510(k) · Cleared
ClearedBKS Revision 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 Oct 25, 2024 as substantially equivalent to K181569 (Ortho Development Corporation, 2018) after a 29-day review. Its family tree reaches back 1 generation to 2018.
- Decided
- Oct 25, 2024
- Review
- 29 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K181569 (2018). No later device cites it as a predicate yet.
- Root · 1 generation backK181569 BKS Revision Sleeves SystemOrtho Development Corporation · 2018
- This deviceK242984 BKS Revision SystemOrtho Development Corp. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K181569 | BKS Revision Sleeves System | Ortho Development Corporation | 2018 | — |
| 0 (this device) | K242984 | BKS Revision System | Ortho Development Corp. | 2024 | — |
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? (1)
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 |
|---|---|---|---|
| * | K181569 | BKS Revision Sleeves SystemSummary page 5…metal/polymer porous-coated uncemented prosthesis. Device Class: Class 2 Primary Predicate BKS® Revision Sleeves System (K181569) Device: Sleeve Junction Box 510(k) – Summary Page 1 1218… | 2018 |
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?
- Its one ancestor has no recall.
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. 2024, 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?
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, BKS TriMax, and BKS Revision are intended for total knee arthroplasty procedures. The BKS is indicated in the salvage of previously failed…
Read the full statement (233 words)
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, BKS TriMax, and BKS Revision are intended for total knee arthroplasty procedures.
The BKS is indicated in the salvage of previously failed surgical attempts where 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.
BKS TriMax is intended in the salvage of previously failed surgical attempts where bone loss does not require the use of augments or stem extensions, where collateral ligaments may be relied upon for medial/lateral stability, where postoperative flexion up to 150° may be desirable, and the patient meets all indications/contraindications requirements.
The BKS Revision system is indicated in the salvage of previously failed surgical attempts where bone loss may require the use of augments, sleeves or stem extensions.
The BKS Revision system is indicated for cemented use only. The porous-coated metaphyseal sleeves are intended for cemented and uncemented applications.
The BKS Revision CK Tibial Insert is indicated for use with the BKS Revision Modular femoral and Modular, Offset, or Sleeve tibial components where collateral ligaments may not be relied upon for medial/lateral (M/L) stability.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242984 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242984: BKS Revision System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242984
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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