510(k) · Cleared
ClearedCPM Medical Consultants Tibial Revision Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cpm Medical Consultants, LLC · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Aug 16, 2021 as substantially equivalent to K142649 (The Progressive Orthopaedic Company, LLC, 2015) and 3 other predicates after a 161-day review. Its family tree reaches back 5 generations to 1992.
- Decided
- Aug 16, 2021
- Review
- 161 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K915132 (1992). 15 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK915132 MCK Maximum Congruent Knee) Knee SystemBiomet, Inc. · 1992 · Recalled
- 4 generations backK023546 Maxim Accel Knee SystemBiomet, Inc. · 2003 · Recalled
- 3 generations backK042757 Vanguard SSK Knee SystemBiomet, Inc. · 2005 · Recalled
- 2 generations backK093293 Vanguard 360 Revision Knee SystemBiomet, Inc. · 2010 · Recalled
- 1 generation backK122183 Augment and Screw, Psa TypeUnited Orthopedic Corp. · 2013
- This deviceK210695 CPM Medical Consultants Tibial Revision Knee SystemCpm Medical Consultants, LLC · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K915132 | MCK Maximum Congruent Knee) Knee System | Biomet, Inc. | 1992 | 6 |
| −4 | K023546 | Maxim Accel Knee System | Biomet, Inc. | 2003 | 13 |
| −3 | K042757 | Vanguard SSK Knee System | Biomet, Inc. | 2005 | 1 |
| −2 | K093293 | Vanguard 360 Revision Knee System | Biomet, Inc. | 2010 | 5 |
| −1 | K122183 | Augment and Screw, Psa Type | United Orthopedic Corp. | 2013 | — |
| 0 (this device) | K210695 | CPM Medical Consultants Tibial Revision Knee System | Cpm Medical Consultants, LLC | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K142649 | Progressive Orthopedic Total Knee SystemSummary page 3…ed use only. The CPM Medical Consultants Tibial Revision Knee System is to be used in conjunction with the Progressive Orthopaedic Company Total Knee System cleared via K142649 & K150783. See below for a compatibility chart between systems. Type of Use (Select one or both, as applicable)… | 2015 |
| * | K150783 | Progressive Orthopaedic Total Knee SystemSummary page 3…y. The CPM Medical Consultants Tibial Revision Knee System is to be used in conjunction with the Progressive Orthopaedic Company Total Knee System cleared via K142649 & K150783. See below for a compatibility chart between systems. Type of Use (Select one or both, as applicable) Presc… | 2015 |
| * | K082424 | United U2 Total Knee SystemSummary page 4…cleared as the Progressive Orthopaedic Company Total Knee System (K142649/K150783), and the United Orthopedic Corporation U2 Total Knee System as the predicate devices (K082424/K122183). The CPM Medical Consultants Tibial Revision Knee System features component designs, materials, indications, and manufac… | 2008 |
| * | K122183 | Augment and Screw, Psa TypeSummary page 4…as the Progressive Orthopaedic Company Total Knee System (K142649/K150783), and the United Orthopedic Corporation U2 Total Knee System as the predicate devices (K082424/K122183). The CPM Medical Consultants Tibial Revision Knee System features component designs, materials, indications, and manufacturing m… | 2013 |
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 29 years and passes through 3 companies; a new generation was cleared every 5.7 years on median.
- 8 of the 15 ancestors have a recall of any class.
- 7 other devices also cite its predicate K142649.
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. 2021, 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 CPM Medical Consultants Tibial Revision Knee System is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly…
Read the full statement (206 words)
The CPM Medical Consultants Tibial Revision Knee System is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. The device is intended for use in patients who require augmentation and/or stem extensions due to inadequate bone stock and/or require constrained stabilization for tibiofemoral joint due to soft tissue in-balance. The tibial augments are to be attached to their respective components with a fixation screw or screws.
The CPM Medical Consultants Tibial Revision Knee System may also be indicated in the salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery. The CPM Medical Consultants Tibial Revision Knee System is designed for cemented use only.
The CPM Medical Consultants Tibial Revision Knee System is to be used in conjunction with the Progressive Orthopaedic Company Total Knee System cleared via K142649 & K150783. See below for a compatibility chart between systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210695 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210695: CPM Medical Consultants Tibial Revision Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210695
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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