System Ultracongruent Tibial Insert may be us…	Intermedics Orthopedics	1995	6

Also cleared against K994370: 5 other devices →

What descends from it? (42)

See all 42

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

Number	Device	Applicant	Decided	Descendants
K112906	Klassic Knee System	Total Joint Orthopedics, Inc.	2012	33
K132752	Ultracongruent Insert	United Orthopedic Corporation	2014	5
K152169	Balanced Knee System TriMax CR Femoral Component and E-Vitalize CR and UC Tibial Inserts	Ortho Development Corporation	2015	1

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jul 11, 2014	Class II	Z-2256-2014	Packaging process control	Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila Insert, and CK Tibil Insert because the foil pouches did not properly seal, allowing air to seep back into the pouch after sealing which…

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 9.0 years on median.
11 of the 14 ancestors have a recall of any class.
Of its descendants, K112906 (Total Joint Orthopedics, Inc., 2012) has gone furthest, with 33 descendants of its own.
5 other devices also cite its predicate K994370.

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. 2009, 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 Ortho Development Balanced Knee ® System is indicated for patients suffering from severe knee pain and disability. Specific indications include femoral, tibial and patellar replacement due to: 1. Loss of joint configuration and joint function. 2. Osteoarthritis of the knee joint. 3. Rheumatoid arthritis of the knee joint. 4., Post-traumatic arthritis of the knee joint. 5. Valgus, varus, or flexion deformities. 6. Revision procedures where other…

Read the full statement (112 words)

The Ortho Development Balanced Knee ® System is indicated for patients suffering from severe knee pain and disability. Specific indications include femoral, tibial and patellar replacement due to:

1. Loss of joint configuration and joint function.

2. Osteoarthritis of the knee joint.

3. Rheumatoid arthritis of the knee joint.

4., Post-traumatic arthritis of the knee joint.

5. Valgus, varus, or flexion deformities.

6. Revision procedures where other treatments or devices have failed.

The Balanced Knee® System is indicated in the salvage of previously failed surgical attempts where femoral bone loss does not require the use of augments or stem extensions and where collateral ligaments may be relied upon for medial/lateral (M/L) stability.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K090705 · printed Nov 6, 2026

Cite this page

510(k) Report. “K090705: Balanced Knee System Ultracongruent 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/K090705

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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