510(k) · Cleared
ClearedBalanced Knee System High Flex PS
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 22, 2013 as substantially equivalent to K994370 (Ortho Development Corp., 2000) and 1 other predicate after a 134-day review. Its family tree reaches back 1 generation to 1999. 4 later devices descend from it.
- Decided
- Mar 22, 2013
- Review
- 134 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K991581 (1999). 2 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK991581 Nexgen Complete Knee Solution Legacy Posterior Stabilized (LPS)…Zimmer, Inc. · 1999 · Recalled
- This deviceK123457 Balanced Knee System High Flex PSOrtho Development Corp. · 2013
- Descendant · cites it directly · 3 of its ownK131337 Balanced Knee System High Flex Vitamin E PS Tibial Insert and PatellaOrtho Development Corp. · 2013
- Descendant · cites it directly · 1 of its ownK152169 Balanced Knee System TriMax CR Femoral Component and E-Vitalize CR…Ortho Development Corporation · 2015
- Descendant · cites it directly · 0 of its ownK253161 Balanced Knee System TriMax Porous Femoral ComponentsOrtho Development Corp. · 2025
- Descendant · 2 generations on · 0 of its ownK233093 Balanced Knee® System TriMax PS Plus Tibial InsertOrtho Development Corporation · 2023
Most influential descendants
Showing 4 of 4 · See all- K131337Balanced Knee System High Flex Vitamin E PS Tibial Insert and PatellaOrtho Development Corp. · 2013 · cites it directly3descendants
- K152169Balanced Knee System TriMax CR Femoral Component and E-Vitalize CR and UC Tibial InsertsOrtho Development Corporation · 2015 · cites it directly1descendant
- K253161Balanced Knee System TriMax Porous Femoral ComponentsOrtho Development Corp. · 2025 · cites it directly0descendants
- K233093Balanced Knee® System TriMax PS Plus Tibial InsertOrtho Development Corporation · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K991581 | Nexgen Complete Knee Solution Legacy Posterior Stabilized (LPS); LPS-Flex… | Zimmer, Inc. | 1999 | 7 |
| 0 (this device) | K123457 | Balanced Knee System High Flex PS | Ortho Development Corp. | 2013 | — |
| +1 | K131337 | Balanced Knee System High Flex Vitamin E PS Tibial Insert and Patella | Ortho Development Corp. | 2013 | — |
| +1 | K152169 | Balanced Knee System TriMax CR Femoral Component and E-Vitalize CR and UC… | Ortho Development Corporation | 2015 | — |
| +1 | K253161 | Balanced Knee System TriMax Porous Femoral Components | Ortho Development Corp. | 2025 | — |
| +2 | K233093 | Balanced Knee® System TriMax PS Plus Tibial Insert | Ortho Development Corporation | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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? (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 | Decided |
|---|---|---|---|
| * | K994370 | Ortho Development Balanced Knee SystemSummary page 1…ned cemented prosthesis, Class 11device DEVICE PRODUCT CODE: JWH PREDICATE DEVICES: Balanced Knee System (K994370), Ortho Development Corp. LPS-Flex Fixed Bearing Femoral and Articular Surface Components… | 2000 |
| * | K991581 | Nexgen Complete Knee Solution Legacy Posterior Stabilized (LPS); LPS-Flex Fixed Bearing…Summary page 1…(K994370), Ortho Development Corp. LPS-Flex Fixed Bearing Femoral and Articular Surface Components (K991581), Zimmer Device Description The Balanced Knee System High Flex PS (High Flex PS) is designed to accommodate increased range o… | 1999 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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. 2013, 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 Balanced Knee® System High Flex PS is intended for use in cemented total knee arthroplasty procedures.
Total knee arthroplasty is indicated for the following conditions:
1. Loss of knee 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 of the knee joint.
6. Revision procedures where other treatments or devices have failed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123457 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123457: Balanced Knee System High Flex PS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123457
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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