510(k) · Cleared
ClearedBalanced Knee System High Flex Vitamin E PS Tibial Insert and Patella
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 Oct 11, 2013 as substantially equivalent to K994370 (Ortho Development Corp., 2000) and 2 other predicates after a 155-day review. Its family tree reaches back 7 generations to 1981. 3 later devices descend from it.
- Decided
- Oct 11, 2013
- Review
- 155 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K810258 (1981). 28 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 6 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 5 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 4 generations backK050327 E-Poly (Vitamin E) Acetabular LinersBiomet, Inc. · 2005
- 3 generations backK070364 100KGY E-Poly Maxrom Acetabular LinersBiomet, Inc. · 2007
- 2 generations backK080528 E-Poly Tibial BearingsBiomet Orthopedics, Inc. · 2008
- 1 generation backK091956 Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model…Encore Medical L.P. · 2010 · Recalled
- This deviceK131337 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 · 2 generations on · 0 of its ownK253161 Balanced Knee System TriMax Porous Femoral ComponentsOrtho Development Corp. · 2025
- Descendant · cites it directly · 0 of its ownK233093 Balanced Knee® System TriMax PS Plus Tibial InsertOrtho Development Corporation · 2023
Most influential descendants
Showing 3 of 3 · See all- 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 · 2 generations on0descendants
- K233093Balanced Knee® System TriMax PS Plus Tibial InsertOrtho Development Corporation · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −6 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −5 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −4 | K050327 | E-Poly (Vitamin E) Acetabular Liners | Biomet, Inc. | 2005 | — |
| −3 | K070364 | 100KGY E-Poly Maxrom Acetabular Liners | Biomet, Inc. | 2007 | — |
| −2 | K080528 | E-Poly Tibial Bearings | Biomet Orthopedics, Inc. | 2008 | — |
| −1 | K091956 | Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712 | Encore Medical L.P. | 2010 | 4 |
| 0 (this device) | 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 | — |
| +2 | K253161 | Balanced Knee System TriMax Porous Femoral Components | Ortho Development Corp. | 2025 | — |
| +1 | 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 |
|---|---|---|
| 1992 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 4 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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…olymer semi-constrained cemented prosthesis, Class 11device DEVICE PRODUCT CODE: OWY, JWH- PREDICATE DEVICES: Balanced KneeO System (K994370), Ortho Development Corp. Balanced KneeO System High Flex PS (K1234S7), Ortho Development… | 2000 |
| * | K123457 | Balanced Knee System High Flex PSSummary page 2…ts are single use only. The High Flex Vit E PS tibial insert must be used in conjunction with the High Flex PS femoral component (K(123457). Used together, these components are designed to accommodate increased range of motion up to 1500 of flexion.… | 2013 |
| * | K091956 | Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712Summary page 2…Ortho Development: Balanced Kni SystemHigFlxS(K247 Material: Extensively Crosslinked Vitamin E DJO Surgical/Encore Medical: Vit E UHMWPE ibial Insert (K091956) Polyethylene UHMWPE (a-tocopherol) There is only one difference between the High Flex Vi… | 2010 |
What descends from it? (3)
2 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?
- The line of descent spans 32 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- 12 of the 28 ancestors have a recall of any class.
- Of its descendants, K152169 (Ortho Development Corporation, 2015) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K994370.
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 kneeO System High Flex Vitamin E PS tibial insert and patella are intended for use in cemented total knee arthropiasty procedures with the following indications:
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/K131337 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131337: Balanced Knee System High Flex Vitamin E PS Tibial Insert and Patella.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131337
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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