510(k) · Cleared
Recalled · Class II · 2019Ortho Development Balanced Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho Development Corp. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Mar 24, 2000 after an 88-day review. The FDA summary names its predicate without a number. 47 later devices descend from it. It has been recalled 6 times.
- Decided
- Mar 24, 2000
- Review
- 88 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 6
- Predicates
- 0
47 later devices descend from it, 6 citing it directly.
- This deviceK994370 Ortho Development Balanced Knee SystemOrtho Development Corp. · 2000
- Descendant · cites it directly · 42 of its ownK090705 Balanced Knee System Ultracongruent Tibial InsertOrtho Development Corp. · 2009 · Recalled
- 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
Showing 5 of 47 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 47 · See all- K090705Balanced Knee System Ultracongruent Tibial InsertOrtho Development Corp. · 2009 · cites it directly42descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K994370 | Ortho Development Balanced Knee System | Ortho Development Corp. | 2000 | — |
| +1 | K090705 | Balanced Knee System Ultracongruent Tibial Insert | Ortho Development Corp. | 2009 | 1 |
| +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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 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 | 9 | 0 |
| 2025 | 3 | 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? (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 |
|---|---|---|---|
| * | — | Performance Total Knee System (Kirschner) Named without a submission number | |
| * | — | NexGen Total Knee System (Zimmer) Named without a submission number | |
| * | — | PCA Modular Total Knee System (Howmedica) Named without a submission number | |
| * | — | Natural Knee System (Intermedics) Named without a submission number | |
| * | — | AGC Modular Total Knee System (Biomet) Named without a submission number | |
| * | — | Foundation Total Knee System (Encore) Named without a submission number |
What descends from it? (47)
See all 476 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090705 | Balanced Knee System Ultracongruent Tibial Insert | 2009 | 42 |
| K112906 | Klassic Knee System | 2012 | 33 |
| K123457 | Balanced Knee System High Flex PS | 2013 | 4 |
| K131337 | Balanced Knee System High Flex Vitamin E PS Tibial Insert and Patella | 2013 | 3 |
| K152169 | Balanced Knee System TriMax CR Femoral Component and E-Vitalize CR and UC Tibial Inserts | 2015 | 1 |
| K020383 | Ortho Development Balanced Knee Tibial Tray Pegged | 2002 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 30, 2019 | Class II | Z-1903-2020 | Nonconforming Material/Component | The locking mechanism of the tibial tray exhibited a manufacturing defect in which a uniform ridge was cut along the inner wall of the "T" and "Y" junctions, which may cause resistance when the Tibial Insert was being assembled. |
| May 30, 2019 | Class II | Z-1904-2020 | Nonconforming Material/Component | The locking mechanism of the tibial tray exhibited a manufacturing defect in which a uniform ridge was cut along the inner wall of the "T" and "Y" junctions, which may cause resistance when the Tibial Insert was being assembled. |
| Jul 11, 2014 | Class II | Z-2255-2014 | 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… |
| Jul 11, 2014 | Class II | Z-2254-2014 | 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… |
| Apr 1, 2014 | Class II | Z-1610-2014 | Process control | A femoral component containing pegs was found in a box for the pegless version. |
| May 29, 2009 | Not classified | Z-1993-2009 | Mixed-up of materials/components | Erroneous lot number on 3 of 28 units of Balanced Knee System. Three units from Lot Number 0055245 were mixed in with the recalled lot (0054891). |
The 5 latest of 6 recalls; the web page lists all.
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 devicesJWH 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
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 Balanced Knee'™ System is intended for single use in primary total knee replacement only. Indications include:
Loss of joint configuration and joint function;
Osteoarthritis of the knee joint;
Rheumatoid arthritis of the knee joint;
Post-traumatic arthritis of the knee joint;
Moderate valgus, varus, or flexion deformities.
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/K994370 · printed Nov 4, 2026
Cite this page
510(k) Report. “K994370: Ortho Development Balanced 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/K994370
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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