510(k) · Cleared
ClearedBalanced Knee Revision System Trabecular Tibial Cone Augments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho Development Corporation · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Oct 31, 2018 as substantially equivalent to K053340 (Zimmer Trabecular, 2006) and 1 other predicate after a 90-day review. Its family tree reaches back 4 generations to 1998.
- Decided
- Oct 31, 2018
- Review
- 90 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K982302 (1998). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK982302 Implex Continuum Knee - Hedrocel Tibial SpacersImplex Corp. · 1998
- 3 generations backK024161 Nexgen Complete Knee Solution - Trabecular Metal AugmentsImplex Corp. · 2003 · Recalled
- 2 generations backK040487 Trabecular Metal Knee System AugmentsImplex Corp. · 2004 · Recalled
- 1 generation backK053340 Trabecular Metal Tibial and Femoral Cone AugmentsZimmer Trabecular · 2006
- This deviceK182085 Balanced Knee Revision System Trabecular Tibial Cone AugmentsOrtho Development Corporation · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K982302 | Implex Continuum Knee - Hedrocel Tibial Spacers | Implex Corp. | 1998 | — |
| −3 | K024161 | Nexgen Complete Knee Solution - Trabecular Metal Augments | Implex Corp. | 2003 | 2 |
| −2 | K040487 | Trabecular Metal Knee System Augments | Implex Corp. | 2004 | 1 |
| −1 | K053340 | Trabecular Metal Tibial and Femoral Cone Augments | Zimmer Trabecular | 2006 | — |
| 0 (this device) | K182085 | Balanced Knee Revision System Trabecular Tibial Cone Augments | Ortho Development Corporation | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2010 | 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 |
|---|---|---|---|
| * | K053340 | Trabecular Metal Tibial and Femoral Cone AugmentsSummary page 4…metal/polymer semi-constrained cemented prosthesis 21 CFR 888.3565: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Class Il JWH, MBH K053340, K102896 — Trabecular Metal Tibial Cone Augments; Zimmer®, Inc. K132312 — Tesera Trabecular Technology (T3) Acetabular Shell Sys… | 2006 |
| * | K102896 | Trabecular Metal Tibial Cone AugmentsSummary page 4…ymer semi-constrained cemented prosthesis 21 CFR 888.3565: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Class Il JWH, MBH K053340, K102896 — Trabecular Metal Tibial Cone Augments; Zimmer®, Inc. K132312 — Tesera Trabecular Technology (T3) Acetabular Shell System; Reno… | 2010 |
| † | K132312 | Renovis Tesera Trabecular Technology (T3) Acetabular Shell System | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
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 20 years and passes through 3 companies; a new generation was cleared every 4.5 years on median.
- 4 of the 9 ancestors have a recall of any class.
- 8 other devices also cite its predicate K053340.
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. 2018, 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?
These devices are intended for use in total knee arthroplasty procedures for the following conditions:
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 of the knee joint.
6. Revision procedures where other treatments or devices have failed.
The BKS Revision is indicated in the salvage of previously failed surgical attempts where bone loss may require the use of augments, sleeves, cones or stem extensions.
The BKS Revision System Trabecular Tibial Cone Augments are for cemented or cementless use.
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/K182085 · printed Nov 5, 2026
Cite this page
510(k) Report. “K182085: Balanced Knee Revision System Trabecular Tibial Cone Augments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K182085
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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